Efficacy of individualized homoeopathic medicines in the symptomatic improvement of menopausal syndrome: A double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Menopause Rating Scale (MRS)
研究概览
简要总结
Menopause is the permanent cessation of menstruation for at least 12 consequent months. Although it is a physiological phenomenon, it is associated with a lot of troublesome symptoms such as hot flashes, palpitations, urogenital complaints, anxiety, disturbed sleep, etc., which have long term consequences to the overall health of a woman. Though homoeopathic medicines are used extensively to treat menopausal syndrome, diligent research evidence in favor of homoeopathy is not well marked. So, I intend to undertake the research to evaluate the efficacy and safety of homoeopathic medicines in the treatment of menopausal syndrome. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 93 women with menopausal syndrome at the OPD of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by evaluating the Menopause Rating Scale (MRS) as the primary outcome, Menopause specific quality of life questionnaire (MENQOL) and Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) as the secondary outcomes. The primary as well as secondary outcomes will be evaluated every month, up to 4 months of intervention. Comparative analysis will be carried out on the Intention-To-Treat (ITT) and Per-Protocol (PP) basis to detect group differences. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients suffering from Menopausal syndrome (ICD-11-GA30.0) presenting with symptoms (hot flashes, mood changes, vaginal dryness, sleep disturbances, etc.) of not less than 3 months of duration
- •Age between 40 and 55 years
- •Mild to moderate menopausal symptoms.
- •MRS score mild 5-8, moderate 9-16
- •Participants having prior experience or knowledge of the treatment; e.g., primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
排除标准
- •Not willing to give informed consent or to comply with the study procedure.
- •Hysterectomy done and/or receiving any kind of hormone therapy.
- •Any life-threatening diseases or recently active physical disease.
- •In some condition when requiring emergency or surgical intervention.
- •Presence of uncontrolled medical conditions such as diabetes, hypertension, cardiac disorder & thyroid disorder.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
- •Undergoing homoeopathic treatment for any chronic disease within last six months.
- •Simultaneous participation in any other clinical trial.
- •Vulnerable population.
- •Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
- •Self-reported immune-compromised state.
- •Tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
结局指标
主要结局
Menopause Rating Scale (MRS)
时间窗: Baseline, every month, up to 4 months
次要结局
- Menopause specific quality of life questionnaire (MENQOL)(Baseline, every month, up to 4 months)
- Measure Yourself Medical Outcome Profile version 2 (MYMOP-2)(Baseline, every month, up to 4 months)
研究者
Manjeet Kaur
D. N. De Homoeopathic Medical College and Hospital