Comparison of the effect of oral tablet of Metronidazole with vaginal cream of Jaft concurrent with oral tablet of Metronidazole on results of Bacterial Vaginosis (BV) management in childbearing age wome
- Conditions
- Bacterial Vaginosis.Diseases of the Genitourinary system
- Registration Number
- IRCT2016071428929N1
- Lead Sponsor
- Vice Chancellor for Research, Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 168
Willingness to cooperate in the study; Married women of reproductive age (18 - 45); Symptoms of BV on clinical examination and confirmed by Amsel criteria (having three of four criteria) and confirmation by Gram stain and Nugent score should be 7-10; Lack of recent use of oral and topical medications such as Alkaloids, Anti-parasitic, Immunosuppressive drugs and other drugs during the past two weeks, according the patient report; No sexual intercourse during the past 24 hours; Lack of abnormal uterine bleeding (AUB); Lack of frequent bacterial infections which are resistant to treatment; Not to be pregnant and lactation; Lack of vaginal douche in the past 48 hours; Lack of specific diseases such as Liver disease, diseases of the Central Nervous System, Diabetes, Immune deficiency, according to patient report; Non-use of broad-spectrum Antibiotics, Anti-prostaglandins, Hormone therapy and Immunosuppressive, Anticoagulant and drug abuse in recent months; No history of hypersensitivity to Metronidazole; The patient should have only BV not other types of Vaginitis.
Possible sensitivity to the drug (vaginal cream of Jaft), which is not seen so far; Lack of application of vaginal cream (Jaft or Placebo) and oral Metronidazole or discontinuing treatment; Taking any medication affecting the vaginal cream including Alkaloid drugs; Taking any medication affecting the symptoms of BV including broad-spectrum Antibiotic to treat other infections in the patient; Unwillingness of patients to continue or to cooperate; People who are considered sick on the patient's clinical symptoms but their test results does not endorse BV.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vaginal Discharge. Timepoint: Before and after the treatment of a week. Method of measurement: Through Smears of Vaginal discharges and Gram stained smears.
- Secondary Outcome Measures
Name Time Method To reduce infectious factors such as bacteria and clinical symptoms. Timepoint: After a week of treatment. Method of measurement: Through the smears of vaginal discharges and gram stained slides.