| CTRI Number |
CTRI/2025/05/087320 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study effect of Trikarshika ghanvati in treating gout ( vaatarakta) |
|
Scientific Title of Study
|
Randomised Controlled Trial of Trikarshika Ghanavati in the management of vaatarakta 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 |
Dr Divya Shriniwas Pogul |
| Designation |
MD Scholar |
| Affiliation |
Department of Kayachikitsa Shree Saptashrungi Ayurved Mahavidyalaya And Hospital Nashik |
| Address |
OPD No.2 , Department Of Kayachikitsa,Shree Saptashrungi
Ayurved Mahavidyalaya And Hospital ,Kamal nagar, HiraWadi,
Panchvati, Nashik, Maharashtra 422003
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
8766573836 |
| Fax |
|
| Email |
poguldivya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Popat Vishvanath Jagtap |
| Designation |
Professor |
| Affiliation |
Department of Kayachikitsa Shree Saptashrungi Ayurved Mahavidyalaya And Hospital Nashik |
| Address |
OPD No. 2 , Department of Kayachikitsa, Shree Saptashrungi Ayurved Mahavidyalaya And Hospital, Kamal nagar, Hirawadi , Panchvati , Nashik , Maharashtra.
422003
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822852144 |
| Fax |
|
| Email |
drpvjagtap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Shriniwas Pogul |
| Designation |
MD Scholar |
| Affiliation |
Department of Kayachikitsa Shree Saptashrungi Ayurved Mahavidyalaya And Hospital Nashik |
| Address |
OPD No.2 , Department Of Kayachikitsa,Shree Saptashrungi
Ayurved Mahavidyalaya And Hospital ,Kamal nagar, HiraWadi,
Panchavati, Nashik, Maharashtra 422003
. India
Nashik
MAHARASHTRA
422003
India |
| Phone |
8766573836 |
| Fax |
|
| Email |
poguldivya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa Shree Saptashrungi Ayurved Mahavidyalaya And Hospital Kamal nagar Hirawadi Panchvati Nashik Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved Mahavidyalaya Kamal nagar Hirawadi Panchvati Nashik |
| Address |
Department of Kayachikitsa
Shree Saptashrungi Ayurved Mahavidyalaya Kamal nagar Hirawadi Panchvati Nashik Maharashtra 422003 |
| 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 Divya Shriniwas Pogul |
Shree Saptashrungi Ayurved Mahavidyalaya And Hospital |
Department of Kayachikitsa Shree Saptashrungi Ayurved Mahavidyalaya And Hospital Kamal nagar Hirawadi Panchvati Nashik Maharashtra 422003
Nashik
MAHARASHTRA |
8766573836
poguldivya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya 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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trikarshika ghanavati, Reference: Chakradatta , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jal), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Febuxostat | Tab .Febuxostat 40 mg BD (Morning evening after food) orally 30 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having uric acid level between 6mg/dl to 10mg/dl |
|
| ExclusionCriteria |
| Details |
1. Amavata (Rheumatoid Arthritis)
2. Sandhigata vaata
3. With H/O malignancy HIV trauma Cardiac disease Neurological disorders etc associated with gout
4. Pregnant women and lactating mother |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of gout. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where trial group stands in comparison with control group in reducing signs and symptoms of gout |
18 months |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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
|
Primary Objective - 1.To study the effect of Trikarshika ghanvati in the management of vaatarakta. Secondary objective- 1.To study the difference of the effect of Febuxostat and Trikarshika ghanvati in the management of vaatarakta. Other Objective- 1.To review and study the literature of vaatarakta. 2.To review and study the literature of Gout.
Study-Randomised Control Trial Intervention- Group A- Trikarshika ghanvati 500 mg bd Group B- Febuxostat 40 mg bd
Duration of Treatment- 30 days Initial Assessment 0n 1 st day Follow up- 15th ,30 th day
Data analysis Data will be analysed using appropriate statistical methods to compare the effectiveness of intervention on the primary and secondary outcomes.
Ethical Consideration - The study will be conducted in accordance with Ethical Guidelines and with informed consent from participants. |