CTRI/2013/09/003983招募中2 期
Management of polycystic ovarian syndrome with homoeopathic intervention versus placebo -A randomized controlled pilot study
Central Council of Research in Homoeopathy0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- •i.Female aged 18 to 36 years
- •ii. Oligomenorrhea (Intermenstrual period of more than 35 days for 3 consecutive
- •cycles)/amenorrhea for more than 3 months (two years after menarche)
- •iii.Ultrasound findings of Polycystic ovaries
- •The PCO should have at least one of the following: either 12 or more follicles measuring 2±9 mm in diameter or increased ovarian volume ( >10 cm3). If there is evidence of a dominant follicle ( >10 mm) or a corpus luteum, the scan should be repeated during the next cycle.
- •Only one ovary fitting this definition or a single occurrence of one of the above criteria is sufficient to define the PCO.
- •iv.Clinical evidence of hirsuitism (Ferriman score 8 and above)16 and/ or acne (acne global severity scale score 1 and above)
- •v.Body mass index (BMI) 23 and above
- •vi.Participants willing to adopt healthy diet and to take regular exercise (at least 30 minutes of exercise at least 5 days a week).
- •vii.Written Informed consent from the patient
排除标准
- •i.History of diabetes mellitus
- •ii.History of cushing disease
- •iii.History of hyperprolactinemia
- •iv.Untreated hypo or hyperthyroidism
- •v.History of adrenal hyperplasia and adrenal tumor
- •vi.Ovarian tumor
- •vii.Hyperthecosis
- •viii.Significant renal impairment
- •ix.History of intake of drugs aldactone/ metformin or history of OCP use or intake of drugs known to interfere with carbohydrate metabolism prior 4 weeks before enrolment
- •x.Pregnancy, breast feeding
- •xi.Cases with other systemic diseases like cardiovascular, endocrinal diseases or Systemic infections or on other treatment therapies
研究者
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