scholarly journals Chinese Herbal Formula Xuefu Zhuyu for Stable Angina (CheruSA): Study Protocol for a Multicenter Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Shaojun Liao ◽  
Zhe Zhang ◽  
Geng Li ◽  
Li Zhou ◽  
Junwen Jiang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Heart Disease ◽  
Stable Angina ◽  
Controlled Trial ◽  
Routine Care ◽  
Control Group ◽  
Herbal Formula ◽  
Chinese Herbal Formula ◽  
Randomized Controlled ◽  
Chinese Herbal

Introduction. Stable angina (SA) in coronary heart disease is a common ischemic heart disease endangering the patient’s quality of life and longevity. Clinical trials have demonstrated that the Chinese herbal formula Xuefu Zhuyu (XFZY) has benefits for SA patients. However, there remains a lack of high-quality evidence to support clinical decision-making. Therefore, we designed a randomized controlled trial (RCT) to evaluate the efficacy and safety of XFZY for SA. Methods and Analysis. This multicenter, double-blinded RCT will be conducted in China. 152 eligible participants will be randomly assigned to either an XFZY group or a control group at a 1 : 1 ratio. Participants in the XFZY group will receive XFZY plus routine care, while those in the control group will receive placebo plus routine care. The study period is 26 weeks, including a 2-week run-in period, a 12-week treatment period, and a 12-week follow-up. The primary outcome is the change in visual analogue scale score for angina pain intensity from baseline to 12 weeks. The secondary outcomes are the angina attack frequency and duration, the nitroglycerin dosage consumed, the Canadian Cardiovascular Society grading of effort angina, the Seattle Angina Questionnaire, the EuroQol-5-Dimensions-5-Level, the incidence of major adverse cardiac events, health cost evaluation, and overall assessment for study drugs. Ethics and Dissemination. The study has been approved by the ethics committee of Guangdong Provincial Hospital of Chinese Medicine (approval no. BF2019-175-01). Results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. This trial is registered with ChiCTR1900026899, registered on 26 October 2019.

scholarly journals The Chinese herbal formula Huoxiang Zhengqi for atopic dermatitis with dampness pattern (CHARM): a study protocol for a double-blinded randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Meiling Xuan ◽  
Xiaohui Guo ◽  
Hongyi Li ◽  
Ting Xie ◽  
Xiumei Mo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Atopic Dermatitis ◽  
Rating Scale ◽  
Controlled Trial ◽  
Herbal Formula ◽  
Chinese Herbal Formula ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
Link Type ◽  
Double Blinded

Abstract Background Atopic dermatitis (AD) is a complex, common inflammatory skin disease. The Chinese herbal formula Huoxiang Zhengqi (HXZQ) has been a common dermatosis treatment in China for many years, but there is no high-level evidence for its effect on AD/eczema. The aim of this trial is to examine the efficacy and safety of HXZQ treating AD/eczema patients. Methods This is a double-blind, multi-center, randomized controlled trial comparing HXZQ to a placebo. It will consist of 4 weeks’ treatment and 4 weeks of follow-up. A total of 218 participants will be randomly allocated into two groups—an HXZQ group and a placebo group, from 7 hospitals in China. Patients diagnosed with AD will be enrolled if they are in accordance with CM dampness pattern, have body surface area (BSA) of 1–10%, have investigator’s global assessment (IGA) of 1–3, have age between 18 and 70 years, and provide signed informed consent. The Eczema Area and Severity Index (EASI) is the primary outcome. The secondary outcomes are the numerical itch rating scale, IGA, BSA, Skindex-29, and EQ-5D-5L score, from baseline to the end of the treatment. Analysis will be on intention-to-treat and per-protocol subject analysis principles. Discussion The goal of this trial is to evaluate the efficacy and availability of HXZQ oral liquid in treating AD/eczema in terms of symptoms and eczematous lesions. It will also address whether it has positive effect on QoL. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx): Chinese herbal formula Huoxiang Zhengqi for atopic dermatitis with dampness pattern (CHARM): a double-blinded randomized controlled trial, ChiCTR1900026700. Registered on 19 October 2019.

scholarly journals The effect of cryotherapy on chemotherapy induced oral mucositis in Egyptian cancer patients: A randomized controlled trial

2019 ◽  
Vol 9 (11) ◽  
pp. 63
Author(s):  
Hanan Mohamed Mohamed Soliman
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Oral Mucositis ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Routine Care ◽  
Control Group ◽  
Adverse Side Effect ◽  
Randomized Controlled ◽  
Oral Cryotherapy

Background and objective: Oral Mucositis (OM) is a common adverse side-effect caused by cancer treatments (chemotherapy and/or radiotherapy).  And can lead to mucosa toxicity. Patients with OM may experience extreme pain and may not be able to eat, drink and talk and, as a result, their quality of life is impaired. Treatment and prevention of OM in adult patients treated with chemotherapy are challenging issues for health care professionals. The aim of this study was to evaluate the effect of cryotherapy on incidence and severity of chemotherapy-induced OM and OM related pain in patients treated with combined chemotherapy (Fluorouracil and Leucovorin).Methods: This study is a randomized controlled trial with a random assignment to cryotherapy and control groups. The study was conducted on 40 cancer patients who underwent chemotherapy. The 20 patients in cryotherapy group were received instructions for sucking ice cubes in their mouth for five minutes before, during and shortly after chemotherapy. The 20 patients in control group received routine care. OM and pain severity were evaluated at 7th, 14th and 21st days of the study after chemotherapy using WHO Mucositis grading and-Numeric Pain Rating Scale.Results: In the majority of patients in cryotherapy group, oral Mucositis was not detected (Grade 0) at 7th, 14th and 21st days similarly incidence of grade 1 and 2 of OM in cryotherapy group significantly lowered when compared with control group where p < .001. During the study period, patients in the control group exhibit a significantly higher level of oral discomfort (p = .001).Conclusions: Oral cryotherapy due to its easy administration, tolerability and lack of adverse effects which makes it a very important method for decreasing the severity and incidence of OM and OM associated pain. The oncology nurses have a pivotal role in the application and success of cryotherapy.

scholarly journals Acupuncture to Improve Symptoms for Stable Angina (AIMS-A): Study Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Judith Schlaeger ◽  
Hui Yan Cai ◽  
Alana D. Steffen ◽  
Veronica Angulo ◽  
Adhir R. Shroff ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stable Angina ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Attention Control ◽  
Chinese Patients ◽  
Control Group ◽  
Mcgill Pain Questionnaire ◽  
Analgesic Effects ◽  
Randomized Controlled

BACKGROUND Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for analgesic effects is the downregulation of M1 macrophages, Interleukin-1β, Interleukin-6, Interleukin-18, and tumor necrosis factor alpha (TNF-α). OBJECTIVE The purpose of this study is to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in healthcare systems and other salient variables. METHODS We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized Traditional Chinese Medicine (TCM) point prescription. The attention control group will view non-pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. Primary outcomes are anginal pain and quality of life. RESULTS Results will be available upon completion of the randomized controlled trial and the analysis of the data. CONCLUSIONS We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a pro-inflammatory state and/or hyperalgesia caused by multiple neural and immune processes not always relieved with medication. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT02914834

scholarly journals Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial

10.2196/14705 ◽  
2019 ◽  
Vol 8 (7) ◽  
pp. e14705 ◽  
Author(s):  
Judith Schlaeger ◽  
Hui Yan Cai ◽  
Alana D Steffen ◽  
Veronica Angulo ◽  
Adhir R Shroff ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stable Angina ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Attention Control ◽  
Chinese Patients ◽  
Control Group ◽  
Mcgill Pain Questionnaire ◽  
Analgesic Effects ◽  
Randomized Controlled

BackgroundAcupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha.ObjectiveThis study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables.MethodsWe are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non–pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life.ResultsThis study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020.ConclusionsWe will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication.International Registered Report Identifier (IRRID)DERR1-10.2196/14705

scholarly journals Efficacy and Safety of a Chinese Herbal Formula (Invigorating Kidney and Strengthening Spleen) in Chronic Hepatitis B Virus Carrier: Results from a Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-12 ◽  
Author(s):  
Jinsong He ◽  
Daqiao Zhou ◽  
Guangdong Tong ◽  
Yufeng Xing ◽  
Yingjie Chen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Control Group ◽  
Herbal Formula ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Chinese Herbal Formula ◽  
Hbv Replication ◽  
Chinese Herbal ◽  
Chronic Hepatitis B Virus ◽  
Chronic Hbv

A Chinese Herbal Formula (CHF) has acquired a certain therapeutic effect on chronic HBV infection. To assess the efficacy and safety of CHF on HBV replication in chronic HBV carriers, we performed a randomized, double-blind, and placebo-controlled trial involving patients from 16 centers. A total of 300 confirmed chronic HBV carriers were randomized at baseline in a ratio of 2 : 1 to receive either CHF or placebo for 52 weeks. The results showed that a greater proportion of CHF than placebo treated patients achieved virological response at week 52; the mean decline of serum HBsAg levels in the CHF group dropped more obviously than that in the control group at all stages of the treatment; however, the rates of HBeAg loss and seroconversion had no difference between the two groups. Meanwhile, were presented significant increases in IFN-γ; IL-2 levels and reductions in IL-4 and IL-10 levels in the treatment group compared to the control group at week 52. There were no drug-related serious adverse events. In conclusion, the treatment with 52-week CHF is safe and effective in inhibiting HBV replication in chronic HBV carriers. The ability of the compound to modulate host immune function probably contributed to this effect.

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