| CTRI Number |
CTRI/2013/05/003658 [Registered on: 21/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
18/05/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effectiveness of probiotics in lower reproductive tract infections in women. |
|
Scientific Title of Study
|
Effectiveness of probiotics in lower reproductive tract infection in women of age group 18 to 45 years. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| probiotics |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rukshana Shamshu |
| Designation |
Junior Resident |
| Affiliation |
Sree Avittom Thirunal Hospital,MCH,Thiruvananthapuram |
| Address |
Ecstacy, C.T.Junction,T.K.M.C. P.O.,Karickode,Kollam
Department of Obstetrics and Gynaecology,SATH,MCH,TVM
Thiruvananthapuram
KERALA
691005
India |
| Phone |
9495703495 |
| Fax |
|
| Email |
rukshanaimtyaz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C NIRMALA |
| Designation |
Professor & HOD |
| Affiliation |
|
| Address |
Department of Obstetrics and Gynaecology,SAT Hospital, Medical College,Thiruvanathapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447047886 |
| Fax |
|
| Email |
trogstvpm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayasree Vaman |
| Designation |
Additional Professor of Obstetrics and Gynaecology, T.D. Medical College, Vanadanam, Alappuzha |
| Affiliation |
|
| Address |
Uthram, Opp. Petrol pump, Kochulloor,
Medical college P.O.,
Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447697850 |
| Fax |
|
| Email |
jysree@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rukshana Shamshu, Department of Obstetrics & Gynaecology,
Sree Avittom Thirunal Hospital (SATH),
Medical College, Thiruvananthapuram,
Thiruvananthapuram - 695011
KERALA |
|
|
Primary Sponsor
|
| Name |
Dr Rukshana Shamshu |
| Address |
Ecstacy,C.T. Junction,T.K.M.C P.O,
Karickode,
Kollam 691005
(Department of Obstetrics & Gynaecology, Sree Avittom Thirunal Hospital (SATH), Medical College, Thiruvananthapuram, Thiruvananthapuram - 695011 KERALA) |
| Type of Sponsor |
Other [Self] |
|
|
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 Rukshana Shamshu |
OPD of Obstetrics & Gynaecology,Sree Avittom Thirunal Hospital (SATH) |
Out Patient Department (OPD) of Obstetrics & Gynaecology,
Room No. 134,
Sree Avittom Thirunal Hospital (SATH),
Medical College, Thiruvananthapuram - 695011,
Kerala
Thiruvananthapuram
KERALA |
9495703495
rukshanaimtyaz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee ,Govt. Medical College, Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Women with complaints of abnormal vaginal discharge suggestive of bacterial vaginosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab Metronidazole and placebo |
500mg 1-1-1 for 7 days for Metronidazole and two capsules per day for thirty days - placebo |
| Intervention |
Tab metronidazole and Probiotic capsule containig more than one million bacilli each of Lactobacillus Rhamnosus GR-I and Lactobacillus Reuteri RC-14 |
Tab metronidazole 500 mg 1-1-1 for 7 days and placebo 2 capsules per day for thirty days to the study group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women between 18 and 45 years attending gynaecology OPD with complaint vaginal discharge and/or vaginal itching who gives informed consent. |
|
| ExclusionCriteria |
| Details |
1. Women of below 18 years and above 45 years age group.
2. Women with history of diabetes mellitus.
3. Women with malignancy or those on cancer chemotherapy.
4. Women with chroic liver disease,chroic renal disease.
5. Women with HIV infection and those on immunosuppressive therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the effectiveness of the probiotic strains having Lactobacillus rhamnosus GR -1 and Lactobacillus reuteri RC-14 in the management of lower genital infections(bacterial vaginosis as an integral therapy with antibiotics. |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the effectiveness of probiotics in maintaining a healthy genital flora throughout the treatment period |
one year |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2012 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In the SAT gynaecology OPD, 40 to 50% women present with vaginal discharge .24.7% of them have a flora suggestive of bacterial vaginosis.Incidence of HIV and STD are on an increase.
Bacterial Vaginosis has been found to be associated with preterm labour, PROM, postpartum endometritis, puerperal and post abortion sepsis which can be prevented by early treatment. it is also associated with post operative infectios ad vaginal cuff cellulitis.
To avoid the rising rates of antibiotic resistance, following use in lower reproductive tract infection the role of probiotics has been considered as a means of protection against lower reproductive tract infection.
Studies have proven the efficacy of probiotics in lower reproductive tract infectio in women.
Hence the significance of this study. |