Single arm pilot clinical trial to evaluate the efficacy of Ayurvedic treatment on Diabetic Macular Edema
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Mean change in Central Subfield Thickness (CST)
研究概览
简要总结
Diabetic macular edema (DME) is one of the leading causes of vision loss worldwide. DME is a condition characterised by thickening and swelling of macula caused by microvascular leakage which can occur in any stage of Diabetic Retinopathy. Intravitreal drug injections are the main therapy for DME. They carry the risk of intraocular damage and represent an enormous economic burden for patients. This study will be conducted on known case of T2DM having CI-DME as confirmed on OCT. Subjects will be given Punarnavadi kashaya in a dose of 10 ml BD mixed in 40ml of warm water half an hour before meals, Dasamoola Hareetaki Lehya orally in a dose of 10gm HS, Madhuyashtyadi Taila orally in a dose of 5ml BD with warm water 1 hour after meals. ETDRS visual acuity, OCT measured Central Subfield Thickness (CST) and Central Retinal Thickness (CRT) and Maximum Macular Thickness (MMT) will be assessed and compared with baseline after 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient who consent for study Study eye having CI-DME as confirmed on OCT.
- •Patients with best corrected ETDRS visual acuity score of at least 79 (Snellen equivalent of 20/25).
- •Patients who decline both intravitreous therapy and laser photocoagulation and willing to take study group medication.
- •Patients with good glycemic control by diet control, lifestyle modifications or systemic hypoglycemic drugs.
- •Only one eye of participant to be included.
- •The eye with worse BCVA will be included in the study.
- •In case both eyes have equal best corrected visual acuity the right eye will be considered for study.
- •Non-pregnant women.
排除标准
- •Patient with diabetic macular edema with proliferative diabetic retinopathy Patients treated with focal/grid laser within 6 month, intravitreal Anti-VEGF injections within 3 month and intravitreal steroid within 6 months of study entry, history of intraocular surgery within 90 days before study entry.
- •Patients with unstable medical status including blood pressure and glycemic control Patients in poor glycemic control who recently initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 6 months.
- •Macular edema is not considered to be due to a cause other than diabetic macular edema.
- •An eye should not be considered eligible (i) if the macular edema is considered to be related to cataract extraction or (ii) clinical examination and/or OCT suggests that vitreoretinal interface disease (e.g. vitreo-retinal traction or epiretinal membrane) is the primary cause of the macular edema.
- •Ocular condition (other than diabetes) that might affect macular edema or alter visual acuity (e.g. vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine- Gass Syndrome).
- •Glaucoma per se is not an exclusion.
- •An ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, dense sub-foveal hard exudates, non- retinal condition).
- •Patients with a history of acute coronary event or stroke, renal failure, pregnancy or lactation.
- •Media clarity, pupillary dilation, and patient cooperation insufficient for adequate fundus and OCT examination.
- •If patient decides to leave the trial to undergo intravitreous standard therapy.
- •â€¨ Any adverse effect observed.
结局指标
主要结局
Mean change in Central Subfield Thickness (CST)
时间窗: 3 months.
次要结局
- Mean change in best corrected viaual acuity (BCVA)(Mean change in Central Retinal Thickness (CRT) and Maximum Macular Thickness (MMT))
研究者
Vijina Ravindran
Banaras Hindu University