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Completed

NCT Number: NCT01780480

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine

Guiyang, Guizhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dynamic Chinese herbal granule formula

Drug

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

Drug

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

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Bathel Index

    Time frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset

  2. modified Rankin Scale

    Time frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset

  3. NIH stroke scale(NIHSS)

    Time frame: Day 0; Day7; Day 14; Day 21; Day 28; Day 90 after onset

  4. EQ-5D scale

    Time frame: Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset

  5. Overall mortality at day 90

    Time frame: Day 90 after onset

  6. Incidence of Recurrent Stroke

    Time frame: Day 90 after onset this time

  7. Incidence of new-onset vascular events

    Time frame: Day 90 after onset this time

  8. Incidence of adverse events (AEs) and serious AEs

    Time frame: From Day 0 to Day 90 after onset

Sponsors and collaborators

Lead sponsor

China Academy of Chinese Medical Sciences

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 31, 2013
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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