CTRI/2023/12/060711招募中3 期
A Randomized, double-blind, three arm, placebo-controlled clinical study to evaluate the modulatory effect of Lutein and Zeaxanthin supplementation (Gleamax or Vividawn) on MPOD levels along with Glare disability and Contrast enhancement in healthy subjects. - NI
BOTANIC HEALTHCARE PVT LTD0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Volunteers of either sex, between 45 to 65 years of age.
- •2. Patients with exudative AMD
- •3. Volunteers with MPOD level between 0.2 to 0.4 d.u.
- •4. Total cholesterol level less than 6.2mmol L
- •5. Volunteers having no clinically significant ocular pathological condition, but clinically non-significant problem with
- •accommodation of the eye can be included.
- •6. Negative HIV 1 and 2 and HBsAG.
- •7. Willing to come for regular follow up visits.
- •8. Able to give written informed consent, willingness to take part
- •in study and able to attend all scheduled visits.
- •9. BMI 25 to 33 kg m2
排除标准
- •1. Not willing to sign the ICF or give the consent
- •2. Taking Drugs Medication
- •a. Drug addicts
- •b. People on hyperlipidemia medications and controlled diets
- •c. People on hormone replacement therapy
- •d. Regular users of supplements or dietary supplements
- •3. Medical conditions
- •a. People with hyperlipidemia, hyper cholesterolemia, renal disorder, liver disorder, diabetes mellitus and other debilitating diseases.
- •b. People with additional ophthalmic dieses will be excluded.
- •c. People undergoing retinal surgery and retinal laser treatment to be excluded.
- •d. People with macular atrophy
- •e. Those with signs of exudative changes in the retina, including sub retinal fluid, pigment epithelial detachment, or hemorrhage.
- •f. Myopia of more than 6 diopters
- •g. Those with cataracts or corneal opacity, glaucoma, pan retinal degeneration
- •h. People who have undergone any surgery.
- •4. Other general information physiological, lifestyle, allergic reactions, etc
- •a. Pregnant and lactating women or those planning to become
- •pregnant b. Those with allergies adverse reactions to the test substance
- •c. Alcohol consumption men greater than or equal to 40 g per day, women greater than or equal to 20 g per day
- •according to WHO guidelines for daily alcohol consumption
- •d. Excessive smokers greater than or equal to 20 cigarettes per day.
- •e. Taking a dietary supplement related to the function within 3 months prior to the start of the study.
- •f. Participation in another clinical trial within the last 3 months.
- •g. Subjects who, in the opinion of the investigator, are unsuitable for the study.
研究者
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