Trial record 7 of 389 for:    Open Studies | "Angina Pectoris"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Shanghai Greenvalley Pharmaceutical Co., Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Shanghai Greenvalley Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01453582
First received: October 13, 2011
Last updated: May 27, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Stable Angina Pectoris
Drug: Total Flavonoids of Propolis dropping pill
Drug: total Flavonoids of Propolis dropping pill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Shanghai Greenvalley Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Improvement of total exercise time of treadmill exercise test [ Time Frame: -2 week, 0 weeks, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The marked effective rate of angina pectoris [ Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    • 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.

  • Attack times of angina pectoris [ Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Pain degree of angina pectoris [ Time Frame: -2 weeks, 0 week, 12 weeks ] [ Designated as safety issue: No ]
  • Duration of angina pectoris attack [ Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Dose change of nitroglycerin [ Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks ] [ Designated as safety issue: Yes ]
    • Withdraw: completely withdrawal after the treatment;
    • Decrease: decrement ≥50% after the treatment;
    • No change: decrement <50% after the treatment.

  • The main symptoms of Chinese Traditional Medicine [ Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

    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%.

  • Score change of the Seattle Angina Questionnaire (SAQ) [ Time Frame: 0 week, 12 weeks ] [ Designated as safety issue: No ]
  • Improvement of ECG [ Time Frame: -2 weeks, 0 week, 12 weeks ] [ Designated as safety issue: Yes ]
    • 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.

  • Improvement of other indexes of treadmill exercise test [ Time Frame: -2 weeks, 0 week, 12 weeks ] [ Designated as safety issue: No ]
    metabolic equivalent, blood pressure, oxygen consumption, speed, grade.

  • Time to ST-segment deviation>1mm and positive symptoms appear [ Time Frame: -2 weeks, 0 week, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: December 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453582

Contacts
Contact: Haiyin Piao, MD 8610-88211886 ext 0 piaohaiyin@163.com

Locations
China, Guangdong
Guangdong Second Provincial Traditional Chinese Medicine Hospital Recruiting
Guangzhou, Guangdong, China, 510095
Contact: Lili Jin    8620-83575734    jinlili99@163.com   
Principal Investigator: Lili Jin         
China, Guangxi
Ruikang Hospital of Guangxi Traditional Chinese Medical University Recruiting
Nanning, Guangxi, China, 530011
Contact: Jinsong He    86771-2188509    jinhesong@126.com   
Principal Investigator: Jinsong He         
China, Hubei
Hubei Hospital of Traditional Chinese Medicine Recruiting
Wuhan, Hubei, China, 430060
Contact: Youzhi Hu    8627-88929224    hyz2003@medmail.com.cn   
Principal Investigator: Youzhi Hu         
China, Jilin
The Affiliated Hospital to Changchun University of Chinese Medicine Recruiting
Changchun, Jilin, China, 130021
Contact: Yue Deng    86431-86178018    dyue7138@sina.com   
Principal Investigator: Yue Deng, M.D.         
China, Liaoning
Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Recruiting
Shenyang, Liaoning, China, 110086
Contact: Bo Dong    8624-86802758    fine_dongbo@126.com   
Principal Investigator: Bo Dong         
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Not yet recruiting
Shenyang, Liaoning, China, 110101
Contact: Ping Hou    8624-86291151    houping57@yahoo.com.cn   
Principal Investigator: Ping Hou         
China, Neimenggu
Neimenggu Hospital of Traditional Chinese and Mongolian Medicine Recruiting
Huhehaote, Neimenggu, China, 010020
Contact: Li Li    86471-6920727    lili333271@soho.com   
Principal Investigator: Li Li         
China, Shanghai
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 201203
Contact: Xiaolong Wang    8621-20256343    wxlqy0214@163.com   
Principal Investigator: Xiaolong Wang         
Shanghai Hospital of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 200071
Contact: Yaorong Dong    8621-56639838    dyr1960018@sina.com   
Principal Investigator: Yaorong Dong         
China, Shanxi
Shanxi Hospital of Traditional Chinese Medicine Recruiting
Taiyuan, Shanxi, China, 030012
Contact: Tianfu Niu    86351-4668191    niutianfu2584@sina.com   
Principal Investigator: Tianfu Niu         
China, Tianjin
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Recruiting
Tianjin, Tianjin, China, 300150
Contact: Lanjun Sun, BD    8622-60335360    tjslj2008@126.com   
Principal Investigator: Lanjun Sun         
Sub-Investigator: Yingqiang Zhao         
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Recruiting
Tianjin, Tianjin, China, 300193
Contact: Xiyan Yang    8622-27432085    yangxiyan888@yahoo.com.cn   
Principal Investigator: Xiyan Yang         
China, Xinjiang
Xinjiang Hospital of Traditional Chinese Medicine Recruiting
Wulumuqi, Xinjiang, China, 830000
Contact: Xiaofeng Wang    86991-5812635    wxf8711@sina.com   
Principal Investigator: Xiaofeng Wang         
Sponsors and Collaborators
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Lanjun Sun Sencond Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
  More Information

No publications provided

Responsible Party: Shanghai Greenvalley Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01453582     History of Changes
Other Study ID Numbers: FJ2011-1.1
Study First Received: October 13, 2011
Last Updated: May 27, 2012
Health Authority: China: Food and Drug Administration

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
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Contraceptives, Oral
Propolis
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 14, 2014