| CTRI Number |
CTRI/2022/07/043684 [Registered on: 04/07/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study To Evaluate The Safety And Efficacy Of Lithobin Tablets In Patients With Renal Calculi |
|
Scientific Title of Study
|
A Prospective, Single-Center, Open-Labelled Study To Evaluate The Safety And Efficacy Of Lithobin Tablets In Patients With Renal Calculi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2202 ver 1.0 dated 05 May 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Disha Shetty |
| Designation |
Project Manager |
| Affiliation |
Samahitha Research Solutions |
| Address |
Second floor Old No.1204, ASHVA,
26th Main Rd, Jayanagara 9th Block,
Bangalore
KARNATAKA
560069
India |
| Phone |
06364147979 |
| Fax |
|
| Email |
disha@samahitha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srivatsa G S |
| Designation |
Managing Director |
| Affiliation |
Samahitha Research Solutions |
| Address |
Second floor Old No.1204, ASHVA,
26th Main Rd, Jayanagara 9th Block,
Bangalore
KARNATAKA
560069
India |
| Phone |
06364147979 |
| Fax |
|
| Email |
sri@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Srivatsa G S |
| Designation |
Managing Director |
| Affiliation |
Samahitha Research Solutions |
| Address |
Second floor Old No.1204, ASHVA,
26th Main Rd, Jayanagara 9th Block,
Bangalore
KARNATAKA
560069
India |
| Phone |
06364147979 |
| Fax |
|
| Email |
sri@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Jammi Pharmaceuticals Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Jammi Pharmaceuticals Pvt Ltd |
| Address |
121 Jammi buildings Royapetth High Road Chennai 600004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sambashiva A C |
Sri Lakshmi Superspeciality Hospital |
No. 301, 3rd Main Rd, Old Extension, Krishnarajapura
Bangalore
KARNATAKA |
9742797117
info@samahitha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 | Classical | | (1) Medicine Name: Lithobin, Reference: Ayurvedic Pharmacopoeia of India, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: No, Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 18-75 years (Both inclusive)
2 Patients with Renal calculi, diagnosis confirmed by plain X-Ray KUB
3 Size of the calculi ranging from 04 mm < 1.5 2cm
4 Able and willing to give written informed consent and comply with the requirements of the study protocol
5 Patients of reproductive potential (males and females) and willing to use a reliable means of contraception |
|
| ExclusionCriteria |
| Details |
1 Complicated cases of Renal Calculi requiring surgical intervention, any condition chronic or current infectious disease such as but not limited to chronic renal infection including active urinary tract infection.
2 Subjects is presenting with symptomatic congestive heart failure (CHF), unstable angina pectoris, myocardial infarction (MI)
3 Any other known urogenital disorders.
4 Subjects on herbal supplements for renal stone disease (plant extracts preparations or herbal medicines etc.) within previous 3 months.
5 Pregnant or breast feeding
6 Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation
7 Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline Patients with psychiatric illness or other condition that would limit compliance with study requirements
8 Actively participating in in other clinical trial or has participated in a clinical trial within the last 30 days.
9 Unwilling/unable to sign the informed consent
10 Any condition in the opinion of the investigator that may compromise the safety of the patient by participating in this study |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the size or absence of kidney stones from baseline to Day 120 |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the size or absence of kidney stones from baseline to Day 30, 60, 90
To evaluate the safety parameters like LFT, RFT, Hematology, Biochemistry and vitals
To evaluate the dependence on analgesics for pain management during the study |
Day 30, 60, 90 and 120 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/07/2022 |
| Date of Study Completion (India) |
09/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open-labelled, single-arm, prospective clinical study to evaluate the safety and efficacy of Tab. Lithobin therapy in patients diagnosed with renal calculi. It is planned to screen and enrol a total of 30 patients for this study. Subjects who will provide assigned informed consent will be evaluated for the inclusion and exclusion criteria. Male and Female subjects aged between 18 and 75 years diagnosed with renal calculi will be enrolled in to this study. Subjects will receive Tab. Lithobin - 2 tablets twice times daily for 120 days (4 months). Primary Objective 1. To evaluate the efficacy of Tab. Lithobin in subjects diagnosed with renal calculi over a period of 4 months
Secondary Objective 1. To evaluate the safety of Tab. Lithobin treatment in subjects diagnosed renal calculi 2. To evaluate the dependence on analgesics for pain management during the study.
|