CTRI

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CTRI Number

CTRI/2026/03/105922 [Registered on: 11/03/2026] Trial Registered Prospectively

Last Modified On:

10/03/2026

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 Comparative Clinical Study on Shunthiyadi Kwatha and Pashanabhedadi Kwatha in the Treatment of Kidney Stones (Mutrashmari)

Scientific Title of Study

A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Shunthiyadi kwatha and Pashanabhedadi kwatha In Mutrashmari WSR Urolithiasis

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
IEC/ACA/2025/02/16	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	DR KOMAL GUPTA
Designation	PG SCHOLAR
Affiliation	National Institute of Ayurveda, Deemed to be university, Jaipur
Address	Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road. Jaipur RAJASTHAN 302002 India
Phone	7023648600
Fax
Email	pkkomalgupta2000@gmail.com

Details of Contact Person
Scientific Query

Name	PROF HARI MOHAN LAL MEENA
Designation	PROFESSOR AND HEAD OF DEPARTMENT
Affiliation	National Institute of Ayurveda, Deemed to be university, Jaipur
Address	Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur RAJASTHAN 302002 India
Phone	9461297017
Fax
Email	hari_mohan68@yahoo.co.in

Details of Contact Person
Public Query

Name	PROF HARI MOHAN LAL MEENA
Designation	PROFESSOR AND HEAD OF DEPARTMENT
Affiliation	National Institute of Ayurveda, Deemed to be university, Jaipur
Address	Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur RAJASTHAN 302002 India
Phone	9461297017
Fax
Email	hari_mohan68@yahoo.co.in

Source of Monetary or Material Support

National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002. India

Primary Sponsor

Name	National Institute of Ayurveda, Deemed To Be University,jaipur
Address	Department Of Kayachikitsha,National Institute of Ayurveda (Deemed to Be University),jaipur Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan-302002
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
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
DR KOMAL GUPTA	National Institute of Ayurveda ,Deemed to be University, Jaipur	OPD NO 1,7,18 ,Department Of Kayachikitsa,, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002. India Jaipur RAJASTHAN	7023648600 pkkomalgupta2000@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional EthicsCommittee-National Institute Of Ayurveda	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

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: Shunthiyadi Kwatha, Reference: YogaRatnakar,Ashmari Chikitsha,1-2,Page70, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: Nil
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Pashanabhedadi Kwatha, Reference: Yoga Ratnakar,Ashmari Chikitsha1-2, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Patients Of Either Sex Male Or Female. 2. Patients Of Age Group From 18 to 60 Years. 3. Patient having renal and ureteric stones with Size Upto Less Than Or Equal To 10mm Will Be Include In This Trial .

ExclusionCriteria

Details

1.Age Below 18 Years And More Than 60 Years.
2.Patient With Obstructive Uropathy.
3.Patient With Chronic Kidney Diseases, Nephrotic Syndrome.
4.Patient With Hydronephrosis .(Grade3 And Grade4)
Grade 3 (Moderate)-
Moderate Dilation Of The Renal Pelvis And Calyces.
Blunting Of Fornices
And Flattening Of Papillae Mild Cortical Thinning May Be Seen.
Grade 4 (severe)-
Gross Dilation Of The Renal Pelvis And Caleyes, Which Appear Ballooned .
Loss Of Border Between The Renal Pelvis And Calcyes. Renal Atrophy Seen As Cortical Thinning
5.Patient With Evidence Of Malignancy.
6.Patient With Poorly Controlled Diabetes Mellitus (HBA1C More Than 8%).
7.Pregnant Or Lactating Women.
8.Symptomatic Patients With Clinical Evidence Of Heart Failure.
9.Patient With Urolithiasis (Mutrashmari) With Complication, Such As AcutE Renal Failure, Sepsis, Anuria, Urinary Tract Infection With Renal Obsturction
10.Urinary Stones Of More Than 10mm Size.
11.Uncontrolled Hypertension (Systolic Blood Pressure More Than 160mmHg Or Diastolic Blood Pressure More Than 100 mmHg).
12.Presence Of Any Other Serious Medical Condition That May Interfere With Study Participation.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
The Primary Outcome Of The Study Will Be Change In Size Of Renal Or Ureteric Calculus As Assessed By Ultrasonography (KUB),From Base Line To End Of The Treatment Period.	Base Line To The End Of The Treatment Period

Secondary Outcome

Outcome	TimePoints
Secondary Outcome Will Include 1.Change In Clinical Symptoms Of Urolithiasis (Pain In Renal Angle And Loin Region,Radiating Toward The Groin, Burning Micturition, Dysuria, Hematuria, Nausea/Vomiting) 2. Change In Urine Microscopic Parameters (Pus Cells, RBCs, Urinary Crystals, Microbial Load). Safety Assessed By Monitoring Adverse Events.	Baseline, Day 15, Day 30, and Day 45.

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

Date of First Enrollment (India)

01/06/2026

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="28"

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 a pathological condition of the urinary system characterized by the formation of urinary calculi anywhere in the urinary tract, from the kidneys to the urinary bladder, posing a significant challenge to healthcare systems. Etiological factors include dietary habits, vitamin A deficiency, hot climate, low citrate levels, urinary stasis, kidney infections, prolonged immobilization, medullary sponge kidney, hyperparathyroidism, hyperoxaluria, cystinuria, and renal tubular acidosis.

Globally, the prevalence of urolithiasis is increasing due to changes in lifestyle, dietary patterns, climate, and comorbid conditions. Current management strategies include conservative treatments, lifestyle modifications, and surgical interventions, yet recurrence rates remain high, highlighting the need for alternative or adjunct therapies.

This study is designed to evaluate the efficacy of Shunthiyadi Kwatha compared to Pashanabhedadi Kwatha, aiming to expand treatment options and improve patient outcomes. The study is entitled:

"A Randomized Comparative Clinical Study to Evaluate the Efficacy of Shunthiyadi Kwatha and Pashanabhedadi Kwatha in Mutrashmari with Special Reference to Urolithiasis."