scholarly journals Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Geng Li ◽  
Zhe Zhang ◽  
Li Zhou ◽  
Shaojun Liao ◽  
Jing Sun ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Intensity ◽  
Controlled Trial ◽  
Primary Dysmenorrhea ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Symptom Scale ◽  
Double Blind ◽  
Chinese Herbal

Abstract Background Epidemiological studies have shown that young women often suffer from primary dysmenorrhea (PD) which is a common cause that affects their routine work and quality of life. Chinese herbal medicine has been widely used for PD in China. A systematic review found that Xuefu Zhuyu (XFZY) has a promising effect on PD management, yet there is a dearth of high-quality evidence in support of this claim. We want to conduct a randomized controlled trial to evaluate the efficacy and safety of XFZY for PD patients. Methods This is a protocol for a multicenter, randomized, placebo-controlled trial. A total of 248 participants with PD will be recruited at 6 centers and randomized into two groups—a herbal treatment group and a placebo group. The participants will receive either XFZY or placebo, three times per day, for 3 menstrual cycles, with a 12-week follow-up. The primary outcome will be the mean change in pain intensity as measured by VAS, while the change in menstrual pain duration, the change in peak pain intensity as measured by VAS, the Cox Menstrual Symptom Scale (CMSS), quality of life EQ-5D-5L, cumulative painkiller consumption, and health economics will be included as secondary outcomes. Adverse events will also be reported. Discussion This protocol describes a multicenter, double-blind, randomized, placebo-controlled trial that investigates the efficacy and safety of XFZY for primary dysmenorrhea. Validated evaluation tools will assess dysmenorrhea severity. We believe that this research will provide important evidence regarding the use of XFZY to treat dysmenorrhea. Trial registration Chinese Clinical Trial Registry ChiCTR1900026819. Registered on 23 October 2019

scholarly journals Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Hongyu Yue ◽  
Shuang Zhou ◽  
Huangan Wu ◽  
Xuan Yin ◽  
Shanshan Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Control Group ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Symptom Scale ◽  
Significance Level

Abstract Background Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%. Discussion This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

scholarly journals Efficacy and safety of Jie-du-qing-nao granules for first-episode schizophrenics: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Ziyan Li ◽  
Yanzhe Ning ◽  
Pei Chen ◽  
Yi Zhang ◽  
Dongqing Yin ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Complete Blood Count ◽  
Controlled Trial ◽  
First Episode ◽  
Control Group ◽  
Study Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Symptom Scale ◽  
Double Blind

Abstract BackgroundAt present, the focus and difficulty of schizophrenia (SCZ) treatment is to improve cognitive function and negative symptoms. Jie-du-qing-nao granules(JQG) , a traditional Chinese medicine(TCM) prescription , has a good clinical effectiveness in enhancing the cognition and negative symptoms of patients with SCZ. However, its clear effectiveness and safety have not been adequately supported by clinical studies. The main objective of this study is to explore the efficacy and safety of JQG for first-episode schizophrenics.Methods/designThis trial is a prospective, randomized, single-centered, parallel-controlled clinical study with double-blind design. A total of 96 eligible participants will be randomly assigned to either the study group or the control group in a ratio of 1:1. Participants allocated to the study group will receive JQG and aripiprazole, control group will receive placebo and aripiprazole. The treatment course will last 12 weeks, with follow-up every 4 weeks. Outcome measurements include Positive and Negative Syndrome Scale (PANSS), self face test , MATRICS Consensus Cognitive Battery (MCCB), TNFα, IL-6, IL-1β, BDNF, vital signs, complete blood count, liver and kidney function tests, urinalysis, and electrocardiograph. Adverse reactions will be evaluated using the Treatment Emergent Symptom Scale (TESS).DiscussionThis study will provide evidence for the efficacy and safety of JQG as a complementary approach, which can be initiated following with antipsychotics therapy. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR1900028250 . Registered on December 16, 2019, http://www.chictr.org.cn/edit.aspx?pid=41880&htm=4 .

scholarly journals Therapeutic Exercise in the Treatment of Primary Dysmenorrhea: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 99 (10) ◽  
pp. 1371-1380 ◽  
Author(s):  
Paloma Carroquino-Garcia ◽  
José Jesús Jiménez-Rejano ◽  
Esther Medrano-Sanchez ◽  
Maria de la Casa-Almeida ◽  
Esther Diaz-Mohedo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Physical Therapy ◽  
Pain Intensity ◽  
Health Problem ◽  
Controlled Trial ◽  
Primary Dysmenorrhea ◽  
Therapeutic Exercise ◽  
Meta Analyses

Abstract Background Dysmenorrhea is a health problem with a high impact on health and society. Some drugs have been shown to be effective at treating dysmenorrhea. Therapeutic exercise is another option for reducing the symptomatology of this health problem, with a low cost and the absence of side effects. Purpose The purposes of this review were to study the efficacy of physical exercise for pain intensity in primary dysmenorrhea and to assess its effectiveness in decreasing the duration of pain and improving quality of life. Data Sources Searches were conducted between February 2017 and May 2017 in the databases Web of Science, Physiotherapy Evidence Database (PEDro), PubMed, Scopus, CINAHL, and Dialnet, using the terms dysmenorrhea, exercise therapy, exercise movement technique, exercise, physical therapy, physical therapy speciality, treatment, primary dysmenorrhea, prevention, etiology, epidemiology, and pain. Study Selection We included randomized controlled trial studies conducted on women who were 16 to 25 years old and had primary dysmenorrhea, studies that included exercise as a type of therapy, studies that assessed the intensity and duration of pain and quality of life, and studies published in English or Spanish. Studies that included women with irregular cycles, women diagnosed with a gynecological disease, women who had had surgery, women with serious diseases, or women who used intracavitary or oral contraceptives were excluded. We started with 455 studies; 16 were included in the systematic review, and 11 were included in the 3 meta-analyses that were carried out. Data Extraction Two authors selected the studies and extracted their characteristics (participants, intervention, comparators, and outcomes) and results. The evaluation of the methodological quality of the studies was carried out by PEDro scale. Data Synthesis There was moderate evidence that therapeutic exercise can be considered a useful tool in the treatment of primary dysmenorrhea in terms of a reduction in pain intensity. Regarding the duration of pain and quality of life, there was low evidence and very low evidence, respectively. In the 3 meta-analyses, the results were significantly positive in favor of exercise for decreases in both the intensity and the duration of pain. Limitations Limitations of this study include the great heterogeneity of the interventions applied in the studies in terms of type of exercise, in combination or alone, and dosage. This review includes a small number of studies with risk of bias, so the present findings must be interpreted with caution. Conclusions Therapeutic exercise reduces pain intensity in patients with primary dysmenorrhea.

scholarly journals Clinical Efficacy and Safety of Low-Level Laser Therapy in Patients with Perennial Allergic Rhinitis: A Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 10 (4) ◽  
pp. 772
Author(s):  
Hahn Jin Jung ◽  
Young-Jun Chung ◽  
Young-Seok Choi ◽  
Phil Sang Chung ◽  
Ji-Hun Mo
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Controlled Trial ◽  
Low Level Laser Therapy ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Sham Treatment ◽  
Double Blind Placebo ◽  
Level Laser

Allergic rhinitis (AR) is a common disease that interferes with the daily activities and reduces the quality of life. Conventional treatments often do not provide complete resolution of the symptoms, and many new treatment modalities have been tried. This study aimed to evaluate the efficacy and safety of low-level laser therapy (LLLT) for AR in a randomized, double-blind, placebo-controlled trial. Patients diagnosed with AR were randomly allocated to receive LLLT or sham treatment. The primary outcome was a change in the reflective total nasal symptom score (TNSS). The secondary outcome was quality of life scores assessed using the Rhinoconjunctivitis Quality of Life Questionnaire. Incidences of adverse events were also recorded. Among 67 randomized subjects, 41 subjects (22 in LLLT group and 19 in sham treatment group) were included for efficacy analysis. The LLLT group showed a significantly improved TNSS score compared to the sham treatment group for decreasing AR symptom severity (p = 0.011) and improving quality of life regarding nasal symptoms (p = 0.036) at the end of treatment. Throughout the treatment period, no severe adverse events occurred. This clinical trial showed that LLLT is an effective and safe option for the management of AR regarding symptom relief and quality of life improvement.

scholarly journals Efficacy of Modified Ban Xia Xie Xin Decoction on Functional Dyspepsia of Cold and Heat in Complexity Syndrome: A Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Luqing Zhao ◽  
Shengsheng Zhang ◽  
Zhengfang Wang ◽  
Chuijie Wang ◽  
Suiping Huang ◽  
...  
Keyword(s):  
Functional Dyspepsia ◽  
Controlled Trial ◽  
Symptomatic Improvement ◽  
Clinical Trial Registry ◽  
Symptom Scale ◽  
Double Blind ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
Symptom Scores ◽  
Boiled Water

Background. Chinese herbal medicine (CHM) has been used in China and elsewhere to treat patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatment are lacking.Objective. To assess the efficacy and safety of modified Ban xia xie xin decoction in patients with FD of cold and heat in complexity syndrome.Methods. We performed a randomized, double-blind, placebo-controlled trial involving patients from five centers. Patients with FD of cold and heat in complexity syndrome(n=101)were randomly assigned to groups given either CHM modified Ban Xia Xie Xin decoction or placebo in a 2 : 1 ratio. Herbal or placebo granules were dissolved in 300 mL of boiled water cooled to 70°C. Patients in both groups were administered 150 mL (50°C) twice daily. The trial included a 4-week treatment period and a 4-week followup period. The primary outcomes were dyspepsia symptom scores, measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4, and 8.Results. Compared with patients in the placebo group, patients in the CHM group showed significant improvements according to the total and single dyspepsia symptom scores obtained from patients(P<0.01)and investigators(P<0.01).Conclusions. CHM modified Ban Xia Xie Xin decoction appears to offer symptomatic improvement in patients with FD of cold and heat in complexity syndrome.Trial Registration. Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-10001074.

scholarly journals Efficacy and tolerability of Native CT-II® on modulating knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled trial

2021 ◽  
Author(s):  
Cheng Luo ◽  
Shalini Srivast
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Knee Joint ◽  
Joint Pain ◽  
Controlled Trial ◽  
Type Ii ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Joint Health

Abstract Background Osteoarthritis (OA) of the knee is the most common type of arthritis, increasing with advancing age and external factors such as obesity. Joint health has historically relied on nutritional supplements derived from herbs and other natural products. Undenatured collagen type II demonstrated positive results with substantially lower therapeutic doses. Hence, the present study was designed to determine the efficacy and safety of Native CT-II®, an undenatured type II collagen, on the symptomatic effects in individuals having joint pain due to OA. Methods A randomized, double-blinded, placebo-controlled, parallel study was conducted on 101 slightly overweight volunteers, whose knee joint pain VAS score was ≥ 60 had been included in the study for at least three months. The participants were divided into three groups, with similar demographic and baseline characteristics. The test product containing Native CT-II®, positive control containing G+C, and the placebo were taken six tablets per day for 84 consecutive days (Three capsules to be taken post-breakfast and three capsules post-dinner). Improvement in overall joint health in each participant from baseline to end of the study was measured by WOMAC, self-administered questionnaire in Native CT-II® as compared to G+C and placebo group. Results This study demonstrated that Native CT-II® had an effective impact on the symptomatic effects of knee impairment associated with OA and in the quality of life of the participants. After 84 days, participants receiving Native CT-II® and G+C had significant improvement in overall joint health as compared to participants receiving placebo. Conclusion Native CT-II® was shown to be effective in relieving symptoms and improving quality of life for patients with knee joint pain associated with OA. Trial registration: The trial was registered with the clinical trial registry of the U.S. National Library of Medicine under National Institutes of Health (NIH) (https://clinicaltrials.gov/) with the National Clinical Trial (NCT) No: NCT04470336, Date of first registration: 14/07/2020.

scholarly journals Efficacy and Safety of Electro-Acupuncture (EA) on Insomnia in Patients with Lung Cancer: Study Protocol of a Randomized Controlled Trial

2020 ◽  
Author(s):  
Hongyu Yue ◽  
Shuang Zhou ◽  
Huangan Wu ◽  
Xuan Yin ◽  
Shanshan Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Control Group ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Symptom Scale ◽  
Significance Level

Abstract Background: Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method: This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square and so on. A two-sided significance level will be set at 5%.Discussion: This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration: ChiCTR, ChiCTR1900026395, Registered 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

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