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
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
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.
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.
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