| CTRI Number |
CTRI/2026/03/106263 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effectiveness of kasisa bhasma in the management of urinary stones (urolithiasis) |
|
Scientific Title of Study
|
A Randomised Controlled Trial to Evaluate the Efficacy of Kasisa Bhasma 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 Bhupesh Sahu |
| Designation |
Pg Scholar shalya tantra |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College and Hospital Ankali |
| Address |
Dept. of Shalya tantra, Dr N.A. Magadum Ayurvedic Medical College Hospital and Research centre Ankali Chikodi taluk Belgavi District Karnataka
Dr N.A. Magadum Ayurvedic Medical College Hospital and Research centre Ankali Chikodi taluk Belgavi District Karnataka
Belgaum
KARNATAKA
591213
India |
| Phone |
9406383224 |
| Fax |
|
| Email |
bhupeshsahu5555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan B Lalsange |
| Designation |
Associate Proffessor |
| Affiliation |
Dr N.A. Magadum Ayurvedic Medical College Hospital and Research centre Ankali |
| Address |
Dept. of Shalya tantra, Dr N.A. Magadum Ayurvedic Medical College Hospital and Research centre Ankali Chikodi taluk Belgavi District Karnataka
Belgaum
KARNATAKA
591213
India |
| Phone |
8748035055 |
| Fax |
|
| Email |
ambiciouspawan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pawan B Lalsange |
| Designation |
Associate Proffessor |
| Affiliation |
Dr N.A. Magadum Ayurvedic Medical College Hospital and Research centre Ankali |
| Address |
Dept. of Shalya tantra, Dr N.A. Magadum Ayurvedic Medical College Hospital and Research centre Ankali Chikodi taluk Belgavi District Karnataka
Belgaum
KARNATAKA
591213
India |
| Phone |
8748035055 |
| Fax |
|
| Email |
ambiciouspawan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Bhupesh sahu |
| Address |
Dr N.A. Magadum Ayurvedic Medical College Hospital and Research centre Ankali Chikodi taluk Belgavi District Karnataka
591213
India |
| 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 Bhupesh sahu |
Dr N.A. Magadum Ayurvedic Medical College and Hospital |
Dr N.A. Magadum Ayurvedic Medical College Hospital and Research centre Ankali Chikodi taluk Belgavi District Karnataka
Belgaum
KARNATAKA |
9406383224
bhupeshsahu5555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. NAMAMC-IEC |
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: Kasisa Bhasma, Reference: Ayurveda Prakasha by mishra, Gulraj sharma 2/272-275, Route: Oral, Dosage Form: Bhasma, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -MAdhu/warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trivikram Rasa, Reference: Yogaratnakara, Ashmari chikitsa, Route: Oral, Dosage Form: Rasayoga, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu/warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 20-60 years
2.Patients with clinical features of urolithiasis like pain abdomen, pain in bladder region, burning micturition, hematuria, obstruction in urine flow
3.Size of calculi less than 10mm
4.Number of calculi less than or equal to 4. |
|
| ExclusionCriteria |
| Details |
1.size of calculi more than 10mm or requiring immediate surgical intervention.
2.Patients with severe renal impairment, moderate to severe hydronephrosis, staghorn calculus, impacted calculi or stones present in the lower pole of the kidney
3.Patients with uncontrolled Diabetes Mellitus and severe Hypertension
4.Pregnant and Lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Size of the calculi
2. Descent of the calculi |
Before treatment and 30th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduce in
1. Pain in the abdomen, flank pain
2. Hematuria
3. Dysuria
4. Burning micturition |
Before treatment and 30th Day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/03/2026 |
| 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 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
|
Mutrashmari (urolithiasis) is a common urological disorder, classified under Ashta Mahagada by Acharya Sushrutha. Its increasing prevalence is attributed to sedentary lifestyle factors, poor hydration and improper diet. Ayurveda offers several affordable and effective formulations for Mutrashmari. Among them, kasisa Bhasma- a preparation of purified ferrous sulphate has been traditionally indicated but remains unexplored in this context. Meanwhile, Trivikrama rasa is already known for its efficacy in earlier studies.
This randomised controlled clinical trial aims to evaluate and compare the efficacy of Kasisa Bhasma and Trivikrama Rasa in 60 patients diagnosed with Mutrashmari. Patients will be divided into two groups, 30 each and administered the respective formulations for 30 days. Assessment will be based on both subjective (burning micturition, renal colic, etc) and objective (stone size, number and location via USG) parameters. Statistical analysis will be applied to assess a significant result.
This study is expected to provide scientific validation for Kasisa Bhasma as an effective, affordable treatment for Mutrashmari (Urolithiasis), supporting its broader clinical application in ayurvedic practices. |