Efficacy and Safety Study of Total Flavonoids of Propolis Dropping Pill to Treat Angina Pectoris

February 6, 2018 updated by: Shanghai Greenvalley Pharmaceutical Co., Ltd.

Phase III Study of Total Flavonoids of Propolis Dropping Pill in Angina Pectoris: A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Clinical Trial on Efficacy and Safety.

The purpose of this study is to confirm the efficacy and safety of total flavonoids of propolis dropping pill to treat angina pectoris, evaluated by total exercise time of treadmill exercise test.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
478

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510095
        • Guangdong Second Provincial Traditional Chinese Medicine Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530011
        • Ruikang Hospital of Guangxi Traditional Chinese Medical University
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Hubei Hospital of Traditional Chinese Medicine
    • Jilin
      • Changchun, Jilin, China, 130021
        • The Affiliated Hospital To Changchun University of Chinese Medicine
    • Liaoning
      • Shenyang, Liaoning, China, 110086
        • Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
      • Shenyang, Liaoning, China, 110101
        • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
    • Neimenggu
      • Huhehaote, Neimenggu, China, 010020
        • Neimenggu Hospital of Traditional Chinese and Mongolian Medicine
    • Shanghai
      • Shanghai, Shanghai, China, 200071
        • Shanghai Hospital of Traditional Chinese Medicine
      • Shanghai, Shanghai, China, 201203
        • Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
    • Shanxi
      • Taiyuan, Shanxi, China, 030012
        • Shanxi Hospital of Traditional Chinese Medicine
    • Tianjin
      • Tianjin, Tianjin, China, 300193
        • First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
      • Tianjin, Tianjin, China, 300150
        • Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
    • Xinjiang
      • Wulumuqi, Xinjiang, China, 830000
        • Xinjiang Hospital of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Class I, Class II and Class III stable angina pectoris, angina attack more than 3 times one week;
  • Qi deficiency and blood stasis syndrome of Traditional Chinese Medicine;
  • In resting electrocardiogram, ST-segment deviation≥0.05mv and/or T-wave inversion≥0.2mv in the leads R-wave is predominant during non-attack period, or ST-segment deviation≥0.1mv and/or T-wave inversion≥0.2mv in the leads R-wave is predominant during angina attack;
  • Total exercise time of treadmill exercise test≥3 minutes.The discontinuance standard should be reached. And the difference of total exercise time between before and after run in period should ≤15%;
  • Other confirmed diagnostic evidence of coronary heart disease, such as definite history of old myocardial infarction, or incomplete revascularization one year after coronary intervention therapy(residual luminal stenosis≥50%), or coronary angiography evidence(at least single vessel disease and luminal stenosis≥50%), or nuclein examination evidence, or computer tomography angiography evidence;
  • Signed the informed consent form.

Exclusion Criteria:

  • Chest pain caused by acute myocardial infarction(AMI), Class IV/serious angina pectoris, psychosis, serious neurosis, climacteric syndrome, hyperthyroidism, Cervical Spondylosis, gallbladder- heart syndrome, gastroesophageal reflux, hiatus hernia, aortic dissection, aortic valve disease;
  • Not well controlled hypertension(systolic pressure≥160mmHg，diastolic pressure≥100mmHg), serious cardiopulmonary insufficiency, serious arrhythmia(rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc);
  • Serious diseases of heart, lung, liver, kidney and blood;
  • Allergic constitution or allergic to the components of total Flavonoids of Propolis dropping pill;
  • Women during pregnancy or lactation;
  • Received any major operation within 4 weeks;
  • Have been in other clinical trials within 30 days;
  • Using but can not withdraw anti-angina medicine as long acting nitrates;
  • Not well controlled hyperglycemia;
  • Not fit for this trial judged by investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Propolis
Total Flavonoids of Propolis dropping pill
Drug: Total Flavonoids of Propolis dropping pill
One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.
Placebo Comparator: Placebo
Simulant of total Flavonoids of Propolis dropping pill
Drug: total Flavonoids of Propolis dropping pill
One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Improvement of total exercise time of treadmill exercise test
Time Frame: -2 week, 0 weeks, 12 weeks
-2 week, 0 weeks, 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The marked effective rate of angina pectoris
Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks
  • Class I: No symptom or almost no symptom, decrease of angina pectoris total score ≥ 1/3；
  • Class II: No symptom or almost no symptom, decrease of angina pectoris total score ≥ 2/3；
  • Class III: Almost no symptom, decrease of angina pectoris total score ≥ 2/3, or the score decrease to the degree of Slight or Class I.
-2 weeks, 0 week, 6 weeks, 12 weeks
Attack times of angina pectoris
Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks
-2 weeks, 0 week, 6 weeks, 12 weeks
Pain degree of angina pectoris
Time Frame: -2 weeks, 0 week, 12 weeks
-2 weeks, 0 week, 12 weeks
Duration of angina pectoris attack
Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks
-2 weeks, 0 week, 6 weeks, 12 weeks
Dose change of nitroglycerin
Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks
  • Withdraw: completely withdrawal after the treatment;
  • Decrease: decrement ≥50% after the treatment;
  • No change: decrement <50% after the treatment.
-2 weeks, 0 week, 6 weeks, 12 weeks
The main symptoms of Chinese Traditional Medicine
Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks

Effect index = (total score before treatment - total score after treatment)/total score before treatment×100%

  • Cured: effect index ≥90%;
  • Marked effective: 90%> effect index ≥70%;
  • Effective: 70%> effect index ≥30%;
  • Ineffective: effect index <30%.
-2 weeks, 0 week, 6 weeks, 12 weeks
Score change of the Seattle Angina Questionnaire (SAQ)
Time Frame: 0 week, 12 weeks
0 week, 12 weeks
Improvement of ECG
Time Frame: -2 weeks, 0 week, 12 weeks
  • Cured: normal or almost normal;
  • Marked effective: ST-segment deviation upturn≥0.05mV, but still abnormal, improvement of T-wave inversion of main leads ≥25%, or flate T-wave change to vertical, improved atrioventricular block or intraventricular block;
  • Effective: almost no charge;
  • Ineffective: anabatic ST-segment deviation, deeper T-wave, or flate T-wave change to inverted.
-2 weeks, 0 week, 12 weeks
Improvement of other indexes of treadmill exercise test
Time Frame: -2 weeks, 0 week, 12 weeks
metabolic equivalent, blood pressure, oxygen consumption, speed, grade.
-2 weeks, 0 week, 12 weeks
Time to ST-segment deviation>1mm and positive symptoms appear
Time Frame: -2 weeks, 0 week, 12 weeks
-2 weeks, 0 week, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Greenvalley Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lanjun Sun, Sencond Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FJ2011-1.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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