A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines on glycemic control in type II diabetes mellitus in the mutual context of standard care
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Blood glycosylated hemoglobin percentage (HbA1c%)
研究概览
简要总结
Diabetes mellitus type 2 (DM2) is one of the costliest diseases due to the population size at risk and the fact that diabetes is a risk factor for almost all other chronic diseases. About 382 million individuals globally are diagnosed with DM2, which will increase to over 430 million by 2030. The disease burden is expected to increase, primarily in developing countries. This trial is aimed at evaluating the efficacy and safety of individualized homeopathic medicines (IHMs) in glycemic control in type 2 diabetes mellitus in the mutual context of standard care. The participants will be allocated to either verum (IHMs plus standard care) or control (placebo plus standard care) in a 1:1 ratio and will continue their usual antidiabetic medicines and lifestyle management. Blood HbA1c% will be the primary efficacy endpoint. Secondary measures include fasting and postprandial blood sugar, lipid profile, liver enzymes, serum urea, creatinine, uric acid, urine routine and microscopy, and the diabetes symptoms checklist score. All the outcomes will be measured at baseline and then every month up to 6 months. Data analysis will follow the intention-to-treat approach and use appropriate statistical tests to detect group differences. The results will be published in a scientific journal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Cases suffering from diabetes mellitus type II (2021 ICD-10-CM diagnosis code E11.9) 2) FBS more than 126 mg/dl; PPBS more than 200 mg per dl; HbA1c% more than 6.5 (ADA criteria) 3) Age between 18 and 65 years 4) Participants of either sex including transgender 5) Literate patients; ability to read and write in Bengali and/or English.
排除标准
- •Excessive blood glucose, FBS more than 300 mg per dl, PPBS more than 450 mg per dl 2) Participants with type I DM 3) Diagnosed cases of unstable psychiatric illness or other uncontrolled or life threatening illness affecting the quality of life or any organ failure 4) Pregnant, puerperal, and lactating women 5) Self-reported immune-compromised state 6) Tobacco, alcohol, or any kind of substance abuse and/or dependence 7) Undergoing homoeopathic treatment for any chronic disease within last 6 months 8) Participants denying written informed consent.
结局指标
主要结局
Blood glycosylated hemoglobin percentage (HbA1c%)
时间窗: Baseline, after 3 months, and after 6 months
次要结局
- Fasting blood sugar (FBS)(Baseline, then every month, up to 6 months)
- Post-prandial blood sugar (PPBS)(Baseline, then every month, up to 6 months)
- Lipid profile (triglyceride, total cholesterol, HDL, LDL, VLDL)(Baseline, then after 3 months, and after 6 months)
- Serum Urea, Creatinine, Uric acid(Baseline, then after 3 months, and after 6 months)
- Urine routine and microscopy(Baseline, then after 3 months, and after 6 months)
- Diabetes Symptom Checklist: Revised (DSC-R) score(Baseline, then every month, up to 6 months)
研究者
Subhranil Saha
D N De Homoeopathic Medical College and Hospital