A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of ForsLean® for weight reduction and energy balance in overweight patients.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 1. To assess mean change in body weight
研究概览
简要总结
The study involves 80 subjects randomized in to two arms. Arm-1 subjects will receive Forslean-250mg Capsule while Arm-2 Subjects will receive Placebo containing MCC-250 mg capsule. Both the groups will take the respective IPs b.i.d for 90 days, 30 minutes before food. A telephonic follow-up will be performed after 15 days following the last visit. The Specific objectives of the study will be measured using Anthropometric measurements, laboratory biomarkers (Leptin, Adiponectin, Lipid Profile and CT scan). A patient diary will be maintained to assess the food habits, physical activity and lifestyle based on calorie intake, energy expenditure and distribution of fats. The final statistical analysis and study report will be complied at the end of thestudy period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female participants whose age ≥18 and ≤ 50 years.
- •Participants must provide written and signed informed consent and comply with the requirements of the study.
- •Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol.
- •Participants with a BMI of ≥ 25 to ≤ 29.
- •Self-reported lack of physical activity and lethargic lifestyle.
- •Participants who are willing to take up walking exercise for a span of 30 minutes daily for 5 days a week.
- •Participants who are willing to follow the recommended calorie intake of 2000 for women & 2500 for men throughout the study.
排除标准
- •Intake of over the counter or prescribed Allopathic/Ayurvedic/ Homeopathic/Naturopathic weight loss medications, centrally acting appetite suppressants in the past three months.
- •Previous weight loss surgeries like bariatric surgery procedures (gastric bypass, sleeve gastrectomy, adjustable gastric band, biliopancreatic diversion with duodenal switch etc.)
- •On other modulators like special diet, diet control, gym, and yoga.
- •Pathophysiologic/genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Prader-Willi syndrome).
- •History of chronic smoking (more than 2 cigarettes a day)
- •Alcoholics (Inability to control drinking due to both physical & emotional dependence on alcohol characterized by uncontrolled drinking & preoccupation with alcohol).
- •Patients with evidence of malignancy
- •Patients with diabetes (Type I or Type II), FBS ≥ 126 mg/dl and HbA1c > 6.5%
- •Patients with Hypertension having BP > 140 / 90 mm of Hg.
- •Patients diagnosed with thyroid disease, on medications for underactive or overactive thyroid and with TSH > 6 µIU/L
- •Patients on lipid lowering drugs.
- •Patients having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Paget’s disease, joint fracture, acromegaly, fibromyalgia, Wilsons disease, Ochronosis, hemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis.
- •Patients having history of coagulopathies, cardiovascular diseases, congestive heart failure, pancreatitis, lactic acidosis, hepatomegaly with steatosis, motor weakness, peripheral sensory neuropathy, psychiatric disorder, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD].
- •Have been diagnosed with an eating disorder, such as anorexia, bulimia, binge eating disorder or nocturnal eating disorder.
- •History of severe psychiatric disorders like schizophrenia or bipolar disorder.
- •Weight loss (±5%) in last 6 months.
- •Patients on prolonged (> 4 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and/or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP)>2 times upper normal limit) or Renal Disorders (defined as S.
- •Creatinine>1.2mg/dL for females or >1.4 mg/dL for males and EGFR <60).
- •History of hypersensitivity to any of the herbal extracts or dietary supplements.
- •All females with history of PCOS (Poly Cystic Ovary Syndrome)
- •Those who have participated in any other clinical trial within three months from the screening.
- •Any other condition which the Principal Investigator thinks may jeopardize the study.
结局指标
主要结局
1. To assess mean change in body weight
时间窗: 1. Screening to Day-90 | 2. Screening to Day-90 | 3. Screening to Day-90 | 4. Screening to Day-90
2. To assess mean change in BMI
时间窗: 1. Screening to Day-90 | 2. Screening to Day-90 | 3. Screening to Day-90 | 4. Screening to Day-90
3. To assess mean change in waist circumference
时间窗: 1. Screening to Day-90 | 2. Screening to Day-90 | 3. Screening to Day-90 | 4. Screening to Day-90
4. To assess mean change in hip circumference
时间窗: 1. Screening to Day-90 | 2. Screening to Day-90 | 3. Screening to Day-90 | 4. Screening to Day-90
次要结局
- 1. To assess the change in lean body mass.(2. To assess mean change in Lipid profile)