| CTRI Number |
CTRI/2014/04/004557 [Registered on: 23/04/2014] Trial Registered Retrospectively |
| Last Modified On: |
25/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study comparing the effect of metronidazol and tinidazol in treating Bacterial vaginosis (BV) |
|
Scientific Title of Study
|
a randomized, double blind, comparative study of oral metronidazole and tinidazole in treatment of bacterial vaginosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indu M raja |
| Designation |
post graduate student |
| Affiliation |
Sri Venkateshwara Medical College Hospital and research center |
| Address |
post graduate student
department of pharmacology
sri venkateswaraa medical college, Ariyur
Pondicherry
PONDICHERRY
605101
India |
| Phone |
9787247963 |
| Fax |
|
| Email |
dr.induraja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Mukherjee |
| Designation |
Prof and head of pharmacology/ Guide |
| Affiliation |
Sri Venkateshwara Medical College Hospital and research center |
| Address |
uide details
Dr Deepali Mukherjee
Prof and head
Department of pharmcology
SVMCH and RC, Ariyur, POndicherrry
Pondicherry
PONDICHERRY
605101
India |
| Phone |
9442359900 |
| Fax |
|
| Email |
anildipali@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indu M raja |
| Designation |
post graduate student |
| Affiliation |
Sri Venkateshwara Medical College Hospital and research center |
| Address |
post graduate student
department of pharmacology
sri venkateswaraa medical college, Ariyur
Pondicherry
PONDICHERRY
605101
India |
| Phone |
9787247963 |
| Fax |
|
| Email |
dr.induraja@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Indu M raja |
| Address |
PG student
Department of pharmacology
SVMCH and RC Ariyur |
| Type of Sponsor |
Other [Dr Indu M raja] |
|
|
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 Indu M raja |
Sri Venkateshwara Medical college and hospital |
Department of pharmaoclogy
Sri Venkateshwaraa Medical College Hospital and Research
center
Ariyur
Pondicherry
PONDICHERRY |
9787247963
dr.induraja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N760||Acute vaginitis, bacterial vaginosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
metronidazol |
tab metronidazol 500mg twice daily for 5days |
| Intervention |
tinidazol |
tablet tinidazol- 500mg once daily for 5days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
women diagnosed with bacterial vaginosis |
|
| ExclusionCriteria |
| Details |
pregnant and lactating mothers, history of smoking and alcohol, previous history of bactrial vaginosis, with STDs, HIV or genital malignancies, antimicrobial use in previous 14 days |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the cure rate of oral metronidazol with tinidazol |
compare the cure rate at the end of 5 days of oral metronidazol with tinidazol |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare adverse effects of metronidazol with tinidazol |
5days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/01/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Raja IM, Basavareddy Asha, Mukherjee D, Meher BR. Randomized, double-blind, comparative study of oral metronidazole and tinidazole in treatment of bacterial vaginosis. Indian J Pharmacol2016;48:654-8. [Pubmed, Scopus] (Impact factor: 0.69) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Bacerial vaginosis is a clinical syndrome of unknown etiology characterized by y over growth of vaginal anaerobes such as Gardenella vaginalis, bacteroids, mycoplasma. It is the commonest form of lower reproductive tract infection. currently metronidazole is considered as the drug of choice with cure rate of 77.9% . there are also studies showing effecac of tinidazole in treating bacterial vaginosis. it is better tolerated compared to metronidazole. this study is aiming in comparing the cure rates of metronidazole an tinidazole. as secondary endpoint we are comparing the safety profile in both the groups |