| CTRI Number |
CTRI/2025/09/094892 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the action of Shunthyadi kwath and Gokshuradi guggulu in renal stone |
|
Scientific Title of Study
|
Clinical evaluation of Shunthyadi kwath and Gokshuradi guggulu in 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 |
Rekha |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15 Department of Shalya-Tantra Patanjali ayurved
hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Delhi Haridwar highway 58 Haridwar Uttrakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9050560808 |
| Fax |
|
| Email |
rekhadhayal0808@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15 Department of Shalya-Tantra Patanjali ayurved
hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Delhi Haridwar highway 58 Haridwar Uttarakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7020108714 |
| Fax |
|
| Email |
surgeonsaurabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15 Department of Shalya-Tantra Patanjali ayurved
hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Delhi Haridwar highway 58 Haridwar Uttarakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7020108714 |
| Fax |
|
| Email |
surgeonsaurabh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan haridwar, uttarakhand, india 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Haridwar Uttarakhand India 249405
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rekha |
Patanjali Ayurvedic Hospital |
OPD 15 Department of Shalya-Tantra Patanjali ayurved
hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Delhi Haridwar highway 58 Haridwar Uttarakhand India
Hardwar
UTTARANCHAL |
9050560808
rekhadhayal0808@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee patanjali ayurved hospital |
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: Shunthyadi Kwath, Reference: Bhaisajya Ratnavali chapter 36 shloka 7-8, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 03 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Gokshuradi Guggulu, Reference: sharangadhara madhyam khanda chapter 7 shloka 84-87, Route: Oral, Dosage Form: Guggulu , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 03 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to undergo trial and ready to give informed and written consent
Patients of both sexes and age group (18 to 50 yrs), irrespective of religion, socioeconomic status occupation will be taken
Radiological evidence of (upto 8 mm) in kidney, ureter, urinary bladder & urethra
|
|
| ExclusionCriteria |
| Details |
Patients does not willing to undergo trial and ready to give informed and written consent.
Complications related to Kidneys/ Ureter / Bladder like - Acute Renal Failure, Chronic Renal Failure, Polycystic Kidney diseases, Impaired Renal function, etc.
Other chronic diseases like TB (Tuberculosis), Hepatitis etc. will be excluded.
Pregnant women and lactating mothers will be excluded.
Patients will be dropped if they develop any complications during the course will also be excluded.
Calculi size more than 8 mm.
Patients having Moderate or severe Hydronephrosis will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters.
Pain
Burning micturition
Dysuria
Frequency of micturition
Hematuria
|
assessment will be done at baseline followed by every 4th week assessment until renal calculi completely removed
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective parameters.
Pain
Burning micturition
Dysuria
Frequency of micturition
Hematuria
|
follow up to 3 months after treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In this trial we are selecting patients of Mutraashmari and take one group of 30 patients . We will do intervention with standard Shunthyadi kwath and Gokshuradai Guggulu . intervention study to be done on the basis of assessment based on subjective and objective parameters. Subjective parameters includes Burning micturition , pain, dysuria , frequency of micturition , hematuria and Objective parameters includes number of calculus , size of calculus . Result will be analysed statistically and discussed accordingly . |