Clinical Trial: Acupuncture in Patients With Stable Angina Pectoris

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Acupuncture in Patients With Stable Angina Pectoris: an Open Label, Randomized, Controlled,Multi-center Clinical Study

Brief Summary: This trail aims to evaluate the efficacy of acupoints on the specific meridian for chronic stable angina pectoris, compared with acupoints on the other meridian, sham acupoints and waiting-list. And to confirm the specificity of acupoints on meridian.

Detailed Summary: The basis of acupuncture is the theory of meridians and acupoints. Meridian and collaterals internally pertain to viscera, and externally spread over the extremities. An acupoint is the place where the visceral qi and meridian qi distributed in. besides acupoints are the stimulus points and reactive points for acupuncture to treat the diseases. Selecting the acupoints on the specific meridian is the basic principle of acupuncture. Recently, as to the existence of specificity of acupoints on the meridian has been questioned by many researchers. This trial using chronic stable angina pectoris as a carrier, select the acupoints on the hand shao yin heart meridian and hand jue yin pericardium meridian to treat chronic stable angina pectoris. Compared with acupoints on the other meridian and non-acupoints ,aiming to evaluate the efficacy, furthermore ,to confirm the existence of the specificity of acupoints on meridian.
Sponsor: Chengdu University of Traditional Chinese Medicine

Current Primary Outcome: Number of angina attacks [ Time Frame: 16 weeks after inclusion ]

The frequency of angina attack during 4-week.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The severity of angina ( VAS score) [ Time Frame: 0 day,4, 8, 12, 16 weeks after inclusion ]
    The VAS score evaluation angina pain severity
  • The dosage of nitroglycerin [ Time Frame: 0 day,4, 8, 12, 16 weeks after inclusion ]
  • Six minute walk test [ Time Frame: 0 day and 4 weeks after inclusion ]
    Six minute walk test in the evaluation of exercise tolerance
  • Dynamic ECG Observation of the changes of ST-T [ Time Frame: 0 day and 4 weeks after inclusion ]
    Dynamic electrocardiogram in six minute walk test to do
  • The Seattle Angina Questionnaire ( SAQ ) score [ Time Frame: 0 day,4, 8, 12, 16 weeks after inclusion ]
  • self-rating anxiety scale [ Time Frame: 0 day,4, 8, 16 weeks after inclusion ]
  • The incidence of cardiovascular episode during the 4 months [ Time Frame: 4, 8, 12, 16 weeks after inclusion ]
    The incidence of cardiovascular episode during the 4 months(develop into unstable angina, acute myocardial infarction, death)
  • Self-rating Depression Scale [ Time Frame: 0 day,4, 8, 16 weeks after inclusion ]


Original Secondary Outcome: Same as current

Information By: Chengdu University of Traditional Chinese Medicine

Dates:
Date Received: August 23, 2012
Date Started: July 2012
Date Completion: July 2017
Last Updated: September 7, 2014
Last Verified: September 2014