scholarly journals Evaluation of the safety and efficacy of Chinese medicine in people with asymptomatic hyperuricemia: Protocol for a prospective, double-blinded, randomized, placebo controlled clinical trial.

2021 ◽  
Author(s):  
Jing-yao Yan ◽  
Ying-yan Zhou ◽  
Qiao-wen Yang ◽  
Jia-qi Wu ◽  
Xiao-hong He
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Chinese Medicine ◽  
Cardiovascular Complications ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Therapeutic Mechanisms ◽  
Double Blinded ◽  
Chinese Medicine Treatment ◽  
Observation Period

Abstract BackgroundHyperuricemia increases the risk of gout and cardiovascular complications. Studys show that Chinese medicine can decrease uric acid through multiple targets, but many of these studys is conducted on animal, because the lack of a consistent prescription and mechanism.So we design this research to study whether Chinese medicine is really effective and which target is essential.MethodsThis study is a prospective, double-blinded, randomized, placebo controlled clinical trial. From March 2020 to December 2021.30 asymptomatic hyperuricemia people will be recruiting and assigned to either Chinese medicine group or placebo group, each group will have 15 subjects.During the 12-week observation period,there will be 4 times of visits.The decline in the uric acid is the main outcome measure, urinary uric acid,inflammatory biomarkers and other index that may involve in lowing uric acid are the secondary outcome measures.DiscussionThis study will probe the effect of Chinese medicine treatment on hyperuricemia, and explore possible therapeutic mechanisms. By performing this trial,we hoping to provide evidence and data to support further large clinical studies.Trial registration:ChiCTR2000038575. Registered on September 24, 2020.

scholarly journals Ultrasound-guided injections for supraspinatus tendinopathy: corticosteroid versus glucose prolotherapy – a randomized controlled clinical trial

2017 ◽  
Vol 10 (3) ◽  
pp. 170-178 ◽  
Author(s):  
Brandi Cole ◽  
Patrick Lam ◽  
Lisa Hackett ◽  
George A. C. Murrell
Keyword(s):  
Clinical Trial ◽  
Corticosteroid Injection ◽  
Supraspinatus Tendon ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Ultrasound Guided ◽  
Shoulder Range Of Motion ◽  
Double Blinded ◽  
And Function

Background Subacromial corticosteroid injections are frequently performed for pain associated with supraspinatus tendinopathy. Glucose prolotherapy has been used clinically for multiple tendinopathies and is hypothesized to be an alternate injection therapy for supraspinatus tendinopathy. Methods A prospective, randomized, double blinded clinical trial was conducted. Thirty-six patients with supraspinatus tendinopathy were randomized into two groups: 17 received an ultrasound-guided injection of glucose into the tendinopathic parts of the supraspinatus tendon and 19 received an ultrasound-guided injection of corticosteroid into the subacromial bursa. Primary outcome was level of pain with overhead activities at 3 months. Secondary outcome measures included level and frequency of pain and function, shoulder range of motion, impingement tests, strength and tendon changes on ultrasound. Results Level of pain with overhead activities was significantly reduced at the 3-month follow-up in the prolotherapy group and at the 6-month follow-up for both the prolotherapy and corticosteroid groups. There were no significant differences between the groups at any time point. Conclusions Both glucose prolotherapy and corticosteroid were generally well tolerated; however, glucose prolotherapy offered no additional benefit over subacromial corticosteroid injection for supraspinatus tendinopathy.

scholarly journals Traditional Chinese Medicine (Xiao Tan San Jie Granule) for Covid-19 Patients in Rehabilitation Stage: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Yingshuai Li ◽  
Junwen Han ◽  
ying Zhang ◽  
Ji Wang ◽  
Jiangming He ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Assessment ◽  
Virus Disease ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Tcm Theory

Abstract Background: The Corona Virus Disease 2019 (Covid-19) caused pandemic all over the world. As more and more patients gradually are recovering from Covid-19, they still have some symptoms like short of breath, cough, and phlegm. how to improve their quality of life and shorten the rehabilitation time is still no widely recognized clinical program. In this study, we designed Xiao Tan San Jie (XTSJ) Granule based on traditional Chinese medicine (TCM) theory and assess its efficiency and safety during rehabilitation stage of Covid-19 patients. Method/Design: This study is a 12-week, randomized, double-blinded, controlled, clinical trial that will include 132 Covid-19 patients. Eligible participants will be randomly assigned to XTSJ granule group or placebo group. Participants will receive 28 days treatment. The primary outcome assessment is scores of lung CT scan at week 2 and week 4. The secondary outcome assessment includes pulmonary function test, scores of Visual Analogue Scale (VAS) of Covid-19 symptoms, Scores of Qi Deficiency and Phlegm Stasis syndrome scale, Scores of St. George's Respiratory Questionnaire (SGRQ) at week 2 and week 4. Discussion: In TCM theory XTSJ granule has a regulate effect on respiratory function, lung infection, cough and phlegm which has the potential treatment effect on COVID19 patients. This study will provide initial evidence regarding the efficacy and safety of XTSJ granule for Covid-19 patients in rehabilitation stage. Trial registration: This study was prospectively registered on Chinese Clinical Trial Registry( number: ChiCTR2000031672). Registration date: April 6,2020.

Liraglutide as an Additional Treatment to Insulin in Patients with Type 1 Diabetes Mellitus—A 52-Week Randomized Double-Blinded Placebo-Controlled Clinical Trial

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 3-LB ◽  
Author(s):  
PARESH DANDONA ◽  
HUSAM GHANIM ◽  
NITESH D. KUHADIYA ◽  
TANVI SHAH ◽  
JEANNE M. HEJNA ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Trial ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Additional Treatment ◽  
Controlled Clinical Trial ◽  
Double Blinded

scholarly journals Administration of Apple Polyphenol Supplements for Skin Conditions in Healthy Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1071
Author(s):  
Toshihiko Shoji ◽  
Saeko Masumoto ◽  
Nina Moriichi ◽  
Yasuyuki Ohtake ◽  
Tomomasa Kanda
Keyword(s):  
Clinical Trial ◽  
Uv Irradiation ◽  
Skin Pigmentation ◽  
Controlled Clinical Trial ◽  
Continuous Administration ◽  
Double Blind ◽  
Healthy Women ◽  
Dependent Relationship ◽  
Skin Conditions ◽  
Double Blinded

This clinical study was performed to evaluate the effects of continuous apple polyphenol (AP) administration on facial skin conditions and pigmentation induced by ultraviolet (UV) irradiation in healthy women participants. Participants (n = 65, age 20–39 years) were randomized to receive tablets containing AP (300 or 600 mg/day) or placebo in a double-blinded, placebo-controlled clinical trial. Continuous administration of AP for 12 weeks significantly prevented UV irradiation induced skin pigmentation (erythema value, melanin value, L value), although a dose-dependent relationship was not clearly observed. In contrast, no significant differences were detected between the groups with regard to water content and trans-epidermal water loss. Our study demonstrated that APs and their major active compounds, procyanidins, have several health benefits. Here, we report that continuous administration of AP for 12 weeks alleviated UV irradiation induced skin pigmentation, when compared with placebo, in healthy women.

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

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