Atrial Premature ComplexesPhase 4NCT04163835

The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats

A Phase 4 study testing Normal-dose Wenxin Granules, 1/2 Normal-dose Wenxin Granules and Twice Normal-dose Wenxin Granules in people with Atrial Premature Complexes, run by China Academy of Chinese Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

A Randomized, double-blind, placebo-controlled, four dose groups, post-marketing clinical trial, to evaluate the efficacy and safety of Wenxin granules in treating atrial premature beats by different doses,to provide a scientific basis for rational clinical use of drug. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Atrial Premature Complexes
What is being tested?: Normal-dose Wenxin Granules, 1/2 Normal-dose Wenxin Granules and Twice Normal-dose Wenxin Granules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteChina
Study dates: 1 Sep 2015to 31 Dec 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

Accord with the diagnostic criteria of arrhythmia (atrial premature beats );
Accord with the diagnostic criteria of deficiency of both qi and yin and heart vessel stasis and obstruction Syndrome;
The number of premature beat of 24 h dynamic electrocardiogram >360 times/h or >8640 times/24h;
Stop using the anti- arrhythmic drugs for more than five half-life (except that who long-term (one month or more) with beta blockers for high blood pressure and exertional angina);
Ages 18 to 75 years old ,all genders;
Voluntary subjects and signed the informed consent form.

Who cannot join

Serious condition that need to merge other anti-arrhythmic drugs(I,II,III,IV) to treat;
Heart rhythm disorders caused by the factors such as drugs ,electrolyte and acid-base balance disorders;
Merge tardy arrhythmia (including sick sinus syndrome and II degree atrioventricular block);
Removed predisposing factors (such as fatigue, nervousness, mood swings, alcoholism, etc.) the premature beats reduced, while the symptoms significantly relieved;
Patients who have pacemaker implanted or have undergone heart percutaneous coronary intervention (PCI) surgery;
Patients with severe hypotension;

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Patients with serious cardiovascular diseases (such as congestive heart failure, cardiac shock, etc.), cerebrovascular disease, and serious primary 8.diseases such as liver, kidney and hematopoietic system (ALT,AST,BUN 2 times higher than normal ceiling, or Cr higher than the upper limit of normal);
Allergic constitution; the test drug allergy or its ingredients or elements allergy;
Pregnancy and lactation women ,recent preparation pregnancy;
Patients with chronic alcoholism , drug dependence, mental illness;
Participated in other clinical trials within 3 months.

Trial locations and contacts

1 site in 1 country.

Hongli Wu contact

Haixia Li contact

China1 site, 1 recruiting

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Haixia Li, 8601088001018, 2272236055@qq.com
Xingjiang Xiong, 8615801463736, 5administration@163.com
Recruiting

Other trials in China

About this study

Official title: The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats of Deficiency of Both Qi and Yin and Heart Vessel Stasis and Obstruction Syndrome : A Randomized, Double-blind, Placebo-controlled Clinical Trial Study

Read the detailed description

Research purpose: To evaluate the efficacy and safety of Wenxin granules in treating atrial premature beats by different doses, to provide a scientific basis for rational clinical use of drug.

Research design: A Randomized, double-blind, placebo-controlled, four dose groups, post-marketing clinical trial.

Sample size:

The ratio of high, medium and low dose groups and placebo group were 1:1:1:1. A total of 60 cases were included in the first phase.The maximum sample size required was determined to be 150 cases.

Therapeutic schedule:

Low-dose Group(1/2 Normal-dose Wenxin Granules ):Wenxin Granules (no sucrose) 2.5g + Wenxin Granules placebo 7.5g.
Medium-dose Group(Normal-dose Wenxin Granules ):Wenxin Granules (no sucrose) 5g + Wenxin Granules placebo 5g.
High-dose Group(Twice Normal-dose Wenxin Granules):Wenxin Granules (no sucrose) 10g.
Placebo Group(Placebo):Wenxin Granules placebo 10g.

Usage and Dosage:The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.

Drug combination:

During the test should not merge the other anti-arrhythmic drugs beyond the provisions of this scheme. Due to merger disease or condition changes ,have to use drugs or other treatment, investigators must record the types (or other treatment ),drug usage, time and reasons, in order to summarize ,analyze and report.

Primary Outcome Measures

Responder rate based on 24-hour Holter monitoring, defined as the proportion (%) of subjects with a ≥ 50% reduction in atrial premature beats during 24-hour Holter monitoring from baseline.

Time Frame: Week 0 to Week 4

Secondary Outcome Measures

Change in Total Score From Baseline in Traditional Chinese Medicine Syndrome Score Scale (TCMSSS). Time Frame: Week 0 to Week 4
Responder rate based on each symptom score, defined as the proportion (%) of subjects with a ≥ 1 score reduction in each symptom score from baseline.

Time Frame: Week 0 to Week 4

Other Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time Frame: Week 0 to Week 4
Impact of treatment on Liver Function Time Frame: Week 0 to Week 4
Impact of treatment on Renal Function Time Frame: Week 0 to Week 4
Impact of treatment on Hemoglobin Levels Time Frame: Week 0 to Week 4
Impact of treatment on White Blood Cells Time Frame: Week 0 to Week 4
Impact of treatment on Blood Platelet Time Frame: Week 0 to Week 4
Impact of treatment on Hematuria and Proteinuria Time Frame: Week 0 to Week 4

Conditions: Atrial Premature Complexes
Being tested: Normal-dose Wenxin Granules, 1/2 Normal-dose Wenxin Granules, Twice Normal-dose Wenxin Granules, Placebo
Keywords: Wenxin Granules, Dose-effect relationship, Deficiency of both Qi and Yin Syndrome, Heart Vessel Stasis and Obstruction Syndrome, Traditional Chinese Medicine, arrhythmia
Medical subject headings: Atrial Premature Complexes, Arrhythmias, Cardiac

What participants receive

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

Normal-dose Wenxin GranulesDrug
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules (no sucrose) 5g + Wenxin Granules placebo 5g.
1/2 Normal-dose Wenxin GranulesDrug
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules (no sucrose) 2.5g + Wenxin Granules placebo 7.5g.
Twice Normal-dose Wenxin GranulesDrug
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules (no sucrose) 10g.
PlaceboDrug
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Ingredients: Wenxin Granules placebo 10g.

Study groups in NCT04163835
Study group	Role	What they receive
Low-dose Group	Experimental	The intervention is half-dose of Wenxin Granules (1/2 normal dose). Receives: Drug: 1/2 Normal-dose Wenxin Granules
Medium-dose Group	Experimental	The intervention is medium-dose of Wenxin Granules (normal dose). Receives: Drug: Normal-dose Wenxin Granules
High-dose Group	Experimental	The intervention is twice-dose of Wenxin Granules (twice normal dose). Receives: Drug: Twice Normal-dose Wenxin Granules
Placebo Group	Placebo comparator	The intervention is a placebo. Receives: Drug: Placebo

What is being measured

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

Responder rate based on 24-hour Holter monitoring.
Defined as the proportion (%) of subjects with a ≥ 50% reduction in atrial premature beats during 24-hour Holter monitoring from baseline.
Measured: Week 0 to Week 4

Secondary outcomes (2)

Change in Total Score From Baseline in Traditional Chinese Medicine Syndrome Score Scale.
The rating scale consisted of 12 items (1 for the main symptoms and 11 for the accompanying symptoms) with 4 options (absent, mild, moderate or severe) for each item. Each option was represented by a fixed score(0,1,2,3), the higher the score, the more severe the symptom, and vice versa. The total score of the rating scale was called syndrome integral.
Symptoms include palpitation, chest distress, chest pain, shortness of breath, lack of strength, insomnia, dreamfulness, dizziness, dim complexion, vexing heat in chest, palms and soles, dry mouth, cyanotic lips and nails.
The changes of TCM syndrome scores before and after treatment were compared.
Measured: Week 0 to Week 4
Responder rate(%) based on each symptom score.
Defined as the proportion (%) of subjects with a ≥ 1 score reduction in each symptom score from baseline.
Measured: Week 0 to Week 4

Timeline

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

1 Sep 201531 Dec 2023

First posted15 Nov 2019
Study start1 Sep 2015
Primary completion31 Dec 2022 (estimated)
Study completion31 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atrial Premature ComplexesStudies 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: The ratio of high, medium and low dose group and placebo groups are 1:1:1:1. A total of 60 cases are included in the first phase.The maximum sample size required is determined to be 150 cases.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04163835
Sponsor's protocol ID: WX20150820
Status last verified: Nov 2022
First submitted: 29 Oct 2019
Last updated: 18 Nov 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Hongli Wu

8601064014411

holiwu@yeah.net

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

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All Atrial Premature Complexes trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats of Deficiency of Both Qi and Yin and Heart Vessel Stasis and Obstruction Syndrome : A Randomized, Double-blind, Placebo-controlled Clinical Trial Study
ClinicalTrials.gov ID: NCT04163835
Acronym / sponsor ID: WX20150820
Conditions: Atrial Premature Complexes
Keywords: Wenxin Granules, Dose-effect relationship, Deficiency of both Qi and Yin Syndrome, Heart Vessel Stasis and Obstruction Syndrome, Traditional Chinese Medicine, arrhythmia
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: China Academy of Chinese Medical SciencesUniversity, hospital or other
Study start: 1 Sep 2015 (actual)
Primary completion: 31 Dec 2022 (estimated)
Study completion: 31 Dec 2023 (estimated)
First posted: 15 Nov 2019 (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.

Detailed description

Research purpose: To evaluate the efficacy and safety of Wenxin granules in treating atrial premature beats by different doses, to provide a scientific basis for rational clinical use of drug.

Research design: A Randomized, double-blind, placebo-controlled, four dose groups, post-marketing clinical trial.

Sample size:

The ratio of high, medium and low dose groups and placebo group were 1:1:1:1. A total of 60 cases were included in the first phase.The maximum sample size required was determined to be 150 cases.

Therapeutic schedule:

Low-dose Group(1/2 Normal-dose Wenxin Granules ):Wenxin Granules (no sucrose) 2.5g + Wenxin Granules placebo 7.5g.
Medium-dose Group(Normal-dose Wenxin Granules ):Wenxin Granules (no sucrose) 5g + Wenxin Granules placebo 5g.
High-dose Group(Twice Normal-dose Wenxin Granules):Wenxin Granules (no sucrose) 10g.
Placebo Group(Placebo):Wenxin Granules placebo 10g.

Usage and Dosage:The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.

Drug combination:

Primary Outcome Measures

Responder rate based on 24-hour Holter monitoring, defined as the proportion (%) of subjects with a ≥ 50% reduction in atrial premature beats during 24-hour Holter monitoring from baseline.

Time Frame: Week 0 to Week 4

Secondary Outcome Measures

Change in Total Score From Baseline in Traditional Chinese Medicine Syndrome Score Scale (TCMSSS). Time Frame: Week 0 to Week 4
Responder rate based on each symptom score, defined as the proportion (%) of subjects with a ≥ 1 score reduction in each symptom score from baseline.

Time Frame: Week 0 to Week 4

Other Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time Frame: Week 0 to Week 4
Impact of treatment on Liver Function Time Frame: Week 0 to Week 4
Impact of treatment on Renal Function Time Frame: Week 0 to Week 4
Impact of treatment on Hemoglobin Levels Time Frame: Week 0 to Week 4
Impact of treatment on White Blood Cells Time Frame: Week 0 to Week 4
Impact of treatment on Blood Platelet Time Frame: Week 0 to Week 4
Impact of treatment on Hematuria and Proteinuria Time Frame: Week 0 to Week 4

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: The ratio of high, medium and low dose group and placebo groups are 1:1:1:1. A total of 60 cases are included in the first phase.The maximum sample size required is determined to be 150 cases.

Arm	Type	Receives
Low-dose Group	Experimental	Drug: 1/2 Normal-dose Wenxin GranulesThe intervention is half-dose of Wenxin Granules (1/2 normal dose).
Medium-dose Group	Experimental	Drug: Normal-dose Wenxin GranulesThe intervention is medium-dose of Wenxin Granules (normal dose).
High-dose Group	Experimental	Drug: Twice Normal-dose Wenxin GranulesThe intervention is twice-dose of Wenxin Granules (twice normal dose).
Placebo Group	Placebo comparator	Drug: PlaceboThe intervention is a placebo.

Who may qualify

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

Key inclusion criteria (6 listed)

Accord with the diagnostic criteria of arrhythmia (atrial premature beats );
Accord with the diagnostic criteria of deficiency of both qi and yin and heart vessel stasis and obstruction Syndrome;
The number of premature beat of 24 h dynamic electrocardiogram >360 times/h or >8640 times/24h;
Stop using the anti- arrhythmic drugs for more than five half-life (except that who long-term (one month or more) with beta blockers for high blood pressure and exertional angina);
Ages 18 to 75 years old ,all genders;

Key exclusion criteria (11 listed)

Serious condition that need to merge other anti-arrhythmic drugs(I,II,III,IV) to treat;
Heart rhythm disorders caused by the factors such as drugs ,electrolyte and acid-base balance disorders;
Merge tardy arrhythmia (including sick sinus syndrome and II degree atrioventricular block);
Removed predisposing factors (such as fatigue, nervousness, mood swings, alcoholism, etc.) the premature beats reduced, while the symptoms significantly relieved;
Patients who have pacemaker implanted or have undergone heart percutaneous coronary intervention (PCI) surgery;

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
Normal-dose Wenxin GranulesThe drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks. Ingredients: Wenxin Granules (no sucrose) 5g + Wenxin Granules placebo 5g.	Drug	Medium-dose Group
1/2 Normal-dose Wenxin GranulesThe drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks. Ingredients: Wenxin Granules (no sucrose) 2.5g + Wenxin Granules placebo 7.5g.	Drug	Low-dose Group
Twice Normal-dose Wenxin GranulesThe drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks. Ingredients: Wenxin Granules (no sucrose) 10g.	Drug	High-dose Group
PlaceboThe drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks. Ingredients: Wenxin Granules placebo 10g.	Drug	Placebo Group

Primary outcome

Responder rate based on 24-hour Holter monitoring.
Time frame: Week 0 to Week 4
Defined as the proportion (%) of subjects with a ≥ 50% reduction in atrial premature beats during 24-hour Holter monitoring from baseline.

2 secondary outcomes

Change in Total Score From Baseline in Traditional Chinese Medicine Syndrome Score Scale.
Time frame: Week 0 to Week 4
Responder rate(%) based on each symptom score.
Time frame: Week 0 to Week 4

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
Individual participant dataSharing planned: No

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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.

Hongli Wu contact

Haixia Li contact

Hongli Wu principal investigator

China Academy of Chinese Medical Sciences

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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Nov 2022. 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?

Results are not available in the source record.

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

Contact Hongli Wu (8601064014411, holiwu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder rate based on 24-hour Holter monitoring. (time frame: Week 0 to Week 4). 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 NCT04163835.

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 18 Nov 2022.