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1
A preliminary pharmacognostical analysis of
“IG-LEPA”(Gomutra Bhavita Indravaaruni
mool churna) and its clinical effect in
Indralupta (Alopecia areata).
Title
2
Scholar
Vipin chaurasiya
Dept. of Dravyaguna Vijnan
Guide
Dr. N Manoj Kumar
MD (Ay), Associate professor
Dept. of Dravyaguna Vijnan
Co- Guide
Dr. Jeena N J
MD (Ay) Associate professor
Dept. of Shalakya Tantra
3
Aim:-
 To assess the efficacy of Indravaaruni mool
(Citrullus colocynthis (L.) schrad. root) in
Indralupta (Alopecia areata).
4
Objectives
 To conduct preliminary pharmacognostical
analysis of “IG-LEPA”.
 To evaluate Safety and Efficacy of “IG-
LEPA” in Indralupta (Alopecia areata).
5
Research question
 Whether topical application of “IG-LEPA”
(Gomutra Bhaavita Indravaaruni mool churna) of
5mm thickness for the time till it dries up, daily
morning for a maximum period of 3 months is
effective in causing hair re-growth in 20
participants with Indralupta (Alopecia areata),
attending the OPD of VPSV Ayurveda College
Kottakkal ?
6
 Null hypothesis(H0):-
There is no significant effect of topical application
of “IG-LEPA” in hair re-growth in participants
with Indralupta (Alopecia areata).
 Alternate hypothesis(H1):
There is significant effect of topical application of
“IG-LEPA” in hair re-growth in participants with
Indralupta (Alopecia areata).
7
Plan of study
 Literary review
 Analytical study
 Clinical study
8
Results of Analytical study
Physiochemical parameters Percentage
1 Total Ash 5%
2 Water insoluble Ash 1%
3 Acid insoluble Ash 2%
4 Moisture content 0%
5 Volatile content 2%
6 Water soluble extractive 48%
7 Alcohol soluble extractive 3.2%
8 Hot Alcohol soluble extractive 39%
9 Successive solvent extraction
1. Petroleum ether 0.8%
2. Cyclohexane 0.6%
3. Ecetone 2%
4.Ethnol 14%9
Qualitative analysis of the extracts
Sl.
no
solvents Alkaloi
ds
phenols Steroid
s
Flavono
ids
Anthra
quinone
s
Saponi
ns
Tannins
1. Water
soluble
extractive
_ _ + _ _ + +
2 Hot Alcohol
soluble
+ _ + _ _ + +
3 Cold Alcohol + _ + _ _ + +
4 Petroleum
ether
_ _ + _ _ _ +
5 Cyclohexan + _ + _ _ _ _
6. Acetone + _ + _ _ + +
10
Powder microscopy of “IG-LEPA”
1. Starch grains
2. Bordered pitted
vessels fragments
3. Reticulate vessels
4. Pitted fibres
5. Fibres with wide
lumen
6. Cork cells
11
21
2 3 3
4
5 6
1
HPTLC- profile of IG-LEPA and
Citrullus colocynthis root powder
254nm 366nm Plants derivatives
1. Ig-lepa
2. Citrullus colocynthis root
Rf = .15(254nm): one
band is missing in Citrullus
powder
Rf =.26(366nm): one extra
band in citrullus
 Ig-lepa at Rf = .10 : one
extra compound is found.
12
1. Ig-lepa
2. Citrullus colocynthis root
13
1. Ig-lepa
2. Citrullus colocynthis root
14
1. Ig-lepa
2. Citrullus colocynthis root
15
Clinical study
 Study design : Open clinical trial
 Sample size :20
 Intervention period : Up to Vyadhiupsamanam
or maximum 3 months
 Follow up : 30 days after stopping treatment
16
Cont...
 Inclusion criteria -
a) On the basis of SALT SCORE(Severity of alopecia tools):-
1)S1 <25% of hair loss
2)S2 =25 to 49% of hair loss
3)S3=50 to 74% hair loss
4)B0 =No body hair involvement
5)N0 =No nails involvement
b) Age- 18 to 50 years.
c)Sex- Either sex.
d)Chronicity-Above 30 days.
e)Participants who are willing to sign the consent form.
17
Cont...
 Exclusion criteria:-
 Androgenic alopecia
 Tinea capitis
 Alopecia after chemotherapy and radiotherapy
 Trichotillomania
 Traumatic alopecia
 Participants under medication for alopecia
 Participants who are tested positive in sensitivity
test.
18
Cont...
 Sensitivity test was done before selection of
participants:
Site : dorsal surface of hand
Thickness : 5mm
Duration : till it dried
19
Con...
 Method of application
Preparation of affected area: rubbing with small
onion for 2 minute.
Application: - mixing with Luke warm water
Thickness :- 5mm
Duration :- till it dried.
20
Assessment criteria
21
 On the basis of SLAT score (severity of alopecia
tool): Average % of hair loss was assessed by
expert panels with the help of global photographs.
 On the basis of area measurement of patches.
 Assessment of safety.
Demographic data of sample
distribution
70%
30%
male
female
22
Distribution according to Education
15%
55%
20%
10%
Uneducated
Primary
secondry
Graduate
Post graduate
23
Economic status
30%
70%
POOR
MIDDLE
UPPER
24
Occupation
30%
25%
45% NO WORK
OFFICE WORK
LABOUR WORK
25
Religion
50%50%
hindu
muslim
christian
other
26
Marital status
30%
70%
UNMARRIE
D
MARRIED
DIVORCED
27
Chronicity
50%
10%
15%
25%
upto 3 months
upto 6 months
upto 1 year
more than 1
year
28
Family history
5%
95%
positive
negative
29
Treatment history
35%
40%
15%
10%
no
allopathic
ayurvedic
more than one
30
Hair colour
70%
5%
25%
black
grey
white
31
Result and discussion
 Area measurement
 Salt score
 Hair re-growth
 Safety
32
1.Area measurement:
0th day 15th day 30th day 45th day
60th day AT AF33
Area measurement
 Pair t-test BT Vs. AT
Area
measureme
nt
Mean T-value P-value Significanc
e level
BT 31.86 2.59 0.017 P<0.05
AT 24.75
34
Area measurement
 Pair t-test BT Vs. AF
Area
measureme
nt
Mean T-value P-value Significanc
e level
BT 31.86 2.64 0.016 P<0.05
AF 24.60
35
2.SALT score assessments: 3 expert panel
 ANOVA test : BT assessments
 No significance difference between experts opinion.
Source
of
variation
SS df MS F- value P- value
Between
groups
33.84 2 15.24 1.88 0.16
Within
groups
461.79 57 8.10
total 492.28 59
36
SALT score : pair t- test BT Vs. Other
groups
Assessment
s
Mean T-value P-value Significance
level
BT 12.86
15th day 12.86 -11.65 4.2 Not
significant
30th day 12.42 -0.36 0.72 Not
significant
45th day 11.93 1.6 0.125 Not
significant
60th day 11.64 2.08 0.051 Not
significant
AT 10.94 3.05 0.006 P<0.01
AF 10.63 3.21 0.004 P<0.01
37
3.Average percentage of hair re-growth
1.33%
9.16%
16.33%
21.60%
28.50%
34.40%
0.00%
5.00%
10.00%
15.00%
20.00%
25.00%
30.00%
35.00%
40.00%
15th day 30th day 45th day 60th day AT AF
Series1
%ofhairre-growth
Assessments
38
Difference of hair re-growth between
assessments
 ANOVA single factor test : hair re-growth
 Significance level : P<0.001
Source
of
variation
SS df MS F- value P- value
Between
groups
15318.23 5 3063.64 5.285 0.00021
Within
groups
66073.78 114 579.59
total 81392.01 119
39
4.Assessment of safety
 Sensitivity test:- No participants were found
sensitive with drug.
 Safety criteria:-
 No participants were reported with redness , swelling
and Itching during and after application of drug on
affected area.
Safety assessment criteria Reported participants
Redness 0
Swelling 0
Itching 0
40
Discussion
 Dropout :04
 Average % of hair re-growth:
AT:- 28.50%
AF:-34.4%
It indicates result was sustain after follow up.
41
Cont...
 Significant decreasing of Area measurement:
effective to reduce extent of patches and enhance
hair re-growth.
 Significant decreasing in SALT score: effective
to reduce extent of patches , enhance hair re-
growth and increase density of hair on the affected
area(thickness of hair ).
42
Probable mode of action of IG-lepa
 Indralupta :-
 Pitta and Vata :- hair fall
 Kapha and Rakta : Marga Avarana
43
44
Autoimmune inflammation
Hair fall
Inflammatory infiltrate deposition
in and around the follicles
Anagen hairs Telogen hairs
Hair cycle stopped
Alopecia areata
Absorption IG-lepa
Blood circulation
Ushna, Teekshna,
Ruksha
 Avarana : - Lekhana properties of Tikta rasa
Teekshna and Ruksha guna
Ushna veerya
Teekshna properties of small onion
Srotovivarana properties of lavana rasa
Indravvaruni Gomutra
Rasa Tikta, Katu Katu, Lavana
Guna Laghu, Sara Laghu, Ruksha, Teeksna
Veerya Ushna Ushna
Vipaka Katu Katu
45
Conclusion
 Phytochemical study: presence of alkaloids, tannin,
saponin and steroids
 Comparative HPTLC : some chemical variation
 The formulation was found to be safe.
 Average percentage of hair regrowth was sustained
in follow up period.
 formulation was showed significant decrease of
area of patches and of SALT score.
46
Cont...
 Null hypothesis :- Rejected
 Alternate hypothesis :- Accepted
 Topical application of “IG-LEPA” is significantly
effective for hair re-growth in participants with
Indralupta ( Alopecia areata).
47
Limitation
 The drug was applied by the patients themselves.
Hence the uniformity in application could not have
been maintained.
 The effect of use of Soaps, Shampoos and oils
cannot be ruled out.
 The add-on effect of rubbing with onion cannot be
excluded.
48
Recommendations
.
 Comparative trial may be done.
 Citrullus colocynthis (L.) schrad. as a single drug
may be evaluated .
 Other Standardization techniques can be used.
49
 Fitzpatrick’s Dermatology in general medicine, seventh
edition. Edited by Klaus wolff et al.vol-1, Page763.
 Latha K.K.,A study on the effect of Rhinacanthus
communis nees. In the management of
Indraluptha:Thiruvananthapuram,1999.
 Gadanigraha of Sri Vaidha Sodhala, by
Dr.Indradevatripathi edited by Sri Ganga sahaaya pandey
, reprint 2005, Varanasi: Chaukhamba Sanskrit sansthan
volume 3rdpage no.25
 Atharvaveda, with Sayam commentary, edited by pandit
S.P. Nirnaya, Bombey: Sager press; Khanda 6, sukta 21,
22, 23, 136,137.
 Agnivesh , ‘Caraka Sam`hitaa’. Revised by Caraka and
Dr`ad`habala with ‘Ayurveda dipika’ commentary, by
Cakrapanidatta, edited by pt. KashinathSastriand Dr.
Gangasahaya Pandey, Varanasi: Chaukhamba
Vishvabharti; reprint 2003, Cikitsa stana 26/132.
References-
50
Con....
51
 Stenn KS, Paus R: Controls of hair follicle cycling. Physiol Rev
81:449, 2001 [PMID: 11152763]
 Botchkarev VA et al: Hair cycle-dependent plastic- ity of skin and
hair follicle innervation in normal murine skin. J Comp Neurol
386:379, 1997 [PMID: 9303424]
 Narisawa Y et al: A high concentration of Merkel cells in the
bulge prior to the attachment of the arrector pili muscle and the
formation of the peri- follicular nerve plexus in human fetal skin.
Arch Dermatol Res 285:261, 1993 [PMID: 8379685]
 Reynolds AJ et al: Trans-gender induction of hair follicles. Nature
402:33, 1999 [PMID: 10573414]
 Whiting DA: Chronic telogen effluvium: Increased scalp hair
shedding in middle-aged women [see comments]. J Am Acad
Dermatol 35:899, 1996 [PMID: 8959948]
 Reynolds AJ et al: Trans-gender induction of hair follicles. Nature
402:33, 1999 [PMID: 10573414]
Thank you
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Alopecia and ayurveda

  • 2. A preliminary pharmacognostical analysis of “IG-LEPA”(Gomutra Bhavita Indravaaruni mool churna) and its clinical effect in Indralupta (Alopecia areata). Title 2
  • 3. Scholar Vipin chaurasiya Dept. of Dravyaguna Vijnan Guide Dr. N Manoj Kumar MD (Ay), Associate professor Dept. of Dravyaguna Vijnan Co- Guide Dr. Jeena N J MD (Ay) Associate professor Dept. of Shalakya Tantra 3
  • 4. Aim:-  To assess the efficacy of Indravaaruni mool (Citrullus colocynthis (L.) schrad. root) in Indralupta (Alopecia areata). 4
  • 5. Objectives  To conduct preliminary pharmacognostical analysis of “IG-LEPA”.  To evaluate Safety and Efficacy of “IG- LEPA” in Indralupta (Alopecia areata). 5
  • 6. Research question  Whether topical application of “IG-LEPA” (Gomutra Bhaavita Indravaaruni mool churna) of 5mm thickness for the time till it dries up, daily morning for a maximum period of 3 months is effective in causing hair re-growth in 20 participants with Indralupta (Alopecia areata), attending the OPD of VPSV Ayurveda College Kottakkal ? 6
  • 7.  Null hypothesis(H0):- There is no significant effect of topical application of “IG-LEPA” in hair re-growth in participants with Indralupta (Alopecia areata).  Alternate hypothesis(H1): There is significant effect of topical application of “IG-LEPA” in hair re-growth in participants with Indralupta (Alopecia areata). 7
  • 8. Plan of study  Literary review  Analytical study  Clinical study 8
  • 9. Results of Analytical study Physiochemical parameters Percentage 1 Total Ash 5% 2 Water insoluble Ash 1% 3 Acid insoluble Ash 2% 4 Moisture content 0% 5 Volatile content 2% 6 Water soluble extractive 48% 7 Alcohol soluble extractive 3.2% 8 Hot Alcohol soluble extractive 39% 9 Successive solvent extraction 1. Petroleum ether 0.8% 2. Cyclohexane 0.6% 3. Ecetone 2% 4.Ethnol 14%9
  • 10. Qualitative analysis of the extracts Sl. no solvents Alkaloi ds phenols Steroid s Flavono ids Anthra quinone s Saponi ns Tannins 1. Water soluble extractive _ _ + _ _ + + 2 Hot Alcohol soluble + _ + _ _ + + 3 Cold Alcohol + _ + _ _ + + 4 Petroleum ether _ _ + _ _ _ + 5 Cyclohexan + _ + _ _ _ _ 6. Acetone + _ + _ _ + + 10
  • 11. Powder microscopy of “IG-LEPA” 1. Starch grains 2. Bordered pitted vessels fragments 3. Reticulate vessels 4. Pitted fibres 5. Fibres with wide lumen 6. Cork cells 11 21 2 3 3 4 5 6 1
  • 12. HPTLC- profile of IG-LEPA and Citrullus colocynthis root powder 254nm 366nm Plants derivatives 1. Ig-lepa 2. Citrullus colocynthis root Rf = .15(254nm): one band is missing in Citrullus powder Rf =.26(366nm): one extra band in citrullus  Ig-lepa at Rf = .10 : one extra compound is found. 12
  • 13. 1. Ig-lepa 2. Citrullus colocynthis root 13
  • 14. 1. Ig-lepa 2. Citrullus colocynthis root 14
  • 15. 1. Ig-lepa 2. Citrullus colocynthis root 15
  • 16. Clinical study  Study design : Open clinical trial  Sample size :20  Intervention period : Up to Vyadhiupsamanam or maximum 3 months  Follow up : 30 days after stopping treatment 16
  • 17. Cont...  Inclusion criteria - a) On the basis of SALT SCORE(Severity of alopecia tools):- 1)S1 <25% of hair loss 2)S2 =25 to 49% of hair loss 3)S3=50 to 74% hair loss 4)B0 =No body hair involvement 5)N0 =No nails involvement b) Age- 18 to 50 years. c)Sex- Either sex. d)Chronicity-Above 30 days. e)Participants who are willing to sign the consent form. 17
  • 18. Cont...  Exclusion criteria:-  Androgenic alopecia  Tinea capitis  Alopecia after chemotherapy and radiotherapy  Trichotillomania  Traumatic alopecia  Participants under medication for alopecia  Participants who are tested positive in sensitivity test. 18
  • 19. Cont...  Sensitivity test was done before selection of participants: Site : dorsal surface of hand Thickness : 5mm Duration : till it dried 19
  • 20. Con...  Method of application Preparation of affected area: rubbing with small onion for 2 minute. Application: - mixing with Luke warm water Thickness :- 5mm Duration :- till it dried. 20
  • 21. Assessment criteria 21  On the basis of SLAT score (severity of alopecia tool): Average % of hair loss was assessed by expert panels with the help of global photographs.  On the basis of area measurement of patches.  Assessment of safety.
  • 22. Demographic data of sample distribution 70% 30% male female 22
  • 23. Distribution according to Education 15% 55% 20% 10% Uneducated Primary secondry Graduate Post graduate 23
  • 28. Chronicity 50% 10% 15% 25% upto 3 months upto 6 months upto 1 year more than 1 year 28
  • 32. Result and discussion  Area measurement  Salt score  Hair re-growth  Safety 32
  • 33. 1.Area measurement: 0th day 15th day 30th day 45th day 60th day AT AF33
  • 34. Area measurement  Pair t-test BT Vs. AT Area measureme nt Mean T-value P-value Significanc e level BT 31.86 2.59 0.017 P<0.05 AT 24.75 34
  • 35. Area measurement  Pair t-test BT Vs. AF Area measureme nt Mean T-value P-value Significanc e level BT 31.86 2.64 0.016 P<0.05 AF 24.60 35
  • 36. 2.SALT score assessments: 3 expert panel  ANOVA test : BT assessments  No significance difference between experts opinion. Source of variation SS df MS F- value P- value Between groups 33.84 2 15.24 1.88 0.16 Within groups 461.79 57 8.10 total 492.28 59 36
  • 37. SALT score : pair t- test BT Vs. Other groups Assessment s Mean T-value P-value Significance level BT 12.86 15th day 12.86 -11.65 4.2 Not significant 30th day 12.42 -0.36 0.72 Not significant 45th day 11.93 1.6 0.125 Not significant 60th day 11.64 2.08 0.051 Not significant AT 10.94 3.05 0.006 P<0.01 AF 10.63 3.21 0.004 P<0.01 37
  • 38. 3.Average percentage of hair re-growth 1.33% 9.16% 16.33% 21.60% 28.50% 34.40% 0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00% 35.00% 40.00% 15th day 30th day 45th day 60th day AT AF Series1 %ofhairre-growth Assessments 38
  • 39. Difference of hair re-growth between assessments  ANOVA single factor test : hair re-growth  Significance level : P<0.001 Source of variation SS df MS F- value P- value Between groups 15318.23 5 3063.64 5.285 0.00021 Within groups 66073.78 114 579.59 total 81392.01 119 39
  • 40. 4.Assessment of safety  Sensitivity test:- No participants were found sensitive with drug.  Safety criteria:-  No participants were reported with redness , swelling and Itching during and after application of drug on affected area. Safety assessment criteria Reported participants Redness 0 Swelling 0 Itching 0 40
  • 41. Discussion  Dropout :04  Average % of hair re-growth: AT:- 28.50% AF:-34.4% It indicates result was sustain after follow up. 41
  • 42. Cont...  Significant decreasing of Area measurement: effective to reduce extent of patches and enhance hair re-growth.  Significant decreasing in SALT score: effective to reduce extent of patches , enhance hair re- growth and increase density of hair on the affected area(thickness of hair ). 42
  • 43. Probable mode of action of IG-lepa  Indralupta :-  Pitta and Vata :- hair fall  Kapha and Rakta : Marga Avarana 43
  • 44. 44 Autoimmune inflammation Hair fall Inflammatory infiltrate deposition in and around the follicles Anagen hairs Telogen hairs Hair cycle stopped Alopecia areata Absorption IG-lepa Blood circulation Ushna, Teekshna, Ruksha
  • 45.  Avarana : - Lekhana properties of Tikta rasa Teekshna and Ruksha guna Ushna veerya Teekshna properties of small onion Srotovivarana properties of lavana rasa Indravvaruni Gomutra Rasa Tikta, Katu Katu, Lavana Guna Laghu, Sara Laghu, Ruksha, Teeksna Veerya Ushna Ushna Vipaka Katu Katu 45
  • 46. Conclusion  Phytochemical study: presence of alkaloids, tannin, saponin and steroids  Comparative HPTLC : some chemical variation  The formulation was found to be safe.  Average percentage of hair regrowth was sustained in follow up period.  formulation was showed significant decrease of area of patches and of SALT score. 46
  • 47. Cont...  Null hypothesis :- Rejected  Alternate hypothesis :- Accepted  Topical application of “IG-LEPA” is significantly effective for hair re-growth in participants with Indralupta ( Alopecia areata). 47
  • 48. Limitation  The drug was applied by the patients themselves. Hence the uniformity in application could not have been maintained.  The effect of use of Soaps, Shampoos and oils cannot be ruled out.  The add-on effect of rubbing with onion cannot be excluded. 48
  • 49. Recommendations .  Comparative trial may be done.  Citrullus colocynthis (L.) schrad. as a single drug may be evaluated .  Other Standardization techniques can be used. 49
  • 50.  Fitzpatrick’s Dermatology in general medicine, seventh edition. Edited by Klaus wolff et al.vol-1, Page763.  Latha K.K.,A study on the effect of Rhinacanthus communis nees. In the management of Indraluptha:Thiruvananthapuram,1999.  Gadanigraha of Sri Vaidha Sodhala, by Dr.Indradevatripathi edited by Sri Ganga sahaaya pandey , reprint 2005, Varanasi: Chaukhamba Sanskrit sansthan volume 3rdpage no.25  Atharvaveda, with Sayam commentary, edited by pandit S.P. Nirnaya, Bombey: Sager press; Khanda 6, sukta 21, 22, 23, 136,137.  Agnivesh , ‘Caraka Sam`hitaa’. Revised by Caraka and Dr`ad`habala with ‘Ayurveda dipika’ commentary, by Cakrapanidatta, edited by pt. KashinathSastriand Dr. Gangasahaya Pandey, Varanasi: Chaukhamba Vishvabharti; reprint 2003, Cikitsa stana 26/132. References- 50
  • 51. Con.... 51  Stenn KS, Paus R: Controls of hair follicle cycling. Physiol Rev 81:449, 2001 [PMID: 11152763]  Botchkarev VA et al: Hair cycle-dependent plastic- ity of skin and hair follicle innervation in normal murine skin. J Comp Neurol 386:379, 1997 [PMID: 9303424]  Narisawa Y et al: A high concentration of Merkel cells in the bulge prior to the attachment of the arrector pili muscle and the formation of the peri- follicular nerve plexus in human fetal skin. Arch Dermatol Res 285:261, 1993 [PMID: 8379685]  Reynolds AJ et al: Trans-gender induction of hair follicles. Nature 402:33, 1999 [PMID: 10573414]  Whiting DA: Chronic telogen effluvium: Increased scalp hair shedding in middle-aged women [see comments]. J Am Acad Dermatol 35:899, 1996 [PMID: 8959948]  Reynolds AJ et al: Trans-gender induction of hair follicles. Nature 402:33, 1999 [PMID: 10573414]
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