| CTRI Number |
CTRI/2018/11/016388 [Registered on: 20/11/2018] Trial Registered Prospectively |
| Last Modified On: |
19/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the effect of Ayurvedic medicines on Kidney stone (urolithiasis) |
|
Scientific Title of Study
|
Clinical evaluation of Varunadi kwath churna and Apamarga Kshara in the management of Mutrashmari(Urolithiasis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Shah Aaditya Bhavanbhai |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute, Rajinder Nagar, Bantalab, Jammu |
| Address |
Regional Ayurveda Research Institute, Rajinder Nagar, Bantalab, Jammu
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9033236720 |
| Fax |
|
| Email |
dr.aadityashah@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shah Aaditya Bhavanbhai |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute, Rajinder Nagar, Bantalab, Jammu |
| Address |
Regional Ayurveda Research Institute, Rajinder Nagar, Bantalab, Jammu
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9033236720 |
| Fax |
|
| Email |
dr.aadityashah@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shah Aaditya Bhavanbhai |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute, Rajinder Nagar, Bantalab, Jammu |
| Address |
Regional Ayurveda Research Institute, Rajinder Nagar, Bantalab, Jammu
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9033236720 |
| Fax |
|
| Email |
dr.aadityashah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Ayurveda Research Institute for Urinary Disorders, Jammu |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences CCRAS |
| Address |
Jawahar Lal Nehru Bhartiya Chikisa Evam Homeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shah Aaditya Bhavanbhai |
Regional Ayurveda Research Institute |
Room No. 1, deptt. of Panchakarma,Regional Ayurveda Research Institute, Rajinder Nagar, Bantalab, Jammu
Jammu
JAMMU & KASHMIR |
9033236720
dr.aadityashah@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Regional Ayurveda Research Institute for Urinary Disorders, Jammu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N20-N23||Urolithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Varunadi Kwath Churna and Apamarga Kshara |
1. Varunadi Kwath Churna (API part II Vol - IV) - 50 ml twice daily before food (to be derived from 25 gm of Kwath Churna) for the duration of 12 weeks
2. Apamarga Kshara (API part II vol- 1) - 250 mg twice daily with water after food |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with or without symptoms of urolithiasis.
Radiological evidence of calculi(upto 10 mm) in kidney/ureter/urinary bladder.
Able and willing to give written consent.
Patients of reproductive potential willing to use a reliable means of contraception |
|
| ExclusionCriteria |
| Details |
1. Acute condition of renal calculi, UTI
2. Complicated cases of renal calculi requiring surgical intervention
3. chronic or current infectious diseases
4. Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction
5. Liver dysfunction
6. Pregnancy or breast feeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the size / number of calculi or expulsion of calculus |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to treatment period in calciuria/oxaluria/citraturia/uricosuria/serum uric acid/calcemia/urine pH. Any episode of renal colic/UTI/complication |
2 years |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
19/05/2019 |
| Date of Study Completion (India) |
22/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The trail results would be published by Central council for research in Ayurvedic sciences at the end of clinical trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The word Ashmari has been derived form the Sanskrit
word ‘Asman’
which literally means a structure resembling stone. Mutrashmari (urolithiasis) is the condition where urinary calculi are formed or located anywhere in the urinary system. It is a common cause of haematuria, abdominal pain, pain in flank or groin. Detailed description of ‘Mutrashmari’
concerning aetiopathogenesis,
clinical features and line of treatment is available in ancient classics of
Ayurveda. 1% of the patients visiting hosptals in
India presents the symptoms of Urolithiasis. Due to unwholesome diet and living
habits aggravated Kapha, reaches in urinary tract and dries up to form the calculus. Though
there are some popular methods like Extra-corporial shock wave lithotripsy and percutaneous nephro-lithotripsy
in conventional medicine but have definite side effects like UTI, blockage in ureter
which in turn causes kidney damage and PNCL. Various
Ayurvedic
classical formulations are being used successfully in the management of Mutrashmari by
Ayurveda physicians since centuries. The present clinical trial is proposed to re-evaluate the therapeutic efficacy and clinical safety of Varunadi kwath churna and Apamara Kshara in the management of Mutrashmai (urolithiasis) at OPD level in Regional Ayurveda research Institute for urinary disorders, Jammu.
|