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IRCT2016071428929N1 IRCT 2016-09-07 Vice Chancellor for Research, Shiraz University of Medical Sciences 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 women BV Bacterial Vaginosis 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 women 2016-09-22 anticipated 168 Complete https://irct.ir/trial/23361 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Bacterial Vaginosis. Intervention 1: The first intervention group, Oral tablet of Metronidazole 250 mg; 2 tablet; every 12 h, is given for 7 days. Intervention 2: The second intervention group vaginal cream of Jaft (one Applicator every night) is given coccurent with oral tablet of Metronidazole 250mg, 2 tablets every 12 h.
public Zeinab Moshfeghy
Namazi squar, Shiraz
Shiraz Iran (Islamic Republic of) +98 917 313 7561 zmoshfeghy1385@yahoo.com School of Nursing and Midwifery, Shiraz University of Medical Sciences scientific Zeinab Moshfeghi
Namazi Squar, Shiraz
Shiraz Iran (Islamic Republic of) +98 917 313 7561 zmoshfeghy1385@yahoo.com School of Nursing and Midwifery, Shiraz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 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. Exclusion Criteria: 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. 18 years 45 years Female N-99 Diseases of the Genitourinary system Treatment - Drugs Treatment - Drugs The first intervention group, Oral tablet of Metronidazole 250 mg; 2 tablet; every 12 h, is given for 7 days. The second intervention group vaginal cream of Jaft (one Applicator every night) is given coccurent with oral tablet of Metronidazole 250mg, 2 tablets every 12 h. Vaginal Discharge. Timepoint: Before and after the treatment of a week. Method of measurement: Through Smears of Vaginal discharges and Gram stained smears. 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. Vice Chancellor for Research, Shiraz University of Medical Sciences Approved 2016-06-06 Ethics committee of Shiraz University of Medical Sciences Zand Street, Shiraz University of Medical Sciences Central building, Shiraz Shiraz Iran (Islamic Republic of)