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A Multicenter, Randomized and Double-blind Controlled Study of Zhenyuan Capsule for Coronary Heart Disease Combined with Abnormal Glucose and Lipid Metabolism:Effectiveness and Safety

A Multicenter, Randomized and Double-blind Controlled Study of Zhenyuan Capsule for Coronary Heart Disease Combined with Abnormal Glucose and Lipid Metabolism:Effectiveness and Safety

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004639
Enrollment
Unknown
Registered
2014-05-04
Start date
2014-07-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease Combined with Abnormal Glucose and Lipid Metabolism

Interventions

Treatment Group:Zhenyuan Capsule+ conventional western medicine tr
Control Group:Zhenyuan Capsule+ conventional western medicine tr

Sponsors

China Academy of Chinese Medical Sciences Xiyuan Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Coronary angiography or coronary angiography shows that at least one of the main branchs of coronary artery stenosis is no less than 50%;2)Triglyceride levels between 1.70-2.2525mmol/L and glycated hemoglobin level is between 5.7% - 7%;3)TCM syndrome differentiation is Qi and Yin deficiency;4)Age between 45-75 years old at screening;5)Provide informed consent form.

Exclusion criteria

Exclusion criteria: 1) Serious cardiovascular diseases: Severe valvular heart disease, Heart valve replacement, refractory heart failure, Cardiac function grade ?(NYHA),cardiogenic shock or Serious cardiac insufficiency(EF 2.5 mg/dl (> 220 umo/l) women > 2.0 mg/dl (> 175 umo/l); 4) hypohepatia, liver enzyme> 2 times of the normal value; 5) Any high risk of hemorrhage, hemophilia, platelet dysfunction or history of thrombocytopenia, who might influence the using of antiplatelet drugs; 6) Activity or emerging (< 3 months) bleeding including gastrointestinal bleeding, stool occult blood, or gross hematuria; 7) Pregnant or who were attempting to become pregnant; 9) Allergic constitution; 10) Join another trial or has received random allocation of this study within three month before entry; 11). Unable or unwilling to sign informed consent form, Non-compliant patient or poor possibility of follow-up visit.

Design outcomes

Primary

MeasureTime frame
glycosylated hemoglobin;fasting blood-glucose;2hour post-meal blood glucose;triglycerid;

Secondary

MeasureTime frame
Seattle Angina Questionnaire;Traditional Chinese medicine syndrome indicators;ultrasonic cardiogram;coagulation indicator;cardiac death; Non fatal myocardial infarcion; coronary revascularization;P-selectin;

Countries

China

Contacts

Public ContactJingchun Zhang
zhangjingchun276@vip.sohu.com+86 18601292386

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026