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    Grant format of NHRC form Grant format of NHRC form Document Transcript

    • NHRC/RES/PROP/GRANT/1 Application for Approval of Research Proposal (GRANT) Nepal Health Research Council (NHRC) Ramshah Path, P.O. Box: 7626, Kathmandu, Nepal Tel: 977-1-254220, 227460 Fax: 977-1-262469, 268284 e-mail: nhrc@nhrc.org.np Note: Please type all entries in English and also submit the same in a CD.
    • NHRC/RES/PROP/GRANT/1 Part I Administrative Data Sheet 1. Name and Title of Principal Investigator responsible for the proposed research: Baral samrat Mr. Designation: Signature: ………………………….. Date: …………………….. Postal Address: Telephone No.: 9846208555 Fax No.: …………………………………………………………... e-mail: 2. Full name of the Institution / University / NGO / INGO associated with the Principal Investigator (if applicable) : School of health and allied science, Pokhara University Postal Address (if different from the address given above): ……………………………………………………………………... ……………………………………………………………………... Telephone No.: ……………………………………………………. Fax No.: …………………………………………………………… e-mail: …………………………………………………………….. 3. Declaration of the head of the Institution / University / NGO / INGO If the proposed research is approved, we will allow him/her to conduct the research in this institution. Signature: ………………………………… Date: …………………….. Passport size photograph (Compulsory)
    • NHRC/RES/PROP/GRANT/1 Khan Mohammadh Gulam Asst. prof. Last (Surname) Middle (if any) First name Title (e.g. Mr. Ms. Dr.) Designation: ……………………………………. Name of the Institution / University / NGO / INGO: School of Health And Allied Sciences , POKHARA UNIVERSITY Postal Address: , P.O. Box 427, Lekhnath, NEPAL Telephone No.: Fax No.: …………………………………………………………... e-mail: …………………………………………………………….. 4. Name and Title of Co-Investigator (if any) responsible for the proposed research: pariyar ramesh Mr. Last (Surname) Middle (if any) First name Title (e.g. Mr. Ms. Dr.) (A copy of the curriculum vitae and list of publications relevant to the proposed research should be annexed) Designation: ……………………………………. Signature: ………………………….. Date: …………………….. Postal Address (if different from the address given above): ……………………………………………………………………... ……………………………………………………………………... Telephone No.: ……………………………………………………. Fax No.: …………………………………………………………… e-mail: …………...………………………………………………… 5. Name and Title of Co-Investigator (if any) responsible for the proposed research: Koirala Suraj Mr. Last (Surname) Middle (if any) First name Title (e.g. Mr. Ms. Dr.) (A copy of the curriculum vitae and list of publications relevant to the proposed research should be annexed) Designation: program co-ordinator (SHAS, PU) Signature: ………………………….. Date: …………………….. Passport size photograph (Optional) Passport size photograph (Optional)
    • NHRC/RES/PROP/GRANT/1 Postal Address (if different from the address given above): ……………………………………………………………………... ……………………………………………………………………... Telephone No.: ……………………………………………………. Fax No.: …………………………………………………………… e-mail: …………...………………………………………………… 6. Name and Title of Co-Investigator (if any) responsible for the proposed research: Timalsina Ananta Mr. Last (Surname) Middle (if any) First name Title (e.g. Mr. Ms. Dr.) (A copy of the curriculum vitae and list of publications relevant to the proposed research should be annexed) Designation: ……………………………………. Signature: ………………………….. Date: …………………….. Postal Address (if different from the address given above): ……………………………………………………………………... ……………………………………………………………………... Telephone No.: ……………………………………………………. Fax No.: …………………………………………………………… e-mail: …………...………………………………………………… (Note: If the Principal Investigator is a foreigner, at least one Co-investigator should be a Nepali researcher and the proposal should have institutional ethical clearance from his/her own country) 7. Is the research responsive to the health priorities and needs of Nepal? Yes ( √ ) No ( ) Explain. Various Nepalese people are suffering from the condition and trying with different medicines and even the expensive methods like graft technique. 8. Is the research sensitive to the Nepali culture and the social values? Yes ( √ ) No ( ) Explain. Passport size photograph (Optional)
    • NHRC/RES/PROP/GRANT/1 The research won’t have any bad implication on our social values and culture, instead tries to authenticate the traditional belief on our plant heritage. 9. Is health insurance being made available to the research participants? If yes, please provide the necessary insurance data. The participants are well familiar with the laboratory settings and the basic precautions they should take to avoid the direct exposure to various chemicals and reagents, so the health insurance is not deemed necessary. 10. List the name(s) and institutional affiliation of foreign researcher(s) (other than co- investigator) to assist your project in Nepal and abroad (if any) Name Institution (a) …………………………………… …………………………………… (b) …………………………………… …………………………………… (c) …………………………………… …………………………………… (d) …………………………………… …………………………………… (Use additional sheet if necessary) 11. List the name(s) of Nepali researcher(s) (other than co-investigator) or Nepalese Institution/hospital/NGO(s) etc. from whom you may seek co-operation (if any) (a) ……………………………………………………………………………………… (b) ……………………………………………………………………………………… (c) ……………………………………………………………………………………… (d) ……………………………………………………………………………………… (Use additional sheet if necessary) 12. List major research equipment(s) (if any) that you may bring to Nepal. (a) ……………………………………………………………………………………… (b) ……………………………………………………………………………………… (c) ……………………………………………………………………………………… (d) ……………………………………………………………………………………… (Use additional sheet if necessary)
    • NHRC/RES/PROP/GRANT/1 13. List details of all specimen(s) (if any) that you may take away from Nepal in relation to your research (if relevant). (a) ……………………………………………………………………………………… (b) ……………………………………………………………………………………… (c) ……………………………………………………………………………………… (d) ……………………………………………………………………………………… (Use additional sheet if necessary) How will you ensure duplicate specimens remain in the country? ………………………………………………………………………………………… ………………………………………………………………………………………….. 14. How are the external sponsors going to strengthen the research capability of the host institution? (if relevant) ………………………………………………………………………………………… …………………………………………………………………………………………. 15. Is this research part of your Thesis? Yes ( √ ) No ( ) If yes, For what degree and in what subject? For bachelor in pharmaceutical science. From which university? Pokhara university From which country? Nepal Part II Financial Data Sheet * 16. Total amount of funds (in Nepalese currency) requested for proposed research project …………………………………………………………………………………………..
    • NHRC/RES/PROP/GRANT/1 Name and Title of officer responsible for financial arrangements for the proposed research ……. ………….…….. .……………….. ………………… Last (Surname) Middle (if any) First name Title (e.g. Mr. Ms.) Designation: ……………………………………. Signature: ………………………….. Date: …………………….. Name and Address of the Bank ………………………………………………………………………………………… …………………………………………………………………………………………. Bank Account Number: ……………………………………………………………… Type of Account: ……………………………………………………………………… (Note: 1. Funds may be provided initially for a maximum period of six months and may be continued as necessary on provision of a satisfactory progress report and a financial statement. 2. Payment shall be made into the bank account) * Not applicable for those applying for under graduate and post graduate research grant BUDGET Budget Items • Personnel Person(s) x Rate x Duration Total (NCRs.) (Include Researchers, Field Supervisors, Clinicians, Secretary, Data Manager etc.) a. Vetenarian: 1000 b. Lab assistant: 1000
    • NHRC/RES/PROP/GRANT/1 c. Correspondence: 2000 (Use additional sheet if necessary) • Non Consumable Supplies (if relevant) (Include major and minor equipment etc.) These will be provided by SHAS, PU (Use additional sheet if necessary) • Consumable and Expendable Supplies (Include Stationery, Photocopying, Photographic films, Cassette Tapes & Batteries etc.) a. Printing: 1000 b. Photocopying:2000 c. Photographs: 1000 d. Books and journals: 2000 (Use additional sheet if necessary) • Clinical Expenses (if relevant) (Include Drugs, Special Clinical Investigations like Clinical Tests, Patients Cost i.e. Transportation/Reimbursement of Travel Expenses/Reimbursement of Lost Income) a. Crude drugs : 10kgs *500=5000 b. Albino rats : 25*100 =2500 c. Diet of rats : 2000 d. Reagents, chemicals and solvents : 15000 e. Drug( minoxidil 2% and 5%): 1500 (Use additional sheet if necessary) • Field / Community related Costs (if relevant) (Include refreshment cost for focus group discussion and other related costs etc.) (Use additional sheet if necessary) • Travel Cost within the Country (if relevant) (Include airfare, Bus fare, Vehicle hiring, Fuel etc.) a. Transportation(bus fare) cost to collection site: 2000 (Use additional sheet if necessary) • Supervision, Monitoring and Auditing Cost (by NHRC)
    • NHRC/RES/PROP/GRANT/1 (Include 10 % of the total budget) • Report Writing (Include Printing and Binding) a. Printing: 500 b. Photocopying: 300 c. Binding: 200 (Use additional sheet if necessary) • Contingency (5 %) 1950 GRAND TOTAL:40950 • Other sources of supplementary funds (if any) If yes, indicate the amount in Nepalese currency …………………………………. Name of funding organization / agency ………………………..…………………. Address of funding organization / agency ………………………………………… ……………………………………………………………………………………… Telephone No.: ……………………………………………………. Fax No.: …………………………………………………………… e-mail: …………...………………………………………………… Explanation and Justification of Budget Items ………………………………………………………………………………………… ………………………………………………………………………………………… …………………………………………………………………………………………. ………………………………………………………………………………………… ………………………………………………………………………………………… …………………………………………………………………………………………. ………………………………………………………………………………………… ………………………………………………………………………………………… …………………………………………………………………………………………. ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………….
    • NHRC/RES/PROP/GRANT/1 ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… …………………………………………………………………………………………. ………………………………………………………………………………………… ………………………………………………………………………………………… (Use additional sheet if necessary) …………………………… Principal Investigator …………………………….. …………………………………. Certified by Research Officer Approved by the Member-Secretary Nepal Health Research Council (NHRC) Part III Research Proposal Description Sheet 17. Title Phytochemical screening and evaluation hair growth promoting activity of maharanga bicolor 18. Objectives General To perform phytochemical screening and hair growth promiting activity
    • NHRC/RES/PROP/GRANT/1 Specific The specific objectives of the present research project are to :  Collect and identify the proposed plant  Prepare and preserve herbaria and the authentic sample of the collected plants sin the Museum of Materia Medica, School of Health and Allied Sciences, Pokhara University  Perform the phytochemical screening of sample  Perform the ethanolic and petroleum ether extraction of the collected samples  Evaluate hair growth activities of the extract of collected samples 19. Summary (Not more than 200 words) Alopecia is a condition of global concern, having affected both sexes of all races to different extents for as long as mankind has existed and has psychological implication on patient with hair loss. Maharanga bicolor is traditionally known to potentiate hair loss. It is found in altitude of 2000- 3000 m and belong to family boraginaceae. The study is aimed to investigate the efficacy of petroleum ether extract of rhizomes of M.bicolor as hair growth promoter. The extract will be incorporated into liquid paraffin and applied topically to shaved denuded skin of albino rats. Minoxidil 2% solution will be applied topically and serve as positive control for comparision. The time in days required for hair growth initiation as well as completion of hair growth will be recorded among different groups of albino rats. 20. Introduction Alopecia is a condition in which there is a abnormal loss of hair and is of global concern. According to scientifc reports, 30% male over the age of 30 and more than 50% over the age of 50 are affected by alopecia on a worldwide scale. The disease also affects women although clinical signs are usually milder and associated with diffuse thinning of the scalp hair. The loss of hair is often trivialized, but hair loss may have a profound effect on a patient’s well-being and quality of life. Because of the psychosocial impact of hair loss, however, it is important to explain to patients what they may expect in terms of continuing hair loss, and that response to any therapy may be slow and may include hair
    • NHRC/RES/PROP/GRANT/1 regrowth or only retardation of further thinning. Presently,minoxidil and finasteride are two US FDA approved synthetic drugs finding concomitant use for treatment of androgenic alopecia although their side effects have abbreviated their usage. Plants and people listed number of plant used in treatment of hair loss Maharanga bicolor is one of herb and its rhizome is used for hair tonic. It is found in 2000-3000m height and belong to family boraginaceae. It is also traditionally used to impart color to hair. The present study was carried out to determine the the effect of M. bicolor on hair growth initiation and promoting with the view of validating the traditional claim. 21. Statement of the Problem Numerous products or surgical procedures are promoted for the treatment of alopecia as well as improving scalp hair growth but their efficacy remains dubious. Natural products have been quiet prevalent in hair care industry and nearly thousand kinds of plant extracts have been examined with respect to hair growth promoting activity, some show excellent potential as hair tonic. 22. Literature Review From literature review M. biclor have not been reported for their hair promoting activity. (database of hinari and pubmed, Current content 2011, february with hit word alopecia ,hair promoting activity, M. bicolor) 23. Rationale / Justification M. bicolor has some ethnomedicinal uses in hair coloring and as a hair tonic. Literature review suggests very few researches have been conducted on this plant. More than that research on its clinical use has not been found till date. That encourages us to conduct the project on this plant. All of these reasons inspire us to conduct the research on this plant. 24. Research Questions (if relevant) ……………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… (Use additional sheet if necessary) 25. Research Hypothesis (if relevant) …………………………………………………………………………………………
    • NHRC/RES/PROP/GRANT/1 ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… (Use additional sheet if necessary) 1. Research Design and Methodology Research Method Qualitative (√ ), Quantitative ( ), Combined ( ) Study Variables Sq.cm of the shaved skin, Length of hair, hair growth initiation time and growth completion time. Type of Study Experimental Study The study will be conducted within the laboratory settings of school of health and allied science, Pokhara university. Study Site and its Justification The study will be conducted within the premise of school of health and allied science, Pokhara university, Lekhnath, Pokhara as we have full access to the laboratory and expert in Natural product chemistry. Target Population The patient suffering from the alopecia, including the interested researchers and the students of relevant subjects. Sampling Methods
    • NHRC/RES/PROP/GRANT/1 Non-probability Sampling ( ) (Specify ……………...………………………………………………….) Probability Sampling ( ) (Specify ……………...………………………………………………….) Sample Size The rhizome of the proposed plant will be taken in a quantity of 10 kgs. (Use additional sheet if necessary) Sampling Frame (if relevant) and Sampling Process including Criteria for Sample Selection The rhizomes will be collected in the month of may/june and it will be collected from the fully grown plant. (Use additional sheet if necessary) Tools and Techniques for Data Collection Tools Autoclave, UV spectrophotometer, Hot air oven, soxhlet apparatus, Grinder, Crude drugs, Beakers, test tubes, Whatman filter paper, petroleum ether, paraffin, methanol, ethanol, rhizome of M. bicolor Techniques Collection and identification of crude drugs Rhizomes of M. bicolor will be collected from the locality of Marpha, Mustang identified by the expert in the month of jestha ( may/june) Collected materials will be air dried in room temperature till complete dryness and crushed into the powder in grinder before storing in closed container for laboratory use. Extraction of crude materials Collected crude powder will be passed through 72 mesh size. 100 g of the sieved powder will be weighed accurately and subjected to extraction in a soxhlet apparatus at room temperature using ethanol and water successively. The extract obtained will
    • NHRC/RES/PROP/GRANT/1 be concentrated in rotary flash evaporator and dried in a vacuum oven, percentage yield of each extract will be calculated and the dried extract will be stored in air tight containers for further studies. Phytochemical screening Phytochemical examinations will be carried out for petroleum ether, ethnolic, methanolic and aqueous extracts as per the standard methods. (Roopashree et al., 2008) 1. Detection of alkaloids: Extracts will be dissolved individually in dilute Hydrochloric acid and filtered. The filtrates will be used to test for the presence of alkaloids. a) Mayer’s Test: Filtrates will be treated with Mayer’s reagent (Potassium Mercuric iodide). Formation of a yellow cream precipitate indicates the presence of Alkaloids. b) Wagner’s test: Filtrates will be treated with Wagner’s reagent (Iodine in potassium iodide). Formation of brown/reddish brown precipitate indicates the presence of alkaloids. c) Hager’s test: Filtrates will be treated with Hager’s reagent (saturated picric acid solution). Formation of yellow colored precipitate indicates the presence of alkaloids. 2. Detection of carbohydrates: Extracts will be dissolved individually in 5 ml distilled water and filtered. The filtrates will be used to test for the presence of carbohydrates. a) Molisch’s Test: Filtrates will be treated with 2 drops of alcoholic α-naphthol solution in a test tube and 2 ml of Conc. Sulphuric acid will be added carefully along the sides of the test tube. Formation of violet ring at the junction indicates the presence of Carbohydrates. b) Benedict’s test: Filtrates will be treated with Benedict’s reagent and heated on water bath. Formation of orange red precipitate indicates the presence of reducing sugars. c) Fehling’s test: Filtrates will be hydrolyzed with dil. HCl, neutralized with alkali and heated with Fehlings A & B solutions. Formation of red precipitate indicates the presence of reducing sugars. 3. Detection of glycosides: Extracts will be hydrolyzed with dil. HCl, and then subjected to test for glycosides. a) Modified Borntrager’s Test: Extracts will be treated with Ferric Chloride solution and immersed in boiling water for about 5 minutes. The mixture will be cooled and shaken with an equal volume of benzene. The benzene layer will be separated and treated with ammonia solution. Formation of rose-pink colour in the ammonical layer indicates the presence of anthranol glycosides.
    • NHRC/RES/PROP/GRANT/1 b) Legal’s test: Extracts will be treated with sodium nitroprusside in pyridine and methanolic alkali. Formation of pink to blood red colour indicates the presence of cardiac glycosides. 4. Detection of saponins a) Froth Test: Extracts will be diluted with distilled water to 20ml and this will be shaken in a graduated cylinder for 15 minutes. Formation of 1 cm layer of foam indicates the presence of saponins. b) Foam test: Small amount of extract will be shaken with little quantity of water. If foam produced persists for ten minutes it indicates the presence of saponins. 5. Detection of phytosterols a) Salkowski’s Test: Extracts will be treated with chloroform and filtered. The filtrates will be treated with few drops of conc. Sulphuric acid, shaken and will be allowed to stand. Appearance of golden yellow colour indicates the presence of triterpenes. b) Libermann Burchard’s test: Extracts will be treated with chloroform and filtered. The filtrates will be treated with few drops of acetic anhydride, boiled and cooled. Conc. Sulphuric acid will be added carefully along the sides of the test tube. Formation of brown ring at the junction indicates the presence of phytosterols. c) Tshugajeu test : Extracts will be treated with chloroform and filtered. Excess of acetyl chloride and a pinch of Zinc Chloride will be added, kept aside for some time till the reaction will be complete and then warmed on water bath. Appearance of eosin red colour indicates the presence of triterpenes. 6. Detection of fixed oils & fats Stain Test: Small quantities of extracts will be pressed between two filter papers. An oily stain on filter paper indicates the presence of fixed oil. 7. Detection of resins Acetone-water Test: Extracts will be treated with acetone. Small amount of water will be added and shaken. Appearance of turbidity indicates the presence of resins. 8. Detection of phenols. Ferric Chloride Test: Extracts will be treated with few drops of ferric chloride solution. Formation of bluish black colour indicates the presence of phenols. 9. Detection of tanninss Gelatin Test: To the extract, 1% gelatin solution containing sodium chloride will be added. Formation of white precipitate indicates the presence of tannins. 10. Detection of flavonoids a) Alkaline Reagent Test: Extracts will be treated with few drops of sodium
    • NHRC/RES/PROP/GRANT/1 hydroxide solution. Formation of intense yellow color, which becomes colorless on addition of dilute acid, indicates the presence of flavonoids. b) Lead acetate Test: Extracts will be treated with few drops of lead acetate solution. Formation of yellow color precipitate indicates the presence of flavonoids. c) Shinoda Test: To the alcoholic solution of extracts, a few fragments of magnesium ribbon and Conc.HCl will be added. Appearance of magenta colour after few minutes indicates presence of flavonoids. d) Zinc hydrochloric acid reduction Test: To the alcoholic solution of extracts, a pinch of Zinc dust and Conc.HCl will be added. Appearance of magenta colour (purplish-pink) after few minutes indicates presence of flavonoids. 11. Detection of proteins and aminoacids a) Xanthoproteic Test: The extracts will be treated with few drops of concentrated Nitric acid solution. Formation of yellow colour indicates the presence of proteins. b) Biuret Test: The extracts will be treated with 1 ml of 10% sodium hydroxide solution and heated. To this a drop of 0.7% copper sulphate solution will be added. Formation of purplish violet colour indicates the presence of proteins. 12. Detection of diterpenes Copper acetate Test: Extracts will be dissolved in water and treated with few drops of copper acetate solution. Formation of emerald green colour indicates the presence of diterpenes. 13.Test for hair growth promoting activity in albino rats: Animals will be divided into 6 groups: Group I will be applied liquid paraffin only and served as control, Group II will be applied 2% ethanol extract in liquid paraffin, Group III 5% ethanol extract in liquid paraffin, Group IV will be topically applied 2% petroleum ether extract, Group V 5% petroleum ether extract and Group VI will serve as positive control and applied 2% alcoholic solution of minoxidil. Qualitative hair growth will be evaluated by visual observation of two parameters: hair growth initiation time i.e. minimum time to initiate perceptible hair growth and hair growth completion time i.e. minimum time taken to cover the denuded skin region with new hair completely [1]. The investigator was blinded about the treatments to various groups under investigation. Hair growth initiation and completion time was recorded for each group of animals and compared with positive control. Hair will be plucked randomly from the shaved area of selected rats, from each group on 15th, 20th, 25th and 30th day of the treatment. The length of 25 hairs will be measured and the average length will be determined. The results will be expressed as the mean length ± S.D. of 25 hairs Pre-testing the Data Collection Tools (if relevant)
    • NHRC/RES/PROP/GRANT/1 ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… (Use additional sheet if necessary) Validity and Reliability of the Research (if relevant) The finding of the research will be validatd with reference to the already published articles on the same objective and by consulting the expert in Natural product chemistry. Biases (if relevant) ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… ………………………………………………………………………………………… (Use additional sheet if necessary) Limitation of the Study (if relevant) Quantitative evaluation of drug extract can’t be performed due to lack of skin biopsies facility and evaluation of anagen and telogen ratio throughout the study. 1. While phytochemical screening some compound present in very trace amount can not be detected by simple laboratory reaction and advanced equipment may necessary which can not be performed in our laboratory. 2. Antibacterial sensitivity test for the selected microbes may fail to show the sensitivity though it has the antibacterial effect to the other microbes. 3. Discontinuation of electrical supply may interfere with the laboratory function. (Use additional sheet if necessary) 27. Plan for Supervision and Monitoring
    • NHRC/RES/PROP/GRANT/1 The research work will be continually supervised and monitored by dr. Nirmala Jamarkattel, (phd. in Natural product chemistry), phr.sushil panta ( M. Pharm in Natural product chemistry) and kalpana Parajuli (M. Pharm in Natural product chemistry) 28. Plan for Data Management The will be collected and presented in graphs and through histogram. 29. Plan for Data Analysis Data will be reported as mean SEM. Statistical analayasis of data was carried out by one way ANOVA comparing all test group versus control using spss v 17.0 software 30. Expected Outcome of the Research Scientific outcomes: Hair growth promoting activity of M. bicolor will be known from our research. The identification of hair growth promoting activity will help to design new drug with potential pharmacological activity. This will provide a great contribution to the scientific field and provides great help in the further study of these plants. Social outcomes: In Nepalese society, there is less awareness about these plant species among the people. Many of them do not know about the medicinal uses of these plants. After the completion of the research project, people will be interested in the cultivation, collection and conversion of these species. Economic outcomes: In developing countries like Nepal, such studies will help in the development of economic status and such unexplored medicines will be utilized for the improvement of health status of rural people. 31. Plan for Dissemination of Research Results After completion of the research work a report will be prepared and submitted to NHRC (Nepal Health and Research Council)and school of health and allied sciences,
    • NHRC/RES/PROP/GRANT/1 Pokhara University . the scientific findings will be prepared in the form of an article and submitted to the relevant journal. 32. Plan for Utilization of the Research Findings (optional) The research findings will be provided to the Ayurvedic industry as well as to the local people to encourage them conserve and if possible cultivate the plant. (Use additional sheet if necessary) 33. Work Plan (should include duration of study, tentative date of starting the project and work schedule / Gantt chart) Program Schedule Weak 1-5 Weak 6-10 Weak 11-15 Weak 16-20 Weak 21-25 Literature review proposal writing Collection and drying of plant material Extraction and performing the laboratory analysis Result evaluation, validation and interpretation Thesis preparation and defense
    • NHRC/RES/PROP/GRANT/1 (Use additional sheet if necessary) Part IV Ethical Consideration 34. Regarding the human participants: Are human participants required in this research? If yes, offer justification. ………………………………………………………………………………………… ………………………………………………………………………………………….. How many participants are required for the research? Explain. ………………………………………………………………………………………… ………………………………………………………………………………………….. What is the frequency of the participant’s involvement in the research? Explain. ………………………………………………………………………………………… …………………………………………………………………………………………..
    • NHRC/RES/PROP/GRANT/1 Clearly indicate the participants responsibilities in the research. What is expected of the research participants during the research? ………………………………………………………………………………………… ………………………………………………………………………………………….. Are vulnerable members of the population required for this research? If yes, offer justification. ………………………………………………………………………………………… ………………………………………………………………………………………….. Are there any risks involved for the participants? If yes, identify clearly what are the expected risks for the human participants in the research and provide a justification for these risks. ………………………………………………………………………………………… ………………………………………………………………………………………….. Are there any benefits involved for the participants? If yes, identify clearly what are the expected benefits for the participants. ………………………………………………………………………………………… ………………………………………………………………………………………….. 35. Informed Consent Form / Ethical Issues: Statements required in the Informed Consent Form include:
    • NHRC/RES/PROP/GRANT/1 A statement that the human participants can withdraw from the study at any time without giving reason and without fear. State clearly how the participants can opt out the study. A statement guaranteeing the confidentiality of the research participants. If required, a statement on any compensation that might be given to the research participant and or their community. A statement indicating that the participants has understood all the information in the consent form and is willing to volunteer / participate in the research. Signature space for the research participants, a witness, and the date. (Informed Consent form should be submitted in English and in the language appropriate to the research participants) Obtaining the Consent How is informed consent obtained from the research participants ? …………………………………………..……………………………………………… …………………………………………….……………………………………………. Please indicate who is responsible for obtaining informed consent from the participants in this research study? …………………………………………..……………………………………………… …………………………………………….……………………………………………. Is there anything being withheld from the research participants at the time the informed consent is being sought? No ( ) Yes ( )
    • NHRC/RES/PROP/GRANT/1 If yes, explain ………………………………………………………………………………………… ………………………………………………………………………………………….. 36. Regarding Clinical Trial: In case of a clinical trial address the following: The trial treatment ………………………………………………………………………………………… ………………………………………………………………………………………….. A detailed explanation of the trial procedures including all invasive procedures. ………………………………………………………………………………………… ………………………………………………………………………………………….. The potential or direct benefits (if any) for the research participants. ………………………………………………………………………………………… ………………………………………………………………………………………….. Alternative procedure(s) or treatment(s) that may be available. ………………………………………………………………………………………… ………………………………………………………………………………………….. The risks, discomforts, and inconveniences associated with the study
    • NHRC/RES/PROP/GRANT/1 ………………………………………………………………………………………… ………………………………………………………………………………………….. Provisions for management of any adverse reactions ………………………………………………………………………………………… ………………………………………………………………………………………….. The provisions of insurance coverage for any permanent disability or death caused directly by the investigational treatment or procedure. ………………………………………………………………………………………… ………………………………………………………………………………………….. The provision of including the name and address, including telephone numbers of person to be contacted in case of adverse events or for any information related to the trial. ………………………………………………………………………………………… ………………………………………………………………………………………….. Is there going to be a transfer of any biological materials from the country? Explain. ………………………………………………………………………………………… ………………………………………………………………………………………….. Part V
    • NHRC/RES/PROP/GRANT/1 Annexes References • Manandhar S (2002) Plants and people of Nepal, Timber Press, pp • Adhirajan N, Dixit VK, Gowri C (2001) Development and evaluation of herbal formulations for hair growth. Indian Drugs 38(11):559–563 • Adhirajan N, Ravi Kumar T, Shanmugasundaram N, Mary B (2003) In vivo and in vitro evaluation of hair growth potential of Hibiscus rosa-sinensis Linn. J Ethnopharmacol 88:235–239 • Uno H (1991) Quantitative models for the study of hair growth in vivo. In: Stenn KS, Messenger AG, Baden HP (eds) Molecular and structural biology of hairs, vol. 642 edn. NY Acad Sci, New York, pp 107–124 • R. K. Roy · Mayank Thakur · V. K. Dixit(2008) Hair growth promoting activity of Eclipta alba in male albino rats. Arch Dermatol Res 300:357–364 ACCEPTANCE OF GENERAL CONDITIONS AND DECLARATION BY THE PRINCIPAL INVESTIGATOR I hereby certify that the above mentioned statements are true, I have read and understood the regulation of the Nepal Health Research Council (NHRC) on the approval of research proposal and will act in conformity with the said regulation in all respects. I agree to accept responsibility for the scientific conduct of the research project. If a grant is awarded as a result of this application, I shall provide progress reports and certified financial statements, and final reports in completion of the study. If the research is terminated, for any reason, I will notify NHRC of this decision and provide the reasons for such actions. I will provide NHRC with a written notice upon
    • NHRC/RES/PROP/GRANT/1 the completion of the research as well as a final summary/full report of the research study. If I publish the results in a journal, I shall acknowledge the NHRC for the financial support and shall provide the Council with three copies of any such articles. ……………………………………… Signature of Applicant Date: …………………