| CTRI Number |
CTRI/2025/08/093221 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| 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 trial to study the effect of mulak kshara on mutrashmari |
|
Scientific Title of Study
|
Randomized control clinical trial of efficacy of mulak kshara on mutrashmari |
| 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 Vaishnavi Balaso Kale |
| Designation |
PG Scholar |
| Affiliation |
Hon. Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
OPD No 05 Shalya Tantra OPD Ground Floor
Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9689294209 |
| Fax |
|
| Email |
kalevaishnavi3108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Patil |
| Designation |
HOD And Professor |
| Affiliation |
Hon. Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
3rd Floor Department Of Shalya Tantra
Hon Shri
Annasaheb Dange Ayurved Medical College Post Graduate And
Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422613195 |
| Fax |
|
| Email |
dr.patilmanoj77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Patil |
| Designation |
HOD And Professor |
| Affiliation |
Hon. Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
3rd Floor Department Of Shalya Tantra
Hon Shri
Annasaheb Dange Ayurved Medical College Post Graduate And
Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422613195 |
| Fax |
|
| Email |
dr.patilmanoj77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center
Ashta Tal Walwa Dist Sangli Maharashtra India 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Kale |
| Address |
OPD No 05 Shalya Tantra Ground Floor
Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Maharashtra |
| 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 Vaishnavi Balaso Kale |
Hon Shri Annasaheb Dange Ayurved Medical College And Dhanvantari Ayurved Hospital Ashta |
OPD No 05 Shalya Tantra Ground Floor
Dhanvantari Ayurved Hospital Ashta Tal Walwa
Sangli
MAHARASHTRA |
9689294209
kalevaishnavi3108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Institutional Ethics Committee |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Mulak Kshara, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Badrashma Pishti, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Mutrashmari confirmed by any of the diagnostic criteria without having any secondary complications
The patient between the age group of 18-60yrs will be selected irrespective of sex, occupation, race and socioeconomic status |
|
| ExclusionCriteria |
| Details |
Patients who are suffering with severe systemic disorders like Renal failure, Tuberculosis, Polycystic kidney, Wilm’s Tumour and Neoplasms
Patient with Acute Urinary Obstructive conditions
Patients who are contra indicated for PaneeyaKshara
Pregnancy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Mulak Kshara in Mutrashmari (Urolithiasis) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study details of Mutrashmari the as per Ayurveda and modern views
2. To evaluate the comparative effect of MulakKshara and Badarashma Pishti in Mutrashmari |
20 days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
29/08/2025 |
| 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="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
|
Urolithiasis is the third most common disease in the world.its incidence is increasing. An analysis from India shows an increase from 0.9% to 9.0% over 20 years. There is geographical variation in stone composition. The analysis from north India shows calcium oxalate 93.4% (monohydrate 80%, dihydrate 20%) mixed (calcium oxalate, phosphate, urate) 2.76%, struvite (magnesium, ammonium, phosphate) 1.42% uric acid 0.95% cystine 0.05%. In India6 Ayurveda, a traditional system of Indian medicine, recommends several medicinal plants and compound medicinal preparations for the treatment of urolithiasis.Mutrashmari is closely related to the causes such as unhealthy diet, habits and environment which are subjective. Which etiological factors of Mutrashmari mentioned in Ayurveda are frequent and whichare the other factors in the contemporary era responsible for Mutrashmari is also needed to be studied. Herbs and herbal drugs have created interest among the people by its clinically proven effects. Trial drug MulakaKshara is a caustic alkaline preparation of the drug Mulaka (Raphenus Sativus Linn). ‘MulakaKshara’ preparation indicated for the management of Mutrakrcchra and Ashmari.7 MulakaKshara is powdered preparation of Mulaka Bhasma and Jala.8 Also inRasamritam, Badarashma Pishti preparation indicated for the management of Ashmari9. Badarashma though it is originally belongs to Unani medicine, but in Ayurveda first time Vaidya Yadavaji explained in his text Rasamurta and Badarashma has mainly having action on mutra vahasrotovikaras. |