CTRI/2017/12/010856已完成2 期
Effect of ayurvedic drug KAL-10 on lowering hyperglycemic in subjects with diabetes: A Randomized Placebo Controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
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
- •Informed consent obtained before any trial-related activities
- •Male or female patients between 18 to 70 years of age
- •Newly diagnosed with hyperglycemia
- •FBSââ?°Â¥110 mg/dL but ââ?°Â¤200 mg/dL, measured on day-1
- •PPBS >120 mg/dL and ââ?°Â¤ 200 mg/dL
- •HbA1c 6% ââ?°Â¥ & ââ?°Â¤ 10%
- •C peptide ââ?°Â¥ 1.0 ng/ml
- •Ability to comply with study requirements
排除标准
- •Females who are pregnant and/or lactating and/or sexually active but not using an acceptable method of contraception
- •History of allergy or contraindications to the ingredients present in the drug
- •History of uncontrolled or poorly controlled serum cholesterol
- •Renal impairment/insufficiency (i.e., nephritis, polycystic kidney disease, acute or chronic renal failure, end stage renal disease, >1.5 times the upper limit of normal (ULN) of serum Creatinine, etc.)
- •AST, ALT >3 times the ULN
- •Thyroid dysfunction
- •Gastrointestinal disorders (ulcerative colitis, etc.)
- •Hepatic impairment/ acute liver disease or persistent elevations in liver function tests (3 times the upper limit of normal (ULN) of LFT Uncontrolled hypertension, as defined by SBP >160 mmHg or DBP >100 mmHg while on anti-hypertensive medication
研究者
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