scholarly journals Efficacy of a Chinese Herbal Medicine, Qinzhuliangxue Granules, for The Treatment of Eczema: A Randomized, Double-Blind, Multi-Center Clinical Trial

2021 ◽  
Author(s):  
Ruiping Wang ◽  
Qi Zheng ◽  
Yu Chen ◽  
Su Li ◽  
Wencheng Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Western Medicine ◽  
Repeated Measures ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Double Blind ◽  
Chinese Herbal

Abstract Background: Eczema is the most common allergic skin disorder in the world. The treatment of eczema with western medicine generally involves antihistamines, antibiotics, glucocorticoids, and immunomodulatory preparations, which are limited by common relapse events following drug withdrawal. Many traditional Chinese medicines have demonstrated significant effects on eczema; however, high-quality clinical studies are lacking.Objectives: We performed a multi-center, randomized, double-blind, clinical trial to evaluate the efficacy and safety of a Chinese herbal medicine, Qinzhuliangxue (QZLX) granules, and its effect on recurrence of eczema.Methods: A total of 342 patients with eczema who met the inclusion criteria were recruited and randomly divided into a traditional Chinese medicine (TCM) treatment group, a Western medicine (WM) treatment group, and a TCM plus WM treatment group, according to random numbers generated using the central stratified zone group random method. The Eczema Area and Severity Index (EASI) score and the level of pruritus were set as the primary outcome measures, and the Dermatology Quality of Life Index (DLQI) score served as the secondary outcome measure. In this study, a two-sided p-value less than 0.05 was considered statistically significant. Results: The median EASI score and the pruritus level at baseline were not statistically significant. However, as the treatment period progressed, the EASI score (including the total score and scores for the head, upper limb, trunk, and lower limb) and pruritus level decreased significantly in all three treatment groups. Repeated measures Analysis of Variance (ANOVA) demonstrated that the DLQI scores in the TCM, WM, and TCM+WM groups decreased significantly over time. Limitations: Basic experiments need to be increased.Conclusions: The Chinese herbal medicine QZLX granules significantly improved the EASI score and decreased the pruritus level in eczema patients, with good safety and no obvious adverse reactions.Trial RegistrationThe protocol for this study was registered with the Clinical Trials database (NCT02517957). Registered 1 May 2015, Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research - Full Text View - ClinicalTrials.gov

Efficacy of quxie capsule in metastatic colorectal cancer: Update of a double-blind, randomized, placebo controlled trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15030-e15030
Author(s):  
Tong Zhang ◽  
Wenting He ◽  
Yun Xu ◽  
Bin He ◽  
Yufei Yang
Keyword(s):  
Colorectal Cancer ◽  
Treatment Group ◽  
Herbal Medicine ◽  
Metastatic Colorectal Cancer ◽  
Chinese Herbal Medicine ◽  
Conventional Therapy ◽  
Controlled Trial ◽  
Control Group ◽  
Double Blind ◽  
Chinese Herbal

e15030 Background: To verify the efficacy of Quxie Capsule in patients with metastatic colorectal cancer (mCRC). Methods: This is a update of a randomized, double-blind, placebo-controlled trial. Between April 2014 and July 2015, 121 patients were enrolled in the study. Sixty patients were eligible and randomized to the two groups at a 1:1 ratio. Treatment group received conventional therapy and Chinese herbal medicine combined with Quxie Capsule for 3 months. Control group received conventional therapy and Chinese herbal medicine combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). As of Dec 31st 2018, one patient in the control group was still alive, and all the other patients reached the main clinical endpoint. Median follow-up time was 19.4 months. Bo Ao Tong (Beijing) Medical Technology Co. Ltd. was responsible for the protocols of blind and block randomization. Results: The median OS were 23.9 months in the treatment group [95% confidence interval (CI) 15.9–28.5] vs. 14.3 months in the control group (95% CI 11.3–21.4) (Kaplan–Meier, Log-rank P=0.032), hazard ratio (95%CI)= 0.55 (0.31, 0.95), P=0.04. In the subgroups of left-sided colon, RAS wild type, non-targeted therapy, colon cancer and ≥second-line therapy, the median OS of the treatment group and the control group were respectively: 20.9 vs 12.2m, 17.4 vs 14.4m, 20.8 vs 12.0m, 25.1 vs 18.5m, 25.1 vs 12.0m ( P=0.037, 0.019, 0.022, 0.018, 0.007). There were no significant differences between the two groups in PFS. Conclusions: Quxie Capsule showed good efficacy, can reduce the risk of death and prolong the OS of patients with mCRC. Clinical trial information: ChiCTR-IOR-16009733.

Efficacy of Chinese Herbal Medicine Jiangniaosuan Formula for Treatment of Hyperuricemia: Study Protocol For A Double-Blinded Non-Inferiority Randomized Controlled Clinical Trial

2021 ◽  
Author(s):  
Yafang Guo ◽  
Hong Lu ◽  
Jing Gan ◽  
Dongdong Li ◽  
Jiandong Gao ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Serum Uric Acid Level ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
To Receive ◽  
Be The Change

Abstract Background: Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.Methods: A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine i.e., febuxostat 40 mg (WG group; n = 24) or Chinese herbal medicine group, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24)still will receive febuxostat 20 mg + Jiangniaosuan formula and the other group(JNSG; n = 24) will continue to receive Jiangniaosuan formula+Placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in Traditional Chinese Medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.Discussion: We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.Dissemination: The results will be published in a peer-reviewed journal and disseminated by academic conferences.Trial registration : This trial is registered with ClinicalTrials.gov, number ChiCTR2000041083. 22 Registered on 3 May 2021.

Zao Ren An Shen capsule for insomnia: A double-blind, randomized, placebo-controlled trial

SLEEP ◽  
2021 ◽  
Author(s):  
Yoann Birling ◽  
Xiaoshu Zhu ◽  
Nicole Avard ◽  
Caterina Tannous ◽  
Paul P Fahey ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Adverse Events ◽  
Chinese Herbal Medicine ◽  
Controlled Trial ◽  
Double Blind ◽  
Subjective Sleep ◽  
Chinese Herbal ◽  
Cohen’S D ◽  
Cohen's D ◽  
Insomnia Severity

Abstract Study Objectives The aim of this study was to test the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for the treatment of insomnia. Methods We conducted a double-blind randomized placebo-controlled trial. After a one-week placebo run-in, a total of 85 people with insomnia were randomly allocated to receive ZRAS or placebo for four weeks. The primary outcomes were insomnia severity assessed with the Insomnia Severity Index (ISI) and the number of participants with adverse events. Secondary outcomes included objective and subjective sleep parameters, psychological status, fatigue level, quality of life, acceptability, and tolerability. Results A non-significant (p > 0.05) difference of 0.7 points in ISI in favor of ZRAS capsule was found at the end of the treatment. The number of participants with adverse events was not significantly different (p > 0.05) between the two groups. Except for subjective sleep onset latency, which had a non-significant (p > 0.05) medium effect (Cohen’s d = 0.5), the effects in secondary efficacy outcomes were all small (Cohen’s d < 0.4) and non-significant (p > 0.05). The acceptability and tolerability were high in the active group. Conclusions ZRAS capsule is safe, acceptable, and tolerable, yet not more effective than placebo in the treatment of insomnia. As previous evidence showed that Chinese herbal medicine was effective for insomnia, these results may be explained by the dose of the product, which was lower than the dose generally used in the clinic.

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