The Effect of a Biscuit Containing the Extract of Salacia Reticulata on Glycaemia in Patients With Type 2 Diabetes Mellitus Randomized Triple Blind Placebo Controlled Two Period Two Sequence Crossover Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Glycosylated Haemoglobin
研究概览
简要总结
The investigators intend to conduct a triple blind randomized clinical trial to investigate the effect of a biscuit containing herbal extract, available in the market on the fasting blood sugar control in patients with diabetes mellitus and also to find out whether there are any side effects on other vital organs such as kidneys and liver.
详细描述
The effect of a biscuit containing the extract of Salacia reticulata (Kothala Himbutu) on the reduction of blood glucose levels in patients with Type 2 Diabetes Mellitus. A single center randomized triple blind placebo controlled two period two sequence crossover clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization code (A or B) was made using a computer and inserted in a sealed, serially numbered, opaque envelopes. Participants were given a serial number after run-in period. Assistant opened the envelope and assigned the patient to either biscuit A or B. The manufacturers held randomization code. Investigators, patients and those assessing the analysis were masked to the group outcome. Both Kothala Himbutu (KH) and placebo biscuits are identical in size, wrapped in same cover, and packed in identical boxes. The investigators tasted both biscuits and KH biscuits were slightly darker with the same taste. The study product is available in the market. Patients participating in the trial were asked about prior consumption of KH biscuits bought from the market (to exclude contamination). At the end of each period patients were asked whether they could assume the type of biscuit (KH biscuit or placebo) given to them and their preference for the type.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for minimum period of 6 months
- •Aged between 30 and 65 years
- •Stable glycaemic control over the preceding 2-3 months. They will be initially selected from a range of HBA1C varying from 6.5 - 14 and the individual subject should not have a variation of >20% between the previous HBA1C and the HBA1C done at the commencement of the study
排除标准
- •Chronic kidney disease with estimated Glomerular filtration rate less than 30ml/hour
- •Severe valvular heart disease or heart failure.
- •Those on Insulin therapy
- •Severe liver disease (AST > 10 X times the upper limit)
研究组 & 干预措施
Kothala Himbutu biscuit
A biscuit containing Kothala Himbutu (Salacia reticulata) extract. This biscuit is available in the supermarkets. Four biscuits twice a day for 3 months.
干预措施: Kothala Himbutu Biscuit (Drug)
placebo biscuit
An identical biscuit without the herbal extract from Kothala Himbutu (Salacia reticulate)
干预措施: Placebo Biscuit (Dietary Supplement)
结局指标
主要结局
Glycosylated Haemoglobin
时间窗: After 3 months and after 7 months (there is one month wash over period as this is a cross over trial)
HBA1c were analyzed at a centrally accredited lab using ion exchange high performance liquid chromatography standardized to NGSP
次要结局
- Liver Adverse Effects(Baseline, after 3 months, and after 7 months)
- Renal Adverse Effects -1(baseline, after 3 months and after 7 months)
- Renal Adverse Effects - 2(Baseline, after 3 months, and after 7 months)