Clinical trial NCT01780480: Dynamic Combination Therapy on Chinese Herbal Granules to Improve the Symptoms in Convalescent Phase of Ischemic Stroke
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 Stroke: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Convalescence
Keywords: Ischemic Stroke
Convalescence
Randomized Controlled Trial
Pilot Study
Traditional Chinese Medicine
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2013-01-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Age: 18 - 75 years.
* Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect, confirmed by CT or MRI scan.
* Clinical diagnosis of "Qixu-Xueyu Zheng" (Qi deficiency and Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales in ischemic stroke on both "Qixue" and "Xueyu" ≥ 7.
* 15 days to 60 days after onset of symptoms.
* Clinical diagnosis of cerebral anterior circulation obstruction.
* 4≤NIHSS\<20.
* Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion Criteria:

* Transient ischemic attack
* Evidence of intracranial hemorrhage (ICH) in 6 months
* Evidence of other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.)on the CT or MRI scan.
* Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent 6 months.
* Woman who is under menstrual period.
* Known history of allergy or suspected allergic to these chinese herbs.
* Complicated with atrial fibrillation.
* Fasting blood glucose ≥8 mmol / l under the treatment of diabetes or complicated with severe cardio-cerebrovascular diseases (eg. hyperlipemia, coronary heart disease with angina attack ≥ 4 times a day).
* Liver function impairment with the value of ALT or AST over 1.5-fold of normal value.
* Renal dysfunction with the value of serum creatinine over normal value.
* Prior disable patients or complicated with osteoarthropathy that influence the motor function of the limbs.
* With mental disorder that can not cooperate with doctor
* Suspected addicted into alcohol or drug abuse.
* With severe complications that would make the condition more complicated assessed by the investigator.
* Patient who is participating in other trials or has been participated in other trials in recent 3 months.

Primary outcomes:
measure: Symptom Scale of the "Qixu-Xueyu Zheng"(Qi Deficiency and Blood Stasis Syndrome) according to the theory of Traditional Chinese Medicine at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Bathel Index
timeFrame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset
measure: modified Rankin Scale
timeFrame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset
measure: NIH stroke scale(NIHSS)
timeFrame: Day 0; Day7; Day 14; Day 21; Day 28; Day 90 after onset
measure: EQ-5D scale
timeFrame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset
measure: Overall mortality at day 90
timeFrame: Day 90 after onset
measure: Incidence of Recurrent Stroke
timeFrame: Day 90 after onset this time
measure: Incidence of new-onset vascular events
timeFrame: Day 90 after onset this time
measure: Incidence of adverse events (AEs) and serious AEs
timeFrame: From Day 0 to Day 90 after onset
Other outcomes:
Locations:
city: Guiyang
country: China
facility: The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
state: Guizhou
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Zhong Wang, Dr.
role: STUDY_CHAIR
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Jun Liu, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
name: Guang-qi Zhu
role: STUDY_DIRECTOR
References: