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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic Chinese herbal granule formula | Experimental | 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. |
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| Placebo | Placebo Comparator | The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Chinese herbal granule formula | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Scale of the "Qixu-Xueyu Zheng"(Qi Deficiency and Blood Stasis Syndrome) according to the theory of Traditional Chinese Medicine at Day 28 | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Bathel Index | Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset | |
| modified Rankin Scale | Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset | |
| NIH stroke scale(NIHSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhong Wang, Dr. | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Study Chair |
| Jun Liu, Dr. | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Principal Investigator |
| Guang-qi Zhu | The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine | Guiyang | Guizhou | China |
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| Placebo | Drug | 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 |
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| Standard medical care | Procedure | 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. |
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| Day 0; Day7; Day 14; Day 21; Day 28; Day 90 after onset |
| EQ-5D scale | Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset |
| Overall mortality at day 90 | Day 90 after onset |
| Incidence of Recurrent Stroke | Day 90 after onset this time |
| Incidence of new-onset vascular events | Day 90 after onset this time |
| Incidence of adverse events (AEs) and serious AEs | From Day 0 to Day 90 after onset |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D003289 | Convalescence |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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