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

Tasly Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Non-proliferative Diabetic Retinopathy

Treatments: Drug: Placebo; Drug: Compound danshen dripping pills

Study type: Interventional

Funder types: Industry

Identifiers

NCT02388984

TCM9001-04

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with non-proliferative diabetic retinopathy(NPDR) and TCM syndrome differentiation of qi-stagnation and blood stasis.
2. aged 30-70 years
3. 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

1. HbAlc>8%, sustained hyperglycemia.
2. The patients who have been received the therapy of Retina laser photocoagulation or diagnosed with proliferative diabetic retinopathy (one or two eyes).
3. Diabetic retinopathy caused by type 1 diabetes mellitus.
4. Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
5. 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.
6. Diabetic nephropathy with renal failure (Azotemia or Uremia).
7. For women of child-bearing potential: pregnant or lactating or intending to become pregnant. Having any allergic reaction to some drugs.
8. Participated in other clinical trial within 3 months.
9. Used drugs for the treatment of diabetic retinopathy within 1 week.
10. Blood pressure > 160/100 (systolic above 160 or diastolic above 100).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 2 patient groups, including a placebo group

Compound danshen dripping pills

Experimental group

Description:

Compound danshen dripping pills,20pills,tid. Duration: 24 weeks.

Treatment:

Drug: Compound danshen dripping pills

Placebo

Placebo Comparator group

Description:

Placebo,20pills,tid. Duration: 24 weeks.

Treatment:

Drug: Placebo