Skip to main content

Table 1 Inclusion and exclusion criteria

From: Efficacy and tolerability of Meratrim for weight management: a randomized, double-blind, placebo-controlled study in healthy overweight human subjects

Inclusion Criteria
• Male or female subjects between 21 to 50 years of age.
• Subject with BMI range (27–32 kg/m2).
• Ability to understand the risks/benefits of the protocol.
• Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
• Willingness to participate in a walking-exercise program (30 min per day) during the course of the study.
• Subject agrees to consume a vegetarian/non-vegetarian diet of approximately 2000 kcal/day (17 % protein, 25 % Fat and 58 % carbohydrate).
• Subjects agree to come to study site in fasting condition for their weight measurement and other laboratory parameters examination in all the scheduled visits.
• Subjects should be available for the entire duration of the study (6–8 months).
• Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue these therapies during this study.
• Subject willing to go for DEXA analysis as per the scheduled visits during the study.
• Subjects agree to maintain the activity dairy.
• Subjects willing to give written informed consent and willing to comply with the trial protocol.
Exclusion Criteria
• Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain.
• Subjects having history of underlying inflammatory arthropathy; septic arthritis; inflammatory joint disease; gout; pseudo-gout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; ochronosis; hemochromatosis; heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis.
• Subjects having history of asthma, cardiovascular diseases, thyroid disease, coagulopathies, hypertension, congestive heart failure.
• Subjects having history of diabetes (Type I or Type II) - except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose ≥ 140–199 mg/dl.
• Subject with Hyperuricemia (males > 480 μmol/L, females > 450 μmol/L).
• Subjects having abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal; elevated Creatinine, males > 125 μmol/L, females > 110 μmol/L).
• Subjects having abnormal findings on complete blood count.
• Subjects with HIV Positive.
• Subjects having history of high alcohol intake (>2 standard drinks per day).
• Pregnant, breast feeding or planning to become pregnant during the study.
• Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
• Any other condition that, in the opinion of the investigator, would adversely affect the subject's ability to complete the study or its measures.
• Subjects participated in any investigational drug study within thirty (30) days prior to screening.