| CTRI Number |
CTRI/2025/05/087319 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| 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
|
Role of Sharadi Panchmoolyadi Ghrita in comparison to Varunadi Kashaya in treatment of Mutraashmari(Urolithiasis) |
|
Scientific Title of Study
|
An Open Label Randomized Controlled Clinical Trial Comparing Sharadi Panchmoolyadi Ghrita with Varunadi Kashaya in Mutraashmari wsr 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 Kavita Rani |
| Designation |
MS PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center |
| Address |
OPD no-3,Department of Shalya Tantra,Kunwar Shekhar Vijendra Ayurved Medical College and Research Center,Shobhit University,Gangoh,Saharanpur,Uttar Pradesh
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9729984607 |
| Fax |
|
| Email |
dr.kavitachaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjit Singh Manhas |
| Designation |
Professor |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center |
| Address |
OPD no-3,Department of Shalya Tantra,Kunwar Shekhar Vijendra Ayurved Medical College and Research Center,Shobhit University,Gangoh,Saharanpur,Uttar Pradesh
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9461940996 |
| Fax |
|
| Email |
dr.raji83@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjit Singh Manhas |
| Designation |
Professor |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center |
| Address |
OPD no-3,Department of Shalya Tantra,Kunwar Shekhar Vijendra Ayurved Medical College and Research Center,Shobhit University,Gangoh,Saharanpur,Uttar Pradesh
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9461940996 |
| Fax |
|
| Email |
dr.raji83@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Kunwar Shekhar Vijendra Ayurved Medical College and Reseacrch center,Gangoh,Saharanpur,Uttar Pradesh,247341 |
|
|
Primary Sponsor
|
| Name |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center |
| Address |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center,Shobhit University,Gangoh,Saharanpur,Uttar Pradesh-247341 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kavita Rani |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Center |
OPD NO-3,Department Of Shalya Tantra,Kunwar Shekhar Vijendra Ayurved Medical College And Research Center,Shobhit University,Gangoh,Uttarpardesh 247341
Saharanpur
UTTAR PRADESH |
9729984607
dr.kavitachaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N22||Calculus of urinary tract in diseases classified elsewhere. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sharadipanchmoolyadi Ghrita, Reference: Chakardutta 34/39, Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -with lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varunadi Kashaya, Reference: Chakardutta 34/27, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Mutraashmari irrespective of chemical composition of calculi
Single/multiple urinary calculi Size of calculi measuring from 1 mm upto 15 mm
Patients suffering from recurrent stones
Patients having mild HDN. |
|
| ExclusionCriteria |
| Details |
Patients bearing size of urinary calculi more than 15 mm Cases with chronic systemic diseases like Diabetes Mellitus,BPH etc. Patients with disease related complications like moderate and severe HDN,uraemia,pyuria etc.
Pregnant women and lactating mothers Cases which require surgical intervention |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief of symptoms like 1. Pain 2. Dysuria |
zero day and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in sign and symptoms like
1. Haematuria 2. Pus cells 3. Radiological Findings a. Site of Stone b. Size of Stone c. Number of Stones |
zero day and 45th day |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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 |
|
Date of First Enrollment (India)
|
28/06/2025 |
| 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
|
This study is randomized , parallel group,active controlled trial comparing Sharadipanchmoolyadi Ghrita with Varunadi Kashaya in Mutraashmari wsr to Urolithiasis in 94 patients aged between 18 yrs to 60 yrs,over a period of 18 months.The patients will be selected on the basis of inclusion and exclusion criteria.Trial will be of 45 days.During the trial assessment will be done on zero day and 45th day. After trial,follow up will be done on the 30th day after cessation of procedure. |