Management of polycystic ovarian syndrome with homoeopathic intervention versus placebo -A randomized controlled pilot study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- •Establishment of regular menstrual cycle along with either ultrasonological improvement of PCO or improvement in hirsutism/ acne.
研究概览
简要总结
Polycystic Ovarian Syndrome (PCOS) is a complex metabolic, endocrine and reproductive disorder affecting approximately 5-10% of the female population in developed countries. However, recent findings from countries like China and India, which are undergoing rapid nutritional transitions due to westernized diets and lifestyle, indicate similar prevalence rates of PCOS. The conventional medical management of PCOS is also not without limitations. Homoeopathic treatment generally has no side effects and holistically treats the individual. Studies have evaluated the Homoeopathic treatment in PCOS. A double blind RCT by Sanchez et al and an observational study by Gupta et al indicate a positive role in PCOD. But these studies had their own limitations. Lifestyle modification including weight reduction has an important role in the management of PCOS. Therefore, the Council proposes to undertake a randomized placebo controlled pilot study to evaluate the efficacy of homoeopathic intervention in the management of PCOS along with lifestyle management with the following objectives-
Primary Objective:
· To determine the feasibility of the study to evaluate the efficacy of homoeopathic intervention as compared with placebo in PCOS in establishing the menstrual regularity with either ultrasonological
improvement of PCO or improvement in hirsutism/ acne.
Secondary Objectives:
· To assess the changes in ultrasound reports of polycystic ovaries in verum and placebo groups.
- To assess the changes in the total and individual domain scores of PCOSQ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 36.00 Year(s)（—）
- 性别
- Female
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.
结局指标
主要结局
•Establishment of regular menstrual cycle along with either ultrasonological improvement of PCO or improvement in hirsutism/ acne.
时间窗: Baseline and 6 months.
次要结局
- •To compare the changes in total and individual domain scores of PCOSQ in verum and placebo groups at monthly interval for 6 months.(Every month for 6 months.)
- •To compare the changes in ultrasound reports of polycystic ovaries at entry and 6 months in verum and placebo groups.(Baseline and 6 months.)