Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: BerBerista Powder: BerBerista powder 500 mg twice daily for 90 days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
M R HEALTHCARE PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: Subjects of either sex between 18 to 50 years of age; Subject with BMI range 26-32; Ability of the subject to understand the risks and benefits of the study; Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, or double-barrier and have a negative pregnancy test at the Screening Visit. Female subjects of non-childbearing potential must be amenorrhoeic for at least one year or had a hysterectomy and/or bilateral oophorectomy; Willingness to participate in a walking-exercise program (5 days a week, 30 min per day) with the scheduled timing per week during the study period; Subject agrees to consume a healthy vegetarian or non-vegetarian diet; Subject should be available for duration of study period (three months); Subjects agree to come to site in fasting state for their weight measurements and other laboratory parameters examination in all the scheduled visits; Subject using other therapies for weight management including physiotherapy or occupational therapy agrees to discontinue these therapies during this study; Subject agrees not to start any new therapies for weight loss during the study period; Subjects agree to maintain the activity dairy; Willing to give written informed consent and willing to comply with trial protocol
Exclusion criteria
Exclusion criteria: Subjects suffering from intractable obesity, has defined weight limits, or have experienced any recent, unexplained weight loss or gain; Having history of underlying inflammatory arthropathy, septic arthritis, gout, inflammatory joint disease, joint fracture, or rheumatoid arthritis, thyroid disease, liver, or kidney diseases, and hypertension; Having history of asthma, cardiovascular diseases, coagulopathies, diabetes (Type I or Type II); History of high alcohol intake (2 standard drinks per day); History of psychiatric disorder that may impair the ability of subjects to provide written informed consent and increase the risk of adverse events or interfere with study assessments; Subjects, who are pregnant, breast feeding or planning to become pregnant during the study; Immunocompromised subjects or subjects with steroids or immunomodulators; Patients of vulnerable group (lactating mother, handicapped, seriously ill or mentally challenged); Any other condition that, in the opinion of the investigator, would adversely affect the subjectâ??s ability to complete the study or its measures; Participated in any investigational study medication within thirty (30) days prior to screening; Known allergy to compounds of investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in body Weight and BMI from baseline to different study visitsTimepoint: At baseline, Day 30, Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from the baseline in waist circumference, waist to hip ratio , Complete Blood Count, Liver Function Test (SGOT), Renal Function Test (Creatinine), Random Blood Sugar, Total Cholesterol and Triglyceride, Incidence of treatment-related adverse eventsTimepoint: Day 1 to Day 90 | — |
Countries
India
Contacts
Public ContactMr Manik Chaudhuri
BIORADIAN LIFESCIENCE
Outcome results
None listed