CTRI/2011/09/001996Other1/2 期
An exploratory, randomized, double blind, parallel, placebo controlled study to investigate the blood sugar lowering effect of EN-DM-02, EN-DM-04 and EN-DM-05 in comparison with placebo in drug naïve/medication free patients with Type II Diabetes Mellitus under Protocol ID: VL/090707/EN/DM/EN-DM-05.
试验速览
- 阶段
- 1/2 期
- 状态
- Other
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- To determine if any or all of the Investigational Products (IPs) ? EN-DM-04, EN-DM-02 and EN-DM-05 are significantly better than placebo in reducing fasting blood sugar levels (FBS) as compared to Day 25 in patients with Type II Diabetes mellitus
研究概览
简要总结
-
Ingredients of EN-DM-02: Mundi ( Sphaeranthus Indicus) - 450 mg per capsule
-
Ingredients of EN-DM-04: Vijaysar (Pterocarpus marsupium) - 200 mg per capsule
-
Ingredients of EN-DM-05: Mundi (450 mg) + Vijaysar (200 mg) = 650 mg per capsule
This trial was terminated because the Ethics Committee was not satisfied with the study design and refused to give the approval. This trial was terminated before enrolling the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Type 2 diabetes mellitus, with FBS 150-180 mg/dl and HbA1c of 7% to 8.5 % who are either drug ?naïve or have been medication free for at least 3 months 2) Body Mass Index between 18.5 and 30 kg/m2 Patients willing and able to follow diet and exercise regime for the study duration.
排除标准
- •Patients requiring insulin / having diabetic complications 2) Hypertensive patients with BP ≥ 160/100 mm of Hg 3) Patients on fibrates and niacin (which are known to affect blood sugar levels) 4) Pregnant and nursing women 5) Patients unwilling to practice contraception.
- •Serious hepatic or renal impairment (Liver Dysfunction as evidenced by SGPT level of 1.5 X ULN and Renal Dysfunction as evidenced by Creatinine level of 1.5 X ULN 7) Significant cardiovascular co-morbidities, e.g. symptomatic heart failure, uncontrolled hypertension, history of ischemic heart disease (as evident from ECG), history of stroke and/or Transient Ischemic Attack.
- •Debilitating neurological or psychiatric disorders 9) Known hypersensitivity or allergy to one or more of the herbal ingredients 10) Recent (within last 3 months) participation in a clinical trial.
- •Subjects otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the study.
结局指标
主要结局
To determine if any or all of the Investigational Products (IPs) ? EN-DM-04, EN-DM-02 and EN-DM-05 are significantly better than placebo in reducing fasting blood sugar levels (FBS) as compared to Day 25 in patients with Type II Diabetes mellitus
时间窗: Fasting Blood Sugar
次要结局
- To determine if any or all of the Investigational Products (IPs) ? EN-DM-04, EN-DM-02 and EN-DM-05 are significantly better than placebo in reducing HbA1c and FBS as compared to the baseline in patients with Type II Diabetes mellitusTo determine if the combination product EN-DM-05 is more efficacious in lowering HbA1c and /or FBS as compared to EN-DM-02 and EN-DM-04(Fasting Blood Sugar (FBS)Glycosylated haemoglobin (HbA1c))
研究者
研究点 (2)
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