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临床试验/CTRI/2025/08/093495
CTRI/2025/08/093495尚未招募2 期

Effect Of Nayanamruta Lauham On Drishtipatalagata Vyadhi With Reference To Age Related Macular Degeneration A Clinical Study

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Mean change in Best-Corrected Visual Acuity (BCVA) in logMAR in the study eye from baseline.

研究概览

简要总结

This is a prospective, parallel arm, open-label clinical study designed to evaluate the effect of Nayanamruta Lauham in the management of Drishtipatalagata Vyadhi with reference to Age-Related Macular Degeneration (AMD). A total of 60 participants diagnosed with non-neovascular AMD will be enrolled. Eligible participants will receive Nayanamruta Lauham as per protocol for a duration of 3 months (12 weeks) with follow-up assessments at baseline, 4 weeks, 8 weeks, and 12 weeks. The primary outcome is the change in Best Corrected Visual Acuity (BCVA) from baseline to 12 weeks. Secondary outcomes include changes in contrast sensitivity, central macular thickness (OCT), metamorphopsia (Amsler grid), and vision-related quality of life (NEI VFQ-25). Safety assessments will include monitoring of adverse events and routine laboratory investigations. The study aims to explore the clinical efficacy and safety of Nayanamruta Lauham as an Ayurvedic intervention for improving visual function in patients with dry AMD.

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
55.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Age related Macular Degeneration.

排除标准

  • Diabetic Retinopathy Hypertensive Retinopathy CRAO Iridocyclitis RD Glaucoma.

结局指标

主要结局

Mean change in Best-Corrected Visual Acuity (BCVA) in logMAR in the study eye from baseline.

时间窗: at baseline,after 7 day,15 day,1 month ,2 month ,3 month.

次要结局

  • Change in central macular thickness (CMT) on Spectral-Domain OCT from baseline.

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr.Yuwaraj D.Kale

Bhausaheb Mulak Ayurved Mahavidyala And Medical Science Research Hospital

研究点 (1)

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