| CTRI Number |
CTRI/2024/11/077175 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of urolithiasis |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF IKSHU PANEEYA KSHARA AND MULAKA PANEEYA KSHARA IN THE MANAGEMENT OF MUTRASHMARI W.S.R 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 Meenakshi |
| Designation |
Post graduate scholar |
| Affiliation |
Taranath government ayurvedic medical college and hospital Dr rajkumar road ballari 583101 |
| Address |
Taranath government ayurvedic medical college and hospital Dr rajkumar road Ballari 583101
Bellary
KARNATAKA
583101
India |
| Phone |
9380987194 |
| Fax |
|
| Email |
meenakshigormude0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivalingappa J Arakeri |
| Designation |
Professor and Head of the Department post graduate studies in Shalyatantra |
| Affiliation |
Taranath government ayurvedic medical college and hospital Dr rajkumar road ballari 583101 |
| Address |
Dr Shivalingappa J Arakeri professor and Head of the department post graduate studies in Shalyatantra
Taranath government ayurvedic medical College and hospital Dr rajkumar road ballari 583101
Bellary
KARNATAKA
583101
India |
| Phone |
8105240452 |
| Fax |
|
| Email |
Shivu.doc.29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivalingappa J Arakeri |
| Designation |
Professor and Head of the Department |
| Affiliation |
Taranath government ayurvedic medical college and hospital dr rajkumar road ballari 583101 |
| Address |
Dr Shivalingappa J Arakeri
Professor and Head of the Department post graduate studies in Shalyatantra
Taranath government ayurvedic medical college and hospital dr rajkumar road ballari 583101
Bellary
KARNATAKA
583101
India |
| Phone |
8105240452 |
| Fax |
|
| Email |
Shibu.doc.29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Taranath government ayurvedic medical college and hospital dr rajkumar road ballari 583101 |
|
|
Primary Sponsor
|
| Name |
Dr Meenakshi |
| Address |
Taranath government ayurvedic medical college and hospital dr rajkumar road ballari 583101 |
| 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 Meenakshi |
Taranath government ayurvedic hospital bellary |
Department of post graduate studies in shalya tanta
Taranath government ayurvedic hospital bellary
Bellary
KARNATAKA |
9380987194
meenakshigormude0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Taranath government ayurvedic medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ikshu paneeya kshara , Reference: Raja nighantu , Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -pashanabhedadi qwatham ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mulaka paneeya kshara , Reference: Raja nighantu , Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Pashanabhedadi qwatha ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with symptoms of Mutrashmari
Pain abdomen
Burning Micturition
Frequency of Micturition
Calculi with mild hydronephrosis
Calculi with controlled DM and HTN
Stone size upto 1-8mm
|
|
| ExclusionCriteria |
| Details |
Stoghorn calculi
Severe hydronephrosis
Calculi with uncontrolled systemic diseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduce symptoms
Disintegration of stone |
28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce complications |
28days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/12/2024 |
| 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="0"
Months="0"
Days="28" |
|
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
|
Study entitled as A comparative clinical study to evaluate the efficacy of ikshu PANEEYA kshara and mulaka paneeya kshara in the management of mutrashmari wsr to urolithiasis is done in the Taranath government ayurvedic medical College and hospital Ballari in two groups and are compared for results. |