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Effectiveness of vaginal tablets of vitamin C with metronidazole on treatment of bacterial vaginosis. (A randomised , double blind , control trial )

Effectiveness of vaginal tablets of vitamin C with metronidazole on treatment of bacterial vaginosis ,clinical trials.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015042521917N3
Enrollment
160
Registered
2015-05-30
Start date
2015-06-22
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. Inflammatory diseases of female pelvic organs

Interventions

Intervention 1: Intervention group will receive vitamin C vaginal tablet 250 mg which produced by Faculty of Medicine Pharmaceutical group in Tabriz university of medical science with oral metronida
Treatment - Drugs
Placebo
Intervention group will receive vitamin C vaginal tablet 250 mg which produced by Faculty of Medicine Pharmaceutical group in Tabriz university of medical science with oral metronidazole ( prescribe
Control group will receive placebo vaginal tablet along with oral metronidazole ( prescribed with the dose of 500 mg twice a day) during 7 days.

Sponsors

Tabriz University of Medical Sciences. Women’s Reproductive Health Research Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: non-pregnant and non breastfeeding married women age between 18 -45 Years Old,diagnosis of bacterial vaginosis with contemporary presence of at least three out of four Amsel criteria and gain score 4 to 6 with clue cells or score 7 to 10 without clue cells in Nugent scoring system, have willing to participate to study , possibility to attending center in schedule time for post treatment follow up , husband’s monogamous , Filling the Informed Consent Form; Exclusion criteria: chronic disease , consumption of vaginal medication or douching during the recent weeks , Immune deficiency syndrome, consumption of antibiotic during the recent weeks , consumption of rifampin –phenytoin- phenobarbital and any anticoagulant agents , other vaginal infections ,presence of unknown vaginal bleeding .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Clinical and laboratory criteria based on Amsel and Nugent scoring system . Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by clinical measurements of diseases and laboratory tests.;Malodon discharge. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by asking from patient.;Itching. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by asking from patient.;Dyspareunia. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by asking from patient.;Having fishy smell during sexual intercourse. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by asking from patient.

Secondary

MeasureTime frame
The vaginal PH change. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: PH paper scale.;Change in Clue Cells. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by laboratory tests.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSevil Hakimi

Tabriz University of Medical Sciences

hakimis@tbzmed.ac.ir; hakimisevil@gmail.com+98 41 3479 6770

Outcome results

None listed

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