A clinical evaluation of Vasant Kusumakar Ras in Prameha Upadrava with special reference to Diabetic Retinopathy -Placebo controlled, open study - NI

I0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Diagnosed with diabetes mellitus (type I & II).
•2. Diagnosed with non-proliferative diabetic retinopathy (mild to Moderate cases), in whom panretinal photocoagulation is not imminently required in the ophthalmologistâ??s judgment.
•3.Best corrected ETDRS VA in study eye >=49 letters (20/100)
•4. HbA1C between 6 to 9 %.
•5.Able and willing to give informed consent

•1.Complicating severe vitreous hemorrhage, or requiring laser and vitrectomy treatment.
•2.The patients who have been received the therapy of Retina laser photocoagulation.
•3.The patients whose dioptric media is so turbid that hard to evaluate the fundus picture.
•4.Retinal conditions which may mask assessment e.g. retinal vein occlusion
•5.Systolic blood pressure greater than 180 mm of hg or diastolic blood pressure greater than 110 mm of hg
•6.History of major ocular surgery (scleral buckle, any intraocular surgery etc in the study eye within prior 6 months
•7.DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month.
•8.History of systemic corticosteroids within 3 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 3 times per week.
•9.Previous treatment with intravitreal or sub tennon triamcinilone within the past 3 months in the study eye.
•10.Previous participation in any studies of investigational drugs within 1 month preceding day 0 (excluding vitamins and minerals)
•11.Subject with other severe Diabetic complication.
•12.Having known allergic reaction to ingredients of Vasant Kusumakar Ras
•13.Pregnant or breast feeding.
•14.Subjects with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
•15.Participated in other clinical trial within 3 month.

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