Efficacy of Moghat in Sarcopenia among elderly; A randomized placebo-controlled study
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- improvement in muscle strength by using Grip Strength,Gait Speed,Time up and go test,SPPB (short physical performance Battery)
概览
简要总结
Sarcopenia is a musculoskeletal disease generally defined by the progressive loss of muscle mass and strength, particularly in elderly populations.The diagnosis of sarcopenia encompasses decreased levels of the following 3 traits: Muscle strength, muscle quantity or quality, and physical performance.
Sarcopenia is a type of muscle atrophy primarily caused by the natural aging process. Scientists believe being physically inactive and eating an unhealthy diet can contribute to the disease.
Sarcopenia is strongly associated with a greater incidence of falls and increased fracture risk.Furthermore, decreased muscle mass or muscle function, both criteria for sarcopenia, are risk factors for loss of independence in patients over the age of 90 years old.
The prevalence of sarcopenia is estimated within the ranges of 5 – 13% and 11 – 50% in patients aged 60 and above, and 80 and above, respectively.The worldwide prevalence of sarcopenia in patients over the age of 60 is estimated to be 10%.Variations observed among studies are likely due to inconsistent diagnostic criteria, and heterogeneous populations studied. Sarcopenia almost exclusively affects elderly populations and affects both sexes equally.Data regarding sarcopenia and ethnicity is inconsistent among studies. Furthermore, the prevalence of sarcopenia is greater in patients with chronic diseases such as COPD, CHF, CKD, DM, HIV, and Cancer.
Sarcopenia presents a great financial burden on the field of healthcare, as well as decreased quality of life in those who suffer from it. Early detection and management/treatment of sarcopenia reduce these burdens and improve the outcomes of the condition.Currently, the most effective modalities available to fight sarcopenia are physical activity and nutrition optimization.
Unani physicians recommend exercise, massage, hammam, mulattif and mufatteh sudud aghzia and advia for health promotion of elderly and prevention of sarcopenia. Unani physicians used har ratab muqawwi azla and musammine badan formulations and single drugs for the treatment of Huzal in elderly. Among which Moghat is an effective one but is not scientifically explored so far. Therefore, this study has been designed to evaluate the efficacy of Moghat in Sarcopenia (Huzal in elderly).
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
- 60.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Age less than and equal to 60 years 2 Grip Strength in Men less than 27 and in Women less than 16 3 Gait Speed less than and equal to 0.8 meter per second 4 Time up and go test(time needed to rise from seated and walk 3 meter away and back with return to seated) less than 20 seconds 5 SPPB(short physical performance Battery) less than 8 points A Standing Balance a)Side by side stand feet in parallel paired position for 10 sec b)Semi tandem stand feet in parallel non paired position for 10 sec c Tandem stand test (put one foot Infront of other) B 4meter walking speed C Chair stand test [Total SPPB Score will be obtain by adding the scores of standing balance test, gait speed test and chair stands test].
排除标准
- •1 Age younger than 60 years 2 Protein-calorie malabsorption(Celiac disease,Crohn’s disease,Tropical sprue, Whipple’s disease,Chronic pancreatitis,cystic fibrosis,Biliary cirrhosis,primary sclerosing cholangitis,Intestinal tuberculosis,Intestinal lymphangiectasia,Intestinal lymphoma) 3 Presence of morbidity(uncontrolled hypertension,and type 2 Diabetes Mellitus, neurologic disorders,metabolic diseases, rheumatic diseases,heart failure,severe chronic obstructive pulmonary disease (COPD), hemocoagulation syndromes, terminal cancer, severe renal diseases, Poor Controlled psychiatric disease such as schizophrenia, and blindness) 4 Use of medication(immunosuppressive drugs, insulin) 5 Immobilization for 1 week during the last 3 months, Patients with acute immobility(i.e. post hip fracture or post-acute hospital admission) should be excluded, orthopedic surgery during the last 2 years or still causing pain or functional limitation 6 Highly trained athletes were excluded.
结局指标
主要结局
improvement in muscle strength by using Grip Strength,Gait Speed,Time up and go test,SPPB (short physical performance Battery)
时间窗: at Baseline, 30th day , 60th day
次要结局
- Assessment of Efficacy(1.Upper arm circumference)
研究者
MOHD MUZAMMIL MOHD IBRAHIM
National Institute of Unani Medicine