CTRI/2017/11/010409已完成未知
Evaluation of the safety and efficacy of Triphala and Trimad in Obese and overweight individuals: A pilot clinical study
Interactive Research school for health Affairs0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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.Obesity (BMI >=30.0 kg/m2); or overweight (BMI >=25.0 kg/m2) with controlled co-morbid dyslipidemia and/or hypertension and/or type 1 or type 2 diabetes
- •2.Stable body weight (less than 5 kg self-reported change during the previous 3 months)
- •3.Age >=18 years to <=60 years
- •4.Willing to give Informed consent before any trial-related activity takes place
排除标准
- •1.Known case of any other endocrinological disorders
- •2.Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including
- •oAllopathic medicines: systemic corticosteroids (except for a short course of treatment, i.e. 7â??10 days),tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium)
- •oAyurvedic medicines: Shatavari, Ashwagandha, Bala etc.
- •3.History of use/ currently using dietary supplements, over-the-counter medications or below mentioned Allopathic /Ayurvedic medicines one month before screening
- •oAllopathic medicines: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, or metformin (either by prescription or as part of a clinical trial)
- •oAyurvedic medicines: Guggulu, Trikatu, Triphala, Trimada, Shilajatu and/ or any other ayurvedic medicine (causing weight reduction) either individually or as a part of any other formulation
- •4.Current participation (past one month) in an organized weight reduction program
- •5.Participants with a history of major depressive or other severe psychiatric disorders or an eating disorder
- •6.Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the investigator
- •7.Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
研究者
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