A series of n-of-1 trials exploring the efficacy of individualized homeopathic medicines in LM potencies along with standard of care on glycemic control in type 2 diabetes mellitus in adults.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Postprandial Plasma Glucose (PPG)
研究概览
简要总结
This study is designed whether IHMs in LM Potencies can produce any significant effect beyond placebo in Postprandial Plasma Glucose in the treatment of type2 Diabetes Mellitus in adults after four months of intervention, using an N-of-1 trial design. The trial will be conducted at the Outpatient Department of D. N. De Homoeopathic Medical College and Hospital, Kolkata. Participants will receive personalized homeopathic medicines, with each treatment cycle followed by a washout phase to assess individual responses. The primary outcome is the change Postprandial Plasma Glucose from baseline. Secondary outcomes include improvement in quality of life measured by the MDQoL 17 (modified diabetes quality of life ) scale. Additionally, investigation including HbA1c, lipid profile( LDL, HDL, LDL HDL Ratio ), and Microalbumin (urine) will be conducted to monitor end-organ damage associated with hypertension. This trial aims to assess the individualized therapeutic response to homeopathy in type2 Diabetes mellitus and explore its potential as a safe, complementary approach in type2 Diabetes mellitus care.
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 type 2 DM (ICD 10 code E11) for more than equals to 1 year (as per ADA criteria) PPG (postprandial plasma glucose) more than equals to 200 mg/dl. HbA1c percent more than equals to 6.5 (ADA criteria) at screening and less than 10.
- •Adults- men or women or transgender with T2DM BMI more than 23 and less than 45 kg/m
- •Patient on stable conventional screening, anti.
- •diabetic therapy (oral diabetic agents) for more than 3months.
排除标准
- •Excessive blood glucose, FBS more than 300 mg/dl, PPBS more than 450 mg/dl Participants with type I DM or secondary diabetes (e.g., pancreatic or steroid-induced) Diagnosed cases of unstable psychiatric illness or other uncontrolled or life threatening illness affecting the quality of life or any organ failure (eg: severe liver or kidney disease, serum creatinine more than 1.4mg/dl in women and more than 1.5mg/dl in men) women of pregnancy, puerperium, lactation. Homeopathic treatment for any chronic disease within last 6 months uncontrolled HTN or severe Dyslipidaemia or diabetic and taking insulin for 6 consecutive days within the prior year Vulnerable population – unconscious, non.
- •ambulatory, too sick for consultation, differently abled, terminally ill or critically ill, mentally incompetent people. Tobacco, alcohol, or any kind of substance abuse and/or dependence participation in another clinical trails Self-reported immune-compromised state.
结局指标
主要结局
Postprandial Plasma Glucose (PPG)
时间窗: At Baseline every 17 days upto 4 months
次要结局
- Modified Diabetes Quality of Life – 17 questionnaire, (MDQoL-17)(At Baseline Every 17 days upto 4 months)
- HbA1c(at Baseline and after 3 months)
- lipid profile (LDL, HDL and their ratio)(At baseline Every 17 days upto 4 months)
- Microalbumin(urine)(At Baseline Every 17 days upto 4 months)
研究者
Rithika Padhi
D.N.DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL