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Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina

NCT02280850 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-11-03

No results posted yet for this study

Summary

Compared with placebo, assess of the efficacy and safety of Guanxin Shutong capsule to treat chronic stable angina (syndrome of blood stasis resistance), and the result will be used for the basis of later Ⅳ clinical trial.

Conditions

  • Angina, Stable

Interventions

DRUG

Guanxin Shutong Capsule

3 capsules three times a day; Duration: 4 weeks. Number of Cycles: until progression or unacceptable toxicity develops.

DRUG

Placebo Capsule

3 capsules three times a day; Duration: 4 weeks.

DRUG

nitroglycerine

Adults: 0.25mg-0.5mg (half pill or 1 pill) once, sub-lingual. One more pill per 5 minutes untill pain relief. If total dose is 3 pills in 15 minutes and the pain is still in, please seek medical advice urgently. The participators in both arms who have agina symptom will take Nitroglycerine. So the accumulated consumption of participators is the one of the maesuremnts.

Sponsors & Collaborators

  • Shaanxi Buchang Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Lv Shuzheng · Beijing Anzhen Hospital

  • Zhang Yan · The Affiliated Hospital of Liaoning Hospital of Traditional Chinese Medicine

  • Chen Bojun · The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

  • Luo Wei · Xuzhou Central Hospital

  • Jiang Binghua · Shandong University of Traditional Chinese Medicine

  • Zhang Zhenxian · Luohe Hospital of Traditional Chinese Medicine

  • Xing Yanjun · First Hospital of Shijiazhuang City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-06-30
Completion
2015-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280850 on ClinicalTrials.gov