| CTRI Number |
CTRI/2020/02/023196 [Registered on: 07/02/2020] Trial Registered Prospectively |
| Last Modified On: |
05/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [CURATIVE] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Trial of Two Ayuredic Treatment in Ekakustha(Psoriasis) |
|
Scientific Title of Study
|
Clinical evaluation of two Ayurveda treatment regimes in Ekakustha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravindra Kumar |
| Designation |
PG Scholar |
| Affiliation |
Ch. Brahm Praskash Ayurved Charak Sansthan |
| Address |
Room no.238 2nd Floor, Panchkarma Department, Ch. Brahm Praskash Ayurved Charak Sansthan ,Khera Dabar, Najafgarh, New Delhi
South West
DELHI
110073
India |
| Phone |
9529453060 |
| Fax |
|
| Email |
RAVINDRA528@YAHOO.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR ARUN GUPTA |
| Designation |
HEAD OF DEPARMENT OF PANCHKARMA |
| Affiliation |
CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
| Address |
Room No 241, Panchkarma Department,Ch. Brahm Praskash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, New Delhi
South West
DELHI
110073
India |
| Phone |
9999155377 |
| Fax |
|
| Email |
ARUN24@HOTMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
RAVINDRA KUMAR |
| Designation |
Pg Scholar |
| Affiliation |
Ch. Brahm Praskash Ayurved Charak Sansthan |
| Address |
Room No 238, Panchkarma Department,Ch. Brahm Praskash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, New Delhi
South West
DELHI
110073
India |
| Phone |
9529453060 |
| Fax |
|
| Email |
RAVINDRA528@YAHOO.COM |
|
|
Source of Monetary or Material Support
|
| Ch. Brahm Praskash Ayurved Charak Sansthan,Khera Dabar,najafgarh,New Delhi |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Praskash Ayurved Charak Sansthan |
| Address |
Ch. Brahm Praskash Ayurved Charak Sansthan,Khera Dabar,Najafgarh ,New Delhi 110073 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ch Brahm Praskash Ayurved Charak Sansthan |
Ch. Brahm Praskash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi 110073 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RAVINDRA KUMAR |
Ch. Brahm Praskash Ayurved Charak Sansthan |
Room No. 238,Panchkarma Department,Ch. Brahm Praskash Ayurved Charak Sansthan,Khera Dabar,najafgarh
South West
DELHI |
9529453060
RAVINDRA528@YAHOO.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Vaman With Krutvedhan Churan |
Vaman With Krutvedhan By Oral Route According To Agni Followed By Virechan With Abhyadi Modak And Panchtikta Panchprasritiki Basti |
| Comparator Agent |
Vaman With Madanphal Churan |
Vaman With Madanphal Churan By oral Route Acc To Agni Followed By Virechan With Abhyadi Modak And Panchtikta Panchprasritiki Basti |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient showing sign and symptoms of
Ekakushtha in Charak Samhita and Psoriasis
Diagnosis on the basis of Modern classics.
2. Patient within the age group of 20-50 years.
3. Disease duration >1 year.
4. Patients not taking corticosteroids since last
3 months.
|
|
| ExclusionCriteria |
| Details |
1.Age below the age is 20 year and above the age
50yr.
2.Patients of hypertension, tuberculosis,
carcinoma, other life–threatening and
complicated disease and major systemic
illnesses.
3.Severe condition of Psoriasis like
Psoriatic arthritis.
4.Disease duration < 1 year.
5.Patients on treatment with any conventional
oral medicines for last one month.
6.Pregnant & lactating mother.
|
|
|
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 |
| Pasi score |
after vaman, after virechan,after basti, on 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| symptoms of ekakustha |
after vaman, after virechan,after basti, on 60th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2020 |
| 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="1"
Days="10" |
|
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
|
this study is a open label parallel group trial comparing the two Ayurveda treatment regimes in Ekakustha. in one group vaman with Krutvedhan Churan will be given followed by Virechan with Abhyadi Modak and Panchatikta Panchaprasrittika Basti. in another group Vaman with Madanphal Churan will be given followed by Virechan with Abhyadi Modak and Panchatikta
Panchaprasrittika Basti .the trial will be conducted in ch. brahm prakash ayurved charak sansthan india.with primary outcome of improvement in PASI SCORE and secondary outcome in symptoms of Ekakustha. |