| 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
|
|
|
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
|
|
|
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. |