ISRCTN74656856
Completed
未知
A prospective, randomized, double-blind, two-arm, parallel, placebo-controlled study to evaluate the efficacy and safety of Lipoxim Fire for weight management in overweight healthy women
INNOVATION LABO0 sites60 target enrollmentDecember 4, 2020
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- INNOVATION LABO
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy non\-smoker Asian or Caucasian female subjects between 25 to 60 years (inclusive) of age
- •2\. Subject with BMI range of 25 \- 29\.9 kg/m² (both inclusive)
- •3\. Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue these therapies
- •4\. Subject agrees not to start any new therapies for weight loss during the course of the study
- •5\. Females of child\-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result at the screening visit. Female subjects of non childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy
- •6\. Willing to give written informed consent and willing to comply with the trial protocol
- •7\. Ability to understand the risks/benefits of the protocol
- •8\. Subject should be available for the duration of the study period (2 months)
Exclusion Criteria
- •1\. Subjects suffered from intractable obesity and had experienced recent unexplained weight loss or gain
- •2\. Subject taking any over the counter weight loss agents, centrally acting appetite suppressants
- •3\. Pathophysiologic/ genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Prader Willi syndrome and thyroid disease)
- •4\. Subject with a history of anorexia nervosa
- •5\. Subject with prior any surgical therapy for obesity
- •6\. Subject with diabetes, dyslipidemia, hypertension, cardiovascular disease and any other co\-morbidity and considered as not healthy
- •7\. Subjects on prolonged (greater than 6 weeks) product with corticosteroids, antidepressants, anticholinergics, antipsychotic drug etc. or any other drugs that may have an influence on the outcome of the study
- •8\. Subjects suffering from major systemic illness necessitating long term drug product intake
- •9\. Alcoholics and/or drug abusers
- •10\. History of hypersensitivity to curcumin and wakame extract or any component of XTRA SLIM 700 formula
Outcomes
Primary Outcomes
Not specified
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