ISRCTN74656856已完成未知
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 个研究点目标入组 60 人开始时间: 2020年12月4日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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)
排除标准
- •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
研究者
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