CTRI/2018/07/014717已完成2 期
Clinical evaluation of the efficacy of Pushyanug churna in the management of SwetaPradara w.s.t. Bacterial Vaginosis (Leucorrhoea) ?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Married women with regular menstrual cycle.
- •2.Presence of 3 out of 4 Amsel’s diagnostic criteria for Bacterial Vaginosis:
- •a) Off white (milky or gray), thin, homogeneous, adherent vaginal discharge, with minimal or absent pruritis.
- •b) Vaginal pH > 4.5
- •c) Positive whiff test ? (fishy odor of the vaginal discharge with the addition of a drop of 10% KOH).
- •d) Presence of clue cells =20% of the total epithelial cells on microscopic examination of the saline wet mount.
- •3.Patient agrees to refrain from use of douches, oral or intra-vaginal antibiotics or anti-fungal agents or lubricants during the entire study period.
- •4.Patient willing and agrees to participate for three months and signs informed consent.
排除标准
- •1.Patient with Pelvic inflammatory disease, Cervicitis or other vaginal infections like Trichomoniasis or candida etc or noninfectious vulvo-vaginitis/ cervicitis.
- •2.Patients with evidence of malignancy or cervical intra-epithelial neoplasia or cervical carcinoma.
- •3.Patient with history of untreated sexually transmitted disease or known to be HIV positive.
- •4.Patient with positive pregnancy test/ Lactating woman.
- •5.Patient has received antifungal or antimicrobial therapy (systemic or intra-vaginal) within last 14 days prior to enrollment.
- •6.Patient with PAP smear more than or equal to LSIL.
- •7.Patient using intrauterine implantable devices [IUD], intrauterine system [IUS] and vaginal rings as a method of birth control.
- •8.Raised liver enzymes twice the upper limit of normal & creatinine more than 1.4 mgm%.
- •9.Patient with poorly controlled Hypertension (more than or equal to 160/100 mm of Hg).
- •10.Patient with poorly controlled Diabetes Mellitus{B.S. (F) more than 130 mg% and or B.S. (2 hr. PP) more than 250 mg% & HbA1c more than 6.5%}.
- •11.Patient on prolonged (more than 6 weeks) medication with oral contraceptives, HRT, corticosteroids, antidepressants, anti-cholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
- •12.Patient who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •13.H/o hypersensitivity to the trial drug or any of its ingredients.
- •14.Patients who are currently participating in any other clinical trial or participated in past 6 months.
- •15.Any other condition which the Principal Investigator thinks may jeopardize the study.
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