Evaluate the effectiveness of individualized Homeopathic medicine as a complement therapy with using complete repertory in the management of non-dialysis chronic kidney disease.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Glomeruli filtration rate (GFR), Creatinine and CKD stage progression
研究概览
简要总结
Chronic Kidney Disease (CKD) is becoming a significant chronic illness globally. Indeed, it has been recently estimated that the age-adjusted incidence rate of ESRD ( end stage renal diseases) in India is 229 per million population, and >100,000 new patients enter renal replacement programs annually in India. in India, there is a prevalence rate of CKD of around 17% and it is worse in stage 3 with a 6% rate. Preventing ESRD is crucial for population health and Economic burden. CKD are a condition in which the kidneys are damaged due to changes in the structure or function of glomeruli. The progression of this condition can lead to kidney and cardiovascular failure. KIDGO defines CKD as kidney damage or glomerular filtration rate 60ml/min/1.73m2 for 3 moths or more, regardless of the causes. Although there are few single medicine trials that support the efficacy of homeopathic medicine for CKD, systematic reviews recommend that future trials of homeopathy be conducted. This trials is designed to assess the complementary efficacy of individualised homeopathic medicine selected through Complete Repertory along with allopathic medicine in the treatment of CKD on 70 OPD patients in an open label, non-randomised (odd-even), controlled experimental design at H N Shukla homeopathic medical college and Hospital, Rajkot. The patients will receives either individualised homeopathic medicine along with allopathic medicine or solely allopathic medicine and will be monitored for 6 months. Data will be gathered using GFR and Serum Creatinine calculation at baseline, after 3 months, and 6 months. Statistical analysis will be used to evaluate the intent to treat the population. To examine any differences between groups, a comparative analysis will be conducted. The outcome will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •The samples will be selected from both sexes, & adolescent to old age group.
- •All stages of Chronic kidney disease (without dialysis) cases with allopathic medicine.
- •Chronic kidney disease associated with Diabetes, Hypertension, Glomerulonephritis, or any other auto immune diseases will be included with their allopathic medicine.
排除标准
- •Chronic kidney disease with dialysis or kidney transplantation.
- •Chronic kidney disease in children.
- •Chronic kidney disease with any other alternative therapy treatment like ayurvedic treatment.
- •Chronic kidney disease with Arthritis cases or cases requires NASAID medicine.
- •Acute kidney diseases.
- •Chronic kidney diseases with pregnancy and breast feeding cases.
结局指标
主要结局
Glomeruli filtration rate (GFR), Creatinine and CKD stage progression
时间窗: 3 month
次要结局
- Effect of Individualised homeopathic medicine from complete repertory according to KIDGO classification (GFR classification)(6 month)
