| CTRI Number |
CTRI/2018/05/013844 [Registered on: 11/05/2018] Trial Registered Prospectively |
| Last Modified On: |
11/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Children cases of white patches (Safed dag) by application Ayurvedic drug and Ayurvedeeya procedures of body cleaning. |
|
Scientific Title of Study
|
Study on roll of Virechana and Pooteekadi Lepa on Shwitra w.s.r. to Vitiligo (Leucoderma) in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrinidhi Kumar K |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
P.G.Department of Kaumarabhritya, National Institute of Ayurveda Jaipur Near Jorawar Singh Gate, Madhav Vilas, Aamer Road Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877151575 |
| Fax |
|
| Email |
ashanidhiacharya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kailash Chandra Kataria |
| Designation |
P.G.Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur (Rajasthan) |
| Address |
P.G.Department of Kaumarabhritya, National Institute of Ayurveda Jaipur Near Jorawar Singh Gate, Madhav Vilas, Aamer Road Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7737396206 |
| Fax |
|
| Email |
kailash.kataria07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kailash Chandra Kataria |
| Designation |
P.G.Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur (Rajasthan) |
| Address |
P.G.Department of Kaumarabhritya, National Institute of Ayurveda Jaipur Near Jorawar Singh Gate, Madhav Vilas, Aamer Road Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7737396206 |
| Fax |
|
| Email |
kailash.kataria07@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda, Jorawar Singh Gate Jaipur, Rajasthan, 302002 |
|
|
Primary Sponsor
|
| Name |
Dr Shrinidhi Kumar k |
| Address |
PG Department of Kaumarabhritya National Institute of Ayurveda Jaipur Rajasthan pin 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kailash Chandra Kataria |
P.G. Department of Kaumarabhritya, National
Institute of Ayurveda, Jaipur,Rajasthan- 302002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrinidhi kumar K |
NATIONAL INSTITUTE OF AYURVEDA,JAIPUR |
Room no. 05, OPD of PG Department of Kaumarabhritya,
Jaipur
Jaipur
RAJASTHAN |
7877151575
ashanidhiacharya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Shwitra or Vitiigo (Leucoderma), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pooteekadi Lepa |
Group A will be received Pooteekadi Lepa as external application followed by sun exposure for 15 minutes.Follow up will be on every fifteen days for 3 month. |
| Comparator Agent |
Sanshodhana Karma (Virechana) followed by Pooteekadi Lepa |
Group B will be priorly administered with Sanshodhana Karma (Virechana) followed by Pooteekadi Lepa as external application followed by sun exposure for 15 minutes.Follow up will be on every fifteen days for 3 month. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex between age group of 05-15 years.
2. Children diagnosed as leucoderma or Vitiligo as per contemporary medical sciences or Shwitra as per clinical features mentioned in Ayurvedic texts.
|
|
| ExclusionCriteria |
| Details |
1. Children below 05 and above 15 years of age.
2. Children with Albinism will be excluded.
3. White anesthetic spots, which are characteristic of leprosy.
4. Old refractory cases not responding after extensive use of modern medicine.
5. Patches in genital area, lip area are excluded from the study.
6. Vitiligo patches complicated by eczema.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change at the site of lesion with formation of the blebs with subsequent reddish discolorization. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete healthy blackish Pigmentation of the whitish patch |
3 months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
24/05/2018 |
| 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
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Vitiligo or leucoderma is one such clinical
dermatological condition which has been analogues with Shwitra in Ayurvedic literature which is responsible for major
cosmetic concern in population. Although Shwitra
don’t produces pain, ulcer or discomfort, but eventually creates an inferiority
complex in individuals, ending up in disturbed social, personnel, psychological
and educational life and considered as social stigma.The present study has been planned to provide an effective, cost
effective, easy treatment for vitiligo by using Ayurvedic principle as human
population especially children is suffering from Shwitra on a large scale and incidences are rising day by day. Present
study has been designed to study the role of Sanshodhana Karma followed by Pooteekadi
Lepa, externally, over the discolored patches in children with subsequent
exposure to sunlight. Pooteekadi Lepa has been quoted in the classics for management
of Shwitra and same on been selected
in the present study. |