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

NCT01780480 | Completed DMC

• 1 other identifier: ZYPF-201212
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 model of "Zhenghou" according to the results of this trial.

Conditions

Ischemic Stroke; Convalescence

Keywords

Ischemic Stroke; Convalescence; Randomized Controlled Trial; Pilot Study; Traditional Chinese Medicine

Outcome Measures

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

  Day 28

Secondary Outcomes (8)

• Bathel Index

  Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset

• modified Rankin Scale

  Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset

• NIH stroke scale(NIHSS)

  Day 0; Day7; Day 14; Day 21; Day 28; Day 90 after onset

• EQ-5D scale

  Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset

• Overall mortality at day 90

  Day 90 after onset

Study Arms (2)

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.

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.

Drug: Placebo; Procedure: Standard medical care

Interventions

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.

Dynamic Chinese herbal granule formula

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

Placebo

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.

Dynamic Chinese herbal granule formula; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• days to 60 days after onset of symptoms.
• Clinical diagnosis of cerebral anterior circulation obstruction.
• ≤NIHSS\<20.
• Patient is willing to participate voluntarily and to sign a written patient informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine

Guiyang, Guizhou, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Convalescence

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhong Wang, Dr.

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

  STUDY CHAIR

• Jun Liu, Dr.

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

  PRINCIPAL INVESTIGATOR

• Guang-qi Zhu

  The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2013
• First Posted: January 31, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

CN (1)