| CTRI Number |
CTRI/2023/01/048748 [Registered on: 04/01/2023] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Kushmanda swarasadi yoga in the management of Mutrashmari(Urolithiasis) |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of kushmanda swarasadi yoga over varunamula 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 Kavitha D |
| Designation |
BAMS PG Scholar |
| Affiliation |
BLDEAS AVS Ayurveda Mahavidyalaya, Vijayapura |
| Address |
Dr Kavitha D
1st Year PG Scholar
Dept of Shalyatantra
BLDEAS AVS Ayurveda Mahavidyalaya, Hospital and Research Centre, Vijayapura 586109
Bijapur
KARNATAKA
586109
India |
| Phone |
7899261107 |
| Fax |
|
| Email |
dr.kavithad7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aneesur Rehman M Madni |
| Designation |
Associate Professor |
| Affiliation |
BLDEAS AVS Ayurveda Mahavidyalaya Vijayapur |
| Address |
DR Aneesur Rehman M Madni
Associate professor
Dept. of PG Studies in Shalyatantra
BLDEAS AVS Ayurveda Mahavidyalaya, Hospital and Research Centre, Vijayapur 586109
Bijapur
KARNATAKA
586109
India |
| Phone |
9538140448 |
| Fax |
|
| Email |
anees8804@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aneesur Rehman M Madni |
| Designation |
Associate Professor |
| Affiliation |
BLDEAS AVS Ayurveda Mahavidyalaya Vijayapur |
| Address |
DR Aneesur Rehman M Madni
Associate professor
Dept. of PG Studies in Shalyatantra
BLDEAS AVS Ayurveda Mahavidyalaya, Hospital and Research Centre, Vijayapur 586109
KARNATAKA
586109
India |
| Phone |
9538140448 |
| Fax |
|
| Email |
anees8804@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatantra OPd
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA,VIDYANAGARA,BAGALKOT ROAD,VIJAYAPURA, 586109 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Kavitha D |
BLDEAS AVS Ayurveda Mahavidyalaya Vijayapur |
Shalyatantra OPD,
BLDEAS AVS Ayurveda Mahavidyalaya Vijayapur 586109
Bijapur
KARNATAKA |
7899261107
dr.kavithad7@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: kushmanda swarasadi yoga, Reference: chakradatta, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varunamula kwatha, Reference: bhavaprakasha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the Diagnostic Criteria.
presence of calculi from 4mm to 9mm size, confirmed by USG either unilaterally or bilaterally.
patients with solitary or multiple calculi.
Pain with or without Hematuria.
Pain with or without Dysuria. |
|
| ExclusionCriteria |
| Details |
Patient with retention of urine due to any other pathology.
patient with other systemic disorder like Diabetes and HTN.
Pregnant women and Lactating mothers
Paneeya kshara anarha patients.
Stag horn calculi
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the size of renal calculi
Expulsion of calculi |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
subsiding of renal pain
subsiding of other associateted symptoms |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/06/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is comparative clinical study to evaluate the efficacy of Kushmanda swarasadi yoga over Varunamula Kwatha in the management of Mutrashmari, that will be conducted in BLDEAS AVS Ayurveda Mahavidyalaya, Hospital and Research Centre, Vijayapur - 586109 Karnataka, India. For this study all the classical and modern literature are gathered by referring all available textbooks, internet sources, articles etc... total 40 patients are included in the study based on includion and exclusion criteria which are randomly divided into 2 groups namely Group A and Group B. Group A patients are treated with Kushmanda swarasadi yoga 24ml before food in BD dose and Group B patients are treated with Varunamula kwatha 20ml before foodin BD dose. All the signs and symptoms are noted and gradings were given before and after the treatment and results were drawn. Statistically result was effective in both groups on comparing group A with Group B, there was no significance difference between both the groups. |