| CTRI Number |
CTRI/2026/01/100774 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The Effect Of Saileya In Patients With Renal Stone. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Study The Effect Of Saileya In Mutrashmari With Special Reference To Renal Calculus. |
| 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 Bhagyashri Prakash Sonawane |
| Designation |
PG student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
7558639069 |
| Fax |
|
| Email |
bhagyashrisonawane0909@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Datta Kumawat |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9049059799 |
| Fax |
|
| Email |
drdkumavat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyashri Prakash Sonawane |
| Designation |
PG student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
7558639069 |
| Fax |
|
| Email |
bhagyashrisonawane0909@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Bhagyashri Prakash Sonawane |
| Address |
Opd No.4 Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403 |
| 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 Bhagyashri Prakash Sonawane |
SMBT Ayurved College and Hospital |
OPD NO.4 Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA |
07558639069
bhagyashrisonawane0909@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Abhaya (Terminalia Chebula ), Reference: Sushruta Samhita. Chikitsasthana. Ch. 7, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshnajal ( Luke Warm Water)), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saileya (Parmelia perlata), Reference: Bhavaprakasha Nighantu, Karpuradi Varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshnajal (Luke Warm Water)), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having clinical sign and symptoms of Mutrashmari like dull pain at renal angle, anorexia, haematuria.
2.All patient age of 18 to 60 years group will be selected irrespective gender, occupation, caste and socioeconomic status.
3.Size of stone – 8 to 10 mm present in kidney.
4.Patient who will give written consent for treatment. |
|
| ExclusionCriteria |
| Details |
1.Patient with medical conditions like DM, HTN, Chronic Hematuria. Carcinoma, Hydronephrosis, Pyelonephritis, Congenital anomalies of kidney.
2.Size of stone above 10 mm.
3.Patient who are suffering from severe systemic disorder like renal failure and infectious disease.
4.PUJ and UVJ calculus if obstructed.
5.If patient with more than 20 RBC in urine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in the size of stone evaluate by USG Abdomen and pelvis.
2. Reduction in symptoms like Pain in Renal angle and Burning micturition assessed by VAS (Visual Analog Scale) |
1. Assessment - Baseline and 30 Day
2. Follow Up - 0 Day, 15 Day, 30 Day
3. Post Follow up - 35 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/01/2026 |
| 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
|
TITLE - A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF SAILEYA IN MUTRASHMARI WITH SPECIAL REFERENCE TO RENAL CALCULUS.
INTRODUCTION - Kidney stones primarily develop within the kidneys and pose a significant health concern, especially due to their high recurrence rate. Preventing their recurrence remains one of the major challenges in modern medicine. When nephrocalcinosis is present alongside nephrolithiasis, it can contribute to approximately 2–3% of all end-stage renal disease cases. Ayurveda has played a vital role in the management of Mutrashmari. Acharya Sushruta has classified its treatment into two broad categories: surgical (Shastrakarma) and non-surgical or conservative (Anushastrakarma) methods. Acharya Bhavprakash has mentioned Saileya in karpuradi varga in Bhavprakash. Saileya mentioned for treatment of Mutrashmari as abhyantar chikitsa hence efficacy of Saileya churna is being studied. Although Shaileya Churna is traditionally mentioned in Ayurveda for the management of Mutrashmari (renal calculi), there is limited scientific evidence available to validate its efficacy through modern research methods. This study aims to fill that gap by evaluating the efficacy of Shaileya as a single drug in the management of renal calculi. Vas Scale used for assessment of pain. Investigation like 1. USG -Abdo pelvis (stone size in mm)- Before & After treatment. (In between If needed) 2. Urine routine and microscopic. 3. BSL-Random. will be done SAMPLE SIZE - The total sample size for this study will be taken as 70. Saileya Churna Group A (trial group) and Abhaya Churna Group B(Control group) will be given patients. Trial and control drugs will be purchased from GMC certified pharmacy. Bothdrugs will be administered in Churma Form for 30 days. All SOP of Churna Vidhi will be strictly followed during and after treatment. Follow up will be done on day 0, day15 and day 30.
Null Hypothesis:(H0) Saileya churna is not effective in Mutrashmari with special reference to renal calculus.
Alternate Hypothesis: (H1) Saileya churna is effective in Mutrashmari with special reference to renal calculus. |