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CTRI Number  CTRI/2024/03/063844 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 13/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Probiotic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Bifilac Capsule in Recurrent Vaginitis infections 
Scientific Title of Study   A Randomized open label study of Prebiotics and Probiotics (BIFILAC CAPSULE) in Recurrent Vaginitis as an add on therapy to Standard treatment 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Poovithaa J 
Designation  Second year PG MD Pharmacology 
Affiliation  Government Kilpauk Medical College and Hospital 
Address  Department of Pharmacology, Faculty Block II floor, Government Kilpauk Medical College and Hospital, Chennai-10

Chennai
TAMIL NADU
600010
India 
Phone  9841230508  
Fax    
Email  poovithapraba@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Poovithaa J 
Designation  Second year PG MD Pharmacology 
Affiliation  Government Kilpauk Medical College and Hospital 
Address  Department ofPharmacology, Faculty block II floor, Government Kilpauk Medical College and Hospital, Chennai - 10.

Chennai
TAMIL NADU
600010
India 
Phone  9841230508  
Fax    
Email  poovithapraba@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aruna 
Designation  Professor & Head 
Affiliation  Government Kilpauk Medical College and Hospital 
Address  Department of Pharmacology,Faculty block II floor, Government Kilpauk Medical College and Hospital, Chennai-10

Chennai
TAMIL NADU
600010
India 
Phone  9444276923  
Fax    
Email  arunabala511@gmail.com  
 
Source of Monetary or Material Support  
Study samples to be provided by Tablets India Limited to Govt Kilpauk Medical College and Hospital 
 
Primary Sponsor  
Name  Tablets India Limited 
Address  No 72 Marshalls Road Egmore Chennai 600008 
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 
Dr Poovithaa  Department of O&G,Government Kilpauk Medical College and Hospital, Chennai-10  822 Poonamallee High Road Kilpauk
Chennai
TAMIL NADU 
9841230508

poovithapraba@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government KilpaukMedicalCollege Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bifilac Capsule  Streptococcus faecalis T-110 JPC 30 million Clostridium butyricum TO-A 2 million Bacillus mesentericus TO-A JPC 1 million cell Lactobacillus sporogenes 50 million 
Comparator Agent  T. Metrogyl 400 mg C. Doxy 100 mg T. Fluconazole 150 mg   Metronidazole 400mg BD -5 days Doxycycline 100mg BD - 5 days Fluconazole 150 mg weekly - 2 weeks 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  58.00 Year(s)
Gender  Female 
Details  Women aged 20 years to 58 years suffering from Recurrent vaginitis infections

Patients willing to give a written informed consent 
 
ExclusionCriteria 
Details  Pregnant and Lactating mother

Not willing to give consent

Patients with Sulfa drug allergy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Prebiotic and probiotic( Bifilac capsule) in reduction of symptoms in Recurrent vaginitis infection as an add on therapy to standard treatment.

Recurrence rate in the recurrent vaginitis infection 
8 weeks + 4 months follow up for recurrence 
 
Secondary Outcome  
Outcome  TimePoints 
Causative organism of recurrent vaginitis

Change in vaginal pH in recurrent vaginitis patients by litmus paper 
8 weeks  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 4 
Date of First Enrollment (India)   22/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/03/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The composition of urogenital microflora of women is crucial for health and wellbeing of women. Vaginitis is common in women of child bearing age. Recurrent vaginitis is repeat infection within three months of an episode. According to a study, over 50% of those who get vaginitis will recur again within 12 months. Considering the nuts of the problem in terms of women infected per year, urogenital infectious receive far too little attention from scientists, government funding agencies, health professionals, and the pharmaceutical industry. In the complex vaginal environment, bacteria of the lactobacilli group (107-108 CFU g-1 of vaginal fluid) are the dominant microorganisms in healthy pre-menopausal women and play an important protective role by limiting growth of pathogenic microorganisms.When lactobacilli are reduced, eliminated, or replaced by pathogenic species, the host has an increased susceptibility to Urinary Tract infections (UTI), genital tract infections (GTI), bacterial vaginitis(BV),vulvovaginal candidiasis(VVC) and infection by Neisseria gonorrhea or Trichomonas vaginalis.

It is now recognized that the intestinal and urogenital microflora are critical for the health and well-being of humans. The concept of replenishing this flora with probiotic organisms seems to be an option that has a growing scientific basis.

Bifilac capsule is empowered with 3 Prebiotics-streptococcus faecalis T-110 30 million cells, clostridium butyricum 2 million cells, bacillus mesentericus 1 million cells and a Probiotic- lactobacillus sporogenes 50 million. Lactobacillus sporogenes is a universally occurring beneficial bacteria .It is a gram positive, spore-forming lactic acid producing probiotic. Lactobacillus sporogenes ensures proliferation of Lactobacillus in the small intestine. Bifilac thus promotes the growth of both Bifidobacterium in the large intestine as well as Lactobacillus in the small intestine, and thereby completely restores healthy balance of’ intestinal flora. This further harbors the UGT by various hypothesis of travelling of these beneficial micro-organisms via the perennial route. Consequently the uro-genital tract is harbored with probiotics thereby reducing the requirement of standard of care and improving cure rate of vaginitis.

 
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