| CTRI Number |
CTRI/2016/05/006901 [Registered on: 05/05/2016] Trial Registered Retrospectively |
| Last Modified On: |
02/05/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Virechana Karma and Nishadi Vati in the management of Eczema. |
|
Scientific Title of Study
|
A Clinical Study on the role of Virechana Karma and Nishadi Ghanavati in the management of Vicharchika w.s.r. to Eczema. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gaurav bapurao Patil |
| Designation |
P.G. 2nd Year Scholar |
| Affiliation |
Akhandanand Ayurveda College |
| Address |
At.Hiwari Post.Kali(DK) Ta.mahagaon Dist.Yavatmal
Yavatmal
MAHARASHTRA
445204
India |
| Phone |
9067793743 |
| Fax |
|
| Email |
gauravpatil241@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sweety Ruparel |
| Designation |
Reader and HOD |
| Affiliation |
Akhandanand Ayurveda College |
| Address |
B/2Garden.view Flats Behind j.m.c.House Near Parimal Garden Ambawadi Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
9429202048 |
| Fax |
|
| Email |
sweetyruparel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaurav bapurao Patil |
| Designation |
P.G. 2nd Year Scholar |
| Affiliation |
Akhandanand Ayurveda College |
| Address |
AT.HAWARI POST KALI (DK)TA.MAHAGAON DIST.YAVATMAL
Yavatmal
MAHARASHTRA
445204
India |
| Phone |
9067793743 |
| Fax |
|
| Email |
gauravpatil241@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Akhandanand Ayurveda College and Hospital, Bhadra, Ahmedabad, 380007, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Govt Akandanand Ayurved College |
| Address |
Govt Akandanand Ayurved College and Hospital,Bhadra, Ahmedabad, 380007 |
| 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 Sweety Ruparel |
Panchakarma Dept.OPD No.11 |
Govt. Akhandanand Ayurved Hospital Bhadra,Ahmedabad,380007
Ahmadabad
GUJARAT |
9429202048
sweetyruparel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Vicarchika W.S.R. to Eczema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nishadi Ghanvati |
2Gms TDS For 8 Weeks |
| Comparator Agent |
Virechana karma Following Nishadi Ghanvati |
Virechana Yoga-Abhayadi modak 500 Mg TO 2Gm
Nishadi Ghanvati-2 Gms TDS For 6 Weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Classical Sign and Symptoms of Vicharchika as per Ayurvedic and Modern Literature. |
|
| ExclusionCriteria |
| Details |
SYSTIMIC SEVERE DISEASES AND OTHER SKIN DISEASE EXCEPT VICHARCHIKA.
PATIENT WHO ARE NOTE ABLE TO VIRECHAN KARMA AS PER AYURVEDIC TEXTS. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All Sign and Symptoms of Vicharchika will be Assigned by score pattern before and after Treatment. |
All Sign and Symptoms of Vicharchika will be Assigned by score pattern before and after Treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/05/2015 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Open for all |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is randomnised participant blinded,parallel group to compar and see the efficacy of Nishadi Ghanvati 2 gms TDS and VIrechana Karma by Abhayadi modaka follow by Nishadi Ghanvati in the management of Vicharchika W.S.R. to Eczema. |