| CTRI Number |
CTRI/2020/12/029697 [Registered on: 10/12/2020] Trial Registered Prospectively |
| Last Modified On: |
08/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vitiligo and its Management through Ayurveda |
|
Scientific Title of Study
|
A Clinical Study of Virechana and Avalgujadi Lepa along with Asanadi gana Kwatha (Internally) in the Management of Shwitra w.s.r to Vitiligo |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harinee S |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU ,Jodhpur |
| Address |
P.G. Department of Panchakarma , University College of Ayurveda , Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University , Karwar , Nagaur Road , Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8015972948 |
| Fax |
|
| Email |
harineekrishna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Assistant Professor |
| Affiliation |
DSRRAU ,Jodhpur |
| Address |
P.G. Department of Panchakarma , University College of Ayurveda , Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University , Karwar , Nagaur Road , Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harinee S |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU ,Jodhpur |
| Address |
P.G. Department of Panchakarma , University College of Ayurveda , Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University , Karwar , Nagaur Road , Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8015972948 |
| Fax |
|
| Email |
harineekrishna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University , Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University ,Karwar, Nagaur Road ,Jodhpur , PIN 342037 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Gyan Prakash Sharma |
Dr. Sarvepaali Radhakrishanan Rajasthan Ayurved University, University Hospital of Ayurveda |
OPD No- 6 , P.G Department of Panchakarma,Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University , Karwar, Nagaur Road ,Jodhpur , PIN 342307
Jodhpur
RAJASTHAN |
9829798701
atreyagyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
virechana karma, lepa and abhyantara kwatha prayoga |
GROUP A- virechana with aragwadha phala majja kashaya and internal administration of asanadi gana kwatha (15ml before food twice a day for 15days )
GROUP B- avalgujadi lepa and internal administration of asanadi gana kwatha (15ml before food twice a day for 15days ) |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with uncomplicated vitiligo , either segmental or generalized
2.Patients indicated for virechana karma |
|
| ExclusionCriteria |
| Details |
1. Vitiligo associated with other systemic diseases like tuberculosis , rheumatoid arthritis ,Systemic lupus erythematous, anaemia,hypothyroidism etc
2. Patches due to burns , chemical explosion etc
3. Patients of albinism of skin |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective parameters |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the comparative efficacy of the treatment in both the groups |
45 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
|
Phase 1 |
|
Date of First Enrollment (India)
|
18/12/2020 |
| 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="0"
Months="6"
Days="0" |
|
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
|
Vitiligo is a common skin disorder that is thought to be mediated by immunological mechanisms .In modern science , main stream of treatment for vitiligo is PUVA (Psoralen + Ultraviolet A), along with corticosteroid therapy ,etc ,which has several adverse effects , also carries health risks . Therefore , its high time to provide the patients of vitiligo with less complicating , fruitful management through ayurveda . This study is open labelled parallel group trial to prove the efficacy of virechana and avalgujadi lepa along with asanadi gana kwatha (internally) in the management of shwitra w.s.r to vitiligo . In one group , 15 patients will be administered virechana karma with aragwadha phala majja kashaya and internal administration of asanadi gana kwatha (15ml before food twice a day for 15 days ) . In another group, 15 patients will be administered with avalgujadi lepa and internal administration of asanadi gana kwatha (15 ml before food twice a day for 15 days )
|