| CTRI Number |
CTRI/2025/01/079402 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study of Vatsadanyadi kwatha and Patoladi kwatha for Gout. |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of vatsadanyadi kwatha and patoladi kwatha in the management of vatarakta with special reference 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 |
DrNisha Amrutrao Dhotre |
| Designation |
PG scholar Kayachikitsa Department |
| Affiliation |
Shree Saptshrungi Ayurved Mahavidyalaya and hospital Kamalnagar Hirawadi Panchavati Nashik |
| Address |
OPD no 2 Kayachikitsa Department ground floor shree saptshrungi ayurved Mahavidyalaya Kamalnagar Hirawadi panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8600431589 |
| Fax |
|
| Email |
drdhotrenisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somdatta Bhaskarrao Kulkarni |
| Designation |
HOD of Kayachikitsa Department |
| Affiliation |
Shree Saptshrungi Ayurved Mahavidyalaya and hospital Kamalnagar Hirawadi Panchavati Nashik |
| Address |
OPD no 2 Kayachikitsa Department ground floor shree saptshrungi ayurved Mahavidyalaya Kamalnagar Hirawadi panchavati Nashik Maharashtra
Nashik
MAHARASHTRA
422003
India |
| Phone |
9860268117 |
| Fax |
|
| Email |
somdattak85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Somdatta Bhaskarrao Kulkarni |
| Designation |
HOD |
| Affiliation |
Shree Saptshrungi Ayurved Mahavidyalaya and hospital Kamal nagar Hirawadi panchavati nashik |
| Address |
OPD no 2 Kayachikitsa Department ground floor shree saptshrungi ayurved Mahavidyalaya Kamalnagar Hirawadi panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9860268117 |
| Fax |
|
| Email |
somdattaak85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree saptashrungi Ayurved medical College and hospital,Kamal nagar,Hirawadi,panchavati,Nashik Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Shree saptshrungi Ayurved Mahavidyalaya,Kamal nagar,Hirawadi,Panchavati,Nashik |
| Address |
Department of Kayachikitsa,shree saptshrungi Ayurved Mahavidyalaya,Kamal nagar,Hirawadi,panchavati,Nashik Maharashtra 420003 |
| Type of Sponsor |
Private 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 Nisha Amrutrao Dhotre |
Shree Saptshrungi Ayurved Mahavidyalaya and hospital Kamalnagar Hirawadi Panchavati Nashik |
OPD no 2 Kayachikitsa Department ground floor shree saptshrungi ayurved Mahavidyalaya Kamalnagar Hirawadi panchavati Nashik
Nashik
MAHARASHTRA |
8600431589
drdhotrenisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Shree Saptshrungi Ayurved Mahavidyalaya and hospital Kamalnagar Hirawadi panchavati nashik |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vatsadanyadi kwatha , Reference: Bharat bhaishajya Ratnakar , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patoladi kwatha , Reference: Yogratnakar samhita , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients will be selected irrespective of their sex religion geographical areas and economical conditions
Patients have fulfilling criteria for vatarakta such as Sandhishul a Sandhisotha Sandhigraha kandu Sandhidaha
Age group 20 to 60 years
Patients having uric acid level greater than 7 mg per dl in male and greater tha 6 mg per dl in female
Newly diagnosed cases of vatarakta |
|
| ExclusionCriteria |
| Details |
1.Amavata (Rheumatoid Arthritis)
2. Sandhigatavata
3. With H/o Tuberculosis, malignancy, HIV, Trauma, Cardiac disease, Neurological disorders etc., associated with gout.
4. patient carring pregnancy and lactating mother.
5.patient having known complications of gout.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the signs and symptoms of vatarakta |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of vatarakta |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
05/02/2025 |
| 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="0"
Days="0" |
|
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
|
Primary Objective: To compare the efficacy of Vatsadanyadi kwatha and Patoladi kwatha in Vatarakta with special reference to Gout.
Secondary Objectives: 1. To study the disease Vatarakta in Detail According to Ayurveda. 2. To Study Gout in Detail. 3. To Study the efficacy of Vatsadanyadi kwatha in Gout with special reference to Gout. 4. To Study the efficacy of Padoladi kwatha in Gout with special reference to Gout.
Participant
60 Adult diagnosed with vatarakta meeting inclusion and exclusion criteria from OPD and IPD of Shree Saptshrungi Ayurved Mahavidyalaya and hospital Kamalnagar Hirawadi Panchavati Nashik
Interventions
30 patient Vatsadanyadi kwatha: administered according to standardized protocol. 30 patient Patoladi kwatha: administered according to standardized protocol.
Primary Outcomes: Reduce signs and symptoms of Vatarakta
Secondary outcomes: No recurrency of vatarakta
Treatment Duration: 30days
Follow up: 0th, 15th, 30th days
Data analysis: Data will be analysed using appropriate statistical method to compare the effectiveness of the intervention on the primary and secondary outcomes
Ethical considerations: The study will be conducted in accordance with ethical guidelines and with informed consent from participants |