CTRI/2016/09/007318进行中（未招募）3 期
Effects of Homoeopathic intervention in pre-diabetes (EHIP): An open label randomized placebo controlled exploratory trial
Central Council for Research in Homoeopathy0 个研究点目标入组 397 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 397
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
- •Indian diabetic risk score(IDRS) more than equal to 60
- •Adults above 35 years with impaired glucose regulation (2hrs oral glucose tolerance test with 75 g glucose load more than equal to 140 mg per dL and ,less than 200 mg per dl, fasting plasma glucose concentration of 6.1mmol/L ( >110 mg/dL) or greater but less than 7.0 mmol per L (126mg per dL) as recommended by WHO (1999).
- •Patients who are negative on Glutamic acid Decarboxylase (GAD) antibodies and insulin antibodies
- •Written informed consent
排除标准
- •Self reported HIV positivity
- •Self reported cardiovascular disease such as bundle block, uncontrolled hypertension (SBP >180 mmHg or DBP >105 mmHg on treatment). Milder degrees of hypertension would prompt referral to primary care provider for treatment but would not exclude.
- •Stroke or transient ischemic attack in the past 6 months
- •Recent or significant abdominal surgery (e.g. gastrectomy) during last six months.
- •Unable or unwilling to give informed consent and comply with study protocol
- •Likely to move away from participating clinics in next 01 year
- •Pregnancy and Lactating mother
- •Major psychiatric disorder which would impede conduct of the study
- •Excessive alcohol intake, either acute or chronic. Those patients who are taking 60 ml in case males and 30 ml in case of females per day
- •Diabetes at baseline evaluation evidenced by any of the following:
- •ï?Fasting blood glucose 126 mg/dL [7.0 mmol/L]
- •ï?2-hour blood glucose 200 mg/dL [11.1 mmol/L] based on 75 gm OGTT
- •ï?Diabetes diagnosed by a physician and confirmed by other clinical data (e.g. documentation of a fasting
- •ï?Plasma glucose 126 mg/dL [7.0 mmol/L] or a positive OGTT
- •Ever used hypoglycemic medication (oral agents or insulin; except during GDM) i.e. in the last six months any medication which would affect the blood glucose metabolism will be excluded (corticosteroids, oral agents, insulin).
- •Any systemic illness to be excluded (LFT, KFT).
- •TSH test to exclude sub clinical and clinical hypothyroidism at baseline.
- •Self reported thyroid disease, sub optimally treated.
- •Patientsâ?? positive for GAD and insulin antibodies will be excluded.
研究者
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