| CTRI Number |
CTRI/2019/10/021789 [Registered on: 24/10/2019] Trial Registered Prospectively |
| Last Modified On: |
23/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of Cystone GNX tablet in UTI |
|
Scientific Title of Study
|
An Open label, Two Arm, Randomized, Comparative Clinical Study to Evaluate the Efficacy and Safety of Cystone GNX tablet in chronic and recurrent UTI |
| Trial Acronym |
Cys_GNX |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/CP/PP/025/2019 Version Number: 1, Dated: Aug 14th 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T Srinivasan |
| Designation |
Consultant Urologist |
| Affiliation |
Jupiter Surgical Speciality Centre |
| Address |
Jupiter Surgical Speciality Centre, No.6, Venkataraman Street, Perambur, Chennai
Chennai
TAMIL NADU
600011
India |
| Phone |
9442217211 |
| Fax |
|
| Email |
srinivasan.euro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Palaniyamma |
| Designation |
Medical Advisor |
| Affiliation |
The Himalaya Drug Company |
| Address |
Room No. 301, 3rd floor, Clinical Pharmacology, R&D, The Himalaya Drug Company
Makali, Tumkur Road, Bangalore
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.palani@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Palaniyamma |
| Designation |
Medical Advisor |
| Affiliation |
The Himalaya Drug Company |
| Address |
Room No. 301, 3rd floor, Clinical Pharmacology, R&D, The Himalaya Drug Company
Makali, Tumkur Road, Bangalore
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.palani@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug COmpany, Makali, Tumkur Road, Bangalore - 562162 |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
Makali, Tumkur Road, Bangalore - 562162 |
| 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 |
| Dr T Srinivasan |
Jupiter Surgical Speciality Centre |
Door No.6, Urology department, Room 2, Venkataraman Street,
Perambur, Chennai
Chennai
TAMIL NADU |
9442217211
srinivasan.euro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cystone GNX tablets |
This is an open label, two arm, randomized, comparative clinical study. Initially, subjects will be initiated for the informed consent process and then screening will be carried out for eligibility and subjects will be screened to have 80 eligible subjects. As per randomization, the subjects will receive either Cystone GNX tablet at a dose of 1 tablet twice daily for a period of 28 days OR Cystone tablet at a dose of 1 tablet twice daily for a period of 28 days. The whole study treatment is for 28 days with visit at day 1, 14 and 28. |
| Comparator Agent |
Cystone Tablets |
This is an open label, two arm, randomized, comparative clinical study. Initially, subjects will be initiated for the informed consent process and then screening will be carried out for eligibility and subjects will be screened to have 80 eligible subjects. As per randomization, the subjects will receive either Cystone GNX tablet at a dose of 1 tablet twice daily for a period of 28 days OR Cystone tablet at a dose of 1 tablet twice daily for a period of 28 days. The whole study treatment is for 28 days with visit at day 1, 14 and 28. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Adult male and female subjects aged ≥18 to ≤ 65 years presenting atleast two of the following UTI symptoms as described in table1
Three or more episodes of recurrent UTI in the past 12 months.
UTI as diagnosed by urine culture more than 105 CFU/mL
Subjects willing to sign informed consent and follow the study procedure.
Subjects who has not participated in any similar kind of clinical study in the last one month.
|
|
| ExclusionCriteria |
| Details |
History of neurogenic bladder, pelvic irradiation or chemical cystitis, presence of urethral, pelvic, or rectal carcinoma, benign or malignant bladder tumors, tuberculous cystitis.
Kidney Infection
Pre-existing urolithiasis condition
Pre-existing systemic disease: cardiac, neurological, renal or hepatic dysfunction.
Antibacterial drug therapy for UTI during the previous 72 hours
Patients with suspected or confirmed prostatitis
Patients with renal transplantation or ileal loops
History of urinary tract structural abnormalities.
Any recent history of trauma to the pelvis or urinary tract.
Pregnant & breast-feeding women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subjects demonstrating percentage improvement in the terms of efficacy parameters such as laboratory and clinical parameters from baseline to end of study. |
The subject will be assessed clinically at day 1, day 14 plus or minus 2 days and at day 28 plus or minus 2 days (End of Study). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety evaluation through Incidence of adverse events during the study period.
Compliance of the subject to the study medication
|
The subject will be assessed clinically at day 1, day 14 plus or minus 2 days and at day 28 plus or minus 2 days (End of Study). |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
04/11/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label,
two arm, randomized, comparative clinical study. Initially, subjects will be
initiated for the informed consent process and then screening will be carried
out for eligibility and subjects will be screened to have 80 eligible subjects.
As per randomization, the subjects will receive either Cystone GNX tablet at a
dose of 1 tablet twice daily for a period of 28 days OR Cystone tablet at a dose
of 1 tablet twice daily for a period of 28 days. The whole study treatment is
for 28 days with visit at day 1, 14 and 28.
|