| CTRI Number |
CTRI/2019/12/022426 [Registered on: 18/12/2019] Trial Registered Prospectively |
| Last Modified On: |
11/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Urinary infections in Diabetic patients |
|
Scientific Title of Study
|
An Open Label Two Arm Randomised Clinical Study to Evaluate the Safety and Efficacy of Cystone SF Liquid in diabetic subjects suffering from Chronic Urinary Tract Infections |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No.: HDC/CP/PP/008/2019 V:2.0. Date: 24APRIL2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandrashekar S Ratkal |
| Designation |
CMD and Chief Urologist |
| Affiliation |
ReSCUE The Urology Centre |
| Address |
ReSCUE The Urology Centre,
#458, 6th Main, Kalikamba Temple Road,
Kengeri Satellite Town, Bangalore 560060
Bangalore
KARNATAKA
560060
India |
| Phone |
9845255378 |
| Fax |
|
| Email |
dr.csratkal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Palaniyamma |
| Designation |
Medical Advisor |
| Affiliation |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company
Makali, Tumkur Road, Bangalore
Bangalore
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 |
The Himalaya Drug Company
Makali, Tumkur Road, Bangalore
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 Chandrashekar S Ratkal |
ReSCUE The Urology Centre |
#458, 6th Main, Kalikamba Temple Road, Room No. 2, Urology department,
Kengeri Satellite Town, Bangalore 560060
Bangalore
KARNATAKA |
9845255378
dr.csratkal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent 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 SF Liquid |
This is an open label single arm clinical study. Initially, subjects will be initiated for the informed consent process and then screening will be carried out for eligibility check.Subjects will be screened to have42eligible subjects who will receive Cystone-SF liquid at a dose of 10 ml twice daily for a period of14 days. The whole study treatment is for 14 days with follow up visit at day 1, 7and 14. This study is divided into Screening period, Active Treatment period and End of Study. |
| Comparator Agent |
No comparator |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult male and female subjects aged more than or equal too 18 years presenting atleast two of the following UTI symptoms like urgency, dysuria, frequency of micturition (nos), suprapubic pain, haematuria, burning micturition, fever, flank pain, chills, nausea and emesis.
Known diabetic subjects with RBS less than or equal to 160 mg/dL.
UTI as diagnosed by urine culture more than 105 CFU/mL
Urine routine microscopy suggestive of increase or normal number of pus cells (white blood cells) per cubic millimetre
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, urinary schistosomiasis.
Subjects with cardiac, neurological, renal or hepatic dysfunction.
Pregnant &breast-feeding women.
Significant medical problems such as uncontrolled hypertension / congestive heart failure or any other medication condition
History of ongoing, chronic or recurrent infectious disease / lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
History of Alcohol or smoking abuse.
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
|
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. |
The subject will be assessed clinically at day 7±3 days and at day 14±3 days (End of Study). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of individuals symptoms free by day 7 (Table 1)
Percentage of individuals symptoms free by day 14 (Table 1)
Compliance of the subject to the study intervention and assessment of adverse effects reported or observed during the study period
|
The subject will be assessed clinically at day 7±3 days and at day 14±3 days(End of Study). |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
26/12/2019 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label single arm clinical
study. Initially, subjects will be initiated for the informed consent process
and then screening will be carried out for eligibility check.Subjects will be
screened to have 42 eligible subjects who will receive Cystone-SF liquid at a
dose of 10 ml twice daily for a period of 14 days. The whole study treatment is
for 14 days with follow up visit at day 1, 7 and 14. This study is divided into
Screening period, Active Treatment period and End of Study. |