Clinical Trial: Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example

Brief Summary:

The purpose of the trial is to take stable angina pectoris of coronary heart disease (CHD) as examples to build a standard evaluation system for efficacy of traditional Chinese medicine (TCM).

  1. Studies of evaluating reliability, validity and reactivates of Patients Report Outcomes of CHD and self-administrated scale of Stable Angina Pectoris
  2. research on all indicators of CHD, and analyze their characteristics, target and function
  3. theory of Invigorating Spleen to Remove Phlegm or replenish Qi, and activating blood and dissolving stasis as an example for clinical efficacy evaluation.

Detailed Summary:

Clinical efficacy is the basis of traditional Chinese medicine development, and scientific evaluation of TCM clinical efficacy and its effectiveness is the way to push TCM modernized and international. TCM theories of Overall concept and Differentiation for life science and diseases are hard to be generally accepted. Besides, no unified and standard methods fit to evaluate the TCM clinical efficacy. Thus, there is a need to do a deeper research of methodology, evaluative index, and evaluative criteria in order to guide the evaluation of TCM clinical efficacy.

Based on the situation above, the study aims to choose the best and characteristic evaluative index of clinical efficacy, compare the demand among practitioners, patients and care givers. After data collected, a new cluster of index among Biochemical, patients report outcomes, endpoint indicators, and TCM soft indicators could be constituted and analyzed to use in respective way according to their characteristics, target and function.


Sponsor: Liaoning University of Traditional Chinese Medicine

Current Primary Outcome:

  • TCM characteristics evaluative index: Traditional Chinese medicine SYndrome Scale (TCMsys) (new developed） [ Time Frame: Taken at day 1 (baseline) and Change from Baseline in 2nd,4th,8th week ]
  • New developed Quality of life evaluative index: patients report outcomes for SAP [ Time Frame: Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week ]
  • New developed Quality of life evaluative index: self-administrated scale of SAP [ Time Frame: Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Symptoms evaluative index: Measure Your Medical Outcome Profile (MYMOP), Angina incentives, symptom score scale, rate of nitroglycerin, angina classification, heart function classification [ Time Frame: Taken at day 1 (baseline) and Change from Baseline in 2nd,4th,8th week; and all except MYMOP taken one more at expected day 7 in screen ]
  • Biochemical index: ECG, ECG exercise test, blood lipids, blood glucose (fasting glucose), Blood, urine, liver function, renal function, coagulation, echocardiography (including heart function), coronary CT (some hospitals choose to do) [ Time Frame: Taken at expected day 7 in the screening period (baseline) and Change from Baseline in 8th week ]
  • Quality of life evaluative index: Seattle angina questionnaire (SAQ) [ Time Frame: Taken at day 1 (baseline) , Change from Baseline in 2nd, 4th, 8th, 12th week ]
  • Quality of life evaluative index: short form-12 (SF-12) [ Time Frame: Taken at day 1 (baseline), Change from Baseline in 2nd, 4th, 8th, 12th week ]
  • TCM characteristics evaluative index: Traditional Chinese medicine Syndrome Scale 2 (criteria) [ Time Frame: Taken at expected day 7 in the Screening period,and Change from Baseline in 2nd,4th,8th week ]
  • Endpoint index （Cardiovascular events, non-cardiovascular events, death, hospitalization due to coronary heart disease cases） [ Time Frame: Taken at 2nd, 4th, 8th, 12th, 26th week ]


Original Secondary Outcome: Same as current

Information By: Liaoning University of Traditional Chinese Medicine

Dates:
Date Received: December 15, 2011
Date Started: May 2011
Date Completion:
Last Updated: December 30, 2011
Last Verified: December 2011