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临床试验/CTRI/2024/09/073759
CTRI/2024/09/073759尚未招募不适用

Efficacy of oral curcumin in improving visual function in eyes with advanced stage glaucoma

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
1.Perimetry

研究概览

简要总结

Potential Novelty of the Proposed Study:

As per the available knowledge, there is a paucity of research examining the efficacy of oral curcumin capsules supplimentation  in treating advanced glaucoma patients. This study aims to bridge this gap by investigating the potential benefits of curcumin, known for its anti-inflammatory and antioxidant properties, in improving visual functions in advanced glaucoma patients.

Rationale of the study:

The rationale for conducting a study on administering oral curcumin alongside standard glaucoma therapy in advanced glaucoma patients lies in the potential synergistic effects of curcumin supplementation. While conventional treatments focus on lowering intraocular pressure, curcumin offers a complementary approach by targeting underlying mechanisms of neurodegeneration and inflammation.

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
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • The following patients will be included in the study 1.Patients willing to give consent for the study 2.Age 18 to 80 years.
  • 3.Patients with advanced stage glaucoma in at least one eye and well-controlled IOP (less than 16 mmHg) in that eye with a Snellen visual acuity of at least 6 by
  • 4.If both eyes of the patient were eligible the eye with the better visual field was included in the study.

排除标准

  • 1.Not willing to follow up.
  • 2.Age less than 18 years 3.Any patient with recent ocular surgery in past 3 months or secondary inflammatory conditions causing glaucoma eg, vernal keratoconjunctivitis (VKC), uveitix, sclerouveitis etc.
  • 4.Patients with contraindications to curcumin or any related allergies.
  • 5.Patients with any other disease that might have contributed to visual field loss at the time of initial visual-field test such as other optic neuropathies, stroke, brain tumors, retinal vein or artery occlusion, macular disease, cataract and proliferative diabetic retinopathy.
  • 6.Any recent surgery in last 3 months.

结局指标

主要结局

1.Perimetry

时间窗: 4 Weeks, 6 Weeks, 12 Weeks

2.Cup-Disc-Ratio (CDR)

时间窗: 4 Weeks, 6 Weeks, 12 Weeks

3.Optical Coherence Tomography Angiography (OCTA)

时间窗: 4 Weeks, 6 Weeks, 12 Weeks

次要结局

  • Multifocal Electroretinography (Mf-erg)(4 Weeks, 6 Weeks, 12 Weeks)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Shikha Gupta

Aiims, New Delhi

研究点 (1)

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