CTRI/2014/12/005286已完成未知
A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DIABOHERB IN PATIENTS WITH TYPE 2 DIABETES MELLITUS.
SBL PVT LTD0 个研究点目标入组 150 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
- 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
- •Males & Females Patients with Type 2 Diabetes Mellitus with age 30â??65 year
- •Only new cases with inadequate glucose control
- •Body mass index between 20-35 kg/m2
- •Having fasting blood glucose > 126 mg/dL
- •Post prandial blood glucose > 200 mg/dL
- •Having no serious Physical abnormalities other than those generally associated with type 2 Diabetes Mellitus.
- •Patient is willing and able to comply with all trial requirements
- •Ability to understand the Informed Consent and Willing to Sign on informed consent along with audio video visual in accordance with GCP and local legislation
- •Patients able to understand and follow the protocol of the trial.
- •Participants who are able to visit the medical institutions throughout the study period
排除标准
- •Patients having Insulin dependent Diabetes Mellitus.
- •Having history of hypersensitivity, liver or kidney damage or gastrointestinal disorders, acute infections, diseases of blood or hematopoietic organs
- •Pregnant or lactating women
- •Patients receiving any concomitant medication, which may have interacted with hypoglycemic action of study drug
- •Previous participation in a clinical trial in the last 6 months.
- •Subjects who are already taking or have taken in the past 2 months any investigational drug.
- •Dehydration by clinical judgement of the investigator.
- •Any contraindication to blood sampling.
- •Severe asthma that is poorly controlled with medication.
- •Significant psychiatric illness, senility, dementia.
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