| CTRI Number |
CTRI/2016/08/007171 [Registered on: 11/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
21/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
management of white patches through ayurvedic medicines Mitrapanchak yoga and Avalgujbeejadi lepa |
|
Scientific Title of Study
|
A comparative clinical study on mitrapanchak yoga and Avalgujbeejadi lepa in the management of Shwitra wsr 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 NIRANK KUMAR |
| Designation |
MD AYU SCHOLAR |
| Affiliation |
ipgtra gujarat |
| Address |
IPGTRA JAMNAGAR GUJARAT
pg boys hostel room no 55
Jamnagar
GUJARAT
361008
India |
| Phone |
9924304547 |
| Fax |
|
| Email |
nirank1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR A R DAVE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ipgtra jamnagar gujarat |
| Address |
IPGTRA JAMNAGAR GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
9824171817 |
| Fax |
|
| Email |
alankruta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NIRANK KUMAR |
| Designation |
MD AYU SCHOLAR |
| Affiliation |
ipgtra gujarat |
| Address |
IPGTRA JAMNAGAR GUJARAT
pg boys hostel room no 55
Jamnagar
GUJARAT
361008
India |
| Phone |
9924304547 |
| Fax |
|
| Email |
nirank1989@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR POST GRADUATE TRAINING AND RESEARCH IN AYURVEDA |
| Address |
Behind Dandia Hanuman Mandir jamnagar gujarat |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nirank Kumar |
ipgtra jamnagar |
Room no 21 Kaya chikitsa department ipgtra jamnagar gujarat ayurved university pin 361008
Jamnagar
GUJARAT |
9924304547
nirank1989@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee ipgtra gau |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Vitiligo
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Avalgujbeejadi- lepa
|
Avalguja
Shudh Hartala
Gomutra
Duration : 60 Days on each 4th day or If blisters appear in between. |
| Intervention |
Mitrapanchaka yoga |
Hartala
Shodhita Gandhaka
Bakuchi,Ghrita,Madhu
Dose: 6gm BD
Anupana: Ghrita,Madhu
Duration: 60 Days
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having signs and symptoms of Shwitra (vitiligo).
2. Patients between age group of 16 years to 60 years will be selected.
|
|
| ExclusionCriteria |
| Details |
1.Patients having chronic condition, more than 10 years
2.Patients having all other de-pigmentory disorders.
3.Patients having serious cardiac, renal, hepatic diseases.
4.Patients having major illness like IDDM, NIDDM which are poorly controlled and any other systemic diseases.
5.Patches due to burning, chemical explosion etc.
6.Located at region of Guhya (Genital region), Panitala (Foot soals and Hand soals), Oshtha (Lips), Aekanga, Sarvanga(whole body).
7.Patches with Raktaloma, Sansakta Mandala
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| will be evaluated |
will be evaluated after 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| will be evaluated |
will be evaluated after 60 days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
08/01/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
MANAGEMENT OF SHWITRA (VITILIGO) WITH MITRAPANCHAK YOGA AND AVALGUJBEEJADI LEPA AFTER MRIDU KOSHTHA SHUDDHI WITH ERANDA BHRISHTHA HARITAKI-A CASE STUDY published in IAMJ(International Ayurvedic Medical Journal) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Shwitra is a disease described in Ayurveda; which is produced by
vitiation of Vata, Pitta and Kapha Doshas. The signs and symptoms of Shwitra are; non exudative white, red or
coppery-red coloured patches on the skin, destruction of the skin lusture, loss
and discolouration of the hair, roughness, dryness, itching and burning
sensation of the patches. It can be correlated with Vitiligo which is
progressive whitening of the skin and hair characterized by the total absence
of melanocytes in affected areas of the skin. Aim:
To assess and compare the clinical efficacy of Mitrapanchaka Yoga with
and without Avalgujbeejadi lepa in
the management of Shwitra (Vitiligo).Material and methods: In this trial, 34 patients were registered, out of which 30
completed the treatment. Patients were randomly divided in two
groups with the help of computer generated random selection method viz. Group A
and Group B. In Group A classical Mridu Samshodhana was given followed by oral administration of Mitrapanchaka Yoga as a Shamana Yoga, followed by Avalgujbeejadi
lepa for local application. In
Group B patients were treated with Mridu
Samshodhana followed by oral administration of Mitrapanchaka Yoga
internally. Special scoring pattern was adopted for
scrutinizing the symptomatology. The score was given on the basis of Size,
Colour, Number of patches, percentage of body area involvement and chronicity
of patches. VASI Score to
know overall effect of therapy on two groups and VIS-22 Score for each patient
was calculated Results:On Applying VASI Score both groups showed
highly significant results.VIS-22 Score was suggestive of high psychological
involvement in disease. Conclusion:
On
comparison group A showed better results in percentage changes, result
difference was significant in improvement in number of patches in Group A, which suggests
that Mitrapanchaka Yoga and Avalgujabeejadi Lepa together give
better results than Mitrapanchaka Yoga alone. |