A study to evaluate the efficacy and safety of Lipoxim Fire for weight management in overweight healthy wome

Not Applicable

Completed

• Conditions: Prevention of obesity in overweight women; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN74656856
• Lead Sponsor: INNOVATION LABO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-04-05
• Study Start: 2020-12-04
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

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
11. Pregnant/lactating woman
12. Subjects using other modulators like diet control, gym and yoga and wish to continue even after enrollment
13. Subjects having a history of psychiatric disorder that may impair the ability of subjects to provide written informed consent
14. Subjects who have completed participation in any other clinical trial during the past 3 months
15. Any other condition which the Principal Investigator thinks may jeopardize the study outcome

Study & Design

• Study Type: Interventional
• Study Design: Not specified