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临床试验/CTRI/2024/12/078689
CTRI/2024/12/078689尚未招募2 期

A CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF CHANDRAKALA RASA IN THE MANAGEMENT OF NON-PROLIFERATIVE DIABETIC RETINOPATHY

Dr Sushobhitha M2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月3日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
120
试验地点
2
主要终点
Improvement in subjective and objective parameters

研究概览

简要总结

Patients with diabetes are more likely to develop eye problems such as cataract and glaucoma, but the disease’s effect on the retina is the main threat to vision.

Diabetic retinopathy refers to retinal changes seen in the patients of diabetes mellitus.Diabetic retinopathy is an ocular micro angiopathy characterized by capillary leakage, hemorrhages, and intra retinal micro vascular abnormalities.

It is estimated that all people of type 1 diabetes mellitus (IDDM), 75% of type 2 diabetes mellitus (NIDDM) will develop diabetic retinopathy after 15 years of duration.18% will develop retinopathy in less than 15 years of duration

In Ayurveda, Prameha is considered as Mahagada and if not properly managed leads to upadravas

It has been mentioned ‘Hrunnetrajihwashravanopadeha’ in the context of Prameha poorvaroopa which gives clue regarding involvement of eye in pramehasamprapthi,

The doshas and dhatus which causes the main disease are also responsible for the manifestation of the upadravas

In prameha major samprapthi ghataka is kleda which contribute much to upadrava rogas.

In Ayurveda many works have been undertaken with promising results in diabetic retinopathy.( Anjana, shirolepa, takradhara).

Aiming at restoration of structural and functional integrity of the disease, a comparative clinical study using, Darvyadi Anjana, Mahavasadi kwatha and Chandrakala rasa orally taken up in the present work, which is said to have properties of controlling raktasrava, shopha pacifying kaphapittta and having chakshushya.

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
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients with minimal visual acuity of 6/36 Patients having minimum history of DM for 10 years Patients with good glycemic control HbA1C less than 7.

排除标准

  • Patients having proliferative diabetic retinopathy changes Patients with history of visual impairments like glaucoma and matured lenticular opacity changes Patients with history of Pathological myopia and other degenerative conditions Patients with other systemic disorders which may interfere with the course of study.

结局指标

主要结局

Improvement in subjective and objective parameters

时间窗: 7weeks

次要结局

  • Sustained effect of treatment on subjective and objective parameters

研究者

发起方
Dr Sushobhitha M
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sushobhitha M

SDM Institute of Ayurveda and Hospital Bengaluru

研究点 (2)

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