CTRI Number |
CTRI/2019/04/018452 [Registered on: 08/04/2019] Trial Registered Prospectively |
Last Modified On: |
15/05/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Clinical study to assess the usefulness of CV-HFU01 tablets in management of recurrent UTI. |
Scientific Title of Study
|
An Open Label, Single arm, Clinical trial to assess the usefulness of CV-HFU01 tablets in management of recurrent UTI. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
CV-HFU01 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Tanuja Panchabhai |
Designation |
Ayurvedic Consultant |
Affiliation |
Lokmanya Medical Research Center |
Address |
Lokmanya Medical Research Centre
4th floor OPD 2 Lokmanya Medical Research Center Chinchwad Pune 33
Pune
MAHARASHTRA
411033
India
Pune MAHARASHTRA 411033 India |
Phone |
9421885129 |
Fax |
|
Email |
tanudsmartdoc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Vd Veena Deo |
Designation |
Consultant |
Affiliation |
climic health pvt ltd |
Address |
Climic Health Pvt Ltd
2 nd floor
Plot no 567 Great Nag Road Baidyanath Square Near Ganesh Peth Bus Stop Pin code 440024
Nagpur MAHARASHTRA 440024 India |
Phone |
9371490527 |
Fax |
0712-2743453 |
Email |
veenadeo@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Mr Prateek Shastrakar |
Designation |
Admin- Executive |
Affiliation |
Siddhayu Pharma |
Address |
Siddhayu Pharma
Plot no 567 Great Nag Road Baidyanath Square Near Ganesh Peth Bus Stop Pin code 440024
Nagpur
MAHARASHTRA
440024
India
Nagpur MAHARASHTRA 440024 India |
Phone |
8412066668 |
Fax |
0712-2743453 |
Email |
prateeksiddhayu@gmail.com |
|
Source of Monetary or Material Support
|
Climic Health Pvt Ltd
2 nd floor
Plot no 567 Great Nag Road Baidyanath Square Near Ganesh Peth Bus Stop Pin code 440024
|
|
Primary Sponsor
|
Name |
Climic Health Pvt Ltd |
Address |
Plot no 567 Great Nag Road Baidyanath Square Near Ganesh Peth Bus Stop Pin code 440024
Nagpur
MAHARASHTRA
440024
India |
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 |
Ms Varsha Bachkar |
Lokmanya Medical Research Centre |
4 th floor opd 5
Telco Road chinchwad railway station Pune 33
Pune MAHARASHTRA |
8446623333
bachkarvarsha@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Lokmanya Medical Research Centre |
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 |
CV-HFU01 Tablets |
V-HFU01 is a polyherbal formulation useful in management of UTI and related symptoms. 1 Tablet is to be consumed twice daily after meal for at least 3 months. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Male or female patients of age 18 to 60 (both inclusive)
2.Patients with subclinical (asymptomatic bacteriuria) and or recurrent UTI (2-3 episodes of UTI in the last 12 months)
3.Patients with or without UTI not responding to antimicrobial therapy due to any cause including multidrug resistance.
4.Patients prone to recurrent UTIs [like geriatric women, geriatric men with symptomatic BPH, patients on clean intermittent catheterization (CIC), chronically catheterized patients (indwelling catheter, supra pubic catheter) patients with spinal cord injury/ stroke/ paraplegia/ abnormalities of urinary tract].
5.Patients with subclinical (asymptomatic)/recurrent UTI who are off any antibiotics for the past two weeks.
The working definition of recurrent UTI used by us for this study: Patients with recurrent UTI (> 2 or equal to episodes) who had culture positive/sensitive UTI and had taken multiple courses of antimicrobials in the past one year or so and desiring alternative therapy were given the option of entering in to this study
|
|
ExclusionCriteria |
Details |
1. Patients with the first episode of symptomatic active UTI
2. Pregnant and or lactating patients.
3. Patients in the pediatric age group.
4. Patients with known history of hyperoxaluria/known renal oxalatestone formers.
6. Patients not consenting for the study
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate mean percentage change in symptoms like
1.Burning micturition
2.Intermittent urination
3.Pain during urination
4. Other symptoms of UTI |
Screening Visit (-5 day), Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90)
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Patients Global Assessment, Physicians global Assessment
2.To assess the safety of CV-HFU01 tablets by observing adverse events
3.To evaluate tolerability and safety of CV-HFU01 tablets in patients with recurrent UTI.
|
Screening Visit (-5 day), Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90)
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 1/ Phase 2 |
Date of First Enrollment (India)
|
10/03/2020 |
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="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
After Ethics committee’s approval, clinical
study will be registered on CTRI website. Subjects [(male and females age
between 18 – 60 years, (both inclusive)] attending OPD of respective study
sites without ongoing antibiotic treatment for UTI and meeting other inclusion and
exclusion criteria will be recruited in the study. Intended to get 30 evaluable
cases at the end of the study.
On screening visit (day -5), a written
informed consent will be obtained from subject for his/her participation in the
study. Subject will undergo physical and systemic examinations. Subject’s
medical and surgical history will be taken. Subject’s current medication will
be noted in the CRF. Subject’s investigations [CBC, Serum uric acid LFT, RFT] will
be done. Clinical symptoms like
burning micturition, intermittent urination and pain during urination
will be assessed. Subjects will be advised to refrain from any
Nutraceutical, Ayurvedic, homeopathic, Siddha, Unani etc. treatment for the
same. Throughout study period, subjects will be advised lifestyle modification
(nutritious diet, exercise etc.) The record of the current medication will be
kept in the CRF. Subject will be called on baseline visit (day 0).
On baseline visit, subjects will be recruited
if he/she meets all the inclusion criteria. Subjects will undergo general and
systemic examinations. Clinical signs and symptoms (if any) will be evaluated
on subjective assessment scale, Subject will be given study medication packed
in HDPE bottle (each containing 60 tablets). Subject will be advised to take
study medication in a dose of 1 tablet twice daily orally after each meals with
water for next 90 days. Subject will be called for follow up on day 30, day 60,
day 90 i.e. till end of study. Subjects who continuously misses dosing for
>3 consecutive days or total missed dose >6 days during the study period
will be treated as drop outs. Subjects will be allowed to come for follow up
either 5 days prior or after the scheduled follow up visit, provided subject
should continue the given treatment.
On every follow up visit, subjects will
undergo general and systemic examinations. Clinical
symptoms like
burning micturition, intermittent urination and pain during urination
will be assessed. Patient will be assessed for presence of any
adverse events.
On last follow up visit, subject’s global
evaluation for overall improvement and Investigator’s global evaluation for
overall improvement will be done. Tolerability of the study drug will be
assessed by the investigator and patient at the end of the study. All the subjects
will be closely monitored for any adverse events/ adverse drug reactions from baseline
visit till the end of the study. On final follow up visit (i.e. day 90), Clinical symptoms like
burning micturition, intermittent urination and pain during urination will
be assessed. Subjects
will be asked to stop trial medication after completion of 90 days of the study
treatment and take investigator’s advice for further treatment |