| CTRI Number |
CTRI/2017/12/011008 [Registered on: 28/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study of Cystone Forte Tablet in Kidney stone |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Cystone Forte Tablet in Urolithiasis – A Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/CP/PP/72/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTSenthil Kumar |
| Designation |
Associate Prof. of Urology |
| Affiliation |
Tamil Nadu medical council |
| Address |
SRM Medical College Hospital and Research Center
Kattankulathur
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
|
| Fax |
|
| Email |
drsenku78@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTSenthil Kumar |
| Designation |
Associate Prof. of Urology |
| Affiliation |
Tamil Nadu Medical Council |
| Address |
Associate Prof of Urology
SRM Medical College Hospital and Research Center
Kattankulathur
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
|
| Fax |
|
| Email |
drsenku78@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrTSenthil Kumar |
| Designation |
Associate Prof. of Urology |
| Affiliation |
Tamil Nadu Medical Council |
| Address |
Associate Prof of Urology
SRM Medical College Hospital and Research Center
Kattankulathur
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
|
| Fax |
|
| Email |
drsenku78@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company,Makali, Bengaluru 562 162, India |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
Makali, Bengaluru 562 162, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| DrTSenthil Kumar |
SRM Medical College Hospital & Research Center |
Potheri, SRM Nagar
Kattankulathur
Kancheepuram
TAMIL NADU |
9444226422
drsenku78@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cystone Forte |
two tablets twice daily everyday starting from day 1 to end of 3 months |
| Comparator Agent |
Placebo |
two tablets twice daily everyday starting from day 1 to end of 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject with Urolithiasis as diagnosed by clinically and ultrasonographically with calculi measuring 5-10mm.
2. Subjects aged between 18-50 years of either sex.
3. Hematologic and Biochemical parameters within normal limits.
4. Willing to sign inform consent document and follow study procedures |
|
| ExclusionCriteria |
| Details |
1.Subjects with severe obstructive uropathy,
2.Subjects with serious systemic medical disorder,
3.Subjects not to have used any drugs for at least 1 week prior to the study,
4.Subjects with a strong history of food or drug allergy,
5.Subjects not to have been on weight reducing diets within 3 months prior to the start of the study,
6.No other drugs (including aspirin) to be ingested during the course of the study,
7.Pregnant and lactating women
8.Patients unwilling to provide informed consent or abide by the requirements of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Cystone Forte tablet in comparison with placebo in the management of Urolithiasis.
Provide rapid symptomatic recovery.
Reporting of adverse events |
Visit 0- At entry visit, baseline
Visit 1- At the end of month 1
Visit 2- At the end of month 2
Visit 3- (End of the treatment) At the end of month 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety of Cystone forte tablet in the management of Urolithiasis.
Reporting of adverse events |
Visit 0- At entry visit, baseline
Visit 1- At the end of month 1
Visit 2- At the end of month 2
Visit 3- (End of the treatment) At the end of month 3 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/04/2017 |
| Date of Study Completion (India) |
21/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)?
|
|
Brief Summary
|
This is a randomized double blind placebo controlled clinical study to
evaluate the efficacy and safety of Cystone Forte Tablets in Urolithiasis.
In this study, 60 cases were enrolled and subjects were instructed to take
Investigational product in a dose of two tablets twice daily everyday starting
from day 1 to end of 3 months. Patients were followed up for Clinical assessment,
Urine examination and Ultrasonography of abdomen and Pelvis. All the 60 patients completed the study period without withdrawal.
Patients on trial group showed improvement in their symptoms from Month 1
onwards till the end of the study.Overall impression by the investigator for
Cystone forte group is found to be 39% cured, 35% had marked improvement, 19%
had moderate improvement, 6% had slight improvement. For placebo group 34% were
cured, 24% had marked improvement, 17% had moderate improvement, 3% had slight improvement
and 21% had no change .In Cystone forte group, of the 31 stones found during
screening, 16 stones were expelled out at month 3, of which 14 were <7mm and
2 were >7mm. In placebo group, at month 3, 14 stones were expelled out of 29
found in screening, out of which 11 were <7mm and 3 were >7mm.
The present study showed that subjects treated with Cystone forte showed
improvement in clinical parameters of urolithiasis and expulsion of kidney
stones. Between the group analysis showed that Cystone forte group was found to
be effective and was beneficial in the management of urolithiasis. The study
results indicate that the polyherbal formulation, Cystone forte, is safe and
effective in the treatment of urolithiasis with significant improvement in
clinical symptoms like the clearance of calculi and symptomatic relief. The
efficacy of Cystone forte can be due to the synergistic actions of the potent
herbs present in the formulation. The overall compliance to the treatment was
good and no treatment discontinuations were reported. Additionally, it is also
found to be beneficial in expelling and/or reducing the size of the renal
stones, including bigger-sized stones. |