Efficacy and safety of traditional Chinese medicine combined with western medicine for early-phase treatment of acute ischemic stroke based on the primary syndrome elements: protocol for a randomized controlled trial

Abstract Background: Depression is one of the most frequent and severe psychiatric conditions. Many chemical drugs to treat depression are associated with adverse reactions and have shortcomings. Traditional Chinese medicine is of great significance in the prevention and treatment of depression. Xiaoyao pills has achieved good results in clinical application, which has the advantages of quick effect and no obvious adverse reactions. The aim of our study is to evaluate the efficacy and safety of Xiaoyao pills on mild to moderate depression patients with syndrome of liver stagnation and spleen deficiency.Methods: This study is a multi-center, double-blinded, randomized and placebo-controlled clinical trial. A total of 108 participants will be assigned to three groups: Xiaoyao pill group taking Xiaoyao pills twice daily for 4 weeks, placebo group taking placebos twice daily for 4 weeks and normal group without taking any drug. The primary and secondary outcome measures are the Hamilton Depression Scale (HAMD) and Traditional Chinese Medicine (TCM) Syndrome Scale. The assessment is at baseline(before treatment initiation), 1 week, 2 weeks 4 weeks after the first treatment. Exploratory outcome is also assessed to explore the mechanism of Xiaoyao pills at baseline and 4 weeks.Discussion: The results from this study will provide clinical evidence on the efficacy and safety of Xiaoyao pills in patients with mild to moderate depression with syndrome of liver stagnation and spleen deficiency.Trial registration: International Standard Randomized Controlled Trial Number Register: ISRCTN12746343. Registered on September 25, 2020.

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Clinical efficacy and safety of Traditional Chinese Medicine combined with Western Medicine in patients with diabetic acute ischemic stroke

Journal of Traditional Chinese Medicine ◽

10.1016/s0254-6272(14)60068-6 ◽

2014 ◽

Vol 34 (2) ◽

pp. 145-149 ◽

Cited By ~ 6

Author(s):

Huan Zhao ◽

Dongdong Yang ◽

Min Shi ◽

Jingtao Liang ◽

Xuhong Yang ◽

...

Keyword(s):

Ischemic Stroke ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Acute Ischemic Stroke ◽

Clinical Efficacy ◽

Western Medicine ◽

Efficacy And Safety

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The Efficacy And Safety of Traditional Chinese Medicine (TCM) To The Patient With Dizziness In Emergency Department — A Randomized Controlled Trial

10.21203/rs.3.rs-439123/v1 ◽

2021 ◽

Author(s):

Chih-Wen Chiu ◽

Tsung-Chieh Lee ◽

Chia-Yun Chen ◽

Lun-Chien Lo

Keyword(s):

Heat Treatment ◽

Emergency Department ◽

Randomized Controlled Trial ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Analogue Scale ◽

Controlled Trial ◽

Far Infrared ◽

Efficacy And Safety ◽

Randomized Controlled

Abstract • Background: A new way of heat treatment with far-infrared and / or acupuncture on acupoints is studied to treat the stubborn dizziness of patients.• Methods: A single-blinded 4-arms parallel randomized controlled trial is designed: arm of acupuncture, arm of far-infrared, arm of acupuncture plus far-infrared, arm of placebo with no far-infrared. There are four acupoints on left limbs and four acupoints on right limbs correspondingly, named as Neiguan (PC6), Hegu (LI4), Zusanli (ST36), and Taichong (LR3). The intervention time is 20 minutes for each. After treatment, visual analogue scale of dizziness, dizziness handicap intervention questionnaire and heart rate variability are used to measure and evaluate the results.• Discussion: This is a prior study in use of far-infrared and / or acupuncture on acupoints for the treatment of stubborn dizziness. It promotes the basis to further acupoints treatment according to the concept of traditional Chinese medicine.• Trial registration: It was registered in ClinicalTrials.gov with number NCT04415307 on date June 1, 2020.

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