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

NCT04163835 | Unknown Phase 4 DMC

• 1 other identifier: WX20150820
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 0 to Week 4

Secondary Outcomes (2)

• Change in Total Score From Baseline in Traditional Chinese Medicine Syndrome Score Scale.

  Week 0 to Week 4

• Responder rate(%) based on each symptom score.

  Week 0 to Week 4

Other Outcomes (7)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Week 0 to Week 4

• Impact of treatment on Liver Function

  Week 0 to Week 4

• Impact of treatment on Renal Function

  Week 0 to Week 4

Study Arms (4)

Low-dose Group

EXPERIMENTAL

The intervention is half-dose of Wenxin Granules (1/2 normal dose).

Drug: 1/2 Normal-dose Wenxin Granules

Medium-dose Group

EXPERIMENTAL

The intervention is medium-dose of Wenxin Granules (normal dose).

Drug: Normal-dose Wenxin Granules

High-dose Group

EXPERIMENTAL

The intervention is twice-dose of Wenxin Granules (twice normal dose).

Drug: Twice Normal-dose Wenxin Granules

Placebo Group

PLACEBO COMPARATOR

The intervention is a placebo.

Drug: Placebo

Interventions

Normal-dose Wenxin Granules DRUG

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.

Medium-dose Group

1/2 Normal-dose Wenxin Granules DRUG

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.

Low-dose Group

Twice Normal-dose Wenxin Granules DRUG

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.

High-dose Group

Placebo DRUG

The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks. Ingredients: Wenxin Granules placebo 10g.

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:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Atrial Premature Complexes; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hongli Wu

  China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongli Wu

CONTACT

8601064014411; holiwu@yeah.net

Haixia Li

CONTACT

860108001018; 2272236055@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study was a double-blind clinical trial, with the patients, the treating physicians, the statisticians, the monitors and any other personnel being unaware of group allocation. Efforts to maintain blinding included identical appearance, packaging and labeling of four groups of experimental drugs. Unblinding should be done by the statisticians when the data collection process was completed or the treating physicians when serious adverse events occurred. The maximum sample size required is determined to be 150 cases.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 15, 2019
• Study Start: September 1, 2015
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)