| CTRI Number |
CTRI/2025/03/082095 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Manjishtadi kwatham and kaisora guggulu in increased serum uric acid level |
|
Scientific Title of Study
|
Effect of Manjishtadi kwatham and kaisora guggulu in 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 ANCY S J |
| Designation |
SECOND YEAR PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
| Address |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
DEPARTMENT OF KAYACHIKITSA GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946131173 |
| Fax |
|
| Email |
ancysj1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANCY S J |
| Designation |
SECOND YEAR PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
| Address |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
DEPARTMENT OF KAYACHIKITSA GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946131173 |
| Fax |
|
| Email |
ancysj1993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANCY S J |
| Designation |
SECOND YEAR PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
| Address |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
DEPARTMENT OF KAYACHIKITSA GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946131173 |
| Fax |
|
| Email |
ancysj1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM , KERALA
PIN CODE 695001 |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT AYURVEDA COLLEGE |
| Address |
DEPARTMENT OF KAYACHIKITSA GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
| Type of Sponsor |
Government 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 ANCY S J |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
DEPARTMENT OF KAYACHIKITSA GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
Thiruvananthapuram
KERALA |
09946131173
ancysj1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITEE FOR ETHICS IN RESEARCH GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MANJISTADI KASAYAM , Reference: SAHASRAYOGAM, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KAISORA GUGGULU, Reference: SAHASRAYOGAM, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants of all gender of age group 30 to 60 years having serum uric acid levels above 7 mg/dl for men and 6 mg/dl for women respectively |
|
| ExclusionCriteria |
| Details |
A Pregnancy and lactation
B Known cases of medications for any type of
neoplastic diseases
C Patients on prolonged medications
antidepressants or diuretics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing lab values on Serum Uric Acid Values |
Based on lab investigation on Serum Uric Acid Values |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Serum uric acid level |
Assessment will be done on 0th and 16th day |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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 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
|
The above study deals with assessing the effect of Manjishtadi kwatham and Kaisora guggulu in hyperuricemia. Evaluation is made on the changes in Serum Uric acid values. Assessment will be done on 0th and 16th day. |