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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02244996 |
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Date of registration:
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17/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum
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Scientific title:
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Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02244996 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Hong Kong
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Contacts
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Name:
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Henry HL Chan, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hong Kong Polytechnic University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Ocular conditions:
- Retinitis pigmentosa;
- best corrected VA LogMAR 0.20 or better;
- Humphrey Visual Field Analysis (HVFA) 30-2 total mean defect > or = 250 Decibel;
- Intra-ocular pressure (IOP) <21 mmHg;
- van Herrick ratio < or = 0.5;
- no other ocular diseases
Dietary conditions:
- Fruit and vegetable intake <10 servings/day;
- spinach or kale intake < or = serving/day;
- dietary lutein intake < or = 5.4mg/day;
- no intake of cod liver oil or omega-3 capsules;
- dietary Lycium barbarum intake < or =10 fruits/week;
- supplement intake < or = 5000 IU/day of Vit. A and < or = 30 IU/day of Vit. E;
- alcoholic consumption < or = 3 beverages/day
Exclusion Criteria:
- BMI > 40;
- intake of any anticoagulants (especially Warfarin),
- pregnant or planning to be pregnant;
- smoking;
- other clinically significant systemic diseases, eg. diabetes, liver disease and heart
disease
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Retinitis Pigmentosa
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Intervention(s)
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Dietary Supplement: Lycium Barbarum
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Dietary Supplement: Placebo
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Primary Outcome(s)
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ETDRS Visual Acuity (High Contrast)
[Time Frame: 12 months]
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Secondary Outcome(s)
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Implicit Times of Flash Electroretinogram
[Time Frame: 12 months]
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Amplitudes of Flash Electroretinogram
[Time Frame: 12 months]
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Visual Field Sensitivity
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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