| 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
|
|
|
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
|
|
|
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 | Comparator Arm (Non Ayurveda) | | - | Potassium Citrate | Potassium Citrate Tablets 2 Tab TDS (15 meq each) After Meal For 90 Days | | 2 | Intervention Arm | Drug | Classical | | (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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