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Effect of Gynophilus Capsule on Treatment of Bacterial Vaginosis (BV)

Clinical Trial of Comparison the Effect of Gynophilus Vaginal Capsule and Clindamycine Gel on Treatment of Bacterial Vaginosis among Pregnant Women under 20 Weeks of Gestation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014040817167N1
Enrollment
150
Registered
2014-06-29
Start date
2013-12-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Bacterial Vaginosis. Other inflammation of vagina and vulva

Interventions

Intervention 1: Intervention: Administration of Gynophilus Vaginal Capsule, Containing of 341 mg, Twice a Day, For 7 Days. Intervention 2: Control: Administration of Clindamycin Vaginal Gel, One Appl
Treatment - Drugs
Intervention: Administration of Gynophilus Vaginal Capsule, Containing of 341 mg, Twice a Day, For 7 Days.
Control: Administration of Clindamycin Vaginal Gel, One Applicator about to 5 mg, Once a Day, for 7 Days.

Sponsors

Golestan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Pregnant Women under 20 Weeks` Gestation with Bacterial Vaginosis; Filing the Informed Consent Form; No Vaginal Bleeding. Exclusion Criteria: No Tendency to Participate in the Study after Entering to the Study; Incomplete Consumption of Medications; No Referring for Second or Third Examinations.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Recurrence. Timepoint: One Month after Treatment. Method of measurement: AMSEL Criteria.;Cure. Timepoint: One Week after Treatment. Method of measurement: AMSEL Criteria.

Secondary

MeasureTime frame
Premature Rupture of Membrane. Timepoint: Total Duration of Pregnancy. Method of measurement: Gestational Age Less Than 37 Weeks.;Preterm labor. Timepoint: Total Duration of Pregnancy. Method of measurement: Gestational Age Less Than 37 Weeks.;Neonate`s APGAR score. Timepoint: First and Ffth Minute of Birth. Method of measurement: APGAR Score Table.;Birth Weight of Neonate. Timepoint: After Birth. Method of measurement: Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Soudeh Ramazanpour

Golestan University of Medical Sciences

dr.ramazanpour@goums.ac.ir+1 733723054

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026