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

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780480
• Other study ID #: ZYPF-201212
• Status: Completed
• Phase: N/A
• First received: January 27, 2013
• Last updated: December 16, 2014
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science FoundationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Convalescence
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Dynamic Chinese herbal granule formula
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.
• Placebo
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

Procedure:
• Standard medical care
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine	Guiyang	Guizhou

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Bathel Index		Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset	No
Secondary	modified Rankin Scale		Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset	No
Secondary	NIH stroke scale(NIHSS)		Day 0; Day7; Day 14; Day 21; Day 28; Day 90 after onset	No
Secondary	EQ-5D scale		Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset	No
Secondary	Overall mortality at day 90		Day 90 after onset	Yes
Secondary	Incidence of Recurrent Stroke		Day 90 after onset this time	Yes
Secondary	Incidence of new-onset vascular events		Day 90 after onset this time	Yes
Secondary	Incidence of adverse events (AEs) and serious AEs		From Day 0 to Day 90 after onset	Yes