A Double-Blind, Randomized Controlled Trial Comparing Helonias Dioica 6C And Individualized Homoeopathic Medicine on Glycemic Control Using HbA1c, FBS and DSC-R Score in Adults with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Mean change in serum Glycated Hemoglobin (HbA1c) from baseline.
研究概览
简要总结
Background: Type 2 Diabetes Mellitus (T2DM) is a significant and growing health problem in India. Many patients seek homeopathic treatment, which typically involves either a specific remedy for the condition or a fully individualized remedy based on the patient’s unique symptoms. However, there is a lack of high-quality clinical trial evidence comparing the effectiveness of these two common homeopathic approaches.
Hypothesis: This study hypothesizes that there will be a statistically significant difference in the improvement of glycemic control (measured by HbA1c) between patients treated with the specific homeopathic remedy Helonias dioica 6C and those treated with an individualized homeopathic medicine.
Methods: This is a prospective, double-blind, randomized controlled trial. A total of 74 adults (aged 35-65 years) with T2DM (HbA1c between 6.5 percent and 8.0 percent) who are not currently taking any conventional oral anti-diabetic drugs or insulin will be recruited. Participants will be randomly assigned to one of two groups. Arm A will receive Helonias dioica 6C, and Arm B (the active control group) will receive an individualized homeopathic medicine. Both groups will also receive standardized counseling on diet, lifestyle, and yoga. The primary outcome is the mean change in HbA1c from baseline to 3 months. Secondary outcomes include changes in Fasting Blood Sugar (FBS), diabetes-related symptoms (using the DSC-R score), and safety.
Aim: The study aims to provide evidence on the relative effectiveness and safety of these two classical homeopathic strategies for managing early T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with Type 2 Diabetes Mellitus according to ICMR 2018 diagnostic criteria.
- •Either: 1) Newly diagnosed T2DM (diagnosed within the last 6 months) and entirely naïve to both oral anti-diabetic drugs (OADs) and insulin therapy, OR 2) Previously diagnosed T2DM but currently managed solely with diet and lifestyle modifications for at least the past 3 months (i.e., not on any OADs or insulin for at least 3 months).
- •Baseline HbA1c between 6.5% and 8.0% (inclusive).
- •Willing and able to provide written informed consent and adhere to study procedures.
排除标准
- •Patients currently taking or having taken any conventional anti-diabetic medication (oral anti-diabetic drugs OR insulin) within the last 3 months.
- •History of requiring continuous or long-term insulin therapy for glycaemic control.
- •Type 1 Diabetes Mellitus, Latent Autoimmune Diabetes in Adults (LADA), Maturity Onset Diabetes of the Young (MODY), or secondary diabetes.
- •Baseline HbA1c less than 6.5% or greater than 8.0%.
- •Severe uncontrolled hypertension (systolic BP greater than 180 mmHg or diastolic BP greater than 110 mmHg despite medication).
- •Presence of severe diabetic complications: proliferative retinopathy requiring active treatment, end-stage renal disease (eGFR less than 30 ml/min/1.73m²), active Charcot foot, major cardiovascular event within the last 6 months.
- •Significant hepatic dysfunction (ALT or AST greater than 3 times the upper limit of normal).
- •Known history of severe psychiatric illness that may interfere with informed consent or study compliance.
- •Pregnant or lactating women, or women planning pregnancy during the study period.
结局指标
主要结局
Mean change in serum Glycated Hemoglobin (HbA1c) from baseline.
时间窗: 3 months
次要结局
- Mean change in Diabetes Symptom Checklist-Revised (DSC-R) total score from baseline.(3 months)
- Mean change in Fasting Blood Sugar (FBS) from baseline.(1 month, 2 months, and 3 months)
研究者
DR AGHOSH B PRASAD
White Memorial Homoeo Medical College