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

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ClinicalTrials.gov Identifier: NCT01453582
Recruitment Status : Completed
First Posted : October 18, 2011
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Greenvalley Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stable Angina Pectoris Drug: Total Flavonoids of Propolis dropping pill Drug: total Flavonoids of Propolis dropping pill Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : December 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Improvement of total exercise time of treadmill exercise test [ Time Frame: -2 week, 0 weeks, 12 weeks ]

Secondary Outcome Measures :
  1. 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. Attack times of angina pectoris [ Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks ]
  3. Pain degree of angina pectoris [ Time Frame: -2 weeks, 0 week, 12 weeks ]
  4. Duration of angina pectoris attack [ Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks ]
  5. 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.

  6. 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%.

  7. Score change of the Seattle Angina Questionnaire (SAQ) [ Time Frame: 0 week, 12 weeks ]
  8. 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.

  9. Improvement of other indexes of treadmill exercise test [ Time Frame: -2 weeks, 0 week, 12 weeks ]
    metabolic equivalent, blood pressure, oxygen consumption, speed, grade.

  10. Time to ST-segment deviation>1mm and positive symptoms appear [ Time Frame: -2 weeks, 0 week, 12 weeks ]


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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453582


Locations
China, Guangdong
Guangdong Second Provincial Traditional Chinese Medicine Hospital
Guangzhou, Guangdong, China, 510095
China, Guangxi
Ruikang Hospital of Guangxi Traditional Chinese Medical University
Nanning, Guangxi, China, 530011
China, Hubei
Hubei Hospital of Traditional Chinese Medicine
Wuhan, Hubei, China, 430060
China, Jilin
The Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, China, 130021
China, Liaoning
Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China, 110086
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China, 110101
China, Neimenggu
Neimenggu Hospital of Traditional Chinese and Mongolian Medicine
Huhehaote, Neimenggu, China, 010020
China, Shanghai
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200071
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 201203
China, Shanxi
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China, 030012
China, Tianjin
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin, China, 300150
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin, China, 300193
China, Xinjiang
Xinjiang Hospital of Traditional Chinese Medicine
Wulumuqi, Xinjiang, China, 830000
Sponsors and Collaborators
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Lanjun Sun Sencond Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Responsible Party: Shanghai Greenvalley Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01453582     History of Changes
Other Study ID Numbers: FJ2011-1.1
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: December 2017

Keywords provided by Shanghai Greenvalley Pharmaceutical Co., Ltd.:
Chest stuffiness of TCM
Qi deficiency and blood stasis of TCM

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Propolis
Anti-Infective Agents