| CTRI Number |
CTRI/2023/05/052761 [Registered on: 17/05/2023] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Guda Haritaki in Gout |
|
Scientific Title of Study
|
Efficacy of Guda Haritaki in the disintegration of pathogenesis of Vatarakta (Gout)- A single arm clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preeti |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary brahm prakash ayurved charak sansthan khera dabar Najafgarh New Delhi 110073 |
| Address |
PG Department of Rog Nidan Evum Vikruti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh New Delhi 110073
South West
DELHI
110073
India |
| Phone |
9315412844 |
| Fax |
|
| Email |
preetiranta4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditaya Nath Tewari |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh NEW Delhi 110073 |
| Address |
PG Department of Rog Nidan Evum Vikruti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh New Delhi 110073
West
DELHI
110073
India |
| Phone |
|
| Fax |
|
| Email |
dr.aditaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditaya Nath Tewari |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh New Delhi 110073 |
| Address |
PG Department of Rog Nidan Evum Vikruti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh New Delhi 110073
South West
DELHI
110073
India |
| Phone |
|
| Fax |
|
| Email |
dr.aditaya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan |
|
|
Primary Sponsor
|
| Name |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi, 110073 |
| Type of Sponsor |
Government medical college |
|
|
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 Preeti |
Ch. Brahm Prakash Ayurved Charak Sansthan |
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar
South West
DELHI |
9315412844
preetiranta4@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: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: Guda Haritaki, Reference: Chakradutta, Vatarakta Chikitsa : chapter 23, 8, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Guduchi kashaya), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients of Vatarakta (Gout) with Hyperuricaemia and presenting with the classical sign and symptoms of Vatarakta (Gout)
Subjects consenting to participate in the study |
|
| ExclusionCriteria |
| Details |
Subjects suffering from other systemic illnesses
Subjects suffering from autoimmune diseases of the joints
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study is expected to be helpful in the management of Vatarakta (Gout)
|
45 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will provide cost effective, safe drug with lesser side effects |
12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| Date of Study Completion (India) |
15/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/05/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vatarakta is Vata pradhan Tridoshaj Vyadhi and its main Dushya is Rakta. According to Acharya Sushrut "Akhorvishamiv krudham deham anusarpati" (in aggravated stage, it spreads in whole body like rat poison)Gout is typically characterized by episodic acute and chronic arthritis and pain and swelling of first metatarsophalangeal joint initially, followed by involvement of other joints.
Hyperuricaemia leads to formation and deposition of monosodium urate crystals (MSU crystals) which advantageously deposits in bursa, joints, tendons and its spaces and eventually forms nodular swellings called tophi.
Vatarakta (Gout) is a common presentation with symptoms like severe pain, inflammation, burning sensation and tenderness in the affected joints. Small joints of feet and hands are mainly affected in Gout.
Present study is aimed to evaluate the efficacy of Guda Haritaki with Guduchi Kashaya in Vatarakta (Gout)
Study type is interventional and study design is Single Arm Clinical Trial with sample size of 50 patients. 3gm of Haritaki along with 3gm of Guda will be given with 40 ml of Guduchi Kashaya, twice daily, before meals for 45 days. This study is expected to be helpful in clinical management of Vatarakta (Gout)
|