| CTRI Number |
CTRI/2024/09/073504 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Oral Metronidazole VS Oral Metronidazole with Oral Probiotics in the treatment of Bacterial vaginosis |
|
Scientific Title of Study
|
A Comparative study on the efficacy of Oral Metronidazole VS Oral Metronidazole with ORAL Probiotics in the management of Bacterial Vaginosis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soundharya G |
| Designation |
Post Graduate |
| Affiliation |
Government Stanley Medical College |
| Address |
Government Stanley Medical College , SSB 1ST Floor , Department of DVL
1 , Old Jail Road,
George town,
Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
8220332489 |
| Fax |
|
| Email |
soundhak99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayanthi N S |
| Designation |
Associate Professor |
| Affiliation |
Government Stanley Medical College |
| Address |
Government Stanley Medical College , SSB 1ST Floor , Department of DVL
1 , Old Jail Road,
George town,
CHENNAI
Chennai
TAMIL NADU
600001
India |
| Phone |
9600694059 |
| Fax |
|
| Email |
jay11079@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soundharya G |
| Designation |
Post Graduate |
| Affiliation |
Government Stanley Medical College |
| Address |
Government Stanley Medical College , SSB 1ST Floor , Department of DVL
1 , Old Jail Road,
George town,
Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
8220332489 |
| Fax |
|
| Email |
soundhak99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Stanley Medical College , SSB 1ST Floor , Department of DVL
1 , Old Jail Road,
George town,
Chennai 600001 |
|
|
Primary Sponsor
|
| Name |
Soundharya G |
| Address |
Government Stanley Medical College , SSB 1ST Floor , Department of DVL
1 , Old Jail Road,
George town,
Chennai 600001 |
| 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 |
| Soundharya G |
Government Stanley Medical College |
SSB 1ST Floor , Department of DVL
1 , Old Jail Road,
George town,
Chennai 600001
Chennai
TAMIL NADU |
8220332489
soundhak99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Stanley Medical College and Hospital, Chennai -01, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oral metronidazole |
Oral Metronidazole 400 mg BD daily
for 1 week
|
| Comparator Agent |
oral metronidazole with oral probiotics |
Oral Metronidazole 400mg BD daily for 1 week plus oral lactobacillus(containing Lactobacillus rhamnosus and Lactobacillus reuteri each 1 million colony forming units ) given twice daily for 4weeks, followed by once daily for next 4 weeks (total – 2months) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient with more than 18 years of age
Patient with complaints of vaginal discharge satisfying Amsel criteria
Patient willing for consent, study and regular follow up
Patient willing to take photograph
|
|
| ExclusionCriteria |
| Details |
Patients below 18 years.
Patients with sexually transmitted diseases such as HIV , Syphilis, Hepatitis B and Hepatitis C
Patient with vaginal discharge due to co-existing genital ulcer
Patient with other infective causes of vaginal discharge such as Trichomonas vaginitis, vulvovaginal candidiasis
Patients who are on treatment with any antibiotics 6 weeks prior to the study
Lactating or Pregnant women
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical and microbiological cure |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decreases the recurrences |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
17/09/2024 |
| 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) |
Not Yet Recruiting |
|
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
|
It is a Randomized Control Study. Patients satisfying the
inclusion criteria will be
included in the study. Patient socio demographic data and a thorough history will be taken. General examination,
systemic examination, Genital examination under
Cusco’s bivalve self-retaining vaginal speculum will be done. Genital discharge smears will be taken from
the posterior fourchette and Vaginal discharge will
be subjected for sniff test, whiff test, vaginal pH examination using litmus papers. Vaginal discharge will be
investigated under saline mount, KOH examination,
Gram staining of vaginal smear. After diagnosis of Bacterial vaginosis using Amsel’s criteria patients are randomized into two groups A and B ( randomization by Simple random sampling ) Group A: Patients in this group will receive Oral Metronidazole 400 mg BD daily for 1 week Group B:
Patients in this group will receive Oral Metronidazole 400mg BD daily for 1 week plus oral lactobacillus(containing Lactobacillus rhamnosus and Lactobacillus
reuteri each 1 million colony forming units ) given twice daily for 4weeks, followed by once
daily for next 4 weeks (total – 2months)
|