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

China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Ischemic Stroke; Convalescence

Treatments: Drug: Placebo; Procedure: Standard medical care; Drug: Dynamic Chinese herbal granule formula

Study type: Interventional

Funder types: Other

Identifiers

NCT01780480

ZYPF-201212

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Dynamic Chinese herbal granule formula

Experimental group

Description:

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.

Treatment:

Procedure: Standard medical care

Drug: Dynamic Chinese herbal granule formula

Placebo

Placebo Comparator group

Description:

The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules.

Treatment:

Procedure: Standard medical care

Drug: Placebo