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

December 16, 2014 updated by: Zhong Wang, China Academy of Chinese Medical Sciences

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guizhou
      • Guiyang, Guizhou, China
        • The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dynamic Chinese herbal granule formula
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.
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.
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.
Placebo Comparator: Placebo
The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules.
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Day 28
Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Bathel Index
Time Frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset
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
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
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
Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset
Overall mortality at day 90
Time Frame: Day 90 after onset
Day 90 after onset
Incidence of Recurrent Stroke
Time Frame: Day 90 after onset this time
Day 90 after onset this time
Incidence of new-onset vascular events
Time Frame: Day 90 after onset this time
Day 90 after onset this time
Incidence of adverse events (AEs) and serious AEs
Time Frame: From Day 0 to Day 90 after onset
From Day 0 to Day 90 after onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Zhong Wang, Dr., Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
  • Principal Investigator: Jun Liu, Dr., Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
  • Study Director: Guang-qi Zhu, The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 27, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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