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

Primary Purpose

Ischemic Stroke, Convalescence

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Dynamic Chinese herbal granule formula

Placebo

Standard medical care

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, Convalescence, Randomized Controlled Trial, Pilot Study, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dynamic Chinese herbal granule formula

Placebo

Arm Description

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.

The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bathel Index

modified Rankin Scale

NIH stroke scale(NIHSS)

EQ-5D scale

Overall mortality at day 90

Incidence of Recurrent Stroke

Incidence of new-onset vascular events

Incidence of adverse events (AEs) and serious AEs

Full Information

NCT ID

NCT01780480

First Posted

January 27, 2013

Last Updated

December 16, 2014

Sponsor

China Academy of Chinese Medical Sciences

Collaborators

National Natural Science Foundation of China

1. Study Identification

Unique Protocol Identification Number

NCT01780480

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Academy of Chinese Medical Sciences

Collaborators

National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, Convalescence

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dynamic Chinese herbal granule formula

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules.

Intervention Type

Drug

Intervention Name(s)

Dynamic Chinese herbal granule formula

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Standard medical care

Intervention Description

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 Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Bathel Index

Time Frame

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

Title

modified Rankin Scale

Time Frame

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

Title

NIH stroke scale(NIHSS)

Time Frame

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

Title

EQ-5D scale

Time Frame

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

Title

Overall mortality at day 90

Time Frame

Day 90 after onset

Title

Incidence of Recurrent Stroke

Time Frame

Day 90 after onset this time

Title

Incidence of new-onset vascular events

Time Frame

Day 90 after onset this time

Title

Incidence of adverse events (AEs) and serious AEs

Time Frame

From Day 0 to Day 90 after onset

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhong Wang, Dr.

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jun Liu, Dr.

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Guang-qi Zhu

Organizational Affiliation

The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine

Official's Role

Study Director

Facility Information:

Facility Name

The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine

City

Guiyang

State/Province

Guizhou

Country

China

12. IPD Sharing Statement

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

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