| CTRI Number |
CTRI/2019/11/022036 [Registered on: 18/11/2019] Trial Registered Prospectively |
| Last Modified On: |
14/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO COMPARE THE EFFICACY OF SOMARAJI GHRITA AND GO GHRITA IN THE MANAGEMENT OF PSORIASIS. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON EFFICACY OF SOMARAJI GHRITA AND MURCHITA GO-GHRITA AS SHODHANARTHA SNEHAPANA PRIOR TO VAMANA KARMA IN EKAKUSHTHA WITH SPECIAL REFERENCE TO PSORIASIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kritika Thakur |
| Designation |
P.G. Scholar, Parul Institute of Ayurved. |
| Affiliation |
Parul Institute of Ayurved. |
| Address |
Panchakarma Department,
Parul Institute of Ayurved,
Parul University,P.O-Limda Tal-Waghodia
Vadodara-391760
Panchakarma Department,
Parul Institute of Ayurved,
Parul University,P.O-Limda,Tal-Waghodia
Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
8557840688 |
| Fax |
|
| Email |
thakurkritika1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta H Toshikhane |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved. |
| Address |
Panchakarma Department,
Parul Institute of Ayurved,
Parul University,P.O Limda,Tal-Waghodia
Vadodara-390019
Panchakarma Department,
Parul Institute of Ayurved,
Parul University,P.O Limda,Tal-Waghodia
Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9964596479 |
| Fax |
|
| Email |
drsangeetaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta H Toshikhane |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved. |
| Address |
Panchakarma Department,
Parul Institute of Ayurved,
Parul University,P.O-Limda,Tal-Waghodia
Vadodara-391760
Panchakarma Department,
Parul Institute of Ayurved,
Parul University,P.O-Limda,Tal-Waghodia
Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9964596479 |
| Fax |
|
| Email |
drsangeetaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital,
Parul University,
Vadodara-390019 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Panchakarma Department,
Parul Institute of Ayurved,
Parul University,P.O-limda,Tal-Waghodia,Vadodara,Gujarat
391760 |
| Type of Sponsor |
Private 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 |
| Kritika Thakur |
Parul Institute of Ayurved |
Department of Panchakarma,
Parul Institute of Ayurved,
Parul University,
Vadodara-390019
Vadodara
GUJARAT |
8557840688
thakurkritika1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L309||Dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Murchita Go-Ghrita |
In Group B 15 sample will be treated with Murchita Go-Ghrita Shodhanartha Snehapana prior to Vamana Karma
Duration: 13 days for each patient. |
| Intervention |
Somaraji Ghrita Shodhanartha Snehapana |
In Group A 15 sample will be treated with Somaraji Ghrita Shodhanartha Snehapana Prior to Vamana Karma.
Duration: 13 days for each patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients indicated for Snehapana
Patients indicated for Vamana
Age group between 18-60 years
Patients having classical signs and symptoms of ekakushtha |
|
| ExclusionCriteria |
| Details |
Patients contraindicated for Snehapana
Patients contraindicated for Vamana
Psoriasis associated with other systemic disorder like DM, HTN, Carcinoma, TB, Infectious diseases and other life threatening disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By giving Somaraji Ghrita prior to Vamana Karma in Ekakushtha patients, symptoms will be subside fast comparative to other Snehapana. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing the symptoms like itching, Scaling, dryness |
4 weeks |
|
|
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/ Phase 2 |
|
Date of First Enrollment (India)
|
20/11/2019 |
| 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="0"
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)?
|
|
Brief Summary
|
Human skin is considered to be the largest organ of the integumentary system, skin reflex our emotions and some aspects of normal physiology, in ayurveda all the skin diseases has been discussed under Vyadhi Kushtha. Kushtha is considered as a one of Ashtha Mahagada. Ekakushtha is one among the kshudra Kushtha. Symptoms of Ekakushtha are Aswedana , Mahavastu,Matsyasaklopamam, Ekakushtha have Kapha Vata dominance. Snehapana is the imporatant poorvakarma for Vamana and Virechana Karma. Benefits of any Sjhodhana Karma depends upon properly carried out Poorvakarma. Shodhanartha Snehapana is a procedure which helps in the proper mobilization of Doshas from the channels. Due to Bahudoshavastha Shodhana is indicated in Kushtha by all Acharyas. Somaraji Grita having proper action as Shodhanartha Snehapana in the management of ekakustha. |