| CTRI Number |
CTRI/2024/07/071116 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
kidney ki pathhri me asardar varunadi aur moringa ka ayurvedic kadha |
|
Scientific Title of Study
|
A Clinico Comparative study of Varunadi Kvatha & Shigru Mula Tvak Kvatha In The Managment Of Mootrashmari Urinary Calculus |
| 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 Meghasinh D Rajput |
| Designation |
PHD Scholar |
| Affiliation |
Shree Swaminarayan Ayurvedic College Kalol Gandhinagar |
| Address |
room no. 12, Kayachikitsa Department, PhD Division, Shree Swaminarayan Ayurvedic College Swaminarayan Univesity Kalol Gandhinagar
Gandhinagar
GUJARAT
382725
India |
| Phone |
7600162153 |
| Fax |
|
| Email |
rajputmeghasinh9595@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tapan kumar Vaidya |
| Designation |
Head of Department of Kayachikitsa Department |
| Affiliation |
Shree Swaminarayan Ayurvedic College Kalol Gandhinagar |
| Address |
Room Number 12, Kayachikitsa Department, PhD Division, Shree Swaminarayan Ayurvedic College Swaminarayan Univesity Kalol Gandhinagar
Gandhinagar
GUJARAT
382725
India |
| Phone |
9924304388 |
| Fax |
|
| Email |
vdtapankumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghasinh D Rajput |
| Designation |
PHD Scholar |
| Affiliation |
Shree Swaminarayan Ayurvedic College Kalol Gandhinagar |
| Address |
Room number 12, Kayachikitsa Department, PhD Division, Shree Swaminarayan Ayurvedic College Swaminarayan Univesity Kalol Gandhinagar
Gandhinagar
GUJARAT
382725
India |
| Phone |
7600162153 |
| Fax |
|
| Email |
rajputmeghasinh9595@gmail.com |
|
|
Source of Monetary or Material Support
|
| Monark Ayurveda Medical College And Hospital Monark University At & Post valelal gam Naroda Dehgam Road Taluka Dascroi Ahmedabad Gujarat India Pincode 382330 |
|
|
Primary Sponsor
|
| Name |
Self funding Dr Meghasinh Rajput |
| Address |
PhD scholar in Kayachikitsa Department Swaminarayan Ayurvedic College Swaminarayan University Kalol Gandhinagar Gujarat India Pincode 382725 |
| 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 |
| Meghasinh Rajput |
Monark Ayurved Medical Hospital And College Monark univesity |
Room number 10 OPD Division Kayachikitsa Department At and Post Vahelal Naroda Dehgam Road Taluka Dascroi District Ahmedabad Gujarat India Pincode 382330
Ahmadabad
GUJARAT |
7600162153
rajputmeghasinh9595@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Swaminarayan University Kalol |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N202||Calculus of kidney with calculus of ureter. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varunadi Kvatha, Reference: AFI-4:22 AYUSH Department, Govt. Of India,, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: total Duration 6 months-3 month of medicine and 3 month of observation (follow up on each month) | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shigrumula tvak, Reference: Astang hridaya chikitsa sthan 11 Mutraghat Chikitsa shlok number 30, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -total duration 6 months-3 month of medicine and 3 month of observation (follow up on each month) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
In irrespective of gender caste religion and region etcetera
Stone size up to 10mm evident in USG
|
|
| ExclusionCriteria |
| Details |
1 Patients with severe and acute pain which require medical emergency treatment or immediate surgical intervention
2 Cases with severe hydronephrosis
3 Severe Hematuria
4 Acute or Chronic renal disease
5 Acute retention of urine for more than 24 hours
6 Hyperparathyroidism
7 Developmental defects or structural abnormalities of kidney
8 Neoplastic conditions
9 Endocrinal diseases
10 Staghorn stone
11 Immuno compromised patients
12 Immigrants |
|
|
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 |
| To analyze the effectiveness of shigrumula tvaka kvatha and vaunadi kvatha in the managment of mutrsahmari |
Total 200 patients from India only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All the sign symptoms & investigation will get compared At the time of enrollment, After 03 month of trial & at the end of trial. |
After 03 month of trial Each Assessment will be carried out based on Changes in Sign Symptoms & Investigations. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
02/08/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
In this PhD thesis study we are comparing the effectiveness of Shigru mula tvak kvatha in the pathological condition of Mutrashmari (Urinary Calculus) along with comparison of a standard well established Ayurveda medicine Varunadi kvatha. Effectiveness of Shigru mula tvak kvatha is not yet well identified by research platform this thus this research study will make this possible. Mentioned Drug "Shigrumula tvak kvatha (decoction)" with the controlled group of already established Ayurveda Classical mentioned medicine "Varunadi kvatha (decoction)" in the managment of mootrashmari (Urinary Calculus). Total sample size would be 200. Both of the groups will contains Equal number of patient 100 in this study. By comparing before treatment and after treatment signs, symptoms & investigational findings this study is lead to determine the effective changes in the pathological conditions of mutrashmari (urinary calculus) which is yet not identified in a detailed manner with the shigrumula tvaka kvatha medicinal benefits With this research we can reach out to the new direction of Ayurveda medicinal benefits in the society which are not yet identified. This Research lead to good cultivation of shigru with further scopes to detailed research on each attribute we are going to be find. Along with that this Research will be publish into recognized and certified platform too. |