scholarly journals Efficacy and Safety of TangWang Prescription for Type 2 Non-Proliferative Diabetic Retinopathy: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
De Jin ◽  
Yuehong Zhang ◽  
Yuqing Zhang ◽  
Wenjing Huang ◽  
Xiang Meng ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Statistical Tests ◽  
Controlled Trial ◽  
Microvascular Complications ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Control Groups ◽  
Double Blind ◽  
Random System ◽  
And Control

Background: Diabetic retinopathy (DR) is one of the most common and severe microvascular complications of diabetes mellitus (DM), which results in blindness among adults worldwide. Presently, the efficacy of drug treatments for diabetic retinopathy (DR) is not satisfactory, thus urgently necessitating effective drug treatment measures. TangWang prescription (TWP) has been found to have retinal protection effects in previous clinical and basic research. However, there is a lack of rigorous, randomized, and controlled studies. This study aims to evaluate the efficacy and safety of TWP in delaying the development of DR.Methods: This study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial, consisting of 384 participants to be randomized in a 1:1 ratio in the treatment and control groups. Furthermore, the treatment and control groups will be administered the TangWang prescription and the placebo, respectively, each at a dose of one bag twice a day. The study period will last for 48 weeks. The primary outcome measure will be the changes in the degree of retinal microvascular lesions before and after treatment. The secondary outcome will be changes in the degree of hemangioma, microvascular bleeding, microvascular leakage, macular edema, and vision. All statistical tests will be two-sided, and a p < 0.05 will be considered statistically significant.Discussion: We hypothesize that the patients with DR will benefit from TangWang prescription, and in addition to the central random system and platform of dynamic information collection, the patients’ conditions will be monitored, and the data collected for analysis. If successful, this study will provide evidence that the TWP formulation delays in the progression of DR.Trial registration: The design of this trial has been registered with the ClinicalTrials.gov (NCT03025399).

scholarly journals Effects of TangWang prescription intervention in type 2 non-proliferative diabetic retinopathy：a study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
WenJing Huang ◽  
De Jin ◽  
Xiang Meng ◽  
Fan Yang ◽  
Yu-jiao Zheng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Diabetic Retinopathy ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Groups ◽  
Random System ◽  
Randomized Controlled ◽  
And Control

Abstract Background: Presently, the efficacy of drug treatments for diabetic retinopathy (DR) is not satisfactory. This study is designed to provide evidence that a traditional Chinese medicine (TCM) formulation delays the development of DR. Methods: This study is a randomized, double-blind, placebo-controlled parallel-group, multicenter clinical trial, consisting of 384 participants to be randomized in a 1:1 ratio in the treatment and control groups, and receive a basic treatment. Furthermore, the treatment and control groups will be administered the TangWang prescription and the placebo, respectively, each at a dose of one bag twice a day. The study period will last for 48 weeks. The primary outcome measure will be the changes in the degree of retinal microvascular lesions before and after treatment. The secondary outcome will be changes in the degree of hemangioma, microvascular bleeding, microvascular leakage, macular edema, and vision. All statistical tests will be two-sided, and a P < 0.05 will be considered statistically significant. Discussion: We hypothesize that the patients with DR will benefit from TangWang prescription, and in addition to the central random system and platform of dynamic information collection, the patients’ conditions will be monitored and the data collected for analysis. If successful, this study will provide evidence that the TCM formulation delays the development of DR. Trial registration: ClinicalTrials.gov, NCT03025399. Registered on January 19 2017. Keywords: Diabetic retinopathy, TangWang prescription, randomized controlled trial, traditional Chinese medicine

scholarly journals Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Nut Koonrungsesomboon ◽  
Saowaros Nopnithipat ◽  
Supanimit Teekachunhatean ◽  
Natthakarn Chiranthanut ◽  
Chaichan Sangdee ◽  
...  
Keyword(s):  
Knee Pain ◽  
Controlled Trial ◽  
Common Adverse Event ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Osteoarthritis Of The Knee ◽  
Efficacy And Safety ◽  
Short Term Treatment ◽  
Double Blind ◽  
Herbal Formulation

Background. Osteoarthritis of the knee is the most common form of arthritis. Identifying effective and safe herbal formulations that are locally available is viewed as a priority for sustainable development in a region. This study aimed to evaluate the efficacy and safety of Thai herbal formulation-6 (THF-6) in comparison with oral diclofenac in patients with moderate-to-severe osteoarthritis of the knee. Methods. This randomized, double-blind, active-controlled, noninferiority trial randomly assigned patients with osteoarthritis of the knee to receive either THF-6 or diclofenac for four weeks. The primary outcome measure was the change from baseline in knee pain as measured by a 100 mm visual analog scale (VAS). Secondary outcome measures included knee stiffness, a stair climb test, the Knee Injury and Osteoarthritis Outcome Score, and safety parameters. Outcomes were assessed on a biweekly basis. Modified intention-to-treat (MITT) and perprotocol (PP) analyses were applied. Results. A total of 200 patients were enrolled of whom 175 (87.5%) were included in the MITT analysis and 153 (76.5%) in the PP analysis. The mean change in VAS pain did not differ between the two groups, and the upper limit of the two-sided 95% confidence interval (CI) for comparison between the two groups was within the prespecified margin of 10 mm for noninferiority (MITT analysis: mean difference = 0.86, 95% CI = -4.39 to 6.10, p = 0.748 ; PP analysis: mean difference = 1.98, 95% CI = -3.61 to 7.56, p = 0.486 ). Significant improvement was observed in all the efficacy parameters in both groups. Dyspepsia was the most common adverse event: 23 patients in the THF-6 group and 28 in the diclofenac group p = 0.417 . Conclusions. THF-6 offers an alternative to oral diclofenac for the short-term treatment of osteoarthritis of the knee. It was shown to be noninferior to oral diclofenac in relieving knee pain. This trial is registered with ChiCTR-IPR-15007213.

scholarly journals Efficacy of a herbal toothpaste on patients with established gingivitis: a randomized controlled trial

2006 ◽  
Vol 20 (2) ◽  
pp. 172-177 ◽  
Author(s):  
Fabiana Ozaki ◽  
Claudio Mendes Pannuti ◽  
Ana Vitória Imbronito ◽  
Wellington Pessotti ◽  
Luciana Saraiva ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Controlled Trial ◽  
Test Group ◽  
Experimental Period ◽  
Positive Control ◽  
Control Group ◽  
Control Groups ◽  
Double Blind ◽  
Significant Difference ◽  
And Control

The aim of this randomised, double blind controlled trial was to verify the efficacy of a herbal dentifrice on the reduction of plaque and gingivitis. Forty eight volunteers with established gingivitis were randomly assigned to either a test group (herbal dentifrice) or positive control group (dentifrice with triclosan and fluoride). The dentifrices were distributed in plain white tubes by an independent pharmacy, which revealed the contents of each tube only after the experimental period. Plaque and gingivitis assessments were carried out on baseline and after 28 days of product use. All examinations were conducted by the same calibrated investigator. Subjects were instructed to brush their teeth three times daily using their assigned dentifrice for 28 days. There was a significant reduction in plaque levels in both the test and control groups. However, there was no significant difference between the groups. A significant reduction in gingivitis was observed in both groups, although there was no significant difference between them. No adverse reactions were reported. The authors concluded that both dentifrices were effective in reducing plaque and gingivitis in subjects with established gingivitis.

scholarly journals Breast Microecology Improvement Using Probiotics Following Needle Aspiration in Patients With Lactational Breast Abscess: a Multi-center Randomized Double-blind Controlled Trial

2021 ◽  
Author(s):  
Yi Zhang ◽  
Yajun Gao ◽  
Jing Qin ◽  
Xiaoting Li ◽  
Fei Jiang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Reaction Rates ◽  
Needle Aspiration ◽  
Healing Time ◽  
Control Group ◽  
Cure Rate ◽  
Control Groups ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
And Control

Abstract Background: Studies show that oral probiotics can improve the breast microecology and thus alleviate the inflammatory response; however, there is a lack of experimental data corresponding to cases with existing abscesses. We aimed to investigate the effect of Lactobacillus fermentum CECT5716 during needle aspiration in patients with lactational breast abscesses.Methods: Patients (aged 20–41 years) with lactational single-cavity breast abscesses (diameter 3–6 cm) from 12 hospitals were randomly assigned to the experimental (n=51) and control groups (n=50). Outcome measures included the abscess cure rate on day-5 of treatment, delactation rate, relieving pain rate, and the number of needle aspirations until day-28.Results: The experimental group’s 5-day cure rate (43.1%, 22/51) was significantly higher (p<0.05). The breastfeeding continuation on day-5 did not differ significantly (experimental group: 88.2%, 45/51; control group: 96.0%, 48/50; p=0.269). In the experimental and control groups, 19.6% and 14.0% of patients experienced moderate to severe pain on day-5, respectively, with no statistically significant differences (p=0.451). The median number of needle aspirations up to day-28 was two in the experimental (1–3 times) and control (1–4 times) groups, with no statistically significant differences (Mann–Whitney U test, p=0.322). Four patients in each group developed diarrhea, with adverse reaction rates of 7.84% (4/51) and 8.0% (4/50), respectively. No adverse reactions were reported in the infants.Conclusion: L. fermentum can shorten the healing time in patients with lactational breast abscesses.Trial registration: This study was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn), registration number: ChiCTR2000032682, registration date: May 6, 2020.

scholarly journals Children Listening to Music or Watching Cartoons During ER Procedures: A RCT

2019 ◽  
Vol 44 (10) ◽  
pp. 1151-1162
Author(s):  
Marianne J E van der Heijden ◽  
Hiske Mevius ◽  
Nicky van der Heijde ◽  
Joost van Rosmalen ◽  
Sebastian van As ◽  
...  
Keyword(s):  
Heart Rate ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Multivariable Analysis ◽  
Pain Scale ◽  
Secondary Outcome ◽  
Control Groups ◽  
Video Footage ◽  
Alder Hey ◽  
And Control

Abstract Objective This study aims to determine if listening to music and watching cartoons are effective to distract children from pain and distress during procedures in the emergency room (ER). Methods This study is a single-center, 3-armed, superiority randomized controlled trial comparing listening to music, watching cartoons, and standard care during ER procedures in children aged 3–13 years. The primary outcome was pain measured from video footage with the Alder Hey Triage Pain Score (AHTPS). Children older than 4 years self-reported pain with the Faces Pain Scale-Revised (FPS-R). The secondary outcome was distress measured with the Observational Scale of Behavioral Distress-revised (OSBD-r). Another indicator of distress was heart rate. Results Data of 191 participants were analyzed for the 3 groups: music (n = 75), cartoon (n = 62), and control (n = 54). The median age was 7.3 years (4.9–9.7). In multivariable analysis, pain assessed with the AHTPS was significantly lower (B = −1.173, 95% confidence interval −1.953, −0.394, p = .003) in the music group than in the control groups. Across the 3 groups, 108 children self-reported pain with the FPS-R after the procedure. The scores were lowest in the music group, but the differences between groups were not significant (p = .077). OSBD-r distress scores assigned during the procedures were not significantly different between the 3 groups (p = .55). Heart rate directly after the procedure was not statistically significantly different between the 3 groups (p = .83). Conclusions Listening to recorded music is a beneficial distraction for children experiencing pain during ER procedures, whereas watching cartoons did not seem to reduce pain or distress.

Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion: A Randomized Double-Blind Clinical Trial

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Shaimaa G Helmy ◽  
Mohammed A El-Kadi ◽  
Mohamed E Elhodiby ◽  
Mohamed H Salama
Keyword(s):  
Controlled Trial ◽  
Secondary Outcome ◽  
Contraceptive Device ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Group 3 ◽  
Group 2 ◽  
Vaginal Misoprostol ◽  
Different Doses ◽  
Group 1

Abstract Objective This study aims to compare the efficacy and safety of different doses of vaginal misoprostol prior to IUCD insertion among women with nulliparous cervix “those who 29never delivered-vaginally”. Study design: The current study was a randomized, double-blind, placebo-controlled trial conducted in the Family Planning Clinic of Ain Shams University’s Maternity Hospital Egypt. It involved women who delivered only by elective CD (cesarean delivery). One hundred and eighty women were randomized into three groups, Group 1 received misoprostol 200 mcg. Group 2 received misoprostol 100 mcg. Group 3 received placebo. The primary outcome was pain scores which were measured using a visual analogue scale (VAS), the secondary outcome was the ease of insertion score (ES). Results VAS and ES were significantly lower in group 1 compared to group 2 and group 3 (P &lt; 0.001).There was insignificant difference among the three groups as regards successful IUD insertion (P = 0.477). Duration of insertion was significantly lower in group 1 than group 2 (P &lt; 0.001). Satisfaction was significantly higher in group 1 compared to group 2 and group 3 (P &lt; 0.001) Conclusion The effect of misoprostol seems to be dose-dependent. Dose of 200mcg seems to be ideal with best efficacy and with no significant increase in the adverse effects Implications: The dose of 200mcg vaginal misoprostol prior to IUD insertion in women, who had never delivered vaginally before, seems to be the most effective dose. Trail to lower the dose to100mcg significantly compromises the efficacy without remarkable benefit on the side effect profile.

scholarly journals Intubation Conditions following Rocuronium: Influence of Induction Agent and Priming

2005 ◽  
Vol 33 (4) ◽  
pp. 462-468 ◽  
Author(s):  
Y. Leykin ◽  
T. Pellis ◽  
M. Lucca ◽  
A. Gullo
Keyword(s):  
Neuromuscular Block ◽  
Controlled Trial ◽  
Onset Time ◽  
Induction Agent ◽  
Priming Dose ◽  
Control Groups ◽  
Double Blind ◽  
Intubating Conditions ◽  
Cardiovascular Depression ◽  
And Control

A small priming dose of rocuronium can shorten the onset time of neuromuscular blockade. Induction agents with less cardiovascular depression also reduce the onset time. We hypothesized that ketamine, compared to thiopentone, would reduce onset time and improve intubating conditions following priming. Sixty patients ASA I to II, randomized by computer-generated sequence to four groups were investigated in a double-blind controlled trial. In the two groups with priming, 0.04 mg/kg of rocuronium was followed by three minutes of priming interval. Induction was followed by an intubation dose of 0.4 mg/kg of rocuronium. After 30 seconds, intubation was attempted within a further 20 seconds. In the two control groups, the same sequence was repeated except sham priming (saline) was given. For induction, S-ketamine (1 mg/kg) or thiopentone (4 mg/kg) were administered. Intubating conditions were graded as excellent, good, poor, or not possible. Neuromuscular transmission was monitored by acceleromyography of the thumb. There were no measured differences in onset time of neuromuscular block or in haemodynamics between the groups. The proportion of good to excellent intubating conditions was higher when ketamine was preceded by priming compared to ketamine without priming (87% vs 20%; P<0.05). In both priming and control groups intubating conditions were improved when using ketamine compared to thiopentone (P<0.05). The mechanism of this effect was not clear from this study.

scholarly journals The efficacy and safety of Ivermectin in patients with mild and moderate COVID-19: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fatemeh Sadat Hosseini ◽  
Alireza Malektojari ◽  
Sara Ghazizadeh ◽  
Mehdi Hassaniazad ◽  
Parivash Davoodian ◽  
...  
Keyword(s):  
Informed Consent ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
List Type ◽  
Efficacy And Safety ◽  
Inclusion Criteria ◽  
Control Groups ◽  
Open Label ◽  
Outpatient Group ◽  
Full Protocol

Abstract Objectives We will evaluate the efficacy and safety of Ivermectin in patients with mild and moderately severe COVID-19. Trial design This is a phase 3, single-center, randomized, open-label, controlled trial with a 2-arm parallel-group design (1:1 ratio). Participants The Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will screen for patients age ≥ 20 years and weight ≥35 kg for the following criteria: Inclusion criteria for patients with mild COVID-19 symptoms (outpatients) Diagnosed mild pneumonia using computed tomography (CT) and/or chest X-ray (CX-R) imaging, not requiring hospitalization. Signing informed consent. Inclusion criteria for patients with moderate COVID-19 symptoms (inpatients) Confirmed infection using PCR. Diagnosed moderate pneumonia using CT and/or CXR imaging, requiring hospitalization. Hospitalized ≤ 48 hours. Signing informed consent. Exclusion criteria Severe and critical pneumonia due to COVID-19. Underlying diseases, including AIDS, asthma, loiasis, and severe liver and kidney disease. Use of anticoagulants (e.g., warfarin) and ACE inhibitors (e.g., captopril). History of drug allergy to Ivermectin. Pregnancy or breastfeeding. Intervention and comparator Intervention groups: Outpatient and inpatient groups will receive the standard treatment regimen for mild and moderate COVID-19, based on the Iranian Ministry of Health and Medical Education's protocol, along with oral Ivermectin (MSD Company, France) at a single dose of 0.2 mg/kg. Control groups: The outpatient group will receive hydroxychloroquine sulfate (Amin Pharmaceutical Company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for seven subsequent days. The inpatient group will receive 200/50 mg Lopinavir/Ritonavir (Heterd Company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day. Other supportive and routine care will be the same in both outpatient and inpatient groups. Main outcome The primary outcomes are composite and include the improvement of clinical symptoms and need for hospitalization for outpatient groups, and the length of hospital stay until discharge, the need for ICU admission until discharge, and the need for mechanical ventilation for inpatient groups within seven days of randomization. The secondary outcome is the incidence of serious adverse drug reactions within seven days of randomization. Randomization Patients in both outpatient (mild) and inpatient (moderate) groups will be randomized into the treatment and control groups based on the following method. A simple randomization method and table of random numbers will be used. If the selected number is even, the patient is allocated to the treatment group, and if it is odd, the patient is allocated to the control group in a 1:1 ratio. Blinding (masking) This is an open-label study, and there is not blinding. Numbers to be randomized (sample size) A total number of 120 patients (60 outpatients and 60 patients) will be randomized into two groups (30 patients in each of the intervention groups and 30 patients in each of the control groups). Trial Status The protocol is Version 1.0, November 17, 2020. Recruitment began November 25, 2020, and is anticipated to be completed by February 25, 2021. Trial registration This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20200506047323N6”. The registration date is November 17, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.

scholarly journals Chinese Classical Prescription (Liang-Xue-Di-Huang Decoction) for Hemorrhoidal Disease: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Qing Zhou ◽  
Shuo-yang Shi ◽  
Ben-sheng Wu ◽  
Cheng-biao Xu ◽  
Ji Geng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Hemorrhoidal Disease ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Randomized Controlled ◽  
Objective Evidence ◽  
Agent Group

Abstract Background: Hemorrhoidal disease (HD) is one of the commonest proctologic condition in the general population. Medical therapy for HD has not been formally confirmed due to the inconsistent of results. Liang-Xue-Di-Huang Decoction, a kind of ancient Chinese classical prescription, has been used to treat HD from the 19th century in China. However, clinical research of Liang-Xue-Di-Huang Decoction in the treatment of HD is lack. We designed this study to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in the treatment of HD. Methods/Design: A randomized, controlled, double blind, double-mimetic agent and multicenter trial to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction is proposed. HD patients (stage I, Ⅱ, Ⅲ) will be randomly assigned into Liang-Xue-Di-Huang Decoction with the addition of Diosmine mimetic agent group and Diosmine with the addition of Liang-Xue-Di-Huang Decoction mimetic agent group. Patients will receive a 7-day treatments and a 7-day follow-up. The primary outcome measure is the French Bleeding Score in 7 and 14 days. The Secondary outcome measures are Goligher Prolapse Score and Quality-of-Life Score in 7 and 14 days. Discussion: This study will provide objective evidence to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in treatment of HD. Trial registration: Chinese Clinical Trial Registry. ChiCTR-1900022531.Registered 19 Apr 2019, http://www.chictr.org.cn/listbycreater.aspx. Keywords: Hemorrhoidal disease, Liang-Xue-Di-Huang Decoction, Chinese classical prescription, Randomized controlled trial.

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.

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