CTRI Number |
CTRI/2017/12/010904 [Registered on: 18/12/2017] Trial Registered Retrospectively |
Last Modified On: |
02/09/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Management Of Renal Calculi with Gaumutra kshara |
Scientific Title of Study
|
EFFECT OF GAUMUTRADI KSHARA IN THE MANAGEMENT OF MOOTRASHMARI W.S.R TO RENAL CALCULI |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dhimant bhatt |
Designation |
PG Scholar |
Affiliation |
Parul institute of Ayurveda |
Address |
Parul institute of Ayurveda,
Department of shalya tantra,parul university,limda.vadodara.Gujarat.391760.India
Vadodara GUJARAT 391760 India |
Phone |
9724967007 |
Fax |
|
Email |
dhimant.dhimantbhatt.bhatt7@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrHemant Toshikhane |
Designation |
H.O.D |
Affiliation |
Parul institute of Ayurveda |
Address |
Parul institute of Ayurveda,
Department of shalya tantra,parul university,limda.vadodara.Gujarat.391760.India
Vadodara GUJARAT 391760 India |
Phone |
8469496525 |
Fax |
|
Email |
hemant.toshikhane@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
Name |
DrHemant Toshikhane |
Designation |
H.O.D |
Affiliation |
Parul institute of Ayurveda |
Address |
Parul institute of Ayurveda,
Department of shalya tantra,parul university,limda.vadodara.Gujarat.391760.India
GUJARAT 391760 India |
Phone |
8469496525 |
Fax |
|
Email |
hemant.toshikhane@paruluniversity.ac.in |
|
Source of Monetary or Material Support
|
parul ayurveda hospital and Parul University Limda Vadodara Gujarat |
|
Primary Sponsor
|
Name |
parul institute of ayurveda and hospital |
Address |
parul university,limda,vadodara,gujarat-391760 |
Type of Sponsor |
Private medical college |
|
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 |
dhimant bhatt |
parul ayurveda hospital |
parul institute of ayurveda,And Parul Ayurveda Hospital Shalya Tantra opd Room no 116 At Limbda Vadodara,Gujarat university,limda,vadodara,gujarat. Vadodara GUJARAT |
9724967007
dhimant.dhimantbhatt.bhatt7@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Gaumutradi kshara
|
250mg
Oral route
Three times a Day with Lukewarm water for 60days
|
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patients having classical signs and symptoms of Mootrashmari (Renal calculi)
2.Size of calculus less than 10 mm will be taken.
3.Patients age between 16 to 60 years.
4.Bilateral and unilateral renal calculi
|
|
ExclusionCriteria |
Details |
• Patient having Urinary Calculus of size more than 10mm.
• In case, Patient requires immediate surgical intervention.
• Chronic systemic illness, DM,HTN, HIV,& other renal diseases
• Pregnant & Lactating women.
• Vesicle calculi
• Ureteric calculi,
• Patients who are contraindicated for kshara administration
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
reduction in the size of renal calculi aftr taking trial medicine |
reduction in the size of renal calculi and get symptomatic relief after taking medicine regularly for 7 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
decrase in pain,burning micturation,nausea,vomitting |
60days |
|
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 1 |
Date of First Enrollment (India)
|
01/05/2017 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Publication prepared after complication of trial |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Mankind has been
affected by renal calculi since centuries, and has been the silent cause of
renal failure also. In India the disease affect all age group, source of morbidity
80% those with Renal calculi are man,(6)
approximately 5-7 million patients suffer from Renal calculi disease and at least 1/1000 of Indian population
need hospitalization due to Renal calculi disease. Thus the disease is a wide
spread, particularly in countries with dry, hot climate, these†stone belt
regions â€of the world are located in countries of middle east, North Africa ,
the Mediterranean region, North Western states of India and Southern states of
USA and area around the great lakes. In India, the stone belt occupied parts of
Maharashtra, Gujarat, Punjab, Haryana, Delhi, Rajasthan etc .In these regions
the disease is so prevalent that most of the family will suffer from Renal
calculi sometime in their lives.(7)
There is no any
specific medical treatment for renal calculi in modern medicine. None of modern
methods have provided the final solution for renal calculi. So in this
condition most effective and curative treatment is required.
In Ayurveda various formulation are mentioned
for the Mootrashmari management viz. Kshara (Paniya Kshara) (8) etc.as
it mentioned in Ayurvedic text that kshara has guna karma of chedna, bhedna,
lekhna.(9)so, it have been
used effectively and economically on Mootrashmari. No research found on
evaluate effect of Gaumutradi kshara in the management of Mootrashmari So,study
on “Effect of Gaumutradi kshara in the
management of Mootrashmari w.s.r to Renal calculi†is undertaken.
|