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

NCT ID: NCT03258242

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2020-02-28

Brief 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.

Detailed Description

This study composes two parts. The first is a 24-week period during which subjects receive designed treatment regimen; after that, subjects will be informed again for the next 24-week regimen (extention phase) and can choose whether or not to participate in the treatment (with the same regimen in the first period) voluntarily.

Conditions

Moderately Severe to Severe NPDR

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: Keluo Xin Capsule

Group Type: EXPERIMENTAL

Keluo Xin capsule

Intervention Type: DRUG

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

Placebo Comparator: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

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

Interventions

Keluo Xin capsule

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

Intervention Type: DRUG

Placebo oral capsule

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years to 70 years;
• Patients diagnosed with type 2 diabetes mellitus;
• Patients diagnosed with nonproliferative diabetic retinopathy;
• Patients diagnosed with traditional Chinese medicine syndrome(TCM) differentiation of both Qi and Yin deficiency with blood Stasis;
• HbA1c≤8.0%;

Exclusion Criteria

• Study eye been received panretinal photocoagulation;
• Study eye with neovascular elsewhere or neovascular of the disc, or neovascularization of iris;
• Prior panretinal photocoagulation in the study eye within 6 months;
• Uncontrolled blood pressure;
• Subjects who develop chronic diarrhoea;
• Any history of acute diabetic complications;
• Any history of allergy to components of Keluo Xin capsule;
• Pregnant or breast-feeding women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu Kanghong Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanping Song, Professor

Role: PRINCIPAL_INVESTIGATOR

Wuhan General Hospital of Guangzhou Military, China

Central Contacts

Yanping Song, Professor

Role: CONTACT

songyanping@medmail.com.cn

+86-27-50772574

Quan Wu

Role: CONTACT

wuquan@cnkh.com

+86-28-87516605

References

American Academy of Ophthalmology, "Diabetic retinopathy.," 2014.

Reference Type: BACKGROUND

Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.

Reference Type: BACKGROUND

PMID: 24002281 (View on PubMed)

Other Identifiers

KH105-B02-CRP-2.0

Identifier Type: -

Identifier Source: org_study_id