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Table 1 Inclusion and Exclusion criteria

From: Efficacy and tolerability of a novel herbal formulation for weight management in obese subjects: a randomized double blind placebo controlled clinical study

Criteria Details
Inclusion Subjects must understand risks and benefits of the protocol.
Adults ages 21–50 years.
BMI ≥30 kg/m².
Willingness to participate in the exercise-walking program, Supervised by a trained exercise specialist.
Willingness to consume the prescribed study diet of approximately 2,000 K Cal per day as outlined in the protocol (meals will be provided at free of coast by the study sponsor).
Written informed consent to participate in the trail.
Willingness to complete standard health history questionnaire before recruitment into the study.
Willingness to participate in 5 clinical visits (Screening, baseline, 2, 4 & 8 weeks).
If female and:Should be negative in pregnancy test. Of child bearing potential, should agree to follow an acceptable method of birth control for the duration of the study, such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), etc.
Exclusion History of thyroid disease or cardiovascular disease or diabetes.
Any other clinically significant disorder.
History of allergy to spices and herbal products.
Non-obese (BMI < 30) & morbidly obese (>40).
Presently using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss.
Pregnant or nursing females.
Recent, unexplained weight loss or gain.
Positive HIV test.
History of hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis.
History of motor weakness or peripheral sensory neuropathy.
Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.