To evaluate the role of Ayurvedic medicine and lifestyle in management of post-menopausal women
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- 1. We expect from this study that the cure rate of menopausal symptoms with Ayurvedic therapies is comparable to standard non-hormonal treatment.
研究概览
简要总结
i. Rationale/Gaps in existing knowledge: Menopause is an important milestone in a woman’s life when she experiences a variety of physical, psychosocial and sexual symptoms. Many of these women have existing NCD which precludes use of MHT. Presently there are only a few effective options for menopausal symptoms in women who are reluctant to use MHT or MHT is contraindicated. There is a need to explore various non-hormonal therapies to treat menopausal symptoms. Ayurvedic therapies remain unexplored to address this issue.
ii. Novelty: To compare ayurvedic medicine and Yoga with standard treatment and physical activity plan using RCT is a novel concept**.**
iii. Objectives: This study will evaluate efficacy of oral Ayurvedic medicine (Shatawari churn 6 gm twice daily and Mukta shukti-pishti 250 mg twice daily) and Yoga in control of menopausal symptoms in women aged 45-65 years as compared to standard treatment and physical activity plan. It will also assess acceptance and compliance of women to Ayurvedic therapies.
iv. **Methods:**This study will recruit a total of 250 postmenopausal women aged 45-65 years who will be assessed for menopausal symptoms using SF-36 questionnaire. All women will undergo screening for NCD, osteoporosis, breast and cervical cancer. Women will be randomized (1:1) into two groups. Group 1 will receive Ayurvedic medicines and Yoga for 6 months and Group 2 will receive standard treatment and physical activity plan as per hospital protocol. Follow-up will be at 1, 3, 6 and 12-months.
v. Expected Outcome: Ayurvedic treatment and Yoga is non-inferior to standard treatment and physical activity plan in the management of menopausal symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Postmenopausal women aged 45 to 65 years
- •Postmenopausal women with natural, induced or surgical menopause
- •Willing to participate in the study.
排除标准
- •Women with T score less than -2.5 of BMD
- •Women with severe menopausal symptoms including stroke, cardiovascular diseases requiring pharmacological treatment
- •Chronic comorbidities requiring treatment
- •Any condition preventing walking/exercise
- •Not willing for follow-up
- •Any condition on PI discretion.
结局指标
主要结局
1. We expect from this study that the cure rate of menopausal symptoms with Ayurvedic therapies is comparable to standard non-hormonal treatment.
时间窗: 3,6 and 12 months
次要结局
- 1. The study will provide us the acceptability of Ayurvedic treatment & Yoga for menopausal symptoms.(2. We will find out the prevalence of various menopausal symptoms, NCD, osteoporosis & risk factors for CVD in Indian menopausal women.)
研究者
Dr Garima Kachhawa
All India Institute of Medical Sciences, New Delhi