Efficacy and Safety of Rituximab in Refractory CIDP With or Without IgG4 Autoantibodies (RECIPE): Protocol for a Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Background Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated peripheral neuropathy that is currently classified into several clinical subtypes, which are presumed to have different pathogenic mechanisms. Recently, studies identified a subgroup of patients with CIDP who were positive for IgG4 autoantibodies against paranodal proteins, such as neurofascin-155 and contactin-1, who respond poorly to first-line therapies for typical CIDP, including intravenous immunoglobulin therapy. Objective This study aims to evaluate the efficacy and safety of intravenous rituximab according to IgG4 autoantibody status in patients with refractory CIDP. Methods The Evaluation of the Efficacy and Safety of Rituximab in Refractory CIDP Patients with IgG4 Autoantibodies in the Exploratory Clinical (RECIPE) trial consists of 2 cohorts: a multicenter, placebo-controlled, randomized study cohort of 15 patients with IgG4 autoantibody-positive CIDP (rituximab:placebo = 2:1) and an open-label trial cohort of 10 patients with antibody-negative CIDP. The primary endpoint is improvement in functional outcome assessed using the adjusted Inflammatory Neuropathy Cause and Treatment Disability Scale score at 26, 38, or 52 weeks after the start of treatment with rituximab in patients with CIDP and anti-paranodal protein antibodies. Secondary outcome measures include grip strength, manual muscle testing sum scores, results of nerve conduction studies, and other functional scales. Results We plan to enroll 25 cases for the full analysis set. Recruitment is ongoing, with 14 patients enrolled as of January 2020. Enrollment will close in September 2020, and the study is planned to end in December 2021. Conclusions This randomized controlled trial will determine if rituximab is safe and effective in patients with anti-paranodal antibodies. An open-label study will provide additional data on the effects of rituximab in patients with antibody-negative CIDP. The results of the RECIPE trial are expected to provide evidence for the positioning of rituximab as a pathogenesis-based therapeutic for refractory CIDP. Trial Registration ClinicalTrials.gov NCT03864185, https://clinicaltrials.gov/ct2/show/NCT03864185 ; The Japan Registry of Clinical Trials jRCT2041180037, https://jrct.niph.go.jp/en-latest-detail/jRCT2041180037 International Registered Report Identifier (IRRID) DERR1-10.2196/17117

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Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05909-y ◽

2022 ◽

Vol 23 (1) ◽

Author(s):

Zhe Xue ◽

Zhen Huang ◽

Shu-li Cheng ◽

Xi-hong Wang ◽

Xuan Zhou ◽

...

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Adverse Reactions ◽

Controlled Trial ◽

Depression Scale ◽

Secondary Outcome ◽

Controlled Clinical Trial ◽

Hamilton Depression Scale ◽

Efficacy And Safety ◽

Moderate Depression

Abstract Background Depression is one of the most frequent and severe psychiatric conditions. Many chemical drugs to treat depression are associated with adverse reactions and have shortcomings. Traditional Chinese medicine is of great significance in the prevention and treatment of depression. Xiaoyao pills has achieved good results in clinical application, which has the advantages of quick effect and no obvious adverse reactions. The aim of our study is to evaluate the efficacy and safety of Xiaoyao pills on mild to moderate depression patients. Methods This study is a multi-centre, double-blinded, randomized and placebo-controlled clinical trial. A total of 108 participants are assigned to three groups: Xiaoyao pill group taking Xiaoyao pills twice daily for 4 weeks, placebo group taking placebos twice daily for 4 weeks and normal group without taking any drug. The primary and secondary outcome measures are the Hamilton Depression Scale (HAMD) and Traditional Chinese Medicine (TCM) Syndrome Scale. The assessment is at baseline (before treatment initiation), 1 week, 2 weeks 4 weeks after the first treatment. Exploratory outcome is also assessed to explore the mechanism of Xiaoyao pills at baseline and 4 weeks. Discussion The results from this study will provide clinical evidence on the efficacy and safety of Xiaoyao pills in patients with mild to moderate depression with syndrome of liver stagnation and spleen deficiency. Trial registration ClinicalTrials.gov ISRCTN12746343. Registered on September 25, 2020.

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Baidu Jieduan granule, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

10.21203/rs.3.rs-44542/v2 ◽

2020 ◽

Author(s):

Wen Zhang ◽

Qin Xie ◽

Xiaoming Xu ◽

Shuting Sun ◽

Tian Fan ◽

...

Keyword(s):

Clinical Trial ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Controlled Trial ◽

Theory And Practice ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Open Label ◽

Randomized Controlled

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

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Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05264-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Gao Huanjia ◽

Cai Hairong ◽

Zhuang Jieqin ◽

Dai Xingzhen ◽

Fu Xue ◽

...

Keyword(s):

Clinical Trial ◽

Angina Pectoris ◽

Stable Angina ◽

Cardiovascular Events ◽

Controlled Trial ◽

Chronic Stable Angina ◽

Secondary Outcome ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

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 evaluate 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, and 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 Chinese Clinical Trial Registry ChiCTR2100044563. Registered on 24 March 2020.

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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 ◽

10.1186/s13063-020-04988-7 ◽

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.

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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

10.21203/rs.2.30/v1 ◽

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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Baidu Jieduan granules, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label, randomized controlled clinical trial

Trials ◽

10.1186/s13063-021-05418-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Wen Zhang ◽

Qin Xie ◽

Xiaoming Xu ◽

Shuting Sun ◽

Tian Fan ◽

...

Keyword(s):

Clinical Trial ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Controlled Trial ◽

Theory And Practice ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Open Label ◽

Randomized Controlled

Abstract Background Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive effects on human health. Due to the absence of antiviral medicine for COVID-19 thus far, there is a desperate need to develop effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, with the aim of achieving clinical efficacy and decreasing the use of antibiotics and glucocorticoids. The aim of this study was to evaluate the efficacy and safety of Baidu Jieduan granules in treating COVID-19. Methods/design This multicentre, open-label, randomized controlled trial will be conducted in 300 patients with COVID-19. The patients will be randomly (1:1) divided into a treatment group and a control group. All patients will receive standard therapy at the same time. Patients in the experimental group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes will be assessed at baseline and at 3, 5, 7 and 14 days after treatment initiation. The primary outcome will be the rate of symptom (fever, fatigue and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial. Discussion The study will provide high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granules in the treatment of moderate COVID-19, and enrich the theory and practice of TCM in treating COVID-19. Trial registration Chinese Clinical Trial Registry ChiCTR2000029869. Registered on 15 February 2020

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Baidu Jieduan Granule in the Treatment of Coronavirus Disease-2019 (COVID-19): Study Protocol for an Open-Label Randomized Controlled Clinical Trial

10.21203/rs.3.rs-44542/v1 ◽

2020 ◽

Author(s):

Wen Zhang ◽

Qin Xie ◽

Xiaoming Xu ◽

Shuting Sun ◽

Tian Fan ◽

...

Keyword(s):

Clinical Trial ◽

Controlled Trial ◽

Theory And Practice ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Clinical Trial Registry ◽

Open Label ◽

Randomized Controlled ◽

Epidemic Diseases

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan Granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan Granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan Granule in treatment of severe COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

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Low-Dose Niacin Supplementation Improves Motor Function in US Veterans with Parkinson’s Disease: A Single-Center, Randomized, Placebo-Controlled Trial

Biomedicines ◽

10.3390/biomedicines9121881 ◽

2021 ◽

Vol 9 (12) ◽

pp. 1881

Author(s):

Chandramohan Wakade ◽

Raymond Chong ◽

Marissa Seamon ◽

Sharad Purohit ◽

Banabihari Giri ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Motor Function ◽

Low Dose ◽

Rating Scale ◽

Controlled Trial ◽

Randomized Study ◽

Secondary Outcome ◽

Open Label ◽

Double Blind

A six-month double-blind, placebo-controlled randomized study was conducted to ascertain whether low-dose daily niacin supplementation would improve motor symptoms in Parkinson’s disease (PD) patients. A total of 47 PD patients were assigned to receive low-dose niacin or a placebo. At the end of the double-blind phase, all participants received open-label niacin for the next six months. All patients were evaluated at baseline, after six months, and after one year of treatment. The primary outcome measure was the Unified Parkinson’s Disease Rating Scale III (UPDRS III) scores. Secondary outcome measures were depression, sleep quality, mental flexibility and cognition, and physical fatigue. Niacin treatment was well-tolerated by forty-five subjects. The mean [95% CI] change in UPDRS III scores at six months of placebo was −0.05 [95% CI, −2.4 to 2.32], and niacin was −1.06 [95% CI, −3.68 to 1.57]. From six to twelve months when both groups received open-label niacin supplementation, the average UPDRS III scores significantly decreased for the placebo group by 4.58 [95% CI, −0.85 to 8.30] and the niacin group by 4.63 [95% CI, 1.42 to 7.83] points. Low-dose niacin supplementation is a well-tolerated adjunct therapy and may improve motor function in PD when taken over a longer period.

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

10.21203/rs.3.rs-58168/v1 ◽

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.

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Efficacy and safety of Guhong injection for treating the Coronary microvascular disease: study protocol for a randomized controlled trial

10.21203/rs.2.13551/v1 ◽

2019 ◽

Author(s):

Jieqin Zhuang ◽

Shuling Liu ◽

Hairong Cai ◽

Xingzhen Dai ◽

Yanhong Chen ◽

...

Keyword(s):

Clinical Trial ◽

Cardiovascular Diseases ◽

Controlled Trial ◽

Microvascular Disease ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Open Label ◽

Double Blind ◽

Randomized Controlled

Abstract Background: Coronary microvascular disease (CMVD) refers to cardiovascular diseases with normal coronary angiography but evidence of myocardial ischemia or microcirculation lesions, often presenting as angina pectoris attack. Coronary artery of microtubules dysfunction is one of the pathogenesis of coronary heart disease,but the occurrence and development and the current of CMVD intervention therapy remains to be further researched.Chinese traditional medicine (TCM)has advantages in the treatment of cardiovascular diseases, therefore, this article describes an ongoing randomized controlled clinical trial, based on the theory of TCM, for the purpose of evaluating the efficacy and safety of Guhong injection ,a Chinese patent medicine,compared with placebo in patients suffering from CMVD. Methods/design: This is a multicenter, randomized, parallel arm, open-label, double-blind, placebo-controlled clinical trial. A total of 260 eligible patients will be allocated and randomly assigned, in a ratio of 1:1, to either the experimental group or the control group. The treatment course is 10 consecutive days, with a 8-week follow-up. The primary outcome is the frequency of angina attacks, Secondary outcomes include myocardial metabolites, ecg changes, quantitative score of TCM syndromes, inflammatory response and endothelial function indicators. Discussion: This trial is strictly designed in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high quality evidence on the efficacy and safety of Guhong injection in the treatment of CMVD. Trial registration: Chinese Clinical Trials Registry, ChiCTR1900022902. Registered on 27 April 2019.

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