Clinical Trial: Acupoint Application in Patients With Stable Angina Pectoris (AASAP)

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

Official Title: Effect of Acupoint Application With Herbal Medicine in Patients With Stable Angina Pectoris: Randomized, Controlled,Double Blind Clinical Study

Brief Summary: Hypothesis: acupoint application is effective for managing chronic stable angina pectoris. Aim: to evaluate the efficacy and safety of acupoint application on the specific acupoints for chronic stable angina pectoris. Design: A Randomized, Controlled,Double Blind trial. 200 participants will be included. Four arms: herbal medicine application on acupoint group , placebo application on acupoint group , herbal medicine application on non-acupoint group and placebo application on non-acupoint group.

Detailed Summary: Acupoint application with herbal medicine is a kind of external treatment of traditional Chinese medicine and has a long history in China, which is use herbal medicine made of plaster and stick to specific acupoints, using the double effects of acupoints and herb to treat disease. In China, acupoint application with herbal medicine has been used in clinical treatment of angina pectoris, but there is no convincing evidence for the efficacy of acupoint application for angina pectoris, due to low methodologic quality and small sample size. The investigators designed the Randomized, Controlled, Double Blind clinical trial to investigates the efficacy of acupoint application in treating angina pectoris, the purpose of this study is to provide the convincing evidence for acupoint application treatment of angina pectoris.
Sponsor: Chengdu University of Traditional Chinese Medicine

Current Primary Outcome: Change from Baseline Number of angina attacks at 12 weeks [ Time Frame: at baseline,4, 8weeks after inclusion ]

The change frequency of angina attack during every 4-week.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from Baseline the severity of angina ( VAS score) at 12 weeks [ Time Frame: at baseline,4, 8weeks after inclusion ]
    The VAS score evaluation angina pain severity
  • Change from Baseline the dosage of nitroglycerin at 12 weeks [ Time Frame: at baseline,4, 8weeks after inclusion ]
    Observed reduction in the dose of nitroglycerin
  • Seattle Angina Questionnaire [ Time Frame: at baseline,4, 8weeks after inclusion ]
  • self-rating anxiety scale [ Time Frame: at baseline,4, 8weeks after inclusion ]
  • Self-rating Depression Scale [ Time Frame: at baseline,4, 8weeks after inclusion ]


Original Secondary Outcome: Same as current

Information By: Chengdu University of Traditional Chinese Medicine

Dates:
Date Received: November 24, 2013
Date Started: October 2012
Date Completion: August 2015
Last Updated: September 7, 2014
Last Verified: September 2014