CTRI/2026/07/113529进行中（未招募）3 期
A prospective, randomized, double-blind, placebo controlled, parallel-group study to evaluate the effectiveness and safety of Metaberine versus placebo in improving metabolic profile in healthy adults. - NIL
Zeus Hygia LifeSciences Pvt Ltd0 个研究点目标入组 100 人开始时间: 2026年7月17日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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.Adults aged between 18 and 65 years.
- •2 Healthy adults having HbA1c levels between 5.4 to 6.4
- •3 Fasting Blood Sugar defined by 85 to 125 mg/dL
- •4 Individuals who having a body mass index 25 to 29.9
- •5 Not on glucose-lowering medication or on stable lifestyle intervention only for at least 3 months
- •6 Willing to follow standardized lifestyle advice and provide written informed consent and comply with study procedures
- •7 Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test UPT at screening
排除标准
- •1.HbA1c levels greater than or equal 6.5% or FBS greater than or equal 126 mg/dL.
- •2.Pregnancy / lactation.
- •3.Clinically diagnosed with chronic diseases.
- •4.Who are currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychological, infectious diseases, malignant tumors, etc.
- •5.Uncontrolled high blood pressure (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher)
- •6.Current use of berberine supplements within 3 months or any other supplements.
- •7.Known hypersensitivity to trial products.
- •8.Participation in another interventional trial within 3 months.
- •9.Diagnosed with type 1 or type 2 diabetes.
- •10.Currently taking medications or dietary supplements related to diabetes.
- •11.History of excessive alcohol consumption or substance abuse.
- •12.Uncontrolled thyroid disorders.
- •13.In the judgment of the principal investigator, who are unlikely to comply with study procedures or have conditions that could interfere with study completion
研究者
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