| CTRI Number |
CTRI/2025/03/082018 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| 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 kidney stone (Mutra Ashmari) |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF VISHADI VATI IN THE MANAGEMENT OF MUTRASHMARI (UROLITHIASIS) WITH TWO DIFFERENT ANUPANAS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Reddy K |
| Designation |
Post Graduate Scholar |
| Affiliation |
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL |
| Address |
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL, CHENNAI BANGLORE HIGHWAY, NAZARATHPET, CHENNAI 600123
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL, CHENNAI BANGLORE HIGHWAY, NAZARATHPET, CHENNAI, 600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7022191397 |
| Fax |
|
| Email |
reddyr268@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Saravanan |
| Designation |
Professor, Department of Rasashastra and Bhaishajya Kalpana |
| Affiliation |
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL |
| Address |
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL, CHENNAI BANGLORE HIGHWAY, NAZARATHPET, CHENNAI 600123
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL, CHENNAI BANGLORE HIGHWAY, NAZARATHPET, CHENNAI, 600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9791844576 |
| Fax |
|
| Email |
drsaravanan2k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Rakesh Reddy K |
| Designation |
Post Graduate Scholar |
| Affiliation |
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL |
| Address |
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL, CHENNAI BANGLORE HIGHWAY, NAZARATHPET, CHENNAI 600123
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL, CHENNAI BANGLORE HIGHWAY, NAZARATHPET, CHENNAI, 600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9791844576 |
| Fax |
|
| Email |
reddyr268@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rakesh Reddy K |
| Address |
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL, CHENNAI BANGLORE HIGHWAY, NAZARATHPET, CHENNAI, 600123 |
| 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 Rakesh Reddy K |
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL |
SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL, CHENNAI BANGLORE HIGHWAY, NAZARATHPET, CHENNAI, 600123
Thiruvallur
TAMIL NADU |
7022191397
reddyr268@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: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: Vishadi Vati, Reference: Basavarajeeyam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Hareetaki Kashaya), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vishadi Vati, Reference: Basavarajeeyam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Tandulodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of any gender and age between 20 to 60 years
2.Patients with Samanya Lakshanas of Mutrashmari
3.Size of stone 6mm and below
4.Patient willing to sign consent form |
|
| ExclusionCriteria |
| Details |
1.Known case of severe systemic disorder like Renal failure, Tuberculosis, Pyelonephritis, Polycystic Kidney disease.
2.Calculus with severe Hydronephrosis.
3.Obstructive calculi with severe infection.
4.Pregnent women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in size of stone, Reduction number of stones, and Reduction in symptoms |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/03/2025 |
| 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="0"
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
|
Urolithiasis is common, with prevalence of about 12% worldwide. Urolithiasis which are commonly called as Kidney stones. In Ayurveda it can be corelated to Mutrashmari as its symptoms goes hand in hand with Urolithiasis. Signs and symptoms of urolithiasis includes Severe, sharp pain in the side and back, below the ribs. Pain that radiates to the lower abdomen and groin. pain or burning sensation while urinating. Nausea and vomiting.
|