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临床试验/CTRI/2025/08/093759
CTRI/2025/08/093759尚未招募2/3 期

The Efficacy of Thazhy with Manjishta Kseera Kalka, against Anjana with Elaneer kuzhambu in improving Visual Acuity in Mild to Moderate Non -Proliferative Diabetic Retinopathy

Self1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
Self
入组人数
100
试验地点
1
主要终点
Examination of Visual acuity by Logmar chart

研究概览

简要总结

A randomized controlled trial to assess the efficacy of Thazhy with Manjishta Ksheera kalka against Anjana With Elaneer kuzhambu in Mild to Moderate Non Proliferative Diabetic Retinopathy. It is a non inferiority trial.  2 groups with 50 participants in each trial(Thazhy) and control(Anjana). The outcome will be assessed by the examination of visual acuity using Logmar chart, OCT macula and Fundus examuination. on 0th and 30th day. Follow up on 60th and 90th days.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ophthalmoscopically assesses mild to moderate non proliferative diabetic retinopathy of any duration participants with visual acuity 6/12 to 6/60.

排除标准

  • Severe NPDR (4– 2 –1 rule) Participants with visual acuity less than 6/60 Participants having cataract Participants having severe macular oedema (CMT more than 400 micrometre) Subjects with poorly controlled diabetes mellitus (HbA1c more than 10%) Those who are unable to follow the treatment regime.
  • Contra indications for either treatment procedure.

结局指标

主要结局

Examination of Visual acuity by Logmar chart

时间窗: 0th day, 30th day

Ophthalmoscpy

时间窗: 0th day, 30th day

fundus photography

时间窗: 0th day, 30th day

OCT macula

时间窗: 0th day, 30th day

次要结局

  • assessment of vision related quality of life assessment using National eye Institute Visual function questionnaire -25(VFQ-25)(0th day, 30 th day)

研究者

发起方
Self
申办方类型
Other [Dr Adithya Babu P T P, professor, VPSV Ayurveda college, Kottakkal]
责任方
Principal Investigator
主要研究者

Dr Adithya Babu P T P

V P S V Ayurveda College Kottakkal

研究点 (1)

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