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

Non-proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02388984
• Other study ID #: TCM9001-04
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 2, 2015
• Last updated: March 20, 2017
• Start date: May 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Tasly Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Non-proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Compound danshen dripping pills
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
• Placebo
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.

Locations

Country	Name	City	State
China	Dongfang Hospital, Beijing University of Chinese Medicine	Bei Jing	Beijing
China	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Bei Jing	Beijing
China	The Affiliated Hospital of Changchun University of Chinese Medicine	Chang Chun	Jilin
China	The First Hospital of Hunan University of Chinese Medicine	Chang Sha	Hunan
China	Teaching Hospital of Chengdu University of TCM	Cheng Du	Sichuan
China	Southwest Hospital, Third Military Medical University	Chong Qing	Chongqing
China	The First Affiliated Hospital of Guangzhou University of TCM	Guang Zhou	Guangdong
China	Jiangxi Provincial People's Hospital	Nan Chang	Jiangxi
China	Jiangsu Province Hospital of TCM	Nan Jing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nan Ning	Guangxi
China	Shanghai General Hospital	Shang Hai	Shanghai
China	Shenyang He Eye Hospital	Shen Yang	Liaoning
China	Hubei Provincial Hospital of TCM	Wu Han	Hubei
China	Union Hospital, Tongji Medical College,Huazhong University of Science and Technology	Wu Han	Hubei
China	Yantai Yuhuangding Hospital	Yan Tai	Shandong
China	Henan Institute of Ophthalmology	Zheng Zhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceuticals, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo		24 weeks.
Secondary	Corrected visual acuity change from baseline at the end of week 24 compared to placebo		24 weeks.
Secondary	The severity of macular edema change from baseline at the end of week 24 compared to placebo		24weeks