Ischemia With Non-Obstructive Coronary ArteryPhase 4LESSNCT04897126

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

A Phase 4 study testing Shexiang Baoxin pill（MUSKARDIA） in people with Ischemia With Non-Obstructive Coronary Artery and Angina Pectoris, run by Shanghai Hutchison Pharmaceuticals Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Ischemia With Non-Obstructive Coronary Artery, Angina Pectoris, Coronary Heart Disease
What is being tested?: Shexiang Baoxin pill（MUSKARDIA）
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: 1 siteChina
Study dates: 11 May 2021to 25 Oct 2023
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 15Show fewer

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.)

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003

Other trials in China

About this study

Official title: Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Conditions: Ischemia With Non-Obstructive Coronary Artery, Angina Pectoris, Coronary Heart Disease, X Syndrome, Angina
Being tested: Shexiang Baoxin pill（MUSKARDIA）, Placebo
Keywords: Shexiang Baoxin Pill, MUSKARDIA, patients with chest pain due to non obstructive coronary artery disease
Medical subject headings: Angina Pectoris, Coronary Disease, Microvascular Angina

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Shexiang Baoxin pill（MUSKARDIA）Radiation
Also called routine treatment
On the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up.
PlaceboRadiation
Also called routine treatment
On the basis of routine treatment, Placebo were added to 4 capsules / day, 3 times per day until the end of follow-up.

Study groups in NCT04897126
Study group	Role	What they receive
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 Receives: 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. Receives: Radiation: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes of Seattle angina pectoris scale
Main evaluation indicators
Measured: 12 weeks ± 1 week

Secondary outcomes (5)

Average number of angina attacks per week
Secondary evaluation index
Measured: 12 weeks ± 1 week
Changes in total dosage of sublingual nitroglycerin buccal tablets
Secondary evaluation index
Measured: 12 weeks ± 1 week
Changes of angina pectoris classification in CCS
Secondary evaluation index
Measured: 12 weeks ± 1 week
Incidence of major cardiovascular events (MACE)
Secondary evaluation index
Measured: 12 weeks ± 1 week
the incremental cost-effectiveness ratio (ICER) was used as the evaluation index
Pharmacoeconomic evaluation
Measured: 12 weeks ± 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 202125 Oct 2023

First posted21 May 2021
Study start11 May 2021
Primary completion4 Jul 2023
Study completion25 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemia With Non-Obstructive Coronary ArteryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 1:1 stratified block random grouping according to the center
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04897126
Sponsor's protocol ID: LESS202010
Acronym: LESS
Status last verified: Apr 2024
First submitted: 19 May 2021
Last updated: 23 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40020628

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Active, not recruiting
Insulin Resistance and Coronary Microvascular Dysfunction in Patients With Myocardial Ischemia and Non-obstructive Coronary Artery Disease
Coronary Microvascular Dysfunction, Coronary Microvascular Disease
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
RecruitingPhase 1
Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)
Angina Patients With Non-obstructive Coronary Artery Disease, Coronary Microvascular Disease
Active, not recruiting
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
Refractory Angina, Microvascular Angina

All Ischemia With Non-Obstructive Coronary Artery trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Shexiang Baoxin Pill in Patients With Ischemia With Non-Obstructive Coronary Artery: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
ClinicalTrials.gov ID: NCT04897126
Acronym / sponsor ID: LESS / LESS202010
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
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Shanghai Hutchison Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
Collaborators: Shanghai Changzheng Hospital, Second Affiliated Hospital of Bengbu Medical College, The Second Affiliated Hospital of Jiaxing University, Zibo Municipal Hospital, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shanxi Cardiovascular Hospital, The First Hospital of Hebei Medical University, Tangshan Central Hospital, Tie Fa Coal Group Ceneral Hospital of Liaoning Health Industry Group, Ceneral Hospital Of Benxi Iron And Steel of Liaoning Health Industry Group, General Hospital of Fuxin Mining Industry Group of Liaoning Health Industry Group
Study start: 11 May 2021 (actual)
Primary completion: 4 Jul 2023 (actual)
Study completion: 25 Oct 2023 (actual)
First posted: 21 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: 1:1 stratified block random grouping according to the center

Arm	Type	Receives
Experimental group	Active comparator	Radiation: Shexiang Baoxin pill（MUSKARDIA）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
Placebo group	Placebo comparator	Radiation: PlaceboThe control group was given placebo（ 4 capsules / day, 3 times / day）on the basis of conventional treatment until the end of follow-up.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Shexiang Baoxin pill（MUSKARDIA）Also: routine treatmentOn the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up.	Radiation	Experimental group
PlaceboAlso: routine treatmentOn the basis of routine treatment, Placebo were added to 4 capsules / day, 3 times per day until the end of follow-up.	Radiation	Placebo group

Primary outcome

Changes of Seattle angina pectoris scale
Time frame: 12 weeks ± 1 week
Main evaluation indicators

5 secondary outcomes

Average number of angina attacks per week
Time frame: 12 weeks ± 1 week
Changes in total dosage of sublingual nitroglycerin buccal tablets
Time frame: 12 weeks ± 1 week
Changes of angina pectoris classification in CCS
Time frame: 12 weeks ± 1 week
Incidence of major cardiovascular events (MACE)
Time frame: 12 weeks ± 1 week
the incremental cost-effectiveness ratio (ICER) was used as the evaluation index
Time frame: 12 weeks ± 1 week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
Derived from this study: PubMed 40020628He 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.
Individual participant dataSharing planned: No

Related trials for Ischemia With Non-Obstructive Coronary Artery

Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Active, not recruiting
Insulin Resistance and Coronary Microvascular Dysfunction in Patients With Myocardial Ischemia and Non-obstructive Coronary Artery Disease
Coronary Microvascular Dysfunction, Coronary Microvascular Disease
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
RecruitingPhase 1
Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)
Angina Patients With Non-obstructive Coronary Artery Disease, Coronary Microvascular Disease
Active, not recruiting
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
Refractory Angina, Microvascular Angina

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chun Liang principal investigator

Shanghai Changzheng Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of Seattle angina pectoris scale (time frame: 12 weeks ± 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04897126, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.