| CTRI Number |
CTRI/2025/08/092268 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study will be conducted to search the effect of virechan karma in the disease vatarakta (gout). |
|
Scientific Title of Study
|
A single arm clinical trial to evaluate the effect of virechan karma in the management of vatarakta |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Ramchandra Dhengle |
| Designation |
MD Scholar Panchakarma |
| Affiliation |
Sumatibhaishah Ayurved Mahavidyalaya Hadapsar Pune |
| Address |
Sumatibhaishah Ayurved Mahavidyalaya, Hadapsar, Pune.
OPD NO 6 Panchakarma Department Sane Guruji Aarogya Kendra, Hadapsar, Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
8551929741 |
| Fax |
|
| Email |
dhenglesumit0731@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Avhad |
| Designation |
Assistant Professor Department of Panchakarma |
| Affiliation |
Sumatibhaishah Ayurved Mahavidyalaya Hadapsar Pune |
| Address |
Sumatibhaishah Ayurved Mahavidyalaya, Hadapsar, Pune.
OPD NO 6 Panchakarma Department Sane Guruji Aarogya Kendra, Hadapsar, Pune .
Pune
MAHARASHTRA
411028
India |
| Phone |
9890608788 |
| Fax |
|
| Email |
drvandanapalve@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Ramchandra Dhengle |
| Designation |
MD Scholar Panchakarma |
| Affiliation |
Sumatibhaishah Ayurved Mahavidyalaya Hadapsar Pune |
| Address |
Sumatibhaishah Ayurved Mahavidyalaya, Hadapsar, Pune.
OPD NO 6 Panchakarma Department Sane Guruji Aarogya Kendra, Hadapsar,Pune .
Pune
MAHARASHTRA
411028
India |
| Phone |
8551929741 |
| Fax |
|
| Email |
dhenglesumit0731@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sane Guruji Aarogya Kendra , Hadapsar, Pune , Maharashtra , India.
Pin - 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Aarogya Kendra Hadapsar Pune |
| Address |
Hadapsar, Pune , PINCODE 411028 , MAHARASHTRA. |
| 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 |
| Dr Sumit Ramchandra Dhengle |
Sane Guruji Aarogya Kendra |
OPD NO 6 Panchakarma Department Sane Guruji Aarogya Kendra, Hadapsar, Pune .
Pune
MAHARASHTRA |
8551929741
dhenglesumit0731@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE SSAM & AYURVED HOSPITAL SANEGURUJI AROGYA KENDRA HADAPSAR PUNE MS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Shukla V. And Tripathi R. D. Edited Caraksamhita of Agnivesa, Published by Chaukhamba Sanskrit Pratishthan, Delhi, Reprinted in2017, Cha CHI. 29/41;Page no. 737., Procedure details: After patient selection snehapana will be given, then snehana swedana will be done and medicine orally given for virechan , after that sansarjankrama asked to be followed.)
(1) Medicine Name: Trivrutta Avhleha with Erand Sneh, Reference: Tripathi. B Edited Ashatanghrudaya of Srimadvagbhata, Published by Chaukhamba Sanskrit Pratishthan, Delhi, Reprinted in 2015 , Ashtang Kalpa. 2/9 ;Page no. 835., Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 40(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients showing classical symptoms of vatarakta.
2)Virechana arha
3)Snehapana arha
4)Age 25 to 60 years |
|
| ExclusionCriteria |
| Details |
1) Pregnancy and Lactation.
2) Patient suffering from severe systemic disorders like Cancer etc which may interfere with the intervention.
3) Any patients suffering from another Arthritic diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A trial to see effect of virechan karma. |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A trial to see effect of virechan karma on lowering Sr Uric acid level. |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
N/A |
|
Date of First Enrollment (India)
|
14/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single arm clinical trial to evaluate the effect of virechan karma in the management of vatarakta. The primary objective is to study the effect of virechan karma in vatarakta and the secondary objective is to study effect of virechan karma in lowering Sr Uric acid levels. |