Effectiveness of Individualized Homoeopathic Medicines In the treatment of Vaso-Motor symptoms (hot flashes and night sweats) during Perimenopause/ Menopause: A single blind randomized controlled clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To determine the effectiveness of Individualized Homoeopathic Medicines in reducing hot flashes and improving the quality of life of menopausal women with VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS), assessed using the Hot Flash Related Daily Interference Scale (HFRDIS)
研究概览
简要总结
This study compares the effectiveness of individualized homeopathic medicines and placebo in treating patients with VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS) during perimenopause/menopause, aged 45-55 years. Patients will be randomly assigned to receive either individualized homeopathic medicines or identical looking placebo. The study will measure the outcomes using Hot Flash Related Daily Interference Scale (HFRDIS). The primary goal is to compare the efficacy of these two approaches in managing VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS) during perimenopause/menopause, improving quality of life, and reducing disease severity. The results will provide valuable insights into the effectiveness of homeopathic approaches in treating VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS) during perimenopause/menopause.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Consented Women between the age of 45-55years.
- •Volunteers experiencing climacteric symptoms of VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS)
- •Volunteers who had discontinued hormone replacement therapy or any other medical treatment for climacteric symptoms at least three months prior to enrolment.
- •Diagnosed cases of VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS).
排除标准
- •1.Volunteers women surgically or artificially induced menopause e.g. bilateral oophorectomyor total hysterectomy, any irradiation, chemotherapy, Drug treatment, or other process thatmay have resulted in menopausal symptoms.
- •Patients of malignancy.
- •Patient too sick for consultation.
- •Diagnosed case of mental illness / psychiatric/ other uncontrolled/ life threatening illnessaffecting quality of life/any organ failure.
- •Unwilling to take part and not giving consent to join the study.
- •Patients unable to complywith the study protocol.
结局指标
主要结局
To determine the effectiveness of Individualized Homoeopathic Medicines in reducing hot flashes and improving the quality of life of menopausal women with VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS), assessed using the Hot Flash Related Daily Interference Scale (HFRDIS)
时间窗: At baseline and then after six months (24th week)
次要结局
- To identify the group of predominant homoeopathic medicines which are more useful in casesof VASOMOTOR SYMPTOMS (HOT FLASHES AND NIGHT SWEATS)(1 year (12 months))
研究者
Dr Shivam Gupta
Dr B R Sur Homoeopathic Medical College, Hospital & Research Centre, New Delhi - 110021