CTRI/2020/09/027807已完成3 期
A randomized, multi-center, double blind, parallel assignment, placebo- controlled, two arm study to assess safety and efficacy of iSlim flat tummies for weight management in adult male and/or female obese or overweight subjects.
IndusViva HealthSciences Pvt Ltd0 个研究点目标入组 70 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
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
入选标准
- •1.Adult male and non-pregnant females aged 18 to 55 years
- •2.BMI ââ?°Â¥ 25 kg/m2 to 40 kg/m2 with one or more of the metabolic risk factors (waist circumference ââ?°Â¥80 cm, fasting glucose ââ?°Â¥100 mg/dL, BP
- •Ã¢â?°Â¥130/85 mmHg, HDL-cholesterol <50 mg/dL OR controlled diabetes, hypertension, dyslipidemia with medications)
- •3.Able to comply with all required study procedures and schedule.
- •4.Able to comply and willing to follow the prescribed diet plan.
- •5.Willing and able to give written informed consent.
- •6.Subjects who agree to stop from using supplements during the study duration time
- •7.Subjects willing to refrain from any obesity treatment
- •8.Subjects willing to follow the suggested diet plan
排除标准
- •1. Participantswithuncontrolledhypertension(systolicblood pressure (SBP) >180 mmHg, or diastolic blood pressure (DBP) >120 mmHg)
- •2. Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >3 x institutional upper limit of normal) or renal disease (serum creatinine >2.0 mg/dL)
- •3. Participants with significant cardiovascular disease or stroke
- •4. Participants with history of seizures
- •5. Endocrine disease such as hypothyroidism or Cushing syndrome
- •6. History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia and so on)
- •7. Use of medication within the past 3 months that could have an effect on weight (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medication having an effect on absorption, metabolism and excretion).
- •8. A know history or present condition of allergic response to any pharmaceutical products and supplements.
- •9. History of weight reduction surgery, bariatric surgery and so on
- •10. Weight reduction > 10% within the past 6 months
- •11. Women in child bearing age unable to practice any form of contraception
- •12. Participants on herbal supplements/any other wellness product
- •13. History of alcohol, tobacco, substance or drug abuse
- •14. Subject who has participated in a clinical study within the last 30 days prior to entering this study.
- •15.Participants with hypersensitivity to any of the ingredients of the study products.
- •16. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
研究者
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