| CTRI Number |
CTRI/2009/091/000919 [Registered on: 01/01/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Single Arm Study |
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Public Title of Study
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A clinical trial to study the effects of evaluation of efficacy and safety of Fermalac Intravaginal Capsule (Lactobacillus Rhamnosus, Lactobacillus Delbrueckii, Streptococcus Thermophilus) in the treatment of Bacterial Vaginosis among the Indian women |
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Scientific Title of Study
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A prospective, non - comparative and multi centric trial to evaluate the efficacy and safety of Fermalac Intravaginal Capsule (Lactobacillus Rhamnosus, Lactobacillus Delbrueckii, Streptococcus Thermophilus) in the treatment of Bacterial Vaginosis among the Indian women |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| ZY/SC/06/2009&Version No:1.0/SC/09 |
Other |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr. V.R.Ambiye |
| Designation |
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| Affiliation |
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| Address |
Mahalaxmi Clinic, Flat No.1, Ground Floor, Nand Dham
Sulochana Shetty Marg, Sion (East)
Mumbai
MAHARASHTRA
400022
India |
| Phone |
02224044912 |
| Fax |
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| Email |
mvambiye@yahoo.co.in |
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Details of Contact Person
Scientific Query
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| Name |
Dr. S.L.Sharma |
| Designation |
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| Affiliation |
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| Address |
Arun & Co, 603/B Polaris, Off Marol Maroshi Road
Behind Sangeet Plaza, Marol, Andheri (East)
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02267723000 |
| Fax |
02267253399 |
| Email |
slsharma@zytex.net |
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Details of Contact Person
Public Query
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| Name |
Mr. D.M.Doshi |
| Designation |
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| Affiliation |
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| Address |
Arun & Co, 603/B Polaris, Off Marol Maroshi Road
Behind Sangeet Plaza, Marol, Andheri (East)
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02267723000 |
| Fax |
02267253399 |
| Email |
dmd@zytex.net |
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
Arun & Co.
603 / B Polaris, Off Marol Maroshi Road,
Behind Sangeet Plaza, Marol,
Andheri (East), Mumbai - 400059
India
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| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. V.R.Ambiye |
Mahalaxmi Clinic. |
Flat No.1, Gr. Flr, Nand Dham Sulochana Shetty Marg,Sion (East)-400022
Mumbai
MAHARASHTRA |
02224044912
mvambiye@yahoo.co.in |
| Dr. Vijaya Smile |
Pondicherry City Hospitals (Pvt.) Ltd |
12, Goubert Street, Kamaraj Nagar,-605011
Pondicherry
PONDICHERRY |
04132211567
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| Dr. Sreelatha S |
Roopesh Clinic |
#2941/e, Opp. To Maruthi Temple Service Road,Vijayanagar-560 040
Bangalore
KARNATAKA |
23385549, 22926537, 9448915477
spandana_veena@yahoo.co.in |
| Dr. Sivakamu Dhandapani |
Sakthi Hospital & Research Centre |
#175, Big Street, Triplicane,-600005
Chennai
TAMIL NADU |
2844 2626, 4215 6633, 98400 88544
sakthi.hospital@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IEC Mumbai |
Approved |
| IEC of Dr. Ambedkar Medical College |
Approved |
| IEC of Pondicherry City Hospitals (P) Ltd |
Approved |
| IEC of Sakthi Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
In this study we will be enrolling cases with Bacterial Vaginosis., |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Fermalac Intravaginal Capsule |
One capsule per day for two weeks |
| Comparator Agent |
Nil |
Nil |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Female patients aged 21-35 years.
2. Non pregnant females
3. Patients with an acute symptomatic episode of vaginal infection satisfying the following clinical and laboratory criteria-
Presence of symptoms such as pruritus, dysuria, irritation, soreness, altered discharge and signs of vulvovaginal inflammation (edema, erythema & vulvar excoriation)
4. Female patients on adequate contraceptive control.
5. Written informed consent by patient.
6. Patient willing to follow up.
7. Restoration of beneficial microflora
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| ExclusionCriteria |
| Details |
1. Pregnant and nursing women.
2. Mixed vaginal infections, including bacterial vaginosis and trichomoniasis or coexistent infections with genital herpes and cervicitis.
3. Abnormal papanicolaou smear (grade 3 or more) in the preceding 12 months
4. Patients who had taken oral or intravenous antifungal agents within 4 weeks or used topical vaginal antifungal drugs within 1 week before enrollment.
5. History of diabetes mellitus.
6. Immunocompromised patients, including those with known human immunodeficiency virus seropositivity or with clinically diagnosed acquired immunodeficiency syndrome or its related complex.
7. Terminally ill patients or patients with severe cardiac, hepatic (ASAT, ALAT values >3 X upper limit of normal laboratory values) renal (creatinine clearance < 20ml/min) or cerebrovascular disease, malignancy, chronic uncontrolled systemic disease e.g. hypertension, collagen disorders, etc or any other serious medical illness.
8. Patients who have participated in a new drug study in the past 3 months.
9. Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| To evaluate the recurrence rate of vaginal infections (by clinical & microbiological evaluation) |
At baseline, day 7 and 14. |
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Secondary Outcome
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| Outcome |
TimePoints |
| 1. To observe change in total score of signs & symptoms
2. To evaluate the safety and tolerability of treatment
3. To assess the overall global improvement |
At Baseline, Day 7 and 14. |
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/11/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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The study is A prospective, non - comparative and multi centric trial to evaluate the Efficacy and Safety of Fermalac intravaginal capsule (Lactobacillus Rhamnosus, Lactobacillus Delbrukii, and Streptococcus Thermophilus) in the treatment of bacterial vaginosis among the Indian Women for 14 days in 240 patients that will be conducted in four centers in India. The primary outcome measure will be to evaluate the recurrence rate of vaginal infections (by clinical & microbiological evaluation). The secondary outcome measure will be
1. To observe change in total score of signs & symptoms
2. To evaluate the safety and tolerability of treatment
3. To assess the overall global improvement
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