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

K

Kanghong Pharmaceutical

Status and phase

Unknown
Phase 2

Conditions

Moderately Severe to Severe NPDR

Treatments

Drug: Keluo Xin capsule
Drug: Placebo oral capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT03258242
KH105-B02-CRP-2.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

198 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

198 participants in 2 patient groups, including a placebo group

Experimental: Keluo Xin Capsule
Experimental group
Treatment:
Drug: Keluo Xin capsule
Placebo Comparator: Placebo
Placebo Comparator group
Treatment:
Drug: Placebo oral capsule

Trial contacts and locations

0

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Central trial contact

Quan Wu; Yanping Song, Professor

Data sourced from clinicaltrials.gov

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