| CTRI Number |
CTRI/2024/08/072127 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate Efficacy and Safety of Clearstone syrup (sugar free)in Asymptomatic renal calculi patients. |
|
Scientific Title of Study
|
A Prospective, Interventional, Randomized, Double-blind, Placebo-controlled, Clinical study to evaluate the Efficacy and Safety of Clearstone syrup (sugar free) in Patients with Asymptomatic Renal calculi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/SBBL/0223/004, Version: 01, Dated: 23 Feb 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipul Jaiswal |
| Designation |
Principal Investigator |
| Affiliation |
Saikrupa Hospital |
| Address |
Room No: OPD 01, Dept: General Medicine, Renuka Corner, Tapkir Chowk, Thergaon, Pune-411033, Maharashtra, INDIA.
Pune
MAHARASHTRA
411033
India |
| Phone |
9422548490 |
| Fax |
|
| Email |
dr.jaiswalvipul123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Managing Director |
| Affiliation |
ICBio Clinical Research Pvt Ltd |
| Address |
#16 & 18, ICBio Tower, Yelahanka Main Road, Chikkabettahalli, Vidyaranyapura.
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Managing Director |
| Affiliation |
ICBio Clinical Research Pvt Ltd |
| Address |
#16 & 18, ICBio Tower, Yelahanka Main Road, Chikkabettahalli, Vidyaranyapura.
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| SBL Pvt. Ltd, SBL House, 2, Commercial complex, Shrestha Vihar, Delhi-110092, India. |
|
|
Primary Sponsor
|
| Name |
SBL Pvt. Ltd |
| Address |
SBL House, 2, Commercial complex, Shrestha Vihar, Delhi-110092, India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshay Mahadev Jadhav |
Care Multispecialty Hospital |
Second floor, Conference hall, Clinical research department, Kotle Arcade Pune Nagar Road, Wagholi, Pune-412207
Pune
MAHARASHTRA |
8830896741
akkiijadhav0@gmail.com |
| Dr Vipul Jaiswal |
Saikrupa Hospital |
Room No: OPD 01, Dept: General Medicine, Renuka Corner, Tapkir Chowk, Thergaon, pune-411033
Pune
MAHARASHTRA |
9422548490
dr.jaiswalvipul123@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Care Multispecialty Hospital Institutional Ethics Committee |
Approved |
| Institute Ethics Commitee, All India Institute of Medical Sciences, Raipur (Chattisgarh) |
Approved |
| Institutional Ethics Commitee, ARAM Hospital |
Approved |
| Saikrupa Hospital Institutional Ethics Committee |
Approved |
| Sri Durgamba Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clearstone syrup (sugar free) |
Dosage form: syrup, route of administration: oral, frequency: 2 tea spoonful (10ml)(TID), treatment duration: 16 weeks, study duration: 17 weeks. |
| Comparator Agent |
Placebo |
Dosage form: syrup, route of administration: oral, frequency: 2 tea spoonful (10ml)(TID), treatment duration: 16 weeks, study duration: 17 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female patients aged 18-70 years with a diagnosis of renal stone size upto 10mm confirmed by non-contrast computerized tomography (CT) scan.
2. Able and willing to give written informed consent and comply with the requirements of the study protocol.
3. Female participants of child bearing potential with negative serum pregnancy test at screening and negative urine pregnancy test at check-in.
4. Male participants with female partners of child-bearing potential must agree to abstinenceif this is in line with the usual lifestyle, or to use condoms plus partner use of an acceptable contraceptive for the duration of the study and until 4 weeks after dosing with the study drug.
5. Patients will to cooperate and give consent for the trial and comes for regular follow up. |
|
| ExclusionCriteria |
| Details |
1. Patients with complications and requiring surgical interventions.
2. Patients with high values of serum creatinine, serum glutamic pyruvic transaminase, serum glutamic oxaloacetic transaminase, alkaline phosphatase and HbA1c at screening.
3. Any systemic disease requiring other medications of surgery for calculus condition.
4. Complicated cases of Renal calculi requiring surgical condition.
5. Chronic or current infectious diseases such as but not limited to chronic renal infection, Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris , myocardial infarction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of expulsion and change in size and density of renal calculi assessed by CT scan |
Baseline(Day 1) to EOT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of change in pain intensity by visual analog scale (VAS)
2. Evaluate the tolerability of IP.
3. Assessment of rate of incidence of AEs and SAEs. |
Baseline (Day 1) to EOT |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2024 |
| Date of Study Completion (India) |
28/04/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
STUDY TITLE: A Prospective, Interventional, Randomized, Double Blind, Placebo-controlled Clinical study to evaluate Efficacy and Safety of Clearstone syrup (sugar free) in patients with Asymptomatic Renal calculi.
Objective: Primary objective To evaluate the efficacy of Clearstone syrup (sugar free) in patients with Asymptomatic Renal calculi.
Secondary objective To evaluate the safety of Clearstone syrup (sugar free) in patients with Asymptomatic Renal calculi.
End points:
Primary Endpoints Evaluation of expulsion and change in size and density of renal calculi assessed by CT scan from baseline (Day 1) to EOT. Secondary Endpoints 1. Evaluation of change in pain intensity by using Visual analog scale (VAS) from baseline (Day 1) to EOT . 2. Evaluate the tolerability of investigational product from baseline (Day 1) to EOT. 3. Assessment of rate of incidence of AEs and SAEs. Number of subjects: A total of 100 participants will be randomized in 1:1 proportion as 50:50 participants in each arm (Clearstone syrup and Placebo respectively) Study Duration: 17 weeks (16 weeks of treatment duration and 1 week follow up after treatment.) |
|