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临床试验/CTRI/2024/04/065524
CTRI/2024/04/065524尚未招募Phase 3 4

A clinical study on the effect of patolyadi ghrita akshitarpana & shilajit rasayana in diabetic retinopathy

Dr BRKR Government Ayurvedic Medical College1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Improve the grading of retinopathy atleast by 1 grade.

研究概览

简要总结

Recent data suggests that diabetic retinopathy is the leading cause of hlindness in diabetis mellitus. It is estimated that there are approximately 33 million adults with diabetes in India. Thin number is likely to increase to 57.2 million by the year 2030.

Treatment for diabetic retinopathy is not cost-effective and though intra vitreal injections play a key-role in the management of DR its very difficult due to nature of progression of disease.

A study revealed that the prevalence of DR among persons with diabetes was 16.9% and the  prevalence of mild retinopathy was 11.8% It is evident that 90% of patients with DM for 15-20 years will have some of the retinopathy changes like aneurysm IRMA etc., Although modern medical science has made tremendous and remarkable progress and advance in the field of ophthalmology in recent times, the importance of ayurvedic treatment in the diseases of eyes cannot be ignored owing to the above mentioned pitfalls of the modern therapy. Ayurveda ocular therapies known as kriya kalpa has proven benefit on ocular pathologies.

Regardless of the method used to detect DR, the prevalence of DR among persons with diabetes ranged from 10% to 30.4%. A study reported a prevalence of 16.9%, which is comparable to other studies using plasma glucose as the criteria for DM; studies relying on self-report of DM had reported a higher prevalence of DM Prevalence of DR was higher in the urban examined population than in the rural population at 20.7% and 15.5% respectively.

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研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Diagnosed case of T2DM for 10-30 years 2.Irrespective of race,religion & sex 3.case of NPDR +/- symptoms of hazyvision,blurred vision,floaters.
  • 4.controlled Hypertension.

排除标准

  • 1.Diagnosed case of T2DM for more than 35 years 2.PDR & other vitreoretinal diseases
  • History of invasive ocular surgeries like vitreoretinal surgeries.
  • 4.Pregnancy, poor glycemic control 5.Malignancy, T1DM.

结局指标

主要结局

Improve the grading of retinopathy atleast by 1 grade.

时间窗: Day 0 | Day 25 | Day 46 | Day 70

次要结局

  • Effect on glycemic index(Day 0)

研究者

发起方
Dr BRKR Government Ayurvedic Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sreeharsha Vedantham

Dr BRKR government Ayurvedic medical college

研究点 (1)

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