Clinical Trial: Dynamic Combination Therapy on Chinese Herbal Granules to Improve the Symptoms in Convalescent Phase of Ischemic Stroke

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

Official Title: Dynamic Combination Therapy on Chinese Herbal Granules Based on Differentiation of Syndrome (Zhenghou)of Traditional Chinese Medicine to Improve the Symptoms in the Convalescent Phase of Ischemic Stro

Brief Summary: To evaluate the effect of the dynamic combination therapy on Chinese herbal granule formula (Fangji) based on differentiation of syndromes ("Zhenghou") according to the theory of traditional Chinese medicine for improving the symptoms in the convalescent phase of ischemic stroke, and to establish the pharmacodynamic model of "Zhenghou" according to the results of this trial.

Detailed Summary:
Sponsor: China Academy of Chinese Medical Sciences

Current Primary Outcome: Symptom Scale of the "Qixu-Xueyu Zheng"(Qi Deficiency and Blood Stasis Syndrome) according to the theory of Traditional Chinese Medicine at Day 28 [ Time Frame: Day 28 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bathel Index [ Time Frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset ]
  • modified Rankin Scale [ Time Frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset ]
  • NIH stroke scale(NIHSS) [ Time Frame: Day 0; Day7; Day 14; Day 21; Day 28; Day 90 after onset ]
  • EQ-5D scale [ Time Frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset ]
  • Overall mortality at day 90 [ Time Frame: Day 90 after onset ]
  • Incidence of Recurrent Stroke [ Time Frame: Day 90 after onset this time ]
  • Incidence of new-onset vascular events [ Time Frame: Day 90 after onset this time ]
  • Incidence of adverse events (AEs) and serious AEs [ Time Frame: From Day 0 to Day 90 after onset ]


Original Secondary Outcome: Same as current

Information By: China Academy of Chinese Medical Sciences

Dates:
Date Received: January 27, 2013
Date Started: January 2013
Date Completion:
Last Updated: December 16, 2014
Last Verified: December 2014