| CTRI Number |
CTRI/2024/08/072228 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of varuna-shigru kwatha with yavakshara prakshepa in the management of mutrashmari w.s.r. urolithiasis. |
|
Scientific Title of Study
|
An open label clinical study to evaluate the efficacy of Varuna-shigru kwatha with yavakshara prakshepa 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 Sugandha Sharma |
| Designation |
P.G. Scholar |
| Affiliation |
Jammu institute of ayurveda and research,Jammu |
| Address |
Jammu institute of ayurveda and research Nardani raipur Jammu Jammu and kashmir India
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9877828721 |
| Fax |
|
| Email |
sugandha27648@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjun Gupta |
| Designation |
Associate Professor |
| Affiliation |
Jammu institute of ayurveda and research,Jammu |
| Address |
Jammu institute of ayurveda and research Nardani Raipur Jammu Jammu and Kashmir India
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9622007600 |
| Fax |
|
| Email |
drarjungupta17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun Gupta |
| Designation |
Associate Professor |
| Affiliation |
Jammu institute of ayurveda and research,Jammu |
| Address |
Jammu institute of ayurveda and research Nardani raipur Jammu Jammu and kashmir India
JAMMU & KASHMIR
181123
India |
| Phone |
9622007600 |
| Fax |
|
| Email |
drarjungupta17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jammu institute of ayurveda and research Jammu Jammu and Kashmir India 181123 |
|
|
Primary Sponsor
|
| Name |
Jammu institute of ayurveda and research |
| Address |
Jammu institute of ayurveda and research Nardani Raipur Jammu Jammu and Kashmir India 181123 |
| 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 Sugandha Sharma |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
P.G. department of Shalya tantra,OPD and IPD of hospital, Nardani Raipur Jammu Jammu and Kashmir India 181123
Jammu
JAMMU & KASHMIR |
9877828721
sugandha27648@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jammu institute of ayurveda and research |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varuna shigru kwatha with yavakshara prakshepa, Reference: Yoga Ratnakara Utaradhgata Ashmari nidana chikitsa prakarana , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 01 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with calculi measuring less than 8 mm in size.
2. Patient aged between 15-60 years.
3. Patients of either sex are taken.
4. Patients who are unwilling for surgery & those who are unfit for surgical intervention will be taken for the study.
|
|
| ExclusionCriteria |
| Details |
1. Patient below 15 years & above 60 years.
2. Calculi measuring more than 8 mm in size.
3. Staghorn calculus.
4. Patient suffering from severe haematuria
5. Patient suffering from Pyelonephritis.
6. Patient suffering from Hydronephrosis.
7. Patient suffering from any kind of Malignancy.
8. Patient suffering from Renal Failure.
9. Participation in any other clinical trial during past 6 months.
10. Patient not willing for trial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient signs and symptoms like pain, hematuria, dysuria, burning micturation, fever will get better and the size of the calculus will also get reduced. |
01 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/01/2025 |
| Date of Study Completion (India) |
31/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Mutrashmari (urinary stone) is one among the Ashtamahagada (eight fatal conditions) in Sushruta Samhita. It is Kapha predominance Tridoshaja Vyadhi. As per the clinical features, it is compared to urolithiasis. It is the common diseases of Murtravaha strotas. The lifetime prevalence of symptomatic urolithiasis is 10% in men and 5% in women, and the chance of the second stone formation within 7years is approximately 50% of population due to the daily lifestyle and the dietary pattern of the people. Urolithiasis is a pathological condition of urinary system where aggregation of urinary crystalloids takes place anywhere in urinary tract i.e. from kidney to urinary bladder. When confined to kidney, it presents the feature of renal calculus. It may pass down into the ureter to become ureteric calculus and further reach the bladder to become a vesical calculus or to be held up in the urethra and become a urethral calculus. |