This is a study to evaluate the efficacy and safety of Slimilyn�® Capsules verses placebo in overweight and obese adult subjects.
- Conditions
- Health Condition 1: E663- Overweight
- Registration Number
- CTRI/2022/03/040987
- Lead Sponsor
- Herbalyn Lifesciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
a. Adult males and non-pregnant females aged 18 to 60 years.
b. Have a BMI of 25.0 kg/m2and above, along with body fat of >25%.
c. Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)
d. Not one of the following eating disorders by subjects declaration anorexia nervosa, bulimia nervosa.
e. Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG), and laboratory evaluation with a special emphasis on metabolic parameters (fasting glucose concentration < 100 mg, normal blood pressure) as per principal investigatorââ?¬•s judgment.
f. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
g. Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.
a. Diagnosis of type 1 or type 2 diabetes
b. Visit 1 thyroid-stimulating hormone (TSH) outside of the range of 0.4- 4.5
�¼IU/mL
c. History of chronic pancreatitis or idiopathic acute pancreatitis and other
chronic gastroenterological disease
d. Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)
e. Current or history of treatment with medications that may cause significant
weight gain for at least 3 months before this trial
f. Current participation in an organized diet reduction program (or within the
last 3 months)
g. Previous surgical treatment for obesity (excluding liposuction if performed
more than one year before trial)
h. Subjects on prescription and non-prescription appetite or weight modifying
drugs including herbal products
i. Used of any investigational drug or device during the study or within 30
days prior to 1st dosing of study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in body weight from baseline to end of the treatment (Day 90) (along with the percentage of participants who achieve a minimum of 10% weight lossTimepoint: day 0 to day 90
- Secondary Outcome Measures
Name Time Method � Change in Body Fat, Waist Circumference and Body Mass Index (BMI) From <br/ ><br>Baseline to end of the treatment (Day 90) <br/ ><br>� Change in lipid profile From Baseline to end of the treatment (Day 90) <br/ ><br>� Change from Baseline for Obesity Weight Loss Quality of Life Instrument <br/ ><br>(OWL-QoL) and Weight-Related Symptom Measure (WRSM). <br/ ><br>� Treatment-emergent adverse events (including laboratory abnormality)Timepoint: day 0 to day 90