| CTRI Number |
CTRI/2025/04/084538 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Ayurvedic treatment study in disease of ashmari (Pathri) |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy of Aanand Bhairvi Vati and Svadamastra Kashay in the Management Of Ashmari W.S.R. 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 |
Kamlesh Kumar Gurjar |
| Designation |
PhD Scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
Rome no 16 MMM Ayurveda medical college and hospital radaji chauraha ambamata udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9057361676 |
| Fax |
|
| Email |
drkamleshgurjar87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ravi Sharma |
| Designation |
Professor |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
Rome no 16 MMM Ayurveda medical college and hospital radaji chauraha ambamata udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414419259 |
| Fax |
9414081252 |
| Email |
rspgkcj2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamlesh Kumar Gurjar |
| Designation |
phd scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
Rome no 16 Dept of Kaya chikista madan mohan malviya ayurved medical college and Hospital udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9057361676 |
| Fax |
9057361676 |
| Email |
drkamleshgurjar87@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMM Government Ayurved College, Ambamata, Udaipur, Rajasthan Pin-313001 |
|
|
Primary Sponsor
|
| Name |
MMM Ayurved medical college and hospital |
| Address |
MMM Ayurved medical college and hospital Ambamata Chouraha Udaipur, Rajasthan, Pin 313001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MMM Ayurved Medical College Udaipur |
Ambamata udaipur |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Ravi Sharma |
MMM Government Ayurved Medical College |
Room No 1, MMM Ayurved medical college and hospital Ambamata Chouraha Udaipur 313001
Udaipur
RAJASTHAN |
9414419259
9414419259
rspgkcj2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee MMM Ayurved Medical College Udaipur |
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: Aanand Bhairavi Vati, Reference: Rasa Ratna Samucchya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Svadamstra Kashay-), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Roasted and grinded wheat granules filled in 500 mg soft gelatin capsule for 30 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with the symptoms of Ashmari Roga.
2. Patients between the age of 20-70 years of either sex.
3. Patients who are fit to take medicine
4. Patients with history of Mootra Ashmari less than 2 years.
5. The calculi size no more than 10 mm.
6. Pain in the renal angle and loin region, radiating towards groin.
7. Burning micturition.
8. Haematuria.
9. Radiographic / USG evidence of the stone.
10. Crystals of stone. |
|
| ExclusionCriteria |
| Details |
1. Renal failure.
2. Case of immediate surgical intervention.
3. Severe haematuria.
4. Stone size more than 10 mm.
5. Patients of carcinoma.
6. Tuberculosis.
7. Hepatitis-B positive
8. Patients having major illness, IDDM, DM which is poorly controlled.
9. Severe hydronephrosis |
|
|
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 |
| Improvement in subjective and objective parameters |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out the comparative efficacy of the treatment in the both grpups |
30 Days |
|
|
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)
|
22/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/04/2025 |
| 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 Applicable |
| 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
|
1.these days it is very common disorder found since water table is going downward and hence we get drinking water containing extra amount of minerals 2. It mainly affects middle ageof life which is the most productive age of life and this disease disturbs a person in his routine activities due to pain . 3. Even when stone does not cause pain it may cause complications like UTI, pyonephrosis, hydronephrosis, hydroureter, renal failure etc
4. Even after surgery the recurrence rate is as high as 60-80 (Williams, 1963)
5. Patients who are not interested or fit for surgery or those who can not afford its expenses remain interested for drug therapy |