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CTRI Number  CTRI/2023/12/060841 [Registered on: 27/12/2023] Trial Registered Prospectively
Last Modified On: 30/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Efficacy Of Amlavetas In Mutrashmari. 
Scientific Title of Study   A Pharmacognostical Study Of Amlavetas (Garcinia pedunculata Roxb.) Fruit And To Evaluate Its Efficacy In Mutrashmari w.s.r. To 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 Faizan 
Designation  MD SCHOLAR 
Affiliation  Ayurveda and Unani tibbia college Karol Bagh New Delhi 
Address  PG Department of Dravyaguna Ayurveda and Unani tibbia college Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  9911966955  
Fax    
Email  fz778866@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Sharma 
Designation  Associate Professor 
Affiliation  Ayurveda and Unani tibbia college Karol Bagh New Delhi 
Address  PG Department of Dravyaguna Ayurveda and Unani tibbia college Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  9868092250  
Fax    
Email  rajsakshi.sharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Sharma 
Designation  Associate Professor 
Affiliation  Ayurveda and Unani tibbia college Karol Bagh New Delhi 
Address  PG Department of Dravyaguna Ayurveda and Unani tibbia college Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  9868092250  
Fax    
Email  rajsakshi.sharma@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and unani tibbia college and hospital, Karol Bagh , New Delhi-05 
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College 
Address  Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005 
Type of Sponsor  Government medical college 
 
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 Rajesh Sharma  Ayurvedic and Unani Tibbia College and Hospital  Opd no 18 PG Department of Dravyaguna Ayurveda and Unani tibbia college Karol Bagh New Delhi
Central
DELHI 
9868992250

rajsakshi.sharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee AUTCH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Potassium CitratePotassium Citrate Tablets 2 Tab TDS (15 meq each) After Meal For 90 Days
2Intervention ArmDrugClassical(1) Medicine Name: Amlavetas, Reference: Dhanvantari Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  kidney Stone Upto 10mm (as measured on USG)
Ueteric stone upto 5mm 
 
ExclusionCriteria 
Details  Patients not willing for trial and follow up
Chronic Renal failure.
Gross Hydronephrosis.
Cases which require surgical intervention.
Gross Hematuria (>50rbc/HPF).
Kidney stone size more than 10 mm
Ureteric stone size more than 5 mm
Known cases of Malignancy, Tuberculosis.
Patients with uncontrolled Hypertension & Diabetes Mellitus. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in cardinal sign and symptoms (Reduction in pain, burning micturition, hematuria etc) of Mutrashmari (Urolithiasis) on the basis of USG.
Evaluation of the drug i.e. Amlavetas [Garcinia pedunculata (Roxb.)] fruit would be assessed on reduction of clinical symptoms of Mutrashmari (Urolithiasis) and improvement in Subjective/Objective parameters as from baseline and after 90 days of therapy. 
3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
At the end of the study, five -point Global Assessment scale for efficacy (Cured, Marked improvement, Moderate improvement, Mild improvement, No improvement) will be used.  3 Months 
 
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/ Phase 3 
Date of First Enrollment (India)   01/02/2024 
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="0" 
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  

Ayurveda has great antiquity dates back to about 5,000 years B.C. The Materia Medica of Ayurveda comprises of resources of plant, animal, metal and mineral origin, which have been prescribed in therapeutics. WHO has considered traditional system of medicine, as a part of integrated system of medicine. It is reported that traditional systems of medicines are being used since centuries for healthcare by people in countries of the Asia Region as well as in other parts of the world. In recent times, public interest has increased towards traditional medicines for various concerns. Herbal medicines are valuable source of remedies to the people around the world to secure their health.

Ashmari (Urolithiasis), a disorder of Mootravaha Srotasa1, included in Ashtomahagada2 is affecting mankind since antiquity which is manifested due to lack of Sodhana procedures (purification of toxic materials lodged in body parts) and indulging of Apathykari (unsuitable)foods leading to aggravation of Shlesma Dosha which after mixing with urine3, leads to crystal formation known as Sharkara or Sikta (gravels /concretion) which further grows like a stone. This concept of Ashmari formation is understood on one hand as stagnation theory and on the other hand theory of supersaturation/ crystallization (physio-chemical theory) of urine according to modern medicine4.

The incidence of urolithiasis is increasing globally, with geographic, racial, and gendervariation in its occurrence. Positive family history of stone disease, young age at onset, recurrent urinary tract infections (UTIs), and underlying diseases like renal tubular acidosis (RTA) and hyperparathyroidism are the major risk factors for recurrence. High incidence and recurrence rate add enormous cost and loss of workdays.

It has been reported that 12% of the total population are prone to urinary stones. Of this 12%, 50% of the population are severely affected by renal damage, which even leads to a loss of kidneys5. Males are most commonly affected than females with a male to female ratio of 3:1.6 the peak age of developing calculi is between 30-50 years and recurrence is common.

In modern medicine, diuretics, smooth muscle relaxants and non-invasive, invasive surgical procedures are adopted to manage urolithiasis.7 But all kinds of non-invasive, invasive surgical procedures are expensive, therefore not possible to advise for poor people and it will not checkthe recurrence of stone. The medicines including diuretics, alkalizers etc are used to prevent the frequency of hypercalciuria and hyperoxaluria (few etiological factors of calculi formation) but they are not promising enough due to their limited effectiveness and low tolerability.

 
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