| CTRI Number |
CTRI/2025/03/081591 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the effect of shvadanshtradi kwatha and varunadi kwatha in urolithiasis urolithias(mutrashmari) |
|
Scientific Title of Study
|
Randomised comparative clinical study to evaluate the efficacy of shvadanshtradi kwatha and varunadi kwatha in the management of mutrashmari with special reference to urolithiasis |
| 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 arvind kumar |
| Designation |
Pg scholar |
| Affiliation |
Madan mohan malviya government ayurved college udaipur rajasthan |
| Address |
Kayachikitsa deparment madan mohan malviya government ayurved college udaipur rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460841957 |
| Fax |
|
| Email |
dhaterwalarvind.885@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr indumati sharma |
| Designation |
Associate professor |
| Affiliation |
Madan mohan malviya government ayurved college udaipur rajasthan |
| Address |
Kayachikitsa deparment madan mohan malviya government ayurved college udaipur rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
7976972310 |
| Fax |
|
| Email |
drindusharma4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr arvind kumar |
| Designation |
Pg scholar |
| Affiliation |
Madan mohan malviya government ayurved college udaipur rajasthan |
| Address |
Kayachikitsa deparment madan mohan malviya government ayurved college udaipur rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460841957 |
| Fax |
|
| Email |
dhaterwalarvind.885@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan mohan malviya govt ayurved college, udaipur, rajasthan pin 313001 |
|
|
Primary Sponsor
|
| Name |
Madan mohan malviya government ayurved college udaipur |
| Address |
Madan mohan malviya govt ayurveda college udaipur rajasthan pin code 313001 |
| 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 arvind kumar |
Madan mohan malviya government ayurveda college udaipur |
OPD no.3 kayachikitsa department Madan mohan malviya govt ayurveda college udaipur rajasthan pin code 313001
Udaipur
RAJASTHAN |
9460841957
dhaterwalarvind.885@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutinal ethics committee mmm govt ayurved college ambamata udaipur raj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N23||Unspecified renal colic. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varunadi kwatha , Reference: Chakrdatt ashmri chikitsa 34/29, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: NA | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shvadanshtradi kwatha , Reference: Chakrdatt ashmri chikitsa 34/30, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1. Age between 18 to 70 years of both sex
2. Clinically and pathologically diagnosed patient all type of Mutrashmari.
3. Patients not taking any other medicine for Mutrashmari.
4. Size of the stone up to 12mm.
5. Stone will be present in kidney, ureter, urinary bladder
6. Multiple urinary stone |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1. Age below 18 years and above than 70 years.
2. Patients with obstructive uropathy.
3. Patients suffering from any major systemic disease like uncontrolled diabetes mellitus, uncontrolled hypertension, Renal failure, Renal tuberculosis etc.
4. Pregnant women.
5. Size of stone more than 12mm. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief in sign and symptoms |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Find changes in usg-size of calculi, Number of calculi
Find changes in Microscopic urine examination-hematuria
Find changes in blood urea, serum creatinine |
30 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 3 |
|
Date of First Enrollment (India)
|
20/04/2025 |
| 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 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
|
RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHVADANSHTRADI KWATHA AND VARUNADI KWATHA IN THE MANAGEMENT OF MUTRASHMARI WITH SPECIAL REFERENCE TO UROLITHIASIS There will be two group in the study. in Group A randamly selected and clinically diagnosed 30 patient of Mutrashmari will be given Shvadanshtradi kwatha twice a day before meal, Group B 30 patient of Mutrashmari will be given Vraunadi kwatha twice a day before meal. both, trial will be conduct for a period of 1 months. Follow up of the case will be after 15 days that is two time during treatment. Final assesment will be done after completion of one month course on the basis of subjective and laborateral assesment.
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