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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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