A clinical trial to study the effects of four drugs, Metronidazole, Tinidazole, Secnidazole and Ornidazole in patients with Bacterial Vaginosis.

Comparative study of oral single dose of Metronidazole, Tinidazole, Secnidazole and Ornidazole in cases of Bacterial Vaginosis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001093

Enrollment

376

Registered

2010-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: secnidazole: 2gms single oral dose Intervention2: Tinidazole: 2 gms single oral dose Intervention3: Ornidazole: 1.5 gms single oral dose Control Intervention1: Metronidazole: 2 gms sing

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age between 18-45 years with regular cycles. 2) Symptoms of vaginal discharge with Bacterial Vaginosis diagnosed by Amsel?s criteria. 3) Asymptomatic but on clinical examination presence of abnormal vaginal discharge with Bacterial Vaginosis diagnosed by Amsel?s criteria. 4) Willing to participate in the study after informed consent.

Exclusion criteria

Exclusion criteria: 1) Menopausal women 2) Pregnant women 3) Malignancy of reproductive tract 4) Less than 6 weeks since last delivery and abortion 5) H/O severe allergic reaction 6) Immunocompromised state

Design outcomes

Primary

Measure	Time frame
Cure rateTimepoint: at 4, 8 and 12 weeks.	—

Secondary

Measure	Time frame
Recurrence rateTimepoint: at 4, 8 and 12 weeks.	—

Countries

India

Contacts

Public ContactDr Jyoti Thulkar

ICMR

jthulkar@hotmail.com09873767704

Outcome results