Phase III Study of Compound Danshen Dripping Pills to Treat Diabetic Retinopathy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Compound Danshen Dripping Pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis).

Detailed Description
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Compound danshen dripping pills is a kind of traditional Chinese medicine(TCM), consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi (Radix Notoginseng) and borneol. This study is being conducted to evaluate the efficacy and safety of compound danshen dripping pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis), when compared with placebo.

Official Title
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A Randomized, Double Blind, Multi-Center Study of Compound Danshen Dripping Pills in Patients With Diabetic Retinopathy (Syndrome Of Qi-Stagnation and Blood Stasis)

Conditions
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Non-proliferative Diabetic Retinopathy

Intervention / Treatment
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* Drug: Compound danshen dripping pills
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with non-proliferative diabetic retinopathy(NPDR) and TCM syndrome differentiation of qi-stagnation and blood stasis. aged 30-70 years voluntary signs the informed consent One eye met the inclusion criteria can be used as research object, if both eyes met the inclusion criteria, please record respectively, and select one eye for efficacy evaluation with reference to the following principles: When the two eyes of fundus conditions in different clinical stage, choose the more serious one. When the two eyes of fundus conditions in the same clinical stage, choose the eye easier for clinical operation. Exclusion Criteria: HbAlc>8%, sustained hyperglycemia. The patients who have been received the therapy of Retina laser photocoagulation or diagnosed with proliferative diabetic retinopathy (one or two eyes). Diabetic retinopathy caused by type 1 diabetes mellitus. Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc. Combined with primarily severe diseases such as cardiovascular, hepatic，renal illness , hemopoietic system disease, and psychosis. Serum transaminase is higher than the limit of normal value of 1.5 times. Diabetic nephropathy with renal failure (Azotemia or Uremia). For women of child-bearing potential: pregnant or lactating or intending to become pregnant. Having any allergic reaction to some drugs. Participated in other clinical trial within 3 months. Used drugs for the treatment of diabetic retinopathy within 1 week. Blood pressure > 160/100 (systolic above 160 or diastolic above 100).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compound danshen dripping pills<br>Compound danshen dripping pills,20pills,tid. Duration: 24 weeks. | Drug: Compound danshen dripping pills<br>* Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.<br>* Other names: Dantonic®;|
| Placebo Comparator: Placebo<br>Placebo,20pills,tid. Duration: 24 weeks. | Drug: Placebo<br>* Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total effective rate of Fundus changes, the severity of diabetic retinopathy change from baseline at the end of week 24 compared to placebo |  | 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo |  | 24 weeks. | 
| Corrected visual acuity change from baseline at the end of week 24 compared to placebo |  | 24 weeks. | 
| The severity of macular edema change from baseline at the end of week 24 compared to placebo |  | 24weeks |