| CTRI Number |
CTRI/2025/04/084922 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Vatarakta w.s.r. to Gout with oral intake of Guduchi Taila followed by Virechana Karma |
|
Scientific Title of Study
|
A clinical study on the effect of Abhyantar Snehapan With Guduchi Taila along with Virechan Karm in the management of Vatarakta w.s.r to Gout. |
| 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 Nirbhay Kumar Chauhan |
| Designation |
MD (Ay.) Scholar ( Dept. of Panchakarma) |
| Affiliation |
Govt. Ayurvedic college and hospital,near budhhamurti,kadamkuan,patna,bihar 800003 |
| Address |
Dept. of Panchakarma, Govt. Ayurvedic college and hospital, near buddhamurti, kadamkuan, Patna, Bihar 800003
Govt. Ayurvedic college and hospital, near buddhamurti, kadamkuan, Patna, Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
8340167343 |
| Fax |
|
| Email |
nirbhaykrchauhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAkhilesh Prasad Singh |
| Designation |
HOD and Associate Professor Department of Panchakarma |
| Affiliation |
Government Ayurvedic college and hospital,near budhhamurti,kadamkuan,patna,bihar 800003 |
| Address |
Department Panchakarma, OPD no.11,Government Ayurvedic college and Hospital, near Buddhamurti,Kadamkuan, Patna,Bihar 800003
Department Panchakarma, OPD no.11,Government Ayurvedic college and Hospital, near Buddhamurti,Kadamkuan, Patna,Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
|
| Email |
drapsinghpatna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Akhilesh Prasad Singh |
| Designation |
HOD and Associate Professor Department of Panchakarma |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Department of Panchakarma, OPD no.11, Government Ayurvedic college and Hospital, near Buddhamurti,Kadamkuan, Patna,Bihar 800003
Department of Panchakarma, OPD no.11, Government Ayurvedic college and Hospital, near Buddhamurti,Kadamkuan, Patna,Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
|
| Email |
drapsinghpatna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Ayurvedic college and hospital,near buddhamurti,kadamkuan,patna,bihar 800003 |
|
|
Primary Sponsor
|
| Name |
Dr. Nirbhay Kumar Chauhan |
| Address |
Govt. Ayurvedic college and hospital,near buddhamurti,Kadamkuan,Patna,Bihar 800003 |
| Type of Sponsor |
Other [other(self)] |
|
|
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 |
| DrNirbhay Kumar Chauhan |
Govt. Ayurvedic college and hospital,near buddhamurti,Kadamkuan,Patna,Bihar 800003 |
Department of Panchakarma,Govt. Ayurvedic college and hospital,near buddhamurti,Kadamkuan,Patna,Bihar 800003
Patna
BIHAR |
8340167343
-
nirbhaykrchauhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) |
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: Charak Samhita Chikitshasthan, Vatarakta Chikitsadhyaya 29/41, Procedure details: After proper Deepana-Pachana, Shodhanartha Snehapana with Guduchi Tail is to be given untill Samyak Snehapan Lakshana & then after gap of 3 days virechana has to be done using Aragavadha Phala Majja kwath in the dose of 100ml.)
(1) Medicine Name: Aragbadh Phal Mazza Kwath, Reference: Charak Samhita Kalapasthan 8/9, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Serum uric acid concentration more than 7.0mg/dl in male and more
than 6.0 mg/dl in female.
Patients having their age more than 18 years.
Patients having sign & symptoms of vatarakta( Gout).
All three essential symptoms with or without non-essential symptoms. |
|
| ExclusionCriteria |
| Details |
Patients having complications of Vatarakta (upadrava) like, moorcha,hikka etc.
Patients having secreting tophus.
Patients associated with HIV, Hepatitis and also pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SPARSHAAGATWAM (Loss of tactile sensation)
KSHATE ATIRUK (Tenderness)
SANDHI SHOOL (Severe pain in affected joint)
Vaivarnya ( Discolouration)
Sandhi shotha (Swelling) |
48 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Normal range of Uric acid in blood |
48 Days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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 study is randomised open clinical trial to study the effect of Abhyantara Snehpana with Guduchi taila alongwith Virechana karma in the management of Vatarakta w.s.r to Gout, that will be conducted in Government Ayurvedic College and Hospital, Patna, Bihar in the department of Panchakarma. In 30 patients, abhayantara snehpana with Guduchi taila will be given. Thereafter, Virechana karma will be done with Aragwadh phal majja kwath. Post intervention follow-up will be done every 15 days for 1 month for total duration of study i.e of 48 days. |