A Two-Arm Longitudinal Randomized Control Trial to Evaluate the Bone Protective Role of an Ayurveda Formulation in Postmenopausal Females.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Change in Bone Mineral Density (BMD) at the lumbar spine, femoral neck, and total hip measured using Dual-Energy X-ray Absorptiometry (DEXA).
研究概览
简要总结
Osteoporosis presents a significant challenge for postmenopausal, geriatric females and current approaches often overlook the personalized aspects of health management crucial for this demographic. Ayurveda, with its emphasis on individual constitution (Prakriti) and doshic balance, provides a promising avenue yet remains underexplored in geriatric health.
(i) Novelty:
This study introduces a novel approach by integrating the principles of Ayurveda, specifically Prakriti and doshic balance, into a rigorous clinical trial. Addressing the gaps in existing knowledge, this research aims to provide Ayurveda intervention for menopausal and geriatric osteoporotic females, acknowledging the diverse constitution and doshic imbalances within these populations.
(ii) Objectives:
The primary objective is to assess the impact of a classical Ayurveda medicine (Lakshadi guggulu 500 mg tablet, 2 tablets BD with Mukta- shukti Pishti250 mg twice daily, with water after food for 6 months) on bone mineral density (BMD) in postmenopausal and geriatric females. The present study will incorporate the assessment of individual Prakriti and doshic balance to evaluate the efficacy of Ayurvedic intervention, thereby emphasizing a comprehensive approach to bone health.
(iii) Methods:
A two-arm longitudinal randomized control trial will be conducted, randomly assigning 220 participants to the Ayurveda formulation (n=110) or control group (n=110). Assessments including DEXA scans (t = 0 and 6 months), blood tests (t = 0, 3 and 6 months), will be conducted at various time points.
(iv) Expected Outcome:
Anticipated outcomes include insights into the efficacy of Ayurveda interventions in preserving and improving BMD, changes in bone turnover markers, and improved quality of life. This study aims to contribute valuable evidence, fostering a paradigm shift towards personalized healthcare approaches for postmenopausal/geriatric females by incorporating Prakriti and doshic balance, ultimately enhancing their bone health and overall well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •postmenopausal females aged 50-70 years, diagnosed with osteoporosis as per World Health Organization (WHO) criteria, (BMD that lies.
- •2.5 standard deviation or more below the average value for young healthy women.
排除标准
- •woman suffering from secondary osteoporosis such as inflammatory joint or bowel disorders, current glucocorticoid therapy, chronic kidney disease, malabsorption, untreated endocrine disorders.
结局指标
主要结局
Change in Bone Mineral Density (BMD) at the lumbar spine, femoral neck, and total hip measured using Dual-Energy X-ray Absorptiometry (DEXA).
时间窗: • Baseline (Week 0) – Before starting the intervention | • At 24 Weeks (End of Treatment) – After completion of the 6-month intervention
次要结局
- This research is designed to provide tailored insights into the potential of Ayurveda formulations for enhancing bone health in menopausal & geriatric females. Positive outcomes could lead to targeted interventions that address the specific needs of these populations, improving their overall quality of life & reducing the burden of osteoporosis- related complications.(Time Points Baseline, 12 Weeks (Mid of Treatment), 24 Weeks (End of Treatment).)
研究者
Dr Ashok Kumar Ahirwar
AIIMS, Delhi