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Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure

NCT03027375 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-10-09

No results posted yet for this study

Summary

This trial will assess the efficacy and safety of QSG in CHF.

Conditions

Interventions

DRUG

Qishen Granules

The QSG are manufactured by Beijing tcmages Pharmaceutical Co., Ltd. (Beijing, China), a company that has obtained Chinese Good Manufacturing Practice for Pharmaceutical Products certification. All the ingredients have been approved by the Chinese Ministry of Food and Drug Safety. 13.6 grams (dry weight) of granules consist of six herbs: Astragalus membranaceus (Fisch.) Bge. var. Mongolicus (Bge.) Hsiao (6g), Salvia miltiorrhiza Bge. (1.5g), Lonicera japonica Thunb. (2g), Scrophularia ningpoensis Hemsl. (2g), Aconitum carmichaeli Debx. (0.9g), and Glycyrrhiza uralensis Fisch. (1.2g).

DRUG

Placebo

The placebo is manufactured by Beijing tcmages Pharmaceutical Co., Ltd. (Beijing, China) as well, following the Specification for processing Chinese medicine in Beijing. The placebo granules are similar in appearance, taste, and scent to the Qishen granules.

Sponsors & Collaborators

  • China-Japan Friendship Hospital

    collaborator OTHER

  • Zhengzhou Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Beijing Anzhen Hospital

    collaborator OTHER

  • Beijing University of Chinese Medicine

    lead OTHER

Principal Investigators

  • Wei Wang, Doctor · Beijing University of Chinese Medicine

  • Huihui Zhao, Doctor · Beijing University of Chinese Medicine

  • Jinping Wang, Master · Beijing University of Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT03027375 on ClinicalTrials.gov