| CTRI Number |
CTRI/2025/08/093460 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
management of kidney stones |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Pashanabhedadi Churnam with and without Yavakshara in the management of Mutrashmari 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 |
Dr K Asha Madhuri |
| Designation |
Post Graduate in Kayachikitsa |
| Affiliation |
Dr.BRKR Govt Ayurvedic College and Hospital |
| Address |
DR. BRKR Govt Ayurvedic College and Hospital, Erragadda, Hyderabad- 500018
DR. BRKR Govt Ayurvedic College and Hospital, Erragadda, Hyderabad- 500018
Hyderabad
TELANGANA
500018
India |
| Phone |
8639620566 |
| Fax |
|
| Email |
ashamadhuri2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Uma Srinivas Rao |
| Designation |
Professor,MD Ayurveda, Department of Kayachikitsa |
| Affiliation |
Dr.BRKR Govt Ayurvedic College and Hospital |
| Address |
DR.BRKR Govt Ayurvedic College and Hospital, Erragadda
Hyderabad- 500018
Hyderabad
TELANGANA
500018
India |
| Phone |
9246346346 |
| Fax |
|
| Email |
dr.nusrao@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Uma Srinivas Rao |
| Designation |
Professor,MD Ayurveda, Department of Kayachikitsa |
| Affiliation |
Dr.BRKR Govt Ayurvedic College and Hospital |
| Address |
DR.BRKR Govt Ayurvedic College and Hospital, Erragadda
Hyderabad- 500018
Hyderabad
TELANGANA
500018
India |
| Phone |
9246346346 |
| Fax |
|
| Email |
dr.nusrao@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Dr. BRKR Govt Ayurvedic College and Hospital,Erragadda,Hyderabad,Telangana,
500018,India |
|
|
Primary Sponsor
|
| Name |
Dr.K.Asha Madhuri |
| Address |
Dr. BRKR Govt Ayurvedic College and Hospital,Erragadda,Hyderabad,Telangana, 500018,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 |
| DrKAsha Madhuri |
Dr.BRKR Govt Ayurvedic College and Hospital |
Department of Kayachikitsa
Room No:1,2,3
Dr.BRKR Govt Ayurvedic College and Hospital
Erragada, Hyderabad, Telangana
500018
Hyderabad
TELANGANA |
8639620566
ashamadhuri2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.BRKR Govt Ayurvedic College and Hospital |
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: MUTRAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pashanabhedadi churnam, Reference: Chakradatta 34th chapter 35th,36th sloka,, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -lukewarm ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yavakshara, Reference: Rasatarangini 13th chapter, 3 to 5, 16th sloka, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical signs and symptoms of Mutrashmari will be included such as
Mutrakrccha(Difficulty in micturition)
Mutradaha (Burning micturition)
Vedana sthapana(Pain)
Sarakta mutrata(Hematuria)
Visheerna dhara (Interrupted flow of urine)
Patients with age group between 18 to 65yrs will be selected irrespective of Gender, Occupation and Socio economic status will be included.
Calculi measuring upto 10mm that located in kidney, ureter and urinary Bladder.
Patients who are willing to give consent for the clinical study.
|
|
| ExclusionCriteria |
| Details |
Age of below 18 and above 65years will be excluded.
Size is more than 10mm.
Patients with uncontrolled Diabetes and Hypertension.
Pregnant and Lactating women.
Sexually transmitted diseases, Malignancy and other Systemic disorders which interfers with the course of treatment will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Reduce the Signs and Symptoms of Renal Calculi and break the stones |
break the stones with in 3 months along with signs and symptoms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Prevent Recurrence of Renal Calculi |
90 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/09/2025 |
| 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 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
|
Mutrashmari, one of the Ashta Mahagadas (eight grave disorders) in Ayurveda, is a disease of the Mutravaha Srotas (urinary system) characterized by the formation of stone-like structures (ashmari) within the urinary tract. It closely correlates with the modern medical condition urolithiasis, which refers to the formation of calculi in the kidneys, ureters, bladder, or urethra. The pathogenesis of Mutrashmari involves the vitiation of Tridoshas, especially Kapha dosha acting as a binding agent, along with obstruction and stagnation in the urinary channels. This results in crystallization of urinary constituents, leading to stone formation. Clinical features described in Ayurveda—such as painful urination (mutrakricchra), hematuria (raktamutrata), retention of urine (mutraghata), and radiating pain—align well with symptoms observed in modern urolithiasis. Ayurvedic management includes herbal diuretics, litholytic drugs (Ashmarighna dravyas), Panchakarma procedures (like Basti), and lifestyle modifications, which aim at both dissolving stones and preventing recurrence.
This study aims to evaluate the clinical efficacy and safety of Ayurvedic interventions in the management of Mutrashmari (urolithiasis), establishing a validated integrative approach through traditional knowledge and modern diagnostic tools. |