scholarly journals Efficacy and Safety of Xiaoyao Pills for Mild to Moderate Depression With Syndrome of Liver Stagnation and Spleen Deficiency: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Zhe Xue ◽  
Zhen Huang ◽  
Shu-li Cheng ◽  
Xi-hong Wang ◽  
Xuan Zhou ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Adverse Reactions ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Spleen Deficiency ◽  
Randomized Controlled ◽  
Moderate Depression

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.

scholarly journals Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Zhe Xue ◽  
Zhen Huang ◽  
Shu-li Cheng ◽  
Xi-hong Wang ◽  
Xuan Zhou ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Adverse Reactions ◽  
Controlled Trial ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Hamilton Depression Scale ◽  
Efficacy And Safety ◽  
Moderate Depression

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. Methods This study is a multi-centre, double-blinded, randomized and placebo-controlled clinical trial. A total of 108 participants are 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 ClinicalTrials.gov ISRCTN12746343. Registered on September 25, 2020.

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

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.

scholarly journals Traditional Chinese Medicine Qingre Huoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis: A Multicenter, Double-Blind, Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Xun Gong ◽  
Wei-Xiang Liu ◽  
Xiao-Po Tang ◽  
Jian Wang ◽  
Jian Liu ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomized Controlled Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
The Other ◽  
Secondary Outcome ◽  
Double Blind ◽  
Randomized Controlled ◽  
Das 28

Traditional Chinese medicine (TCM) has been used successfully to treat rheumatoid arthritis (RA). Qingre Huoxue treatment (Qingre Huoxue decoction (QRHXD)/Qingre Huoxue external preparation (QRHXEP)) is a therapeutic scheme of TCM for RA. To date, there have been few studies comparing the efficacy and safety of QRHXD and conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of active RA. This was investigated in a multicenter, double-blind, randomized controlled trial involving 468 Chinese patients with active RA [disease activity score (DAS)-28 > 3.2] treated with QRHXD/QRHXEP (TCM group), methotrexate plus hydroxychloroquine [Western medicine (WM) group], or both [integrative medicine (IM) group]. Patients were followed up for 24 weeks. The primary outcome measure was the change in DAS-28 from baseline to 24 weeks. The secondary outcome measures were treatment response rate according to American College of Rheumatology 20, 50, and 70% improvement criteria (ACR-20/50/70) and the rate of treatment-related adverse events (TRAEs). The trial was registered at ClinicalTrials.gov (NCT02551575). DAS-28 decreased in all three groups after treatment (p < 0.0001); the score was lowest in the TCM group (p < 0.05), while no difference was observed between the WM and IM groups (p > 0.05). At week 24, ACR-20 response was 73.04% with TCM, 80.17% with WM, and 73.95% with IM (based on the full analysis set [FAS], p > 0.05); ACR-50 responses were 40.87, 47.93, and 51.26%, respectively, (FAS, p > 0.05); and ACR-70 responses were 20.87, 22.31, and 25.21%, respectively, (FAS, p > 0.05). Thus, treatment efficacy was similar across groups based on ACR criteria. On the other hand, the rate of TRAEs was significantly lower in the TCM group compared to the other groups (p < 0.05). Thus, QRHXD/QRHXEP was effective in alleviating the symptoms of active RA—albeit to a lesser degree than csDMARDs—with fewer side effects. Importantly, combination with QRHXD enhanced the efficacy of csDMARDs. These results provide evidence that QRHXD can be used as an adjunct to csDMARDs for the management of RA, especially in patients who experience TRAEs with standard drugs.Clinical Trial Registration: ClinicalTrials.gov, identifier NCTNCT025515.

scholarly journals Effects of TangWang prescription intervention in type 2 non-proliferative diabetic retinopathy：a study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
WenJing Huang ◽  
De Jin ◽  
Xiang Meng ◽  
Fan Yang ◽  
Yu-jiao Zheng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Diabetic Retinopathy ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Groups ◽  
Random System ◽  
Randomized Controlled ◽  
And Control

Abstract Background: Presently, the efficacy of drug treatments for diabetic retinopathy (DR) is not satisfactory. This study is designed to provide evidence that a traditional Chinese medicine (TCM) formulation delays the development of DR. Methods: This study is a randomized, double-blind, placebo-controlled parallel-group, multicenter clinical trial, consisting of 384 participants to be randomized in a 1:1 ratio in the treatment and control groups, and receive a basic treatment. Furthermore, the treatment and control groups will be administered the TangWang prescription and the placebo, respectively, each at a dose of one bag twice a day. The study period will last for 48 weeks. The primary outcome measure will be the changes in the degree of retinal microvascular lesions before and after treatment. The secondary outcome will be changes in the degree of hemangioma, microvascular bleeding, microvascular leakage, macular edema, and vision. All statistical tests will be two-sided, and a P < 0.05 will be considered statistically significant. Discussion: We hypothesize that the patients with DR will benefit from TangWang prescription, and in addition to the central random system and platform of dynamic information collection, the patients’ conditions will be monitored and the data collected for analysis. If successful, this study will provide evidence that the TCM formulation delays the development of DR. Trial registration: ClinicalTrials.gov, NCT03025399. Registered on January 19 2017. Keywords: Diabetic retinopathy, TangWang prescription, randomized controlled trial, traditional Chinese medicine

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