| CTRI Number |
CTRI/2023/04/051931 [Registered on: 24/04/2023] Trial Registered Prospectively |
| Last Modified On: |
21/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the efficacy and safety of URAL tablet |
|
Scientific Title of Study
|
A Open label Clinical Study to Evaluate the Efficacy and Safety of URAL
Tablet in Urolithiasis |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| TG/CLI/068, Dated 30 Oct 2023, version 3.1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandrashekar S Ratkal |
| Designation |
Principal Investigator |
| Affiliation |
Rescue Urology Center |
| Address |
Ratkal Speciality Hospital Pvt. Ltd.
Rescue Urology Center
458, 6th Main Road, Stage I , Kengeri Satellite Town, Bengaluru , Karnataka
Bangalore Rural
KARNATAKA
560060
India |
| Phone |
9845255378 |
| Fax |
|
| Email |
dr.csratkal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekar S Ratkal |
| Designation |
Principal Investigator |
| Affiliation |
Rescue Urology Center |
| Address |
Ratkal Speciality Hospital Pvt. Ltd.
Rescue Urology Center
458, 6th Main Road, Stage I , Kengeri Satellite Town, Bengaluru , Karnataka
KARNATAKA
560060
India |
| Phone |
9845255378 |
| Fax |
|
| Email |
dr.csratkal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO Representative |
| Affiliation |
TrialGuna Pvt Ltd |
| Address |
467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore Rural
KARNATAKA
560083
India |
| Phone |
9972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
|
Vasu Research Centre
A2/624-625/2, G.I.D.C., Makarpura,
Vadodara 390010 (Gujarat) India
|
|
|
Primary Sponsor
|
| Name |
Vasu Research Centre |
| Address |
Vasu Research Centre
A2/624-625/2, G.I.D.C., Makarpura,
Vadodara 390010 (Gujarat) India
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandrashekar S Ratkal |
Ratkal Speciality Hospital Pvt. Ltd. |
Ratkal Speciality Hospital Pvt. Ltd.
Rescue Urology Center
Ground Floor
458, 6th Main Rd, Stage I, Kengeri Satellite Town, Bengaluru, Karnataka 560060
Bangalore Rural
KARNATAKA |
9845255378
dr.csratkal@gmail.com |
| Dr Shankar S |
SDM Institute of Ayurveda and Hospital |
Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway, Bangalore, Karnataka 560074
Bangalore
KARNATAKA |
9844669713
shankarsswamy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics commitee |
Approved |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N200||Calculus of kidney. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Boerhaavia diffusa (Punarnava) Dry Extract, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 800(mg), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject with Urolithiasis as diagnosed by clinical with calculi measuring < 10mm. Hematologic and Biochemical parameters within normal limits (Study specific parameters: calcium, uric acid cannot be more than 2 times upper limit of normal value).
2. Aged between ≥18 to ≤ 50 years.
3. Subjects willing to sign informed consent and follow the study
procedure and instructions.
4. Subjects who are diagnosed of diabetes mellitus, whose blood
glucose level is under good control with consumption of
Anti-hyperglycemic medications and the Random Blood Sugar
(RBS) reading is ≤ 200mg/dl during the screening period, can
be included in the study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with severe obstructive uropathy, those with serious
systemic medical disorder- uncontrolled hypertension and
diabetes mellitus, other metabolic disorders, endocrinal
disorders and cardiac illness.
2. The subjects not to have used any drugs, for at least 1 week
prior to the study for concurrent illness with diabetes and
Hypertension.
3. Subjects with a strong history of food or drug allergy of any
kind |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in calculi deposit/kidney stone size
2. Recovery in clinical symptoms and signs like Colicky pain at the loin, Hematuria,
Dysuria, Nausea/vomiting, frequency of micturition, fever.
3. Improvement in laboratory parameters: Hematological, Serological, Urine,
Radiological.
|
Day 1, Week 4, Week 8, Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Safety profile and overall compliance
2. Self-reported AEs & SAEs |
Day 1, Week 4, Week 8, Week 12 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/04/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Renal Calculi is a common condition experienced by individuals across the world population.
Renal calculi are also known as Urolithiasis and commonly called Kidney stones. Kidney
stones are mainly composed of calcium salts, uric acid, cysteine, and struvite. Calcium
oxalate and calcium phosphate are the most common types accounting for >80% of stones,
followed by uric acid (8–10%) and cysteine, struvite in remainders.The main aim of the present study is to evaluate the safety and efficacy of URAL tablets in
reduction in size of calculi deposits and recovery from the clinical signs and symptoms of renal
calculi.This is a randomized, open labelled clinical study to evaluate efficacy and safety of URAL
tablets in subjects with Urolithiasis.
The potential subjects will be screened as per the inclusion and exclusion criteria only after
obtaining written informed consent from the subjects. |