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.
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
- 否
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
Homoeopathic treatment for menstrual disorders in females with PCOS
干预措施: Homoeopathic Remedies (Other)
Homoeopathic remedies and yoga in PCOS
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
Dr Anita Fernandes
Professor
Fr Muller Homoeopathic Medical College
