An open observational clinical study of individualized homoeopathic treatment in polycystic ovarian syndrome (PCOS) and validation of the Bengali version of modified polycystic ovarian syndrome questionnaire (MPCOSQ)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Pelvic/transvaginal ultrasound and blood LH:FSH level
研究概览
简要总结
Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder, affecting women of reproductive age, with an estimated prevalence of 4-25%. Its prevalence among infertile women is 15-20%. It is characterized by irregular menses, anovulation, clinical and/or biochemical signs of hyperandrogenism (including hirsutism, acne and alopecia), ovarian micropolycystic appearance and metabolic abnormalities, such as hyperinsulinaemia and obesity. As there is currently no cure, the management of PCOS is directed towards improving the patients’ health-related quality of life (HRQoL) by means of symptomatic alleviation and prevention of long-term complications (e.g. metabolic syndrome, cardiovascular diseases, type II diabetes mellitus etc.). Evidence based medical management emphasises a multidisciplinary approach for PCOS, as conventional pharmaceutical treatment may be contra-indicated, is often associated with side-effects and not effective in some cases. PCOS has earlier been reported to be one of the most frequently reported medical conditions in the obstetrics and gynaecology (O&G) outpatient of a homoeopathic hospital in West Bengal, and is also consistent with the finding from another O&G outpatient from another homoeopathy hospital in West Bengal. Physician-rated +2/+3 improvement was recorded in 58.6% and in 33.3% PCOS patients on a 7-point -3 to +3 Likert scale in the two hospitals. Thus PCOS was identified as one of the promising and priority research areas by this systematic documentation research. However, till date, clinical trials in this field have remained seriously compromised. In this open, observational, multicentric, pre-post comparison clinical trial, 100 patients will be given individualized homoeopathic medicines to examine treatment effect over 6 months. Prior to that, psychometric validity of the translated Bengali version of the Modified PCOS Questionnaire (MPCOSQ) will be tested. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Diagnosed PCOS as per Rotterdam diagnostic criteria [23] (developed in 2003 to aid clinicians in the systematic and accurate diagnosis of PCOS).
- •It states that two of the following three criteria should be present for a diagnosis: a) oligo-ovulation or anovulation; b) clinical and/or biochemical signs of hyperandrogenism; and c) polycystic ovaries.
- •Furthermore, the likelihood of other similar illnesses (such as Cushing’s syndrome) should first be systematically excluded.
- •New criteria have recently been proposed by the Androgen Excess and PCOS Society, which suggest tighter definitions are required by focusing on only two criteria: a) hyperandrogenism (clinical hirsutism or biochemical hyperandrogenaemia, or both); and b) ovarian dysfunction (oligo-ovulation or anovulation, or polycystic ovaries, or both).
- •Age 18-45 years
- •Symptomatic for at least last 3 months
- •Patients taking oral contraceptive pills (OCPs) will be advised to stop pills till it exhaust for the ongoing cycle, followed by re-assessment of symptoms in the next cycle enrolment
- •Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months
- •Patients with known but controlled systemic diseases with medication
- •Ability to read Bengali
- •Patients giving written consent to participate.
排除标准
- •Unevaluated gynaecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases (PID) within one month, patients with suspicious adenomyosis, gross developmental defect or congenital abnormalities of the uterus etc.
- •Genito-urinary tract malignancy
- •Patients desiring immediate surgical management for PCOS
- •Patients with psychiatric diseases
- •Pregnancy and lactation
- •Cases suffering from uncontrolled systemic illness or life-threatening infections or any vital organ failure
- •Cases already undergoing homoeopathic treatment for any chronic disease
- •Substance abuse and/or dependence 10.
结局指标
主要结局
Pelvic/transvaginal ultrasound and blood LH:FSH level
时间窗: Baseline and after 6 months
次要结局
- Modified PCOS questionnaire (MPCOSQ); translated Bengali version(Baseline, after 3 and 6 months)
- EQ-5D-5L questionnaire; validated Bengali version(Baseline, after 3 and 6 months)