| CTRI Number |
CTRI/2024/12/077754 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study efficacy of Simhasyadi kwatha in management of Hyperuricemia. |
|
Scientific Title of Study
|
A clinical study of the effect of Simhasyadi kwatha in the management of Hyperuricemia. |
| 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 Aditi Acharya |
| Designation |
PG scholar |
| Affiliation |
Govt Ayurvedic College and Hospital Guwahati |
| Address |
Govt. Ayurvedic College and Hospital, Guwahati-14
Kamrup
ASSAM
781014
India |
| Phone |
9395876468 |
| Fax |
|
| Email |
dr.acharya.aditi271999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Pranabjyoti Baishya |
| Designation |
Principal i/c cum Professor , Govt Ayurvedic College Guwahati (Guide) |
| Affiliation |
Govt Ayurvedic College and Hospital Guwahati |
| Address |
Govt Ayurvedic College and Hospital Guwahati
Kamrup
ASSAM
781014
India |
| Phone |
8638019124 |
| Fax |
|
| Email |
drpjbaishya1967@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manir Uddin Dewan |
| Designation |
Assistant Professor, Dept of Kayachikitsa (co-guide) |
| Affiliation |
Govt Ayurvedic college and hospital Guwahati |
| Address |
Govt Ayurvedic College and Hospital Guwahati
Kamrup
ASSAM
781014
India |
| Phone |
9864174788 |
| Fax |
|
| Email |
dr.manir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic college and hospital Guwahati.781014 |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Acharya |
| Address |
Govt Ayurvedic college and hospital Guwahati, 781014 |
| 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 Aditi Acharya |
Govt Ayurvedic college and hospital Guwahati -14 |
OPD and IPD of Dept of Kayachikitsa, Govt Ayurvedic College and Hospital Guwahati -14
Kamrup
ASSAM |
9395876468
dr.acharya.aditi271999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Govt Ayurvedic College and Hospital Guwahati -14 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Febuxostat 40mg | Tab Febuxostat 40mg once daily after food | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Simhasyadi kwatha , Reference: Bhavaprakasha Vatarakta chikitsa prakaran 29/50-51, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both the sex and age between 20-70 years.2.Naive patients or newly diagnosed patients of Hyperuricemia.3.Patients having serum uric acid more than 6.9mg/dl.4. Patients of Hyperuricemia with Gouty Arthritis.5.Patient recently diagnosed with uncomplicated Hyperuricemia & Gouty Arthritis.6.Hyperuricemic patients suffering from controlled hypertension, diabetes mellitus, CKD upto stage 3. |
|
| ExclusionCriteria |
| Details |
1.Asymptomatic patient with Hyperuricemia. 2.Patients suffering from the complications of Hyperuricemia & Gouty Arthritis. 3.Pregnant and lactating women. 4.Presence of disease like CA, HIV, malignant hypertension, uncontrolled diabetes. 5. Patients suffering from major systemic illness or under long term drug treatment. 6.History of hypersensitivity to any of the trial drugs or their ingredients. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the effectiveness of SIMHASYADI KWATHA in management of symptomatology of Hyperuricemia. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of SIMHASYADI KWATHA and FEBUXOSTAT on serum uric acid level parameter. |
30, 45 and 60 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/ Phase 3 |
|
Date of First Enrollment (India)
|
17/12/2024 |
| 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 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
|
This is a clinical study of SIMHASYADI KWATHA in management of Hyperuricemia. This study is done as a mandatory Post graduation thesis work. Total number of 60 patients will be studied for 60 days each. |