Efficacy and Safety of Xuesaitong Soft Capsule for Coronary Heart Disease Unstable Angina

NCT03083119 | Unknown Phase 2

• 1 other identifier: 81473561
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, typical cases of coronary heart disease are selected. They will be intervened by Xuesaitong soft capsules to investigate efficacy and safety for Coronary Heart disease.

Conditions

Coronary Heart Disease; Unstable Angina

Outcome Measures

Primary Outcomes (3)

• major adverse cardiovascular events

  death, myocardial infarction, hospitalization for unstable angina or stroke

  60 days

• Seattle Angina Questionnaire

  to evaluate patients by Seattle Angina Questionnaire

  60 days

• blood stasis syndrome scale of Coronary heart disease angina pectoris

  to evaluate patients by blood stasis syndrome scale of Coronary heart disease angina pectoris

  60

Secondary Outcomes (1)

• lipid

  60

Study Arms (2)

Xuesaitong soft capsule group

EXPERIMENTAL

Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and Xuesaitong soft capsule.

Drug: Xuesaitong soft capsule

Placebo Comparator

PLACEBO COMPARATOR

Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and placebo.

Drug: Placebo oral capsule

Interventions

Xuesaitong soft capsule DRUG

Panax Notoginseng Saponins, Specification:0.33 per bag, once take two pills and twice a day during a month.

Xuesaitong soft capsule group

Placebo oral capsule DRUG

Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.

Placebo Comparator

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of coronary angiography unstable angina
• Clinical diagnosis of unstable angina
• Age of 30 to 75 years old
• Not use thrombolysis, dilate coronary drugs within two weeks
• Sign the consent

You may not qualify if:

• Severe valvular heart disease
• Insulin-dependent diabetes
• mental disease
• Combined with severe liver, kidney, hematopoietic system disorder
• Patients with malignant tumors
• Pregnancy or breast-feeding women
• Recent history of trauma
• Drug allergy

Sponsors & Collaborators

• Jie Wang: lead

Study Sites (1)

Guang Anmen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (1)

• Duan L, Liu Y, Li J, Zhang Y, Dong Y, Liu C, Wang J. Panax notoginseng Saponins Alleviate Coronary Artery Disease Through Hypermethylation of the miR-194-MAPK Pathway. Front Pharmacol. 2022 Jun 16;13:829416. doi: 10.3389/fphar.2022.829416. eCollection 2022.

  PMID: 35784716 DERIVED

MeSH Terms

Conditions

Coronary Disease; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jie Wang

  Guang Anmen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lian Duan

CONTACT

+8601088001817; popale2003@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 17, 2017
• Study Start: March 20, 2017
• Primary Completion: April 20, 2017
• Study Completion: August 20, 2017
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

CN (1)