| CTRI Number |
CTRI/2021/04/032723 [Registered on: 12/04/2021] Trial Registered Prospectively |
| Last Modified On: |
07/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AYURVEDIC MANAGEMENT OF MELASMA-CLINICAL TRIAL |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Amlika Moola Lepa And Amlika Beeja Lepa In The Management Of Vyanga With Special Reference To Melasma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEPIKA R |
| Designation |
P.G. Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room No 104,Department of Dravyaguna, Sri Sri College of Ayurvedic Science and Research Hospital,21st km, Kankapura road, Uadayapura post, Bengaluru
SSCASR,#21st km, Uadayapura post, Kankapura road, Bengaluru.
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
8073263390 |
| Fax |
|
| Email |
deepikasrivathsa7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMahesh CD |
| Designation |
M.D(Ayu),Professor,Department of Dravyaguna |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room number-207, Department of PG Studies in Dravyaguna, Sri Sri College of Ayurvedic Science and Research,21st km, Uadayapura post, Kankapura road, Bengaluru.
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9986303884 |
| Fax |
|
| Email |
drmaheshcd@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DEEPIKA R |
| Designation |
P.G. Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room No 104,Department of Dravyaguna, Sri Sri College of Ayurvedic Science and Research Hospital,21st km, Kankapura road, Uadayapura
SSCASR,#21st km, uadayapura post,kanakapura road
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
8073263390 |
| Fax |
|
| Email |
deepikasrivathsa7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital |
|
|
Primary Sponsor
|
| Name |
Deepika R |
| Address |
No.10,Sundara Padma Nilaya, Pappana Layout, Maruthinagara, Kogilu road, Yelahanka, Bengaluru. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepika R |
Sri Sri Ayurveda Hospital |
Department of Dravyaguna, KC-3, R.no.104
Bangalore
KARNATAKA |
8073263390
deepikasrivathsa7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tamarindus indicus root powder |
External application of Tamarindus indicus root powder
Dosage-Quantity as required
External application on affected parts with water for 21 days |
| Intervention |
Tamarindus indicus seed powder |
External application of Tamarindus indicus seed powder
Dosage-Quantity as required
External application on affected parts with water for 21 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subject of either gender with age group between 20-50 years.
subject fulfilling the criteria of vyanga with special reference to Melasma. |
|
| ExclusionCriteria |
| Details |
Female on oral contraceptive pills,pregnant women,lactating woman.
Hyperpigmentation since birth.
Any other condition interfering the course of treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the discolouration, size |
21days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complete Reduction in the discolouration, size |
35 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/04/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Skin is the largest organ which acts as a physical, biochemical and immunological barrier between outside world and the body. The concept of beauty having an age old origin is expressed through the skin which is manifested in the form of complexion. In Ayurveda it is understood in terms of Varna. Natural complexion of the body since birth is termed as Prakrutha Varna, where in Prakrutha avastha of Varna indicates healthy and radiant skin and any changes in Prakrutha Varna can be considered as Roga and one among them is Vyanga. Vyanga is one among Kshudra Roga which might produces distress for the person due to hyperpigmentation of the skin over the face which on the basis of clinical features can be compared with Melasma |