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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • Attack times of angina pectoris [ Time Frame: -2 weeks, 0 week, 6 weeks, 12 weeks ]
  • Pain degree of angina pectoris [ Time Frame: -2 weeks, 0 week, 12 weeks ]
  • Duration of angina pectoris attack [ Time Frame: -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.
  • 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%.
  • Score change of the Seattle Angina Questionnaire (SAQ) [ Time Frame: 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.
  • Improvement of other indexes of treadmill exercise test [ Time Frame: -2 weeks, 0 week, 12 weeks ]
    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 ]


Original Secondary Outcome: Same as current

Information By: Shanghai Greenvalley Pharmaceutical Co., Ltd.

Dates:
Date Received: October 13, 2011
Date Started: December 2011
Date Completion: September 2012
Last Updated: May 27, 2012
Last Verified: May 2012