A 12-Week, Randomized, Double Blind, Placebo Controlled, Parallel Study to Evaluate the Efficacy and Safety of Caralluma fimbriata On the Improvement of Weight Management.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Body Fat Rate.
研究概览
简要总结
Obesity is a chronic and progressive disease with serious health consequences, but weight loss brings significant improvements in metabolic markers and overall health. Even small amounts of weight loss yield improvements in metabolic markers, with greater benefits observed as weight loss increases. Overweight and obesity, and a static body mass index (BMI) commonly conceal sarcopenia (gain in body fat but loss of muscle mass and functional capacity) in older people, aggravated by inactivity. The prevalence of obesity (defined as BMI 30 kg/m2) in the over 80-year group is about a half of that in the 50–59-year group
Caralluma fimbriata, a species of the genus Caralluma R. Brown (family Apocynaceae, subfamily Asclepiadoideae), is a perennial, quadrangular succulent native to the arid regions of tropical Asia, the southern Mediterranean, and parts of Africa. C. fimbriata is particularly rich in bioactive compounds such as pregnane glycosides, saponins, flavonoids, alkaloids, and terpenoids, many of which contribute to its pharmacological activities. It has demonstrated promising anti-diabetic, anti-obesogenic, antioxidant, hepatoprotective, and anti-inflammatory properties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Male and female individuals aged from 19 to 60 both inclusive 2 BMI between greater than or equal to 25 and less than 32 kg per m2 3 Those who voluntarily agrees to participate and signs on informed consent form.
排除标准
- •1 Participants with a history of hypersensitivity to drugs food ingredients herbal extracts or dietary supplements 2 Participants who have had participated in a commercial weight loss program or clinical trial for obesity within the last three months 3 Participants taking drugs or diet foods that affect their weight within 3 months prior to screening absorption inhibitors appetite suppressants health functional foodssupplements related to obesity improvement psychiatric drugs such as depression diuretics contraceptives steroids female hormones 4 Participants with intentional weight loss of at least 5 percentage within 3 months prior to screening 5 Participants who have undergone surgery such as gastroplasty and intestinal resection to lose weight within 6 months prior to screening 6 Endocrine diseases such as hypothyroidism and Cushings syndrome 7 Participants with severe cerebrovascular disease cerebral infarction cerebral hemorrhage etc heart disease angina pectoris myocardial infarction heart failure arrhythmia in need of treatment lung disease chronic obstructive pulmonary disease etc within the last 6 months However those who are clinically stable may participate in the trial at the investigator discretion 8 Serious dysfunction of the liver alanine and aspartate aminotransferase levels of 3.0 times the upper limit or normal or kidney creatinine more than 2.0 mg per dL 9 Uncontrolled hypertension blood pressure More or equal than 160 per 100 mmHg 10 Fasting blood glucose more or equal than 126 mg per dL or random blood glucose more or equal than 200 mg per dL or diabetic patients taking oral hypoglycaemic agents or insulin 11 Malignant tumor diagnosed within 3 years prior to screening 12 Participants who complain of severe gastrointestinal symptoms such as heartburn and indigestion 13 Participants with a psychologically significant medical history or current disease schizophrenia epilepsy anorexia bulimia etc or a history of alcohol or the other drug abuse 14 Participants who have irregular dietary habit and intakes excessive alcohol caffeine and smoke 15 Participants who are determined to be unable to exercise due to musculoskeletal disorders 16 Pregnant or lactating participants or women of childbearing age who do not agree to use contraception during the trial 17 Participants with a history of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing 18 Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigators opinion.
结局指标
主要结局
Body Fat Rate.
时间窗: Day 1 and Day 84
Body Fat Mass
时间窗: Day 1 and Day 84
Primary outcome:
时间窗: Day 1 and Day 84
•DEXA (Dual Energy X-ray Absorptiometry)
时间窗: Day 1 and Day 84
次要结局
- Secondary Outcomes:(•Body Weight)
- Secondary outcomes:(•Skinfold of Biceps and Triceps of Arm)
研究者
Dr Ashok Godavarthi
Radiant Research Services Private Limited