Efficacy of individualized homeopathic medicines in the treatment of peripheral diabetic neuropathy in adults A double-blind, randomized, placebo-controlled trial with mutual antidiabetic standard care
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Neuropathy total symptom score(NTSS-6)
研究概览
简要总结
Diabetic neuropathy (ICD E11.40) is defined as the presence of symptoms and/or signs of peripheral nerve dysfunction in a patient with diabetes, after the exclusion of other causes. In course of diabetes, exceeding 50% people eventually develop peripheral diabetic neuropathy . Though the use of homoeopathic medicines is extensive globally to treat the condition, diligent research evidence in favor of homoeopathy is not well Marked. So, we intend to undertake the research to evaluate the efficacy and safety of homoeopathic medicines in the treatment of PDN. A double blind randomized placebo controlled trial will be conducted upon 142 middle aged individuals at the outpatient of D.N.De homoeopathic medical college and hospital. Assessment will be done by NTSS 6 scale [primary outcome], DN4, DNE, Measure Yourself Medical outcome Profile version 2 (MYMOP-2) score, FBS and PPBS [secondary outcome] to be measured at base line and every month up to 3 months. HbA1c %, , lipid profile, liver enzymes (ALT, AST), urea, creatinine, urine profile [secondary outcome] at baseline and after 3 month of intervention. Comparative analysis will be carried out to detect group difference (if any).
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged of 30-65 years
- •Participant of either sex or transgender.
- •person who had been diagnosed with diabetic neuropathy for at least 3 months.
- •DNE score greater than 3.
排除标准
- •Individuals with other neurological disorders.
- •Abnormal gait, loss of arch with multiple fractures in tarsal bones wrist, foot drop.
- •Diabetic complications (such as retinopathy or renal involvement with history of recurrent acute complaints like hypoglycaemia, keto-acidosis).
- •Self-reported immune-compromised state.
- •Tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
- •Pregnant or lactating women, unstable mental health.
- •Those who requiring insulin with an HbA1c equal or more than
- •Participants who had received homeopathic treatment for chronic diseases in the last 6 months or were critically ill were also excluded from the study.
- •Vulnerable population-Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
结局指标
主要结局
Neuropathy total symptom score(NTSS-6)
时间窗: Baseline, every months up to three months
次要结局
- Douleur Neuropathique 4 Questions (DN4) scale(Baseline, every months up to three months)
- Diabetic Neuropathy Examination (DNE) score(Baseline, every months up to three months)
- Measure Yourself Medical outcome Profile version 2 (MYMOP-2) score(Baseline, every months up to three months)
- Fasting blood sugar (FBS),(Postprandial blood sugar (PPBS))
- HbA1C%, lipid profile, liver enzymes (ALT, AST), urea, creatinine, urine profile(At baseline and after three months of interventions)
研究者
Samiul Alam
D N DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL