An interventional study of Dynamic Chinese herbal granule formula and Placebo in Ischemic Stroke and Convalescence, sponsored by China Academy of Chinese Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-12-18.
Sponsored by China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 120 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →China Academy of Chinese Medical Sciences is the lead sponsor of 61 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Based on standard medical care, after evaluated the style of the syndrome (Zhenghou) by an experienced integrative medicine doctor, the patients should be given a combination therapy of a Chinese herbal granule formula twice a day for 4 weeks, which should be selected from 10 kinds of Chinese herbal granules, including 3 gram of Huangqi(Astragalus root), 2 gram of Renshen(ginseng), 2.5 gram of Danggui(Angelica sinensis), 2 gram of Danshen(Salvia miltiorrhiza), 2 gram of Dilong(Geosaurus), 3 gram of Chishao(Radix Paeoniae Rubra), 2 gram of Honghua(Safflower), 2 gram of Chuanxiong(Rhizoma Chuanxiong), 2 gram of Sanqi(Radix Notoginseng), 3 gram of Shudihuang(Radix Rehmanniae Preparata). The Chinese herbal granule formula could be weekly changed according to differentiation of Zhenghou.
Drug: Dynamic Chinese herbal granule formula · Procedure: Standard medical care
The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules.
Drug: Placebo · Procedure: Standard medical care
After evaluated the style of the syndrome (Zhenghou) by an experienced integrative medicine doctor, the patients should be given a Chinese herbal granule formula twice a day for 4 weeks, which should be selected from 10 kinds of Chinese herbal granules and weekly changed according to differentiation of syndromes (Zhenghou) of patients.
The 10 kinds of matched placebo granules were of the similar appearance, taste, smell with the corresponding Chinese herbal granules respectively. The interventional process of the placebo group is similar as the Chinese herbal granule formula group
Standard medical care is the basic treatment for all enrolled patients, including aspirin 75-100mg per day, standard rehabilitation training, treatment for their primary diseases, etc.
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
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
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
China Academy of Chinese Medical Sciences