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A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy

NCT03258242 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2017-08-24

No results posted yet for this study

Summary

This is a study aiming to assess the efficacy and safety of Keluo Xin capsule in patients with moderately severe to severe nonproliferative diabetic retinopathy (NPDR). Two-thirds of participates will receive Keluo Xin capsules while other one third will receive placebo.

Conditions

  • Moderately Severe to Severe NPDR

Interventions

DRUG

Keluo Xin capsule

four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.

DRUG

Placebo oral capsule

four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.

Sponsors & Collaborators

  • Chengdu Kanghong Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yanping Song, Professor · Wuhan General Hospital of Guangzhou Military, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2019-08-31
Completion
2020-02-28

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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 NCT03258242 on ClinicalTrials.gov