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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by China Academy of Chinese Medical Sciences
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01780480
First received: January 27, 2013
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Ischemic Stroke
Convalescence
Drug: Dynamic Chinese herbal granule formula
Drug: Placebo
Procedure: Standard medical care

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

Resource links provided by NLM:


Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bathel Index [ Time Frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset ] [ Designated as safety issue: No ]
  • modified Rankin Scale [ Time Frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset ] [ Designated as safety issue: No ]
  • NIH stroke scale(NIHSS) [ Time Frame: Day 0; Day7; Day 14; Day 21; Day 28; Day 90 after onset ] [ Designated as safety issue: No ]
  • EQ-5D scale [ Time Frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset ] [ Designated as safety issue: No ]
  • Overall mortality at day 90 [ Time Frame: Day 90 after onset ] [ Designated as safety issue: Yes ]
  • Incidence of Recurrent Stroke [ Time Frame: Day 90 after onset this time ] [ Designated as safety issue: Yes ]
  • Incidence of new-onset vascular events [ Time Frame: Day 90 after onset this time ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events (AEs) and serious AEs [ Time Frame: From Day 0 to Day 90 after onset ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780480

Contacts
Contact: Jun Liu, Dr. 8610-64014411 ext 2805 franlj1104@yahoo.com.cn

Locations
China, Guizhou
The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine Recruiting
Guiyang, Guizhou, China
Contact: Yuan-hua Wu    86-13984837323      
Principal Investigator: Yong Shao         
Sub-Investigator: Yuan-hua Wu         
Sub-Investigator: Yuan Huang         
Principal Investigator: Guang-qi Zhu         
Sub-Investigator: Bin Zuo         
Sub-Investigator: Xiu-yan Zhong         
Sub-Investigator: Rong Hu         
Sub-Investigator: Jing Cai         
Sub-Investigator: Li-ping Cao         
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
National Natural Science Foundation of China
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
  More Information

No publications provided

Responsible Party: Zhong Wang, Professor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01780480     History of Changes
Other Study ID Numbers: ZYPF-201212
Study First Received: January 27, 2013
Last Updated: September 10, 2014
Health Authority: China: National Natural Science Foundation
China: Food and Drug Administration

Keywords provided by China Academy of Chinese Medical Sciences:
Ischemic Stroke
Convalescence
Randomized Controlled Trial
Pilot Study
Traditional Chinese Medicine

Additional relevant MeSH terms:
Convalescence
Ischemia
Stroke
Cerebral Infarction
Disease Attributes
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 14, 2014