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

Vice Chancellor for Research, Shiraz University of Medical Sciences0 个研究点目标入组 168 人开始时间: 待定最近更新: 2018年2月22日

适应症

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•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.

发起方

Vice Chancellor for Research, Shiraz University of Medical Sciences