| CTRI Number |
CTRI/2025/07/090380 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Classical ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of haridraamrutak kwath in management of vatarakta in 20 to 60 years age group pepole |
|
Scientific Title of Study
|
Assessment of efficacy of Haridraamrutak kwath in Vatarakta : Randomized 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 Vaibhav Asaram Late |
| Designation |
PG Student |
| Affiliation |
PMT’S Ayurved College, shevgaon, Ahmednagar |
| Address |
PMT’S Ayurved College, Department of kayachikitsa,OPD and IPD, shevgaon, 414502 District Ahmednagar, Maharashtra
Ahmednagar
MAHARASHTRA
414502
INDIA
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
7020149340 |
| Fax |
|
| Email |
Vaibhavlate10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Shinde |
| Designation |
HOD and professor of KAYACHIKITSA DEPARTMENT |
| Affiliation |
PMT’S Ayurved College, shevgaon District Ahmednagar, Maharashtra |
| Address |
PMT’S Ayurved College, Department of kayachikitsa, shevgaon, 414502 District Ahmednagar, Maharashtra
Ahmadnagar
Maharashtra
414502
INDIA
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9405766631 |
| Fax |
|
| Email |
Vd.sandeepshinde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Shinde |
| Designation |
HOD and professor of KAYACHIKITSA DEPARTMENT |
| Affiliation |
HOD and professor of KAYACHIKITSA DEPARTMENT, PMT’S Ayurved College, shevgaon, Ahmednagar |
| Address |
PMT’S Ayurved College, Department of kayachikitsa third floor , shevgaon, District Ahmednagar, Maharashtra 414502 india
Ahmadnagar
Maharashtra
414502
INDIA
PMT’S Ayurved College, Department of kayachikitsa third floor, shevgaon, District Ahmednagar, Maharashtra 414502 ,India
Ahmadnagar
Maharashtra
414502
INDIA
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9405766631 |
| Fax |
|
| Email |
Vd.sandeepshinde@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMT’S Ayurved College shevgaon, 414502, District Ahmadnagar, Maharashtra |
|
|
Primary Sponsor
|
| Name |
PMTS Ayurved College shevgaon District Ahmednagar |
| Address |
PMT’S Ayurved College, Department of kayachikitsa, shevgaon,414502 District Ahmednagar, Maharashtra, INDIA |
| 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 Vaibhav Late |
Sant Eknath Ayurved Rugnalya,shevgaon District Ahmednagar |
Sant Eknath Ayurved Rugnalya
Department of kayachikitsa, OPD no 102 Shevgaon, 414502 District Ahmednagar, Maharashtra
Ahmednagar
Maharashtra
414502
INDIA
Ahmadnagar
MAHARASHTRA |
7020149340
-
Vaibhavlate10@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: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: Haridraamrutak kwath, Reference: Bhavaprakash madhyam khand vatarakta 29/79, 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: Amrutadi kwathb, Reference: Bhaishajyaratnavali 27/26, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient will be irrespective of socioeconomic status
2. Classical sign and symptoms of vatarakta
3. Patients willing to give informed written consent for clinical trial
4.age 20 to 60 years of either sex
|
|
| ExclusionCriteria |
| Details |
1. Patients with known case disorders like TB, Malignancy, HIV, trauma,
cardiac disease, Neurologicaldisorders,uncontrolled DM & HTN etc., associated with gout.
2. Pregnancy and lactating women.
3. Diagnosed cases of any severe arthritis condition like rheumatoid
arthritis, severe osteoarthritis and osteoporosis & deformities |
|
|
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 haridraamrutak kwath in treatment of vatarakta for 8weeks
|
Follow up on 2nd week, 4th week, 6th week ,8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To review literature about vatarakta in detail from ayurved samhita & textbooks.
2. To review literature about gout from modern books & internet.
3. To review literature about kwatha kalpna in the treatment of Vatarakta
4. To evaluate the efficacy of amrutadi kwatha in treatment vatrakta
5. To compare the efficacy of haridraamrutak kwatha & amrutadi kwatha the
treatment of vatarakta.
6. To observe the adverse drug reaction if any.
|
Assessment will be done on 0, 2nd,4th, 6th & 8th week for follow up.
|
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
18/07/2025 |
| 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="0"
Days="10" |
|
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 haridraamrutak 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 |