| CTRI Number |
CTRI/2025/02/081333 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Navakarshik ghanvati in vatarakta. |
|
Scientific Title of Study
|
Randomised open controlled clinical study to evaluate the efficacy of Navakarshik ghanvati in 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 Krishna Punasing pawar |
| Designation |
PG Scholer |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8329828951 |
| Fax |
|
| Email |
krishnapawar019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipali Swami |
| Designation |
Associated professor in kaychikisa deparment |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960003947 |
| Fax |
|
| Email |
drdipaliswamis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Punasing Pawar |
| Designation |
PG Scholer |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8329828951 |
| Fax |
|
| Email |
krishnapawar019@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kolhapur Maharashtra 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Krishna Punasing Pawar |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India |
| 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 Krishna Punasing Pawar |
Yashwant Dharmartha Rugnalay |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA |
8329828951
krishnapawar019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur Maharashtra India |
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: NAVAKARSHIK GHANAVATI, Reference: Chakrdat vatrakta chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: Consumption with pathya ahara vihara | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi Guggul, Reference: Shardharshmita madham khand, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: Consumption with pathya ahara vihara | | 3 | Comparator Arm | Drug | Classical | | | | 4 | Comparator Arm | Drug | Classical | | | | 5 | Comparator Arm | Drug | Classical | | |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting Toda Shotha and Sthabdhata in relation to Parvasandhi
Patients having serum uric acid level more than 7mg/dl in male and more than 6mg/ dl in female. |
|
| ExclusionCriteria |
| Details |
Known case of Amavata Sandhigatvata SLE
Patient on chronic use of NSAIDS and steroidal inflammatorydrugs
Pregnancy Lactating mothers
Patients prediagnosed with autoimmune diseases of joint
Patients with severe toxicity, ulceration, progressive gangrenous changes, and suffering from diseases of immunological basis.
Patients associated with metabolic disorders and systemic diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Nawakarshika ghanvati in vatarakta. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce the signs and symptoms of Vatarakta.
To assess the improvement by signs, symptoms and gradation of assessment criteria.
To study etiopathology & clinical manifestation of Vatarakta.
To improve quality of life and reduce discomfort of Patient.
To achieve the outcome of study in 1 month. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
05/03/2025 |
| 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="1"
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
|
RANDOMISED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE
THE EFFICACY OF NAVAKARSHIK GHANAVATI IN VATRAKTA W.S.R. TO GOUT.
The assesment of signs and symptoms will be done at regular follow ups. Observation will be drawn from the outcomes achieved in 30 days .
|