scholarly journals A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Huang Qi Gui Zhi Wu Wu Tang granules in patients with rheumatoid arthritis

2018 ◽  
Author(s):  
Yang Liu ◽  
Yi-Ru Wang ◽  
Zhi-jie Xi ◽  
Yang Yu ◽  
Li Liu ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Decision Making ◽  
Controlled Trial ◽  
Rate Of Change ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Multicenter Randomized Controlled Trial

Abstract Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by swelling, pain, and synovial damage. Effective methods lack in the treatment of RA. A traditional prescription in use for thousands of years in China, Huang Qi Gui Zhi Wu Wu Tang (HQGZWWT) granule is still chosen to relive pain and prevent joint malformation in RA patients. However, no evidence-based medical research has been organized to assess the effectiveness and safety of HQGZWWT granules for RA. Methods/design: We will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether HQGZWWT granules can relieve pain and protect joints. We will randomly divide 120 patients with active arthritis for 3 months. Main measurements include ratio of 50 of ACR (American College of Rheumatology), change of DAS (28) from baseline to 3 months, and SHARP scores of van der Heijde from baseline to 12 months. SecondarymeasurementsincludeACR20, ACR70, Health Assessment Questionnaire-Disability Index (HAQ-DI), arthritis pain score, and Patient Global Assessment of Arthritis. The time points are set as baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months. In addition, the rate of change (score) in the ACR50 and DAS28 from the baseline to 2-week, 1-month, 2-month, 6-month, and 12-month follow-up are also the secondary outcome measures. Discussion: The findings of this research will elucidate the efficacy and safety of HQGZWWT granules and provide an alternative treatment for RA. In addition, our data will benefit the clinical decision-making on active RA and possibly be incorporated into future guidelines. Trial registration: ClinicalTrials.gov ID: NCT03593837. Keywords: Traditional Chinese medicine, Huang Qi Gui Zhi wu wu granules, placebo, active rheumatoid arthritis, multicenter, randomized controlled trial.

scholarly journals Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trial

2021 ◽  
Author(s):  
Ya-xi Shang ◽  
Xia Dong ◽  
Zhi-min Xie ◽  
Xiao-peng Li ◽  
Xin-chang Wang ◽  
...  
Keyword(s):  
Joint Pain ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Gouty Arthritis ◽  
Tibetan Medicine ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Vas Score

Abstract BackgroundAcute gouty arthritis (AGA) is an inflammatory arthritis clinically characterized by severe pain, swelling, and restricted movement of joints, which may cause physical disability and decrease quality of life. The use of recommended first-line treatment agents for AGA may be limited by adverse events. There has been a traditional use of alternative therapies for AGA. Tibetan medicine Qingpeng ointment is one of the on-market herbal products used for symptom relief of AGA. Previous clinical studies indicated that Qingpeng ointment can relieve pain, swelling, redness and dysfunction of joints in patients with AGA. However, there is no rigorous randomized trial to demonstrate its benefit for AGA. In order to evaluate the efficacy and safety of Qingpeng ointment for AGA, we designed a randomized controlled trial. MethodsThis study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Two hundred and six adults with acute flare of gout, and visual analogue scale (VAS) score of joint pain ≥ 3 points will be recruited. Participants will be randomly assigned to herbal treatment or placebo group at a ratio of 1:1. Qingpeng ointment, or equal placebo ointment will be applied topically at involved joints twice a day for consecutive seven days. Patients in both groups would be allowed giving diclofenac sodium sustained-release tablets as rescue therapy when VAS score of joint pain ≥ 7 points during the treatment. The primary outcomes will be joint pain measured by VAS score, and joint swelling measured using width and thickness of affected joints and VAS score. Other outcome measures will be joint mobility, joint redness, C-reactive protein, serum uric acid, and the use of rescue medicine as well as adverse effect. DiscussionTo the best of our knowledge, this study is the first multi-center, randomized, double-blind, and placebo-controlled clinical trial to assess the efficacy of Tibetan medicine Qingpeng ointment for AGA. The findings of this study would provide evidence for its use to relieve symptoms of AGA. Trial registrationISRCTN, ISRCTN34355813. Registered 25 January 2021, https://www.isrctn.com/ISRCTN34355813

scholarly journals Efficacy and safety of Naoxintong Capsule for treating Chronic Stable Angina: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Gao Huanjia ◽  
Cai Hairong ◽  
Zhuang Jieqin ◽  
Dai Xingzhen ◽  
Fu Xue ◽  
...  
Keyword(s):  
Angina Pectoris ◽  
Stable Angina ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Chronic Stable Angina ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Increased Risk

Abstract Background Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction.Naoxintong (NXT)Capsule is a classical traditional Chinese medication used to treat CSA, however, few evidence to support the wide utility of NXT capsule for the treatment of CSA .We design this study to evaluating the efficacy and safety of NXT capsule versus placebo in patients with CSA. Methods/design This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 260 eligible participants will be enrolled. The participants will be randomized assigned in an equal ratio to groups receiving either NXT or placebo for 12 weeks. After a 2-week run-in period, they will receive either NXT or placebo (3 pills, 3 times daily) for 12 weeks. The primary outcome is therapeutic efficacy. Secondary outcome measures include the quantitative score of TCM syndromes, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of seattle angina scale, serum homocysteine, incidence of cardiovascular events. Safety outcomes and adverse events will be monitored throughout the trial. Discussion We designed this study in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide clinical evidence of the efficacy and safety of NXT Capsule in the treatment of CSA. Trial registration: ChiCTR2000034871.

scholarly journals A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis

2010 ◽  
Vol 48 (3) ◽  
pp. 318-324
Author(s):  
J.M. Pinto ◽  
N. Mehta ◽  
M. DiTineo ◽  
J. Wang ◽  
F.M. Baroody ◽  
...  
Keyword(s):  
Chronic Rhinosinusitis ◽  
Controlled Trial ◽  
Mucosal Inflammation ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Cellular Inflammation ◽  
Olfactory Testing

Evidence suggests IgE may play a role in chronic rhinosinusitis (CRS). We sought to determine if treatment with a monoclonal antibody against IgE (omalizumab) is effective in reducing CRS inflammation. We performed a randomized, double blind, placebo controlled clinical trial in subjects with CRS despite treatment (including surgery). Subjects were randomized to receive omalizumab or placebo for 6 months. The primary outcome was quantitative measurement of sinus inflammation on imaging. Secondary outcome measures included quality of life, symptoms, and cellular inflammation, nasal airflow (NPIF) and olfactory testing (UPSIT). Subjects on omalizumab showed reduced inflammation on imaging after treatment, whereas those on placebo showed no change. The net difference, however, was not different between treatments. Treatment with omalizumab was associated with improvement in the Sino-Nasal Outcome Test (SNOT-20) at 3, 5, and 6 months compared to baseline with no significant changes in the control group. Remaining measures showed no significant differences across treatments. We conclude that IgE plays, at most, a small role in the mucosal inflammation of CRS and the symptoms. Placebo controlled, blinded studies with larger enrollment are needed to determine the clinical significance of any potential change.

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