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临床试验/NCT03579303
NCT03579303Unknown不适用

A Comparative Study of Homoeopathic Treatment Versus Integrated Approach of Homoeopathy and Yoga in the Treatment of Menstrual Disorders in Females With Polycystic Ovarian Syndrome.

Fr Muller Homoeopathic Medical College2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
84
试验地点
2
主要终点
To assess if the interventions can facilitate regular menstrual cycle.

研究概览

简要总结

This study is undertaken to compare effectiveness of homoeopathic treatment versus integrated approach of homoeopathy and yoga in the treatment of menstrual disorders in females with Polycystic ovarian syndrome.

详细描述

Polycystic ovarian syndrome (PCOS) is a complex metabolic, endocrine and reproductive disorder affecting approximately 5-10% of the female population in developed countries. The developing countries like China and India, undergoing rapid nutritional transitions due to westernised diets and lifestyle also indicate similar prevalence (9.13%). Its prevalence among infertile women is 15%-20%. The aetiology of Polycystic ovarian syndrome remains unclear; however, several studies have suggested that Polycystic ovarian syndrome is X-linked dominant condition.Women with Polycystic ovarian syndrome have abnormalities in the metabolism of androgens and oestrogen and in the control of androgen production. High serum concentrations of androgenic hormones, such as testosterone, androstenedione, and dehydroepiandrosterone sulfate (DHEAS), may be encountered in these patients. However, individual variation is considerable, and a particular patient might have normal androgen levels.

Polycystic ovarian syndrome is also associated with peripheral insulin resistance and hyperinsulinemia, and obesity amplifies the degree of both abnormalities. Insulin resistance in Polycystic ovarian syndrome can be secondary to a post binding defect in insulin receptor signalling pathways, and elevated insulin levels may have gonadotropin-augmenting effects on ovarian function. In addition, insulin resistance in Polycystic ovarian syndrome has been associated with adiponectin, a hormone secreted by adipocytes that regulates lipid metabolism and glucose levels. Both lean and obese women with Polycystic ovarian syndrome have lower adiponectin levels than women without Polycystic ovarian syndrome .

An anovulation and elevated androgen level suggests that under the increased stimulatory effect of luteinizing hormone (LH) secreted by the anterior pituitary, stimulation of the ovarian theca cells is increased. In turn, these cells increase the production of androgens (eg, testosterone, androstenedione). Because of a decreased level of follicle-stimulating hormone (FSH) relative to LH, the ovarian granulosa cells cannot aromatize the androgens to estrogens, which lead to decreased estrogen levels and consequent anovulation. Growth hormone and insulin-like growth factor 1 may also augment the effect on ovarian functioning.

The clinical manifestation of Polycystic ovarian syndrome varies from a mild menstrual disorder to severe disturbance of reproductive and metabolic functions. Women with Polycystic ovarian syndrome are predisposed to type 2 diabetes or develop cardiovascular disease . Factors implicated in the low fertility in these patients include anovulation, increased risk of early miscarriage, and late obstetric complications.

The diagnostic criteria of the syndrome were revised by the Rotterdam European Society for Human Reproduction/American Society of Reproductive Medicine (ASRM), where the following criteria were established: oligo/amenorrhea, clinical and biochemical signs of hyperandrogenism, and sonographically confirmed Polycystic ovarian syndrome. . Diagnostic criteria for Rotterdam diagnosis of polycystic ovary syndrome

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 36 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female aged 18-36years
  • Females diagnosed with Polycystic ovarian syndrome according to Rotterdam criteria.
  • Participants willing to adopt a healthy life style and regularly practice yoga (at least 30 minutes for 5 days a week).

排除标准

  • Diabetes mellitus, Cushing's disease, hyper-prolactinemia
  • Untreated hypo or hyperthyroidism
  • Adrenal hyperplasia and adrenal tumour
  • Ovarian tumour hyperthecosis
  • History of intake of drugs aldactone/metformin or history of oral contraceptive pills (OCP) use or intake of drugs known to interfere with carbohydrate metabolism 4 weeks prior to enrolment pregnancy, breast feeding cases with any systemic disease.

研究组 & 干预措施

Homoeopathic remedies in PCOS

Active Comparator

Homoeopathic treatment for menstrual disorders in females with PCOS

干预措施: Homoeopathic Remedies (Other)

Homoeopathic remedies and yoga in PCOS

Active Comparator

Homoeopathic treatment integrated with yoga therapy for menstrual disorders in females with PCOS

干预措施: Homoeopathic Remedies (Other)

结局指标

主要结局

To assess if the interventions can facilitate regular menstrual cycle.

时间窗: 3yrs

Assessment of regularity in menstrual cycles will be done during the patients monthly visits to the out patient department ,recording the last menstrual period and duration of menses through a questionnaire

次要结局

  • To assess reduction in hyperandrogenism(3yrs)

研究者

发起方
Fr Muller Homoeopathic Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Anita Fernandes

Professor

Fr Muller Homoeopathic Medical College

研究点 (2)

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