Possible effect of blonanserin on gambling disorder:A clinical study protocol and a case report

BACKGROUND Gambling disorder is characterized by excessive and recurrent gambling and can have serious negative social consequences.Although several psychotherapeutic and pharmacological approaches have been used to treat gambling disorder,new treatment strategies are needed.Growing evidence suggests that dopamine D3 receptor plays a specific role in the brain reward system.AIM To investigate if blonanserin,a dopamine D3 receptor antagonist,would be effective in reducing gambling impulses in patients with gambling disorder.METHODS We developed a study protocol to measure the efficacy and safety of blonanserin as a potential drug for gambling disorder,in which up to 12 mg/d of blonanserin was prescribed for 8 wk.RESULTS A 37-year-old female patient with gambling disorder,intellectual disability,and other physical diseases participated in the pilot study.The case showed improvement of gambling symptoms without any psychotherapy.However,blonanserin was discontinued owing to excessive saliva production.CONCLUSION This case suggests that blonanserin is potentially an effective treatment for patients with gambling disorder who resist standard therapies,but it also carries a risk of adverse effects. Further studies are needed to confirm the findings.

外耳道真菌病的病原学特征以及三种不同治疗方案的疗效分析

目的剖析外耳道真菌病的病例特征、病原菌分布以及不同治疗方案的疗效。方法回顾性分析97例外耳道真菌感染患者的临床资料,根据症状、外耳道分泌物镜检、真菌培养结果进行诊断,分别采用硝酸咪康唑乳膏、醋酸曲安奈德益康唑乳膏、3%硼酸洗液联合醋酸曲安奈德益康唑乳膏治疗,治疗周期2~4周。比较不同方案的临床疗效、不良反应及复发情况。结果97例外耳道真菌病中以≥51岁患者居多,男性多于女性。110侧真菌感染患耳中曲霉菌所占比例最大。3种治疗方案临床有效率比较,差异有统计学意义(χ^(2)=13.1996,P<0.05),联合用药组疗效最好,醋酸曲安奈德益康唑组次之。3个组不良反应发生率、疾病复发率均无明显差异(P>0.05)。结论外耳道真菌病与不良生活习惯关系密切,病原菌以曲霉菌最为常见,使用3%硼酸洗液联合醋酸曲安奈德益康唑乳膏治疗效果显著,且安全性好。

鼓室注射地塞米松磷酸钠注射液与注射用甲泼尼龙琥珀酸钠治疗突发性聋疗效观察及不良反应分析

目的探讨地塞米松磷酸钠注射液与注射用甲泼尼龙琥珀酸钠鼓室内注射治疗突发性聋的临床疗效并分析两种注射治疗后的不良反应。方法 2018年9月~2019年12月收治的单侧突发性聋患者94例,按数字表法随机分为A组(注射用甲泼尼龙琥珀酸钠组)和B组(地塞米松磷酸钠注射液组)各47例,分别行鼓室内注射注射用甲泼尼龙琥珀酸钠和鼓室内注射地塞米松磷酸钠注射液治疗,分析两组患者治疗前后纯音听阈值变化情况,并观察两组不良反应和空腹血糖变化情况。结果两组患者治疗后纯音听阈较治疗前均有明显改善(A组:t=9.86,P=0.001;B组:t=2.91,P=0.005),A组总有效率82.9%,B组总有效率为63.8%,两组总有效率比较,差异有统计学意义(χ2=4.41,P=0.036);两组总体不良反应率比较,差异无统计学意义(P>0.05);两组治疗前后空腹血糖变化比较,差异无统计学意义(P>0.05)。结论两种治疗方法均能改善突发性聋患者的纯音听阈,但注射用甲泼尼龙琥珀酸钠效果较地塞米松磷酸钠注射液更佳,两者的不良反应情况基本相仿。

Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis:study protocol of a multicenter randomized controlled trial

BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.

Evaluation on the efficacy and safety of Chinese herbal medication Xifeng Dingchan Pill in treating Parkinson's disease: study protocol of a multicenter, open-label, randomized active-controlled trial

BACKGROUND： Parkinson＇s disease （PD） is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its complex pathogenesis. Adverse effects from Western drug-based medical intervention prevent long-term adherence to these therapies in many patients. Traditional Chinese medicine （TCM） has long been used to improve the treatment of PD by alleviating the toxic and adverse effects of Western drug-based intervention. Therefore, the aim of this study is to evaluate the efficacy and safety of Xifeng Dingchan Pill （XFDCP）, a compound traditional Chinese herbal medicine, taken in conjunction with Western medicine in the treatment of PD patients at different stages in the progression of the disease. METHODS AND DESIGN： This is a multicenter, randomized controlled trial. In total, 320 patients with early- （n = 160） and middle-stage PD （n = 160） will be enrolled and divided evenly into control and trial groups. Of the 160 patients with early-stage PD, the trial group （n = 80） will be given XFDCP, and the control group （n = 80） will be given Madopar. Of the 160 patients with middle-stage PD, the trial group （n = 80） will be given XFDCP combined with Madopar and Piribedil, and the control group （n = 80） will be given Madopar and Piribedil. The Unified Parkinson＇s Disease Rating Scale scores, TCM symptoms scores, quality of life, change of Madopar＇s dosage and the toxic and adverse effects of Madopar will be observed during a 3-month treatment period and through a further 6-month follow-up period. DISCUSSION： It is hypothesized that XFDCP, combined with Madopar and Piribedil, will have beneficial effects on patients with PD. The results of this study will provide evidence for developing a comprehensive therapy regimen, which can delay the progress of the disease and improve the quality of life for PD patients in different stages. TRIAL REGISTRATION： This trial has been registered in the Chinese Clinical Trial Registry with the identifer ChiCTR-TRC-12002150.

Assessment of load-sharing thoracolumbar injury: A modified scoring system

BACKGROUND Many classification systems of thoracolumbar spinal fractures have been proposed to enhance treatment protocols,but none have achieved universal adoption.AIM To develop a new patient scoring system for cases with thoracolumbar injury classification and severity score(TLICS)=4,namely the load-sharing thoracolumbar injury score(LSTLIS).METHODS Based on thoracolumbar injury classification and severity score,this study proposes the use of the established load-sharing classification(LSC)to develop an improved classification system(LSTLIS).To prove the reliability and reproducibility of LSTLIS,a retrospective analysis for patients with thoracolumbar vertebral fractures has been conducted.RESULTS A total of 102 cases were enrolled in the study.The scoring trend of LSTLIS is roughly similar as the LSC scoring,however,the average deviation based on the former method is relatively smaller than that of the latter.Thus,the robustness of the LSTLIS scoring method is better than that of LSC.LSTLIS can further classify patients with TLICS=4,so as to assess more accurately this particular circumstance,and the majority of LSTLIS recommendations are consistent with actual clinical decisions.LSTLIS is a scoring system that combines LSC and TLICS to compensate for the lack of appropriate inclusion of anterior and middle column compression fractures with TLICS.Following preliminary clinical verification,LSTLIS has greater feasibility and reliability value,is more practical in comprehensively assessing certain clinical circumstances,and has better accuracy with clinically significant guidelines.

Management of Otitis Media with Effusion

Otitis media with effusion is one of the most common diseases in children. Its treatment remains controversial. Clinical practice guidelines of OME allow watchful waiting for 3 months before treatment if the child with OME is not at risk for speech/language/or learning problems. Tympanostomy tube insertion is the preferred initial procedure when a child becomes a surgical candidate. Complementary or alternative medicine is not recommended as a treatment for OME. This paper provides a systematic review of management of OME, which we hope will be helpful for clinicians.

Delivery of acupuncture in clinical trials:Research acupuncturists’perspectives

Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly those trained in traditional Chinese medicine(TCM), are often required to set aside valued precepts of traditional care, including diagnosing imbalances, individualizing treatment, and forging a therapeutic relationship with patients. TCM-trained acupuncturists express mixed feelings about participating in clinical trials. Many are eager to play a vital role in the advancement of acupuncture science and appreciate the need for strict protocol adherence to minimize bias. However, the acupuncturist(s) may also have concerns about clinical trial methodology, including but not limited to the delivery of a control condition, e.g., sham acupuncture. Investigators should anticipate certain questions and even a level of resistance to the requirements of research among acupuncturists and be prepared to address them. This manuscript presents a brief review of the subjective experience of the research acupuncturist within the available scientific literature as it pertains to the delivery of active and sham clinical research protocols. Our goals are to better understand the perspectives of acupuncturists who may participate in clinical research, so that their concerns may be addressed in study design and methodology. To that end, we suggest the creation of a novel training program specifically for clinical trial acupuncturists, intended for qualified TCM-and Western-trained practitioners, that would help to standardize the research acupuncturist’s role and help to strengthen the design and execution of acupuncture studies.

Analysis of Interventional Clinical Research Protocols Related to Coronavirus Disease 2019 and Future Expectations

Coronavirus disease 2019(COVID-19)is a newly emerging infectious disease.After its outbreak,researchers started a large number of clinical interventional studies,using a variety of interventions to study the different types of COVID-19 cases.In this article,we searched the websites of Chinese Clinical Trial Registry,Clinical Trials.gov,etc.,to study the publicly registered research information.Through the classification and summary of interventional methods,evaluation indicators,research design,etc.,this article provided readers with the outline of clinical research about COVID-19,and looked forward to the scientificity,feasibility,and future evidence of the clinical researches.

Effects of anterior sciatic nerve acupuncture on lower limb paralysis after cerebral infarction:study protocol for a randomized controlled trial

Stroke is the main cause of disability in the middle and old age.Hemiplegia,especially lower limb paralysis,often leads to the loss of self-care ability and a series of secondary injuries.The main method to improve hemiplegic limb movement is exercise therapy,but there are still many patients with disabilities after rehabilitation treatment.As one of the non-pharmacological therapies for stroke,acupuncture has been recognized to improve motor function in patients.Here,we propose a new method,anterior sciatic nerve acupuncture,which can stimulate both the femoral nerve and the sciatic nerve.We designed this study to determine the effect of this method on lower limb motor function.Sixty participants recruited with hemiplegia after cerebral infarction will be randomly assigned to the test group or control group in a 1:1 ratio.The control group will receive Xingnao Kaiqiao acupuncture,and the test group will receive anterior sciatic nerve acupuncture on this basis.All participants will get acupuncture treatment once a day,6 times a week for 2 weeks.The primary outcome is Fugl-Meyer Assessment of Lower Extremity and the secondary outcomes are Modified Ashworth Scale and Modified Barthel Index.Data will be collected before treatment,1week after treatment,and 2 weeks after treatment,and then statistical analysis will be performed.This study can preliminarily verify the effect of anterior sciatic nerve acupuncture on improving lower limb motor function in patients with cerebral infarction,which may provide an alternative approach for clinical treatment of hemiplegia.

Chinese Expert Consensus on the Diagnosis and Treatment of Adult Dermatomyositis (2022)

Dermatomyositis,an idiopathic inflammatory myopathy,is characterized by distinctive skin manifestations,proximal muscle weakness,and multiple organ involvement and can be accompanied by malignancies.To provide a reference for dermatologists and clinicians in other relevant fields of clinical practice,experts from the Dermatology Branch of the China International Exchange and Promotion Association for Medical and Health Care and the National Clinical Research Center for Dermatologic and Immunologic Diseases developed this consensus on the diagnosis and treatment of adult dermatomyositis using Chinese and international literature and expert advice.

Severe facial paralysis:early clinical manifestations and treatment

The study explained features of severe facial paralysis of early stage from the level and degree of nerve injury,syndromes and clinical manifestations of peripheral facial paralysis.Treating protocols with acupuncture were worked out concerning its characteristics to acquire the law of treatment,especially on the severe case.Severe facial paralysis is not only known as the focus of the study on acupuncture treatment,but also the key point to approve the effectiveness of acupuncture on peripheral facial paralysis.

Efficacy and safety of the Qiguiyin formula in severe pneumonia: study protocol for a randomized, double-blind, placebo-controlled clinical trial

OBJECTIVE: To evaluate the clinical efficacy and safety of Qiguiyin(QGY) formula in patients with severe pneumonia in China compared with a placebo.METHODS: This is a multicenter double-blind, placebo-controlled, randomized clinical trial with two parallel arms. There will be 530 patients enrolled and randomized into either the experimental group(QGY formula) or the control group(placebo). Therapies for patients in the two groups above will be based on the conventional therapy. The primary outcome is 28-day mortality. Secondary outcomes include:(a) duration of hospital stay;(b) duration of time in the intensive care unit(ICU) stays;(c) duration of mechanical ventilation;(d) antibiotic DDD value(which means the doses of antibotics during the treatment period);(e) serum procalcitonin(PCT) level;(f) serum C-reactive protein(CRP)level;(g) Pneumonia severity index(PSI) score;(h)Sequential Organ Failure Assessment(SOFA) score;(i) sputum culture results;(j) blood routine examination results;(k) routine urine test results;(l) stool routine examination results;(m) electrocardiogram results;(n) alanine aminotransferase levels;(o) aspartate amino transferase levels;(p) total bilirubin;(q) creatinine levels;(r) urea nitrogen levels;and(s)adverse events.ETHICS AND DISSEMINATION: The protocol has been approved by the Research Ethics Committee of Beijing Hospital of Traditional Chinese Medicine,Affiliated with Capital Medical University(2018 BL-053-02). This trial aims to provide evidence for QGY formula combined with conventional therapy in treating patients with severe bacterial pneumonia,and to verify the clinical effectiveness and safety of QGY formula in China compared with placebo. Additionally, this trial will reveal the effect of QGY formula on delaying/reversing the characteristics of drug-resistant bacteria.Trial registration number: Chi CTR1800019785.

Bloodletting puncture in the treatment of acute ischemic stroke:protocol for a mixed-method study of a multi-center randomized controlled trial and focus group

This study is to investigate the effectiveness and safety of bloodletting puncture(BP)for acute ischemic stroke(AIS)when used in combination with standard treatment,as well as the patients'feelings and attitudes toward the treatment.This is a mixed method research which includes a multi-center,superiority,randomized controlled clinical trial,and focus group interview.A total of 360 AIS participants will be enrolled.They will be randomized into one of the following two groups for 7 d:(a)BP with standard treatment group(n=180);(b)standard treatment group(n=180).The primary outcome will be National Institute of Health stroke scale(NIHSS)score at day 7 after treatment.Secondary outcomes will be changes of Glasgow Coma Scale score,NIHSS score,mRS and Traditional Chinese Medicine syndrome score from baseline to 7,14,and 30 d after treatment,recurrence rate and all-cause mortality rate within 30 d,and the safety assessments.The focus group will be conducted with a purposive sample of 1-2 acupuncturists and 1-2 patients respectively at each center at 7 and 30 d after treatment.We designed a mixed method study to evaluate the effect of BP,an acupuncture therapy for patients with AIS.If the findings of this study confirm the effectiveness of BP to reduce the NIHSS score and other related outcomes and patients are willing to accept the therapy,we believe this study will help the implementation of this therapy in clinical practice,and provide new evidence for the treatment of AIS.

Contralateral needling at the foot of unaffected side combining with rehabilitation treatment for motor dysfunction of hand after ischemic stroke:study protocol for a randomized controlled pilot trial

This pilot study is to assess the feasibility and the effect of a combination therapy of rehabilitation treatment and contralateral needling,which is manipulated at the foot of the unaffected side,for the recovery of the paretic hand post-stroke.This prospective pilot clinical trial will recruit 72 stroke patients with paretic hands and a disease course of 14 to 90 d.Patients will be randomized into two groups:the control group will receive conventional Xingnao Kaiqiao acupuncture and basic treatment for the stroke;based on the control group,the observation group will receive the contralateral needling at the foot of the unaffected side combined with the rehabilitation movement of the paretic hand.12 sessions will be administrated for 2 weeks.The primary outcome,FuglMeyer Assessment,and the secondary outcomes,the handgrip strength,the range of motion,the modified Barthel index,and the Brunnstrom recovery stages,will be measured the recovery of the hand motor function during the 2 weeks'intervention.This study aims to investigate the instant effect of contralateral needling at the foot of the unaffected side combined with the rehabilitation treatment movement for patients with the paretic hand of Poststroke motor dysfunction and provide the previous evidence for the future large sample studies.

Therapy of replenishing Yin and regulating Yang for manic episode in bipolar disorder:study protocol for a prospective,double-blind,randomized controlled trial

Bipolar disorder(BD) is a chronic and recurrent disorder characterized by biphasic mood episodes of mania or hypomania and depression.It affects more than 1% of the global population and is a leading cause of disability in young people.Currently available treatments for BD are still fairly limited in terms of efficacy,with high rates of non-adherence,non-response,and undesirable side effects.Traditional Chinese medicine(TCM) has a long history and rich experience in stabilizing mania and improving quality of life.Aiming at rebalancing Yin and Yang in BD,therapy of replenishing Yin and regulating Yang(RYRY therapy) has been in clinical use for years in China.The present prospective,double-blind,randomized controlled trial is designed to investigate the efficacy and safety of RYRY therapy for bipolar mania and its possible mechanism from the point of regulating gut microbiota and anti-inflammation.A total of 60 eligible participants will be recruited from Beijing Anding Hospital.They will be randomized to either the study group or the control group in a ratio of 1∶1.Participants allocated to the study group will receive RYRY granule,while placebo granule will be applied in the control group.Participants in both groups will be prescribed conventional therapy for manic episode in BD.Four scheduled visits will be conducted over 4 weeks.Outcome measurements include Young Mania Rating Scale,TCM Symptom Pattern Rating Scale,Treatment Emergent Symptom Scale,levels of C-reactive protein,interleukin-6 and tumor necrosis factor-α and the gut microbial community profile of stool samples.Safety outcomes and adverse events will also be recorded.In this study,we set a number of scientific and objective assessments to evaluate the efficacy of RYRY therapy and study into its possible mechanism,hopefully offering clinicians an alternative approach to BD.

Effectiveness and safety of Chinese herbal medicines for hepatitis B virus-related acute-on-chronic liver failure:study protocol for a multicenter randomized controlled trial

OBJECTIVE:To conduct a multicenter randomized controlled trial of the efficacy of standardized Chinese herbal medicines(CHMs)against acuteon-chronic liver failure(ACLF)and provide reproducible and high-level evidence for clinical practice.METHODS:This is a prospective,multicenter,centrally randomized controlled trial.Patients diagnosed with hepatitis B virus-related ACLF(n=510)will be allocated to the standard medical therapy or CHM group at a 1∶1 ratio.Two CHMs will be used on the basis of the traditional Chinese medicine syndrome:Liangxue Jiedu granules for excess syndromes and Yiqi Jiedu granules for deficiency syndromes.The primary outcome is transplant-free survival at week 12.The secondary outcomes are(a)transplant-free survival at week 24,(b)liver function as assessed using the model for end-stage liver disease score at week 12,(c)liver function as assessed using the Child-Pugh score at week 12,and(d)the incidence of complications at week 12.DISCUSSION:The effectiveness and safety of CHM formulations will be assessed following treatment for ACLF.TRIAL REGISTRATION:The trial was registered at Clinical Trials.gov(NCT03577938)on June 24,2018.

An international multicentric phaseⅢrandomized controlled trial of time-acupoints-space acupuncture for the prevention of chemotherapy-induced fatigue in patients with early stage breast cancer:a study protocol

OBJECTIVE:To determine the difference in prevention of chemotherapy-induced fatigue between time-acupointsspace acupuncture(ATAS)administered weekly compared to sham acupuncture and non-acupuncture in patients with early breast cancer receiving adjuvant chemotherapy by epirubicine-cyclophosphamide(EC)followed by paclitaxel,as measured by the multidimensional fatigue inventory(MFI)over the previous week and Visual Analogue Scale measuring fatigue(VAS-F),and to evaluate the effects of ATAS on selfreported neuropathy pain,sleep,anxiety and depression.METHODS:In this multicenter clinical trial,we have randomized patients into 3 groups:ATAS,Sham and nonacupuncture with an unequal randomization of 2∶1∶1.A cloud related electronical clinical report form and smartphone platform was established for data entry.Patients with a history of stageⅠ-Ⅲbreast cancer scheduled to receive adjuvant chemotherapy.Acupuncture will be delivered once a week during chemotherapy with VAS-F evaluation.In order to qualify and quantify the mechanism of fatigue induced by chemotherapy with or without acupuncture,an evaluation of immune profiling was incorporate in this study.RESULTS:The presence and seriousness of chemotherapy-induced fatigue should be considered in therapeutic programs for early breast cancer treatment.Fatigue induced by adjuvant chemotherapy in patients with breast cancer remains a major concern affecting the quality of life significantly.Unfortunately,we do not have effective pharmacological interventions yet.And clinical trials of acupuncture in preventing chemotherapyinduced fatigue in patients with early breast cancer have not been reported.CONCLUSION:The findings of the trial will allow us to determine the effects of acupuncture treatment approach.We will also be able to confirm whether ATAS is better than sham acupuncture and non-acupuncture treatments.

Effect of plum-blossom needling versus tropicamide eye drops on adolescent myopia: protocol for a randomized crossover trial

OBJECTIVE: Myopia is the most common eye problem and affects an estimated 28.3% of the global population. Its incidence is increasing annually. Myopia treatment is limited to correcting visual acuity.Acupuncture is one of the main therapies in traditional Chinese medicine and includes plum-blossom needling, which has been widely used forboth the prevention and treatment of adolescent myopia. We hypothesized that plum-blossom needling would be effective in treating myopia compared with a tropicamide eye drops control.METHODS: This is a crossover randomized controlled trial involving adolescents with myopia. Participants will be randomized 1∶1 to plum-blossom needle or tropicamide eye drops arms. Subjects in each arm will be treated for 20 d, followed by a 1-month washout period and treatment change for another 20 d. The primary outcome is uncorrected distance and cycloplegic refractive errors. The secondary outcomes comprise corneal curvature, lens thickness, axial length, ciliary body thickness, accommodation amplitude, the NRA/PRA(negative/positive relative accommodation), flexible adjustment, and near point of convergence. The outcome measures will be assessed at baseline, after the first treatment course(the first month), at the end of the washout period(the second month), after the second treatment course(the third month), and at follow-up(the sixth month).DISCUSSION: The results of the trial will help to provide evidence for the efficacy of plum-blossom needling for myopia in China.

Efficacy and safety of a sequential treatment with clearing heat and eliminating phlegm and tonifying Qi and activating blood circulation in treating acute ischemic stroke: study protocol for a randomized controlled trial

OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying Qi and activating blood circulation(TQABC)formula in patients with acute ischemic stroke(AIS)within a 72 h time window.METHODS:In this randomized,multicenter,doubleblinded,placebo-controlled trial,500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+TQABC group or control group.In addition to guidelinebased standard medical care,participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days,while those in the control group will receive CHEP formula placebo and TQABC formula placebo consecutively.The primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after randomization.The secondary outcome measures will include the scores on the modified Rankin Scale,Barthel Index,Patient-Reported Outcomes,TCM symptom pattern(Zheng-hou)evaluation Scale,and the incidence of in-hospital complications.Safety assessment will include the physical examination,laboratory detection,any adverse events or serious adverse events,and the proportion of any complications during hospitalization.DISCUSSION:The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on“integrating disease and symptom pattern”for patients with AIS.