Clinical trial on eye health
- Registration Number
- CTRI/2023/12/060711
- Lead Sponsor
- BOTANIC HEALTHCARE PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Changes in MPOD levels <br/ ><br>2. Changes in glare disability <br/ ><br>3. Changes in contrast enhancement measurements <br/ ><br>4. Changes in Lutein and Zeaxanthin plasma concentrationsTimepoint: Dy 0 Day 30 Day 60 and Day 90
- Secondary Outcome Measures
Name Time Method 1. To assess the safety of the product through Safety assessments <br/ ><br>like hematology, biochemistry (Lipid profile, LFT, RFT), and <br/ ><br>Urine analysis and feedback questionnaires. <br/ ><br>2. Percentage change in Photostress recovery time.Timepoint: Day 0 and Day 90