EVALUATING THE EFFICACY OF INDIVIDUALISED TREATMENT IN HOMOEOPATHY AS AN ADJUVANT THERAPY TO STANDARD MEDICAL CARE IN THE MANAGEMENT OF NON-PROLIFERATIVE DIABETIC RETINOPATHY: A SINGLE BLIND, RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Retinal microvasculature as measured by Retinal fundoscopy and assessed using ICDR scale
研究概览
简要总结
Diabetic retinopathy (DR) represents a significant global health challenge, especially given the rising prevalence of diabetes mellitus worldwide. In recent years, there have been remarkable strides in the diagnosis, technological advancements, and treatment options for DR, which have significantly changed the way we approach and manage the condition. Key developments such as the widespread availability of optical coherence tomography (OCT) for imaging, as well as the introduction of anti-vascular endothelial growth factor (VEGF) therapies, have dramatically improved both the early detection and treatment of DR. These advancements have paved the way for better outcomes for patients. However, the field continues to evolve, with ongoing research and innovations offering promising new solutions for further improving the management and treatment of diabetic retinopathy. Homoeopathy has the potential to treat various ophthalmic conditions quickly, effectively, and safely, with minimal risk of recurrence.
AIM: to test the efficacy of individualized treatment in homoeopathy as an adjuvant therapy to standard medical care in the management of non-proliferative diabetic retinopathy.
MATERIALS AND METHODS: A prospective, single blind, randomized controlled trial with a 6-month follow-up period, will be conducted at BHARATI VIDYAPEETH (Deemed to be University) HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL OPD, Pune. Thirty participants fulfilling the inclusion criteria will be randomized into 2 groups- group A will receive Individualized homoeopathic treatment along with standard medical care while group B will receive placebo .The cases will be analyzed and evaluated for the condition over a duration of 6 months with monthly follow ups. The ophthalmologist and homoeopathic expert will follow up concurrently. Frequency for fundoscopy follow up will be determined by ophthalmologist on basis of symptoms of the patient. At the end of the study, the patient is again evaluated on the parameters of baseline assessment and the results are concluded after the analysis with appropriate statistical tools.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Clinically confirmed Non proliferative diabetic retinopathy (mild to moderate severity) Currently receiving standard medical care for diabetes and Non proliferative diabetic retinopathy Willingness to participate with written consent.
排除标准
- •Proliferative diabetic retinopathy HbA1c more than 10.0 percent Hypertensive retinopathy Cases needing surgical intervention Recent (less than 6 months) ocular surgery Pregnancy or planned pregnancy during study period Current participation in other clinical trial Significant hepatic impairment having more than and including Class B child phug score Angle closure glaucoma Renal impairment with GFR less than 59 ml per min per 1.73m3.
结局指标
主要结局
Change in Retinal microvasculature as measured by Retinal fundoscopy and assessed using ICDR scale
时间窗: 6 months with monthly follow ups
次要结局
- improvement in Vision-related quality of life (NEI-VFQ-25)(6 months with monthly follow ups)
研究者
Dr Samanvitha T
BHARATI VIDYAPEETH (Deemed to be University) HOMOEOPATHIC MEDICAL COLLEGE & HOMOEOPATHIC HOSPITAL
