A randomized, double-blind, placebo-controlled, parallel group, single center clinical trial to assess the efficacy and safety of Terminalia bellirica extract versus placebo for body fat loss in overweight subjects
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in the following parameters from baseline to end of treatment (Day 0 to Day 84)
研究概览
简要总结
Although there are pharmacological agents available to treat obesity / overweight, each drug has its unique profile of unfavorable side effects. Despite the enormous advancements in medical research over the past century, obesity / being overweight is still poorly managed. As obesity / overweight is a complex and interlinked clinical condition, a therapy which addresses these abnormalities is always sought for. Hence the quest for novel medications continues which can address obesity / overweight in a holistic approach of disease management.
Terminalia bellirica is a versatile medicinal plant with a rich history of use in traditional medicine and promising pharmacological properties. Terminalia bellirica extract contains multiple natural compounds with a wide range of biological effects on different tissues in the body. It has been extensively researched for its potential in the treatment of various conditions. Additionally, Terminalia bellirica extract has demonstrated potential as a weight lowering agent in laboratory animals. The present study is designed to evaluate the efficacy and safety of Terminalia bellirica extract in individuals who are mildly overweight with the study title—“ A randomized, double-blind, placebo-controlled, parallel group, single center clinical trial to assess the efficacy and safety of Terminalia bellirica extract versus placebo for body fat loss in overweight subjects.”
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged between 18 and 60 years
- •Body mass index (BMI) ranging between 25 to
- •Subjects failing to control their body weight through diet therapy alone.
- •Subjects willing to follow the medication, diet, and exercise requirements as determined by the investigators.
- •Subjects with stable body weight (patient-reported body weight change less than 5 kg) in the last 3 months.
- •Capacity and willingness to provide written informed consent and adhere to the study protocols.
排除标准
- •Subjects who have received any medications or dietary supplements for weight reduction or management within 1 month prior to screening.
- •Subjects who have received GLP 1 receptor agonists, DPP 4 inhibitors, SGLT 2 inhibitors, or insulin therapy within 3 months prior to screening.
- •Subjects who are pregnant, intending to become pregnant during the study period, or are lactating.
- •Subjects who are participating in any rigorous exercise programs.
- •Subjects with a history of substance abuse, including drugs and alcohol.
- •Subjects with type 1 diabetes or secondary diabetes.
- •Subjects with fasting blood glucose levels greater than or equal to 126 mg/dL or who are currently on any antidiabetic medications.
- •Subjects with acute metabolic complications, such as diabetic ketoacidosis or hyperglycemic coma, within 6 months before screening
- •Subjects with obesity caused by endocrine diseases, such as Cushings syndrome.
- •Subjects with abnormal thyroid stimulating hormone (TSH) levels.
- •Subjects with thyroid nodules of unknown etiology at the time of screening, considered clinically significant by the investigator.
- •Subjects with a past or family history of medullary thyroid carcinoma (MTC) (grandparents, parents, siblings) or multiple endocrine neoplasia type 2 (MEN2).
- •Subjects with a history of pancreatic cancer or acute or chronic pancreatitis, or with acute or chronic pancreatitis at the time of screening.
- •Subjects with acute gallbladder disease (e.g., cholecystitis, gallstones) more than twice in the 1 year before screening.
- •Subjects with severe gastrointestinal disorders affecting food intake.
- •Subjects with medical conditions known to impact serum lipid levels.
- •Subjects with uncontrolled hypertension, defined as systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
- •Subjects with a history of binge eating behavior, characterized by consuming a large amount of food in a short period of time with a sense of loss of control.
- •Subjects with any central nervous system disorder impeding exercise capability.
- •Subjects with major depressive disorder (MDD), anxiety disorder, or other mental illnesses at the time of screening.
- •Subjects with any musculoskeletal disorders preventing participation in exercise.
- •Subjects who have treated or plan to treat obesity with surgery or body weight loss devices during the trial.
- •Subjects with recent participation in any obesity program within the past 3 months.
- •Subjects intending to participate in another clinical study within the next month.
- •Subjects with any serious systemic diseases as determined by the investigator, or other diseases believed by the investigator to potentially interfere with the results of this study or abnormal laboratory tests with clinical significance.
- •Subjects who, according to the opinion of investigators, are not suitable to participate in clinical trials, including those who are physically or psychologically unable to comply with the protocol.
结局指标
主要结局
Change in the following parameters from baseline to end of treatment (Day 0 to Day 84)
时间窗: Day 0 and Day 84
Total body fat mass and body fat ratio through DEXA scan (Dual Energy X-ray Absorptiometry)
时间窗: Day 0 and Day 84
次要结局
- Change in the following parameters from baseline to end of treatment (Day 0 to Day 84)(1. Lean body mass through DEXA scan)
- Change in the following parameters from Day 0 to Day 42 and Day 84(1. Body weight)
- 1. Safety (incidence of adverse events) assessment.(2. Abnormal findings in vital signs & medical interviews.)
研究者
Dr Suma D
The Oxford Medical College, Hospital & Research Centre