| CTRI Number |
CTRI/2020/03/024115 [Registered on: 20/03/2020] Trial Registered Prospectively |
| Last Modified On: |
18/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE TREATMENT OF BIOPURIFICATION AND AUSHADH CHIKITSA IN VICHARCHIKA(KUSTHA) |
|
Scientific Title of Study
|
Clinical Evaluation of SHODHANA and SHAMANA Chikitsa in Vicharchika |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj katara |
| Designation |
Assistant professor (DEPT OF PANCHKARMA) |
| Affiliation |
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
| Address |
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI 110073
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI 110073
South West
DELHI
110073
India |
| Phone |
9910430500 |
| Fax |
|
| Email |
drpankajkatara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Katara |
| Designation |
Assistant professor (panchkarma department) |
| Affiliation |
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
| Address |
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI 110073
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI 110073
South West
DELHI
110073
India |
| Phone |
9910430500 |
| Fax |
|
| Email |
drpankajkatara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAHESH KHUNDIA |
| Designation |
MD SCHOLAR |
| Affiliation |
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
| Address |
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI 110073
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI 110073
South West
DELHI
110073
India |
| Phone |
9467675037 |
| Fax |
|
| Email |
maheshkhundia786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi, India |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar Najafgarh New Delhi- 110073 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Chaudhary Brahm Prakash 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 |
| DR MAHESH KHUNDIA |
Chaudhary Brahm prakash Ayurved Charak Sansthan |
Panchakarma
department, therapy
section, room no 238
South West
DELHI
South West
DELHI |
9467675037
maheshkhundia786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| iec cbpacs |
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 |
| Intervention |
Vamana karma AND VIRECHAN karma |
Vamana karma with madanphala AND VIRECHAN KARMA WITH ABHYADIMODAK |
| Comparator Agent |
AROGYAVARDHINI VATI |
500mg BD
Frequency- twice a day for 28 days
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
•Patients of either sex between 20 to 60 years of age.
•Patients diagnosed as a case of Vicharchika on the basis of Lakshanas :
1.Kandu (Iching)
2.Pidaka(Eruption)
3 Shyavavarna (Depigmentation)
4. Rukshata (Dryness)
according to the clinical features as described in Charak samhita will be selected irrespective of gender/ occupation and socio-economic status.
•Disease duration > 6 month
•Willing to sign the consent for study participation.
|
|
| ExclusionCriteria |
| Details |
•Patients on allopathic treatment.
•Patients who are unfit for shodhana karma as per text.
•Pregnant women. |
|
|
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 |
| EASI SCORE |
After Vaman Karma, After Virechana Karma,On 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| symptoms of vicharchika |
After Vaman Karma, After Virechana Karma,on 60th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/03/2020 |
| 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="2"
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
|
this study is a open label parallel group trial comparing the shodhana and shamana chikitsa in vicharchika. in one group vaman with madanphala Churan will be given followed by Virechan with Abhyadi Modak . in another group arogyavardhini vati as shamana chikitsa will be given.the trial will be conducted in ch. brahm prakash ayurved charak sansthan india.with primary outcome of improvement in EASI SCORE and secondary outcome in symptoms of vicharchika.. |