Dynamic Combination Therapy on Chinese Herbal Granules to Improve the Symptoms in Convalescent Phase of Ischemic Stroke
NCT ID: NCT01780480
Last Updated: 2014-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
120 participants
INTERVENTIONAL
2013-01-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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
The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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 Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Natural Science Foundation of China
OTHER_GOV
China Academy of Chinese Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhong Wang
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhong Wang, Dr.
Role: STUDY_CHAIR
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Jun Liu, Dr.
Role: PRINCIPAL_INVESTIGATOR
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Guang-qi Zhu
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
Guiyang, Guizhou, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZYPF-201212
Identifier Type: -
Identifier Source: org_study_id