| CTRI Number |
CTRI/2025/03/081582 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Haritaki churna with Guduchi kwath in Vaatrakta w.s.r. to Gouty Arthritis. |
|
Scientific Title of Study
|
A Clinical Study on efficacy of Haritaki churna with Guduchi kwath in Vaatrakta w.s.r. to Gouty Arthritis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Mishra |
| Designation |
MD(Ay.) Scholar(Kayachikitsa) |
| Affiliation |
Government Ayurvedic College and Hospital, Kadamkuan, Patna |
| Address |
Department of Kayachikitsa Government Ayurvedic College and Hospital, Kadamkuan, Patna
Patna
BIHAR
800003
India |
| Phone |
7982713752 |
| Fax |
|
| Email |
swatim216@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Bahadur Singh |
| Designation |
H.O.D , Associate Professor, Department of Kayachikitsa |
| Affiliation |
Government Ayurvedic College and Hospital, Kadamkuan, Patna |
| Address |
Department of Kayachikitsa, Government Ayurvedic College and Hospital, Kadamkuan, Patna
Patna
BIHAR
800003
India |
| Phone |
7004642738 |
| Fax |
|
| Email |
vijay.md09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Bahadur Singh |
| Designation |
H.O.D ,Associate Professor, Department of Kayachikitsa |
| Affiliation |
Government Ayurvedic College and Hospital, Kadamkuan, Patna |
| Address |
Department of Kayachikitsa,
Government Ayurvedic College and Hospital, Kadamkuan, Patna
Patna
BIHAR
800003
India |
| Phone |
7004642738 |
| Fax |
|
| Email |
vijay.md09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar - 800003 |
|
|
Primary Sponsor
|
| Name |
Dr Swati Mishra |
| Address |
Department of Kayachikitsa,Government Ayurvedic College and Hospital, Kadamkuan, Patna ,Bihar - 800003 |
| Type of Sponsor |
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 |
| Dr Swati Mishra |
Government Ayurvedic College and Hospital, Kadamkuan, Patna |
OPD No.-9,
Department of Kayachikitsa,Government Ayurvedic College and Hospital,Kadamkuan,Patna
Patna
BIHAR |
7982713752
swatim216@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Ayurvedic College, Kadamkuan, Patna |
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 | Drug | Classical | | (1) Medicine Name: Haritaki churna , Reference: Bhaisajya Ratnawali 27/8, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Sahapan- guda, Anupana-Guduchi kwath), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: -18 year to 65 year.
2.Patient having the clinical feature of vaatrakta and Gout
3.Patient having chronicity of vaatrakta less than 1year.
|
|
| ExclusionCriteria |
| Details |
1.Age- less than 18 year and more than 65 years.
2.Patient suffering from uncontrolled diabetes , cancer, cardiac problems, uncontrolled hypertension, acquired immunodeficiency syndrome(AIDS), tuberculosis (TB),renal disorder.
3.Other co-musculoskeletal disorders
4.Pregnant women and lactating mother.
5.Drug or Alcohol Abuse: A Known or suspected history of chronic alcohol or drug abuse.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The improvement in the patients will be assessed on the basis of relief in symptoms of disease like pain and stiffness in joints and numbness. |
The assessment of patients will be done at the interval of 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The analysis of the values of the serum uric acid will be done before and after the treatment and during the follow up to compare the condition of affected joints. |
The assessment of patients will be done at the interval of 15 days. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
06/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 interventional prospective trail to study the effect of haritaki churna with guduchi kwath in the management of vatarakta with special reference to gout in a group of 30 patients. This study will be conducted in Government Ayurvedic College and Hospital,Patna,Bihar in the department of Kayachikitsa. Follow up will be done every 15 days for the total duration of study i.e of 45 days. |