- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01780480
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
Status
Completed
Conditions
Intervention / Treatment
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.
Collaborators
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZYPF-201212
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.
Clinical Trials on Ischemic Stroke
-
Nordsjaellands HospitalRigshospitalet, Denmark; Metropolitan University CollegeCompletedTransient Ischemic Attack | Stroke, Ischemic | Stroke HemorrhagicDenmark
-
University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Second Affiliated Hospital, School of Medicine,...Shanghai Zhongshan Hospital; First Affiliated Hospital of Wenzhou Medical University and other collaboratorsRecruitingAcute Ischemic Stroke and Transient Ischemic AttacksChina
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic Bakken Research CenterCompletedCryptogenic Symptomatic Transient Ischemic Attack | Cryptogenic Ischemic StrokeNetherlands, United States, France, Belgium, Germany, Sweden, Italy, Austria, Canada, Denmark, Finland, Greece, Slovakia, Spain
-
University Hospital, BrestCompletedStroke, Ischemic | Stroke HemorrhagicFrance
-
Umbria Bioengineering TechnologiesRecruitingStroke, Ischemic | Stroke HemorrhagicItaly
-
Sheffield Teaching Hospitals NHS Foundation TrustUnknownFatigue | Stroke, Ischemic | Stroke HemorrhagicUnited Kingdom
-
BayerRecruitingAcute Non-cardioembolic Ischemic Stroke | Prevention of Ischemic Stroke | High-risk Transient Ischemic AttackUnited States, Switzerland, Belgium, Australia, Sweden, Canada, Taiwan, Spain, Korea, Republic of, Latvia, Israel, Malaysia, China, Greece, Japan, Turkey, Netherlands, Romania, United Kingdom, Portugal, Hungary, Italy, Brazil, France, S... and more
-
University of AlbertaCompletedTransient Ischemic Attack | Minor Ischemic StrokeCanada
-
Stephanie HarrisonActive, not recruitingTransient Ischemic Attack | Stroke, IschemicUnited Kingdom
Clinical Trials on Dynamic Chinese herbal granule formula
-
Carmel Medical CenterUnknown
-
Chang Gung Memorial HospitalTaipei Veterans General Hospital, Taiwan; Taipei Medical University; National...Not yet recruitingAtopic Dermatitis
-
Henan University of Traditional Chinese MedicineUnknownPulmonary Disease, Chronic Obstructive
-
Hong Kong Sanatorium & HospitalChinese University of Hong KongTerminatedAllergy to Fish | Allergy to Shrimp | Allergy to CrabHong Kong
-
Guang'anmen Hospital of China Academy of Chinese...CompletedUrinary IncontinenceChina
-
Shanghai Yueyang Integrated Medicine HospitalShanghai Skin Disease and Venereal Disease HospitalNot yet recruiting
-
Taipei City HospitalNational Yang Ming UniversityCompletedLiver DysfunctionTaiwan
-
Heilongjiang University of Chinese MedicineUnknown
-
Korea Health Industry Development InstituteUnknown
-
Lady Davis InstituteCompleted