Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery

NCT04897126 | Completed Phase 4

• 1 other identifier: LESS202010
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The control group was treated with placebo 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up, while the experimental group was treated with MUSK Pill 4 pills / day, 3 times / day on the basis of conventional treatment until the end of follow-up.

Conditions

Ischemia With Non-Obstructive Coronary Artery; Angina Pectoris; Coronary Heart Disease; X Syndrome, Angina

Keywords

Shexiang Baoxin Pill; MUSKARDIA; patients with chest pain due to non obstructive coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Changes of Seattle angina pectoris scale

  Main evaluation indicators

  12 weeks ± 1 week

Secondary Outcomes (5)

• Average number of angina attacks per week

  12 weeks ± 1 week

• Changes in total dosage of sublingual nitroglycerin buccal tablets

  12 weeks ± 1 week

• Changes of angina pectoris classification in CCS

  12 weeks ± 1 week

• Incidence of major cardiovascular events (MACE)

  12 weeks ± 1 week

• the incremental cost-effectiveness ratio (ICER) was used as the evaluation index

  12 weeks ± 1 week

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

The experimental group was treated with Shexiang Baoxin pill（MUSKARDIA） (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up

Radiation: Shexiang Baoxin pill（MUSKARDIA）

Placebo group

PLACEBO COMPARATOR

The control group was given placebo（ 4 capsules / day, 3 times / day）on the basis of conventional treatment until the end of follow-up.

Radiation: Placebo

Interventions

Shexiang Baoxin pill（MUSKARDIA） RADIATION

On the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up.

Also known as: routine treatment

Experimental group

Placebo RADIATION

On the basis of routine treatment, Placebo were added to 4 capsules / day, 3 times per day until the end of follow-up.

Also known as: routine treatment

Placebo group

Eligibility Criteria

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

You may qualify if:

• The age was 18-75 years old, and the gender was not limited;
• The clinical diagnosis of angina pectoris or angina pectoris equivalent symptoms (attack at least twice a week), Within 1 year, coronary CTA or coronary angiography examination of coronary artery normal or lesions \< 50%;
• Willing to follow up and sign informed consent.

You may not qualify if:

• Patients were selected and had no angina pectoris without medication
• History of vascular reconstruction within 6 months, CABG or PCI;
• Preparation for CABG or PCI during the trial period
• The maximum lesions of major branches of major vessels were ≥ 50% in CTA or angiographic examination;
• Severe cardiovascular and pulmonary vascular diseases: stubborn heart failure or cardiogenic shock, hypertrophic obstructive cardiomyopathy, severe aortic stenosis, incomplete closure, aortic dissection, pulmonary embolism;
• There were three months of acute myocardial infarction;
• Severe respiratory disease, COPD or active pulmonary infection;
• Although the patients with poor blood pressure control were treated with hypertension, the hypertension was not controlled and / or systolic pressure ≥ 180mmhg and diastolic pressure ≥ 110mmhg before the end of screening period;
• Severe liver and kidney diseases, such as liver and kidney dysfunction (alt, AST ≥ 1.5 times of the upper limit of normal value, Cr \> 1.5 times of normal value), active liver disease, cirrhosis or uremia patients;
• Any other serious diseases or conditions such as malignant tumor, severe anemia, severe renal artery stenosis, severe anxiety depression (HAMD-17) and suicide or maniac mental illness;
• Participated in other clinical studies within 30 days before the selection, or is currently participating in other clinical studies;
• Pregnant, lactating women and women and men with recent birth plans;
• Allergic constitution or allergy to known components of the study drug;
• The researchers judged that the patients who were not suitable for the study were not suitable.
• (Note: patients need to stop using other cardiovascular traditional Chinese patent medicines and simple preparations or traditional Chinese medicine for 7 days before enrollment.)

Sponsors & Collaborators

• Shanghai Hutchison Pharmaceuticals Limited: lead
• Shanghai Changzheng Hospital: collaborator
• The Second People's Hospital Of Bengbu: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator
• Zibo Municipal Hospital: collaborator
• Affiliated Hospital of Liaoning University of Traditional Chinese Medicine: collaborator
• Shanxi Cardiovascular Hospital: collaborator
• The First Hospital of Hebei Medical University: collaborator
• Tangshan Central Hospital: collaborator
• Tie Fa Coal Group Ceneral Hospital of Liaoning Health Industry Group: collaborator
• Ceneral Hospital Of Benxi Iron And Steel of Liaoning Health Industry Group: collaborator
• General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group: collaborator

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Related Publications (1)

• He Z, Li N, Zhang W, Meng X, Wang J, Gong L, Liu B, Zheng M, Shang Z, Xu J, Jiang P, Zhao Q, Xu B, Liang C. Efficacy and safety of Shexiang Baoxin Pill in patients with angina and non-obstructive coronary arteries: A multicenter, randomized, double-blind, placebo-controlled, phase Ⅳ clinical trial. Phytomedicine. 2025 Apr;139:156556. doi: 10.1016/j.phymed.2025.156556. Epub 2025 Feb 23.

  PMID: 40020628 DERIVED

MeSH Terms

Conditions

Angina Pectoris; Coronary Disease; Microvascular Angina

Condition Hierarchy (Ancestors)

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

Study Officials

• Chun Liang

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 stratified block random grouping according to the center

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 21, 2021
• Study Start: May 11, 2021
• Primary Completion: July 4, 2023
• Study Completion: October 25, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)