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Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum

NCT02244996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-02-19

Study results available
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Summary

Objectives: To study the immediate effect and the persistent effect of Lycium barbarum (LB) treatment on retinal functions, especially the cone function, and retinal structure in patients with retinitis pigmentosa (RP) Design: Randomised controlled double-masked trial

Setting: Primary Care clinical trial

Participants: 120 RP subjects will be recruited from Ophthalmology department at The University of Hong Kong and the Retina Hong Kong. Interventions: Subjects will be randomly allocated to LB (treated with LB granules) or control (treated with placebo) groups for 1 year. After the 1st year, both groups will stop the treatment and all subjects will also have the same eye exam in 6-month period for the 2nd year.

Main outcome measures: The primary outcome is the total sensitivity scores of 30-2 \& 60-4 programmes of Humphrey Visual Field Analysis (HVFA). The secondary outcomes are the b-wave amplitudes of Full-field Electroretinogram (ffERG) responses, the amplitudes of direct component and induced component of Multifocal Electroretinogram (mfERG), and the ETDRS visual acuity.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lycium Barbarum

Traditional Chinese Herbs

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • The University of Hong Kong

    collaborator OTHER

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Henry HL Chan, PhD · The Hong Kong Polytechnic University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-04-30
Completion
2017-11-30

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02244996 on ClinicalTrials.gov