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An Innovative Chinese Herbal Formula for Macular Edema

NCT05122702 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-11-15

No results posted yet for this study

Summary

Macular edema (ME) is caused by hyperpermeability of retinal vessels and/or decreased efflux of fluid across the retinal pigment epithelium induced by outer/inner blood-retinal barrier dysfunction (BRB). It is most commonly seen following many diseases such as diabetes mellitus (DM), intraocular surgery, uveitis, retinal vein occlusion, and posterior segment inflammatory disease. An estimated 11% of patients with DM develop diabetic macular edema (DME). While the overall prevalence of DME among patients with DM aged 20 to 79 years is approximately 7.5%, the risk increases over time. Currently, there is no cure for ME.

Chinese medicine (CM) is widely used to manage ME in China and other East Asian countries. Among them, Shenling Baizhu San (SBS) is one of the most commonly used formulae. In this proposal, a randomized, double-blind, placebo-controlled, multicenter clinical trial will be undertaken to evaluate the efficacy and safety of modified SBS (mSBS) developed by the project team for the treatment of ME.

Eligible subjects will be recruited and assigned randomly to receive orally mSBS or placebo twice a day for 12 consecutive weeks, with follow-up for another 4 weeks after stopping the treatment to observe the duration of efficacy.

Conditions

  • Macula Edema

Interventions

DRUG

modified Shenling Baizhu San

modified Shenling Baizhu San granules, twice daily for 12 weeks.

OTHER

Placebo

Placebo granules, twice daily for 12 weeks.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Zhixiu Lin, PhD · Hong Kong Institute of Integrative Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-12
Primary Completion
2024-07-31
Completion
2025-01-01

Countries

  • Hong Kong

Study Locations

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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 NCT05122702 on ClinicalTrials.gov