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

Completed

Phase N/A Results N/A

Trial Description

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

Interventions

  • Placebo Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules.
  • Standard Medical Care Procedure
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Dynamic Chinese herbal granule formula
    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.
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules.
  • Dynamic Chinese herbal granule formula Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Dynamic Chinese herbal granule formula
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 No
Secondary Bathel Index Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset No
Secondary modified Rankin Scale Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset No
Secondary NIH stroke scale(NIHSS) Day 0; Day7; Day 14; Day 21; Day 28; Day 90 after onset No
Secondary EQ-5D scale Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset No
Secondary Overall mortality at day 90 Day 90 after onset Yes
Secondary Incidence of Recurrent Stroke Day 90 after onset this time Yes
Secondary Incidence of new-onset vascular events Day 90 after onset this time Yes
Secondary Incidence of adverse events (AEs) and serious AEs From Day 0 to Day 90 after onset Yes

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