| CTRI Number |
CTRI/2025/05/086232 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of patients of Vatarakta with Mustadi kwath |
|
Scientific Title of Study
|
Assessment of efficacy of Mustadi kwath in Vatarakta: Randomised controlled trial |
| 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 Balraj Vishwanathrao Lokhande |
| Designation |
PG Student |
| Affiliation |
PMT’s Ayurved College Shevgaon, Ahmednagar |
| Address |
PMT’s Ayurved College, Department of Kayachikitsa, OPD & IPD, Shevgaon 414502, District Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9860534993 |
| Fax |
|
| Email |
Lokhandebalrajv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Shinde |
| Designation |
HOD & Professor of KAYACHIKITSA DEPARTMENT |
| Affiliation |
PMT’s Ayurved College Shevgaon, Ahmednagar |
| Address |
PMT’s Ayurved College, Department of Kayachikitsa , Shevgaon, 414502, District Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9405766631 |
| Fax |
|
| Email |
vd.sandeepshinde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Shinde |
| Designation |
HOD & Professor of KAYACHIKITSA DEPARTMENT |
| Affiliation |
PMT’s Ayurved College Shevgaon, Ahmednagar |
| Address |
PMT’s Ayurved College ,Department of Kayachikitsa,Shevgaon, 414502, District Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9405766631 |
| Fax |
|
| Email |
vd.sandeepshinde@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMT’s Ayurvedic College Shevgaon 414502, District Ahmednagar, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Balraj Vishwanathrao Lokhande |
| Address |
PMT’s Ayurved College , Department of Kayachikitsa,Shevgaon, 414502, District Ahmednagar, Maharashtra |
| 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 Balraj Vishwanathrao Lokhande |
PMT’s Ayurved College & Sant Eknath Ayurved Rugnalaya, Shevgaon |
PMT’s Ayurved College, Department of Kayachikitsa OPD IPD,Shevgaon, 414502, District Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA |
9860534993
Lokhandebalrajv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E729||Disorder of amino-acid metabolism,unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mustadi kwath, Reference: Bhavprakash madhyam khand vatrakta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vasadi kwath, Reference: Yogratnakar Vatrakta chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Erand Tail), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 20 to 60
2. Classical sign & symptoms of any type of vatarakta.
3. Patients of Hyperuricemia |
|
| ExclusionCriteria |
| Details |
1. Patients with known cases of TB, Malignancy, HIV, Trauma, Cardiac disease, Neurological Disorders, Uncontrolled Diabetes Mellitus, Hypertension etc.
2. Pregnant and lactating mothers.
3. Diagnosed cases of rheumatoid arthritis, severe osteoarthritis and osteoporosis etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Mustadi Kwath in treatment of Vatarakta. |
Assessment will be Regular follow up On 0th, 2nd , 4th , 6th, 8th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To review literature about Vatarakta & Kwath Kalpana from various Samhita’s.
2. To review literature about Gout from various Modern Medicine books.
3. To evaluate the efficacy of Vasadi Kwath in treatment of Vatarakta.
4. To compare the efficacy of Mustadi Kwath & Vasadi Kwath in the
management of Vatarakta.
5. To observe adverse drug reaction if any occurs. |
Assessment will be Regular follow up On 0th, 2nd , 4th , 6th, 8th week. |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
12/05/2025 |
| 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="10"
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
|
To assess the efficacy of Mustadi Kwath in treatment of Vatarakta. Study will be carried out in OPD IPD of Kayachikitsa in PMT’s Ayurveda College and Sant Eknath Rugnalaya Shevgaon Ahmednagar. |