| CTRI Number |
CTRI/2025/03/083016 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [AAHAR VIHAR] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Aahar Vihar & Guduchi Churna in the management of Vatarakta. |
|
Scientific Title of Study
|
Study of Aahar Vihar & Guduchi Churna 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 Gangadhar Singh |
| Designation |
Professor & Head of Department |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna |
| Address |
DEPARTMENT OF SWASTHAVRITTA, GOVERNMENT AYURVEDIC COLLEGE AND HOAPITAL KADAMKUAN
BUDHAMURTI
Patna
BIHAR
800003
India |
| Phone |
9431093876 |
| Fax |
|
| Email |
gdsingh1960@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gangadhar Singh |
| Designation |
Professor & Head of Department |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna |
| Address |
DEPARTMENT OF SWASTHAVRITTA, GOVERNMENT AYURVEDIC COLLEGE AND HOAPITAL KADAMKUAN
BUDHAMURTI
Patna
BIHAR
800003
India |
| Phone |
9431093876 |
| Fax |
|
| Email |
gdsingh1960@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gangadhar Singh |
| Designation |
Professor & Head of Department |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna |
| Address |
DEPARTMENT OF SWASTHAVRITTA, GOVERNMENT AYURVEDIC COLLEGE AND HOAPITAL KADAMKUAN
BUDHAMURTI
BIHAR
800003
India |
| Phone |
9431093876 |
| Fax |
|
| Email |
gdsingh1960@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD 8 Government Ayurvedic College and Hospital Kadamkuan Patna Bihar-800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Kadamkuan Patna Bihar |
| Address |
Department of Swasthavritta and Yoga, Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003 |
| 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 Roshan Kumar |
Government Ayurvedic College and Hospital |
OPD Room N.-08 Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR |
8340512197
roshankumar10515@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patna Bihar 800003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M10||Gout. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi Churna, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Erand Tail), Additional Information: - | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Aahar Vihar, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs & symptoms of vatarakta (Gout).
Patients having their age more than 18 years.
Patients having Serum uric acid conc. more than 7.0mg/dl in male and more than 6.0 mg/dl in female. |
|
| ExclusionCriteria |
| Details |
Patients having complications of vatarakta (upadrava) like, moorchha, hikka etc.
Patients having secreting tophus.
Patients associated with HIV, Hepatitis and also pregnant women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical sign and symptoms (Itching, Burning sensation, twitching, swelling, joint pain, discolouration of skin, tenderness) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Recent reports of the prevalence and incidence of gout vary widely according to the population studied and methods employed but range from a prevalence of <1% to 6.8% and an incidence of 0.58-2.89 per 1,000 person-years. Gout is more prevalent in men than in women, with increasing age 7, According to above data, it becomes a great concern how to deal with Gout and treat properly. Modern science is using quick acting NSAIDS & uricosuric drugs to treat which have control over joint pain but have potential adverse effects also. Hence, an attempt has been made on the management on Vatarakta (Gout) with ayurvedic medicine in the form of Aahar Vihar & Guduchi churna. |