Ischemic StrokePhase 4NCT01762163

Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke

A Phase 4 study testing Qizhitongluo Capsule, Naoxintong Capsule and Aspirin Enteric-coated Tablets in people with Ischemic Stroke, run by China Academy of Chinese Medical Sciences at 13 sites in China.

Completed

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

Official record

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Trial summary

This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a 8-week post-treatment safety… Read more about this study

Who is it for?: Ages 35 to 80 years
Conditions the study is for: Ischemic Stroke
What is being tested?: Qizhitongluo Capsule, Naoxintong Capsule and Aspirin Enteric-coated Tablets
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 622 participants
Where: 13 sitesChina
Study dates: Oct 2013to Oct 2016
Phase: Phase 4
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 35 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age≥35 years and <80 years;
Diagnosis of ischemic stroke in recovery phase, according to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2010;
Diagnosis of ischemic stroke with qi deficiency and blood stasis syndrome;
The interval from the onset to recruitment was 15-28 days;
FM score <90 or AQ<93.8 and diagnosis of aphasia;
Diagnosis of cerebral anterior circulation obstruction;
4≤ NIHSS score<20;
Patient is willing to participate voluntarily and to sign a written patient informed consent.

Who cannot join

Evidence of intracranial hemorrhage (ICH) or other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.) on CT or MRI.
Known history of allergy or suspected allergic to the study drugs.
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 1.5-fold of normal value.
Cerebral embolism caused by cerebral tumor, cerebral trauma, cerebral parasitosis, rheumatic heart disease, coronary heart disease or other cardiac diseases complicated with atrial fibrillation.
Prestroke score on the mRS ≥2.

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Space-occupying lesions, CT or MRI revealed midline structure shift; CT revealed that massive cerebral infarction including more than one lobe of brain or over 1/3 of blood-supply area of middle cerebral artery.
Disable patients prescribed by law（blind, deaf, dumb, mental retardation, mental disorders and physical disabilities which due to other causes affect neural function deficient scale).
Hemorrhagic tendency or recent severe or dangerous bleeding in 3 months.
Suspected addicted into alcohol or drug abuse; with severe complications that would make the condition more complicated assessed by the investigator.
Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent.
Patient who is participating in other trials or has been participated in other trials in recent 3 months.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

China13 sites

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, 100700
Guang'anmen Hospital Nan District,China Academy of Chinese Medical Sciences
Beijing
the affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
West China Hospital,Sichuan University
Chengdu, Sichuan
201 Hospital of People's Liberation Army
Dalian, Liaoning
Zhongshan Hospital Dalian University
Dalian, Liaoning
Langfang TCM Hospital
Langfang, Hebei
Luohe Hospital of Chinese Medicine
Luohe, Henan, 462000
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, 530023
Second Hospital affiliated to Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning
First Teaching Hospital of Tianjin University of TCM
Tianjin
the First affiliated Hospital of Henan University of TCM
Zhengzhou, Henan

Other trials in China

About this study

Official title: Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke With Qi Deficiency and Blood Stasis Syndrome: a Multicenter, Randomized,Double-blind，Placebo- and Active-controlled Adaptive Study

Conditions: Ischemic Stroke
Being tested: Qizhitongluo Capsule, Naoxintong Capsule, Aspirin Enteric-coated Tablets, the routine recovery training, placebo
Keywords: Ischemic Stroke,adaptive design, randomized, double-blind
Medical subject headings: Ischemic Stroke

What participants receive

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

Qizhitongluo CapsuleDrug
Also called QZTL group
Naoxintong CapsuleDrug
Also called NXT group
Aspirin Enteric-coated TabletsDrug
the routine recovery trainingBehavioural
placeboDrug

Study groups in NCT01762163
Study group	Role	What they receive
Qizhitongluo Capsule	Experimental	Basic treatment：Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per night;the routine recovery training. intervention treatment:the Capsules were administered orally, four capsules each time, three times a day after each meal（placebo was taken only after lunch, and Qizhitongluo Capsule was taken after breakfast and supper)for 12 weeks. Receives: Drug: Qizhitongluo Capsule; Drug: Aspirin Enteric-coated Tablets; Behavioral: the routine recovery training; Drug: placebo
Naoxintong Capsule	Active comparator	Basic treatment：Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per night; the routine recovery training. intervention treatment:Naoxintong Capsule was administered orally, four capsules each time, three times a day after each meal for 12 weeks. Receives: Drug: Naoxintong Capsule; Drug: Aspirin Enteric-coated Tablets; Behavioral: the routine recovery training
Placebo	Placebo comparator	Basic treatment：Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per night and the routine recovery training. intervention treatment:placebo capsule was administered orally four capsules each time, three times a day after each meal for 12 weeks. Receives: Drug: Aspirin Enteric-coated Tablets; Behavioral: the routine recovery training; Drug: placebo

What is being measured

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

change in the Lower Extremity Fugl-Meyer score
Measured: baseline, after 4,12 weeks of treatment, after 90 days of onset.

Secondary outcomes (10)

Change in Aphasia Quotient（AQ) score
Measured: baseline, after 4,12 weeks of treatment, after 90 days of onset.
Change in Barthel Index score and proportion of subjects with Barthel Index score ≥90
Measured: baseline, after 4,12 weeks of treatment, after 90 days of onset.
Change in the Upper Extremity Fugl-Meyer score
Measured: baseline, after 4,12 weeks of treatment, after 90 days of onset.
Change in the total Fugl-Meyer motor score
Measured: baseline, after 4,12 weeks of treatment, after 90 days of onset.
Change in the syndrome score of Qi Deficiency and Blood Stasis
Measured: baseline, after 4,12 weeks of treatment, after 90 days of onset.
the incidence of New-onset cardiovascular events
Measured: during the 20-weeks
Changes in plasma glucose and lipid concentrations and blood coagulate
Measured: baseline and after 12 weeks of treatment
physical examination、 laboratory tests and ECG
Measured: baseline and after 12 weeks of treatment
the incidence of adverse events
Measured: during the 20-weeks
all cause mortality
Measured: during the 20-weeks

Timeline

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

Oct 2013Oct 2016

First posted7 Jan 2013 (estimated)
Study startOct 2013
Primary completionOct 2016
Study completionOct 2016

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 622 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01762163
Sponsor's protocol ID: QZTL2013
Other IDs: QZTL
Status last verified: Oct 2016
First submitted: 4 Jan 2013
Last updated: 12 Oct 2016
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

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke With Qi Deficiency and Blood Stasis Syndrome: a Multicenter, Randomized,Double-blind，Placebo- and Active-controlled Adaptive Study
ClinicalTrials.gov ID: NCT01762163
Acronym / sponsor ID: QZTL2013
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke,adaptive design, randomized, double-blind
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 622 participants (actual)
Lead sponsor: China Academy of Chinese Medical SciencesUniversity, hospital or other
Study start: Oct 2013
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 7 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: 3

Arm	Type	Receives
Qizhitongluo Capsule	Experimental	Drug: Qizhitongluo Capsule, Drug: Aspirin Enteric-coated Tablets, Behavioral: the routine recovery training, Drug: placeboBasic treatment：Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per night;the routine recovery training. intervention treatment:the Capsules were administered orally, four capsules each time, three times a day after each meal（placebo was taken only after lunch, and Qizhitongluo Capsule was taken after breakfast and supper)for 12 weeks.
Naoxintong Capsule	Active comparator	Drug: Naoxintong Capsule, Drug: Aspirin Enteric-coated Tablets, Behavioral: the routine recovery trainingBasic treatment：Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per night; the routine recovery training. intervention treatment:Naoxintong Capsule was administered orally, four capsules each time, three times a day after each meal for 12 weeks.
Placebo	Placebo comparator	Drug: Aspirin Enteric-coated Tablets, Behavioral: the routine recovery training, Drug: placeboBasic treatment：Aspirin Enteric-coated Tablets was administered orally at a dosage of 100mg/d once per night and the routine recovery training. intervention treatment:placebo capsule was administered orally four capsules each time, three times a day after each meal for 12 weeks.

Who may qualify

Ages: 35 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age≥35 years and <80 years;
Diagnosis of ischemic stroke in recovery phase, according to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2010;
Diagnosis of ischemic stroke with qi deficiency and blood stasis syndrome;
The interval from the onset to recruitment was 15-28 days;
FM score <90 or AQ<93.8 and diagnosis of aphasia;

Key exclusion criteria (12 listed)

Evidence of intracranial hemorrhage (ICH) or other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.) on CT or MRI.
Known history of allergy or suspected allergic to the study drugs.
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 1.5-fold of normal value.
Cerebral embolism caused by cerebral tumor, cerebral trauma, cerebral parasitosis, rheumatic heart disease, coronary heart disease or other cardiac diseases complicated with atrial fibrillation.

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
Qizhitongluo CapsuleAlso: QZTL group	Drug	Qizhitongluo Capsule
Naoxintong CapsuleAlso: NXT group	Drug	Naoxintong Capsule
Aspirin Enteric-coated Tablets	Drug	Naoxintong Capsule, Placebo, Qizhitongluo Capsule
the routine recovery training	Behavioural	Naoxintong Capsule, Placebo, Qizhitongluo Capsule
placebo	Drug	Placebo, Qizhitongluo Capsule

Primary outcome

change in the Lower Extremity Fugl-Meyer score
Time frame: baseline, after 4,12 weeks of treatment, after 90 days of onset.

10 secondary outcomes

Change in Aphasia Quotient（AQ) score
Time frame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
Change in Barthel Index score and proportion of subjects with Barthel Index score ≥90
Time frame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
Change in the Upper Extremity Fugl-Meyer score
Time frame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
Change in the total Fugl-Meyer motor score
Time frame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
Change in the syndrome score of Qi Deficiency and Blood Stasis
Time frame: baseline, after 4,12 weeks of treatment, after 90 days of onset.
the incidence of New-onset cardiovascular events
Time frame: during the 20-weeks
Changes in plasma glucose and lipid concentrations and blood coagulate
Time frame: baseline and after 12 weeks of treatment
physical examination、 laboratory tests and ECG
Time frame: baseline and after 12 weeks of treatment
the incidence of adverse events
Time frame: during the 20-weeks
all cause mortality
Time frame: during the 20-weeks

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 12 Oct 2016.

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
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Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
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Recruiting
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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, Ph.D. study director

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

Yingzhen Xie, M.D. principal investigator

Dongzhimen Hospital, Beijing

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

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 12 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 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

change in the Lower Extremity Fugl-Meyer score (time frame: baseline, after 4,12 weeks of treatment, after 90 days of onset.). 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 NCT01762163.

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 12 Oct 2016.