Effectiveness of Ayush Osto (coded Ayurvedic formulation) in post -menopausal women with Osteopenia- A prospective single arm multi centric study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in bone mineral density
研究概览
简要总结
Osteopenia is a clinical term used to describe a decrease in bone mineral density (BMD) below normal reference values, yet not low enough to meet the diagnostic criteria to be considered osteoporotic . Osteopenia, as defined by the World Health Organization (WHO), is a t-score between -1 to -2.5, while values less than -2.5 are diagnostic for osteoporosis. Decreasing BMD values are reflective of an underlying disruption in the microarchitecture of bone and osteopenia, and osteoporosis is considered quantitative, not qualitative, disorders of bone mineralization. While it is estimated that heritable factors dictate up to 80% of our ability to achieve and maintain optimal bone mineralization levels, modifiable factors attributed to the rate of natural bone mass reduction into adulthood include weight-bearing exercises, nutrition status (adequate calcium and vitamin D daily intake), body mass, and hormonal milieu. Postmenopausal women are more likely to develop osteoporosis, which not only causes morbidity but also has a substantial negative influence on their quality of life. It is necessary to evaluate the quality of life of women with reduced BMD before fractures occur, to aid development of health education aiming to reduce the incidence of osteoporosis and prevent fractures.
Since there is decrease of bone tissue in this disease, it can be considered as Asthi-Majjakshaya because of its core of pathogenesis: 1) degeneration of bone tissue and 2) vitiation of Vata .A few studies on the use of herbal and herbo mineral drugs for the treatment of osteopenia/osteoporosis have been conducted before. Ayush Osto is a coded Ayurvedic formulation for the management of Asthikshaya (Osteoporosis & Osteopenia undertaken for drug development by the Council through a systematic process of drug development viz. drug standardization and experimental toxicity studies [Acute toxicity in mice, repeated dose toxicity (28 days and 90 days) in wistar rats.] The test drug was found safe at different dose levels.
Keeping in view of the above scenario, this multicentric study has been designed to evaluate the effect of Ayush Osto in improving bone mineral density.
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
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •i.Women between 50 and 70 years with history of spontaneous amenorrhea for equal or more than 12 months.
- •B.M.D. T score between -1.0 and -2.5 measured by DXA Scan of neck of femur or lumbar spine.
排除标准
- •1.Patients with a history of congenital disorders related to bone like Dysosteogenesis, Marfans Syndrome, Osteomalacia and Pagets disease.
- •2.Patients with a history of Endocrinal disorders like Thyroid and parathyroid dysfunction, Hyperprolactinemia and Cushings syndrome.
- •Patients with history of Malabsorption syndrome.
- •5.Patients with a history of any Malignancy.
- •6.Known cases of uncontrolled diabetes mellitus with HbA1c more than 8 percent, uncontrolled hypertension with BP equal or more than 160 per 100 mm Hg, Renal dysfunction defined as Serum creatinine more than 1.2 mg per dl, Hepatic dysfunction defined as AST and ALT more than 2 times of the normal upper limit, cardiac dysfunction, urolithiasisis and any other condition that may jeopardize the study.
- •7.Patients on calcium and Vitamin D supplementation or any osteopenia treatment or hormone replacement therapy.
- •8.Patients who are participating in any clinical trial currently or have completed participation in any other clinical trial during the past 6 months.
结局指标
主要结局
Change in bone mineral density
时间窗: At Baseline, 90th day( for every 10th patient) and 180th day assessed by DXA scan.
次要结局
- i.Change in hematological & biochemical parameters (Liver function test & renal function tests)(ii.Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events during the study period.)