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临床试验/CTRI/2018/04/013410
CTRI/2018/04/013410招募中2 期

Validation of translated Bengali questionnaires assessing menopausal syndrome & open observational trial to evaluate effectiveness of individualized homoeopathic treatment

National Institute of Homoeopathy Ministry of AYUSH Govt of India3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月23日最近更新:

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
Greene climacteric scale (GCS); translated Bengali version

研究概览

简要总结

Menopause is the final menstrual period, and occurs at an average age of 51 years. Menopause is defined as the permanent cessation of menstrual cycles where pathological causes of this state can be diagnosed. Demographic data show that every year 25 million women worldwide experience menopause . Hormone replacement therapy is the standard treatment for early symptoms in post-menopausal women, but increases the risks of stroke, heart diseases, vaginal bleeding, nausea, vomiting, migraine, mastalgia, and breast cancer in older women. Menopausal symptoms have been treated with homoeopathic medicines for more than one and a half centuries. In spite of promising potentials of homoeopathic treatment of menopausal syndrome, it has remained anecdotal rather than being evidence-based. 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 versions of the Greene climacteric scale (GCS), Menopause rating scale (MRS), and Utian Quality of Life (UQOL) questionnaires 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
40.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • Cases suffering from menopausal syndrome; i.e. cessation of menstruation for at least 1 year
  • Age: 40-55 years
  • Ability to read Bengali
  • Patients giving written consent to participate.

排除标准

  • Patients who had an artificial menopause and were on HRT
  • Patients having history of breast or reproductive organ cancer
  • Patients with psychiatric diseases.
  • Cases suffering from uncontrolled systemic illness or life-threatening infections
  • Cases already undergoing homoeopathic treatment for any chronic disease
  • Self-reported immune-compromised state.

结局指标

主要结局

Greene climacteric scale (GCS); translated Bengali version

时间窗: At baseline and after 3 and 6 months

次要结局

  • Menopause rating scale (MRS); translated Bengali version(At baseline and after 3 and 6 months)
  • Utian quality of life (UQOL) scale; translated Bengali version(At baseline and after 3 and 6 months)

研究者

发起方
National Institute of Homoeopathy Ministry of AYUSH Govt of India
申办方类型
Government medical college

研究点 (3)

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