Ischemic StrokeNCT01780480

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

A study testing Dynamic Chinese herbal granule formula and Standard medical care in people with Ischemic Stroke and Convalescence, run by China Academy of Chinese Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Ischemic Stroke, Convalescence
What is being tested?: Dynamic Chinese herbal granule formula and Standard medical care
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteChina
Study dates: Jan 2013to Dec 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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 locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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

Conditions: Ischemic Stroke, Convalescence
Being tested: Dynamic Chinese herbal granule formula, Placebo, Standard medical care
Keywords: Ischemic Stroke, Convalescence, Randomized Controlled Trial, Pilot Study, Traditional Chinese Medicine
Medical subject headings: Ischemic Stroke, Convalescence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dynamic Chinese herbal granule formulaDrug
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.
PlaceboDrug
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 careProcedure or surgery
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.

Study groups in NCT01780480
Study group	Role	What they receive
Dynamic Chinese herbal granule formula	Experimental	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. Receives: Drug: Dynamic Chinese herbal granule formula; Procedure: Standard medical care
Placebo	Placebo comparator	The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules. Receives: Drug: Placebo; Procedure: Standard medical care

What is being measured

The primary outcome is the main question the study is designed to answer.

Symptom Scale of the "Qixu-Xueyu Zheng"(Qi Deficiency and Blood Stasis Syndrome) according to the theory of Traditional Chinese Medicine at Day 28
Measured: Day 28

Secondary outcomes (8)

Bathel Index
Measured: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset
modified Rankin Scale
Measured: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset
NIH stroke scale(NIHSS)
Measured: Day 0; Day7; Day 14; Day 21; Day 28; Day 90 after onset
EQ-5D scale
Measured: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset
Overall mortality at day 90
Measured: Day 90 after onset
Incidence of Recurrent Stroke
Measured: Day 90 after onset this time
Incidence of new-onset vascular events
Measured: Day 90 after onset this time
Incidence of adverse events (AEs) and serious AEs
Measured: From Day 0 to Day 90 after onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Dec 2014

First posted31 Jan 2013 (estimated)
Study startJan 2013
Primary completionMay 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01780480
Sponsor's protocol ID: ZYPF-201212
Status last verified: Dec 2014
First submitted: 27 Jan 2013
Last updated: 18 Dec 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic

All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01780480
Acronym / sponsor ID: ZYPF-201212
Conditions: Ischemic Stroke, Convalescence
Keywords: Ischemic Stroke, Convalescence, Randomized Controlled Trial, Pilot Study, Traditional Chinese Medicine
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: China Academy of Chinese Medical SciencesUniversity, hospital or other
Collaborators: National Natural Science Foundation of China
Study start: Jan 2013
Primary completion: May 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 31 Jan 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dynamic Chinese herbal granule formula	Experimental	Drug: Dynamic Chinese herbal granule formula, Procedure: Standard medical careBased 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.
Placebo	Placebo comparator	Drug: Placebo, Procedure: Standard medical careThe process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dynamic Chinese herbal granule formulaAfter 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.	Drug	Dynamic Chinese herbal granule formula
PlaceboThe 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	Drug	Placebo
Standard medical careStandard 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.	Procedure or surgery	Dynamic Chinese herbal granule formula, Placebo

Primary outcome

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

8 secondary outcomes

Bathel Index
Time frame: 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
NIH stroke scale(NIHSS)
Time frame: 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
Overall mortality at day 90
Time frame: Day 90 after onset
Incidence of Recurrent Stroke
Time frame: Day 90 after onset this time
Incidence of new-onset vascular events
Time frame: Day 90 after onset this time
Incidence of adverse events (AEs) and serious AEs
Time frame: From Day 0 to Day 90 after onset

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.

Related trials for Ischemic Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhong Wang, Dr. study chair

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Jun Liu, Dr. principal investigator

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Guang-qi Zhu study director

The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic Chinese herbal granule formula and Standard medical care in people with Ischemic Stroke and Convalescence, run by China Academy of Chinese Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01780480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.