Procalcitonin and C-Reactive Protein/Procalcitonin Ratio for Distinguishing between Infectious and Neoplastic Fever in Cancer Patients.

Objective: This study aims to investigate the potential of procalcitonin (PCT) levels and the C-reactive protein/procalcitonin (CRP/PCT) ratio as markers for distinguishing between infectious and neoplastic fever among febrile patients with malignant tumors. Methods: A retrospective analysis was conducted on febrile patients admitted to the hospital with malignant tumors. The patients were categorized into an infection group (67 cases) and a non-infection group (73 cases) based on the presence or absence of positive cultures. PCT levels, CRP levels, and CRP/PCT ratios were compared between the two groups. The receiver operating characteristic curve (ROC) was used to identify optimal cut-off values. Results: Data from 140 patients between January 2017 and December 2021 were extracted for analysis. Patients in the infected group showed elevated PCT levels and significantly decreased CRP/PCT ratios compared to the non-infected group (P < .01). The calculated cut-off values for distinguishing infectious and neoplastic fever were 0.52 ng/mL for PCT and 101.80 for CRP/PCT ratio. The ROC curve results revealed good sensitivity for both PCT (74.63%) and CRP/PCT (70.15%), while CRP/PCT demonstrated higher specificity (78.08%) compared to PCT (58.90%). Conclusions: PCT and CRP/PCT are both sensitive markers for identifying infection in patients with malignant tumors, with PCT showing slightly better sensitivity but lower specificity than CRP/PCT. Our findings suggest that CRP/PCT may be more valuable than PCT in distinguishing between infectious fever and neoplastic fever in cancer patients.

When Knowledge Is Not Enough: Applying a Behavioral Design Approach to Improve Fever Case Management in Nigeria.

BACKGROUND: We sought to encourage health care providers to adhere to national malaria case management guidelines. This requires them to conduct malaria parasite tests for every patient presenting with a fever and provide malaria treatment only to those who test positive for malaria. Our goal was to make it easier for providers to follow guidelines by addressing drivers of nonadherence uncovered through facility observations and interviews with staff and clients. IMPLEMENTATION AND MONITORING: The case management interventions were piloted in 12 public health facilities in Akwa Ibom, Kebbi, and Nasarawa states in Nigeria between October and December 2019. Participating facilities included 1 hospital and 3 primary health centers in each state. Relevant changes included the following: (1) providers at each facility participated in facilitated discussions to correct misconceptions about the reliability of malaria test kits; (2) testing procedures were integrated into existing triage systems; (3) treatment algorithms were integrated into medical record forms; (4) providers were issued pictorial brochures outlining danger signs to share with clients, together with instructions for when to seek further care; and (5) a process was created for facilities to monitor their own adherence to guidelines. LESSONS LEARNED: The lessons learned include: (1) disentangling the drivers of behavior allows for more targeted solutions, (2) solutions that streamline processes for overburdened providers allow them to redirect their attention and efforts where they can be most impactful, and (3) changing staff perceptions of workplace norms can support a holistic and sustained approach to behavior change.

Protocol for fever-range whole-body hyperthermia (WBH) in mice to study febrile effect on T-cell adhesion and migration.

Fever is a complex physiological response enhancing immune surveillance during infection and inflammation. Fever-range whole-body hyperthermia (WBH) treatment can experimentally mimic the febrile condition in mice. Here, we describe a protocol for the treatment of mice with WBH and normothermia. We describe the isolation of T cells from mouse spleen followed by the evaluation of T-cell adhesion and transmigration. This animal model can be applied to studying the dysfunction of the immune system induced by fever. For complete details on the use and execution of this protocol, please refer to Lin et al. (2019).

Improved seizure burden and cognitive performance in a child treated with responsive neurostimulation (RNS) following febrile infection related epilepsy syndrome (FIRES).

Responsive neurostimulation (RNS) is an emerging therapy for patients with refractory focal epilepsy who are not candidates for surgical resection, with limited published experience in the pediatric population. We report a case of refractory multifocal epilepsy following febrile infection related epilepsy syndrome (FIRES) in which surgical resection was not feasible due to multifocal independent seizures and risk of cognitive deficit, and RNS was pursued. Relevant RNS data and neuropsychological testing results were reviewed. By eight months after implantation, decreased frequency and severity of clinical seizures were noted, and RNS data revealed decreased "long episodes," reduced spread of electrographic seizures, and fewer detections. Neuropsychological assessment, though potentially confounded by stimulant medication, revealed significant improvement in multiple cognitive domains, particularly working memory and processing speed, at six months. These findings illustrate success in detecting and aborting seizures, and additionally suggest a neuromodulatory effect of RNS stimulation. Our case demonstrates feasibility, efficacy and safety of RNS in a pediatric patient with FIRES, with evidence to also suggest cognitive improvement.

Micronutrients as immunomodulatory tools for COVID-19 management.

COVID-19 rapidly turned to a global pandemic posing lethal threats to overwhelming health care capabilities, despite its relatively low mortality rate. The clinical respiratory symptoms include dry cough, fever, anosmia, breathing difficulties, and subsequent respiratory failure. No known cure is available for COVID-19. Apart from the anti-viral strategy, the supports of immune effectors and modulation of immunosuppressive mechanisms is the rationale immunomodulation approach in COVID-19 management. Diet and nutrition are essential for healthy immunity. However, a group of micronutrients plays a dominant role in immunomodulation. The deficiency of most nutrients increases the individual susceptibility to virus infection with a tendency for severe clinical presentation. Despite a shred of evidence, the supplementation of a single nutrient is not promising in the general population. Individuals at high-risk for specific nutrient deficiencies likely benefit from supplementation. The individual dietary and nutritional status assessments are critical for determining the comprehensive actions in COVID-19.

Non-contact infrared versus axillary and tympanic thermometers in children attending primary care: a mixed-methods study of accuracy and acceptability.

BACKGROUND: Guidelines recommend measuring temperature in children presenting with fever using electronic axillary or tympanic thermometers. Non-contact thermometry offers advantages, yet has not been tested against recommended methods in primary care. AIM: To compare two different non-contact infrared thermometers (NCITs) to axillary and tympanic thermometers in children aged ≤5 years visiting their GP with an acute illness. DESIGN AND SETTING: Method comparison study with nested qualitative component. METHOD: Temperature measurements were taken with electronic axillary (Welch Allyn SureTemp®), electronic tympanic (Braun Thermoscan®), NCIT Thermofocus® 0800, and NCIT Firhealth Forehead. Parents rated acceptability and discomfort. Qualitative interviews explored parents' experiences of the thermometers. RESULTS: In total, 401 children were recruited (median age 1.6 years, 50.62% male). Mean difference between the Thermofocus NCIT and axillary thermometer was -0.14°C (95% confidence interval [CI] = -0.21 to -0.06°C); lower limit of agreement was -1.57°C (95% CI = -1.69 to -1.44°C) and upper limit 1.29°C (95% CI = 1.16 to 1.42°C). A second NCIT (Firhealth) had similar levels of agreement; however, the limits of agreement between tympanic and axillary thermometers were also wide. Parents expressed a preference for the practicality and comfort of NCITs, and were mostly negative about their child's experience of axillary thermometers. But there was willingness to adopt whichever device was medically recommended. CONCLUSION: In a primary care paediatric population, temperature measurements with NCITs varied by >1°C compared with axillary and tympanic approaches. But there was also poor agreement between tympanic and axillary thermometers. Since clinical guidelines often rely on specific fever thresholds, clinicians should interpret peripheral thermometer readings with caution and in the context of a holistic assessment of the child.

Clinical features and treatment of COVID-19 patients in northeast Chongqing.

The outbreak of the novel coronavirus in China (SARS-CoV-2) that began in December 2019 presents a significant and urgent threat to global health. This study was conducted to provide the international community with a deeper understanding of this new infectious disease. Epidemiological, clinical features, laboratory findings, radiological characteristics, treatment, and clinical outcomes of 135 patients in northeast Chongqing were collected and analyzed in this study. A total of 135 hospitalized patients with COVID-19 were enrolled. The median age was 47 years (interquartile range, 36-55), and there was no significant gender difference (53.3% men). The majority of patients had contact with people from the Wuhan area. Forty-three (31.9%) patients had underlying disease, primarily hypertension (13 [9.6%]), diabetes (12 [8.9%]), cardiovascular disease (7 [5.2%]), and malignancy (4 [3.0%]). Common symptoms included fever (120 [88.9%]), cough (102 [76.5%]), and fatigue (44 [32.5%]). Chest computed tomography scans showed bilateral patchy shadows or ground glass opacity in the lungs of all the patients. All patients received antiviral therapy (135 [100%]) (Kaletra and interferon were both used), antibacterial therapy (59 [43.7%]), and corticosteroids (36 [26.7%]). In addition, many patients received traditional Chinese medicine (TCM) (124 [91.8%]). It is suggested that patients should receive Kaletra early and should be treated by a combination of Western and Chinese medicines. Compared to the mild cases, the severe ones had lower lymphocyte counts and higher plasma levels of Pt, APTT, d-dimer, lactate dehydrogenase, PCT, ALB, C-reactive protein, and aspartate aminotransferase. This study demonstrates the clinic features and therapies of 135 COVID-19 patients. Kaletra and TCM played an important role in the treatment of the viral pneumonia. Further studies are required to explore the role of Kaletra and TCM in the treatment of COVID-19.

Biochemical detection of fatal hypothermia and hyperthermia in affected rat hypothalamus tissues by Fourier transform infrared spectroscopy.

It is difficult to determinate the cause of death from exposure to fatal hypothermia and hyperthermia in forensic casework. Here, we present a state-of-the-art study that employs Fourier-transform infrared (FTIR) spectroscopy to investigate the hypothalamus tissues of fatal hypothermic, fatal hyperthermic and normothermic rats to determine forensically significant biomarkers related to fatal hypothermia and hyperthermia. Our results revealed that the spectral variations in the lipid, protein, carbohydrate and nucleic acid components are highly different for hypothalamuses after exposure to fatal hypothermic, fatal hyperthermic and normothermic conditions. In comparison with the normothermia group, the fatal hypothermia and hyperthermia groups contained higher total lipid amounts but were lower in unsaturated lipids. Additionally, their cell membranes were found to have less motional freedom. Among these three groups, the fatal hyperthermia group contained the lowest total proteins and carbohydrates and the highest aggregated and dysfunctional proteins, while the fatal hypothermia group contained the highest level of nucleic acids. In conclusion, this study demonstrates that FTIR spectroscopy has the potential to become a reliable method for the biochemical characterization of fatal hypothermia and hyperthermia hypothalamus tissues, and this could be used as a postmortem diagnostic feature in fatal hypothermia and hyperthermia deaths.

Pyrogens, a polypeptide produces fever by metabolic changes in hypothalamus: Mechanisms and detections.

Fever is one of the cardinal symptoms of onset of an infection or inflammation and is the common clinical indicator for medical consultation in mammalian host worldwide. Simply, fever manifested with elevation of body temperature from normal physiological range represents adaptive response of immune system on challenge with an infectious and non-infectious circumstance. Fever usually initiated in the periphery as a result of interaction of immune cells with exogenous or endogenous pyrogens. Peripheral pyrogenic signals gain access to the central nervous system via humoral and neural route. Humoral pathway was initiated with production of pyrogenic cytokines and prostaglandins from immune cells of blood as well as liver, transmitted directly to pre-optic area of hypothalamus through the circumventricular organ of brain. On the other hand an alternative pathway was initiated by the same cytokines indirectly via stimulating the vagal sensory neurons result in pyrogenic fever; so-called neuronal pathway. If the magnitude of pyrogens associated fever is very high, it will lead to severe illness ranging from septic shock to death. So it is necessary to evaluate the presence of pyrogens in implants, medical devices, drugs and biological materials to ensure safety in biomedical applications and therapeutics. Classification, route of administration, mechanism of action and detection of pyrogens and associated products are the major subject of this review.

Local classifications of fever and treatment sought among populations at risk of zoonotic diseases in Ghana.

In the past four decades, there has been an increase in the occurrence of zoonotic diseases. Some outbreaks have been devastating because of the inability of individuals and health workers to identify the diseases early. Generally, most zoonotic diseases are heralded by a fever. While fevers are common, they are often the symptoms of different diseases. This paper explores how a population at potential risk of zoonotic diseases identify fevers, and what treatments they seek when they develop fevers. The data are from focus group discussions and a survey of three communities in the Brong Ahafo, Volta and Greater Accra regions in Ghana. The quantitative data were analysed using descriptive statistics while the qualitative data were analysed using thematic analysis. The findings indicate that the perceived causes of fever differ from the traditional biomedical view. While orthodox treatment was the preferred choice for most participants, rural dwellers utilised traditional medicine more than their urban counterparts. Though there is no record of bat-borne zoonotic disease in Ghana, our findings could be used as a proxy to indicate how populations at risk of exposure might respond in the event of a spillover event from a zoonosis. We recommend that educational campaigns on zoonotic diseases should target rural dwellers, especially farmers, who may be most at risk of zoonoses.

[Connotation interpretation of "only one syndrome is evident for disease" in Treatise on Febrile Diseases by Zhang Zhongjing].

"Only one syndrome is evident for disease", a clinical guiding ideology in the Treatise on Febrile Diseases proposed by Zhang Zhongjing, has caused widespread controversy among physicians over the ages. The core lies in the divergence of the understanding of "one syndrome". The reason is that although many physicians sum up experience on the basis of their clinical experience, the premise of the clinical environment is ignored when interpreting the connotation. On the one hand, "only one syndrome is evident for disease" emphasizes the flexibility of grasping the main symptoms clinically. On the other hand, it emphasizes the evidence sufficiency of "one syndrome" as the basis for diagnosis. Generally speaking, specific symptoms are higher evidence as a basis for diagnosis. However, because of the clinical complexity, the symptoms with lower specificity, less targeting and lower evidence strength in common cases may become the key points of the final prescription selection in specific cases sometimes, increasing the strength of evidence and becoming the only important factor in determining the overall situation. In addition to the objective clinical conditions, some subjective factors such as clinical level and academic quality of the physicians are also important factors that affect the clinical application of "only one syndrome is evident for disease". Therefore, it is necessary to not only pay attention to the clinical objective conditions, but also try to improve the physicians' clinical level, appreciate the "only one syndrome is evident for disease" thought in the clinical environment, which is the key to solve this problem.

Electronic clinical decision algorithms for the integrated primary care management of febrile children in low-resource settings: review of existing tools.

BACKGROUND: The lack of effective, integrated diagnostic tools poses a major challenge to the primary care management of febrile childhood illnesses. These limitations are especially evident in low-resource settings and are often inappropriately compensated by antimicrobial overprescription. Electronic clinical decision algorithms (eCDAs) have the potential to close these gaps by guiding antibiotic use and better identifying serious disease. AIMS: This narrative review summarizes existing eCDAs, to provide an overview of their degree of validation and to identify gaps in current knowledge and prospects for future innovation. SOURCES: Structured literature review in PubMed and Embase complemented by Google search and contact with developers. CONTENT: Six integrated eCDAs were identified: three (eIMCI, REC and Bangladesh digital IMCI) based on Integrated Management of Childhood Illnesses (IMCI); four (SL electronic iCCM, MEDSINC, electronic iCCM and D-Tree electronic iCCM) on Integrated Community Case Management (iCCM); two (ALMANACH, MSFeCARE) with a modified IMCI content; and one (ePOCT) that integrates novel content with biomarker testing. The types of publications and evaluation studies varied greatly: the content and evidence base were published for two (ALMANACH and ePOCT) and ALMANACH and ePOCT were validated in efficacy studies. Other types of evaluations, such as compliance and acceptability, were available for D-Tree electronic iCCM, eIMCI and ALMANACH. Several evaluations are still ongoing. Future prospects include conducting effectiveness and impact studies using data gathered through larger studies to adapt the medical content to local epidemiology, improving the software and sensors, and assessing factors that influence compliance and scale-up. IMPLICATIONS: eCDAs are valuable tools that have the potential to improve management of febrile children in primary care and increase the rational use of diagnostics and antimicrobials. Next steps in the evidence pathway should be larger effectiveness and impact studies (including cost analysis) and continuous integration of clinically useful diagnostic and treatment innovations.

Tropical diseases in the ICU: A syndromic approach to diagnosis and treatment.

Tropical infections form 20-30% of ICU admissions in tropical countries. Diarrheal diseases, malaria, dengue, typhoid, rickettsial diseases and leptospirosis are common causes of critical illness. Overlapping clinical features makes initial diagnosis challenging. A systematic approach involving (1) history of specific continent or country of travel, (2) exposure to specific environments (forests or farms, water sports, consumption of exotic foods), (3) incubation period, and (4) pattern of organ involvement and subtle differences in manifestations help in differential diagnosis and choice of initial empiric therapy. Fever, rash, hypotension, thrombocytopenia and mild derangement of liver function tests is seen in a majority of patients. Organ failure may lead to shock, respiratory distress, renal failure, hepatitis, coma, seizures, cardiac arrhythmias or hemorrhage. Diagnosis in some conditions is made by peripheral blood smear examination, antigen detection or detection of microbial nucleic acid by PCR. Tests that detect specific IgM antibody become positive only in the second week of illness. Initial therapy is often empiric; a combination of intravenous artesunate, ceftriaxone and either doxycycline or azithromycin would cover a majority of the treatable syndromes. Additional antiviral or antiprotozoal medications are required for some specific syndromes. Involving a physician specializing in tropical or travel medicine is helpful.

Febrile illness in Asia: gaps in epidemiology, diagnosis and management for informing health policy.

BACKGROUND: Increasing evidence is becoming available on the aetiology and management of fevers in Asia; the importance of these fevers has increased with the decline in the incidence of malaria. AIMS: To conduct a narrative review of the epidemiology and management of fevers in South and South-East Asia and to highlight gaps in our knowledge that impair evidence-based health policy decisions. SOURCES: A narrative review of papers published since 2012 on developments in fever epidemiology, diagnosis and treatment in South and South-East Asia. The papers that the authors felt were pivotal, from their personal perspectives, are discussed. CONTENT: We identified 100 studies. Among the 30 studies (30%)-including both children and adults-that investigated three or more pathogens, the most frequently reported fever aetiology was dengue (reported by 15, 50%), followed by leptospirosis (eight, 27%), scrub typhus (seven, 23%) and Salmonella serovar Typhi (six, 20%). Among four studies investigating three or more pathogens in children, dengue and Staphylococcus aureus were the most frequent, followed by non-typhoidal Salmonella spp, Streptococcus pneumoniae, Salmonella serovar Typhi, and Orientia tsutsugamushi. Increased awareness is needed that rickettsial pathogens are common but do not respond to cephalosporins, and that alternative therapies, such as tetracyclines, are required. IMPLICATIONS: Many key gaps remain, and consensus guidelines for study design are needed to aid comparative understanding of the epidemiology of fevers. More investment in developing accurate and affordable diagnostic tests for rural Asia and independent evaluation of those already on the market are needed. Treatment algorithms, including simple biomarker assays, appropriate for empirical therapy of fevers in different areas of rural Asia should be a major aim of fever research. Enhanced antimicrobial resistance (AMR) surveillance and openly accessible databases of geography-specific AMR data would inform policy on empirical and specific therapy. More investment in innovative strategies facilitating infectious disease surveillance in remote rural communities would be an important component of poverty reduction and improving public health.

[THE DIFFERENTIATED APPROACH TO PREVENTION OF NEURAL TUBE DEFECTS IN CHILDREN].

Neural tube defects occupy second place in frequency after the defects of the cardiovascular system. The folate metabolism violation and hyperhomocysteinemia in women are proved to be the leading risk factors for the NTD of the fetus. Polymorphism of the 5,10-methylenetetrahydrofolate reductase gene (MTHFR) is a genetic determinant of folate metabolism violation. Admission of folic acid in a standard dose of 0.4 mg and / or the use of fortified foods does not allow reaching the protective level of folic acid if there is a mutation of the MTHFR gene or when several risk factors combine, which requires a higher dose of folic acid. The aim of the study is to develop an algorithm for the identification of women of reproductive age with the risk of having a child with NTD and to apply differentiated approach to the choice of a preventive dose of folic acid. A retrospective analysis of NTD cases in the Odessa region (Ukraine) for 2000-2013 was carried out. The frequency of the birth of children with CNS defects and NTD, risk factors of NTD in children were studied. Mothers and their children with NTD were evaluated for the level of folic acid, homocysteine and the presence of C677T and A1298C MTHFR polymorphisms. The incidence of spina bifida aperta is 4.9 per 10,000 newborns. Two groups of significant risk factors for the NTD in children were identified: 1) risk factors that can be eliminated - the absence of preconceptional prevention of NTD with folic acid (AR 0.4), second-hand tobacсo smoking (AR 0.33), fever/hot baths in the first trimester of pregnancy (AR 0.64), use of well water for cooking (AP 0.44); 2) risk factors that can not be eliminated, and which indicate a genetic risk of NTD - a family history of a stroke, heart attack, thrombosis, congenital malformations, malignant tumors (AR 0.54-0.7), an obstetrical history of miscarriage (AR 0.56 ), mother's diseases (varicose disease, obesity), NTD in other children in this family (AR 0.74). The mothers of children with NTD showed a decreased level of folic acid and an increased level of homocysteine in addition to the correlation of hyperhomocysteinemia with the mutations of the MTHFR gene. The algorithm for assessing the individual risk of having a child with NTD includes the evaluation of risk factors. If a genetic factor of folate metabolism violation or environmental risk factors that can not be eliminated are found, we recommend an additional examination. It includes determining the level of homocysteine and the MTHFR polymorphisms (in the case of hyperhomocysteinemia), which will identify the required dose of folic acid.

Leptospirosis: Report from the task force on tropical diseases by the World Federation of Societies of Intensive and Critical Care Medicine.

Leptospirosis is a zoonosis caused by a gram negative aerobic spirochete of the genus Leptospira. It is acquired by contact with urine or reproductive fluids from infected animals, or by inoculation from contaminated water or soil. The disease has a global distribution, mainly in tropical and subtropical regions that have a humid, rainy climate and is also common in travelers returning from these regions. Clinical suspicion is critical for the diagnosis and it should be included in the differential diagnosis of any patient with a febrile hepatorenal syndrome in, or returning from endemic regions. The leptospiremic phase occurs early and thereafter there is an immunologic phase in which the most severe form, Weil's disease, occurs. In the latter, multiple organ dysfunction predominates. The appropriate diagnostic test depends on the stage of the disease and consists of direct and indirect detection methods and cultures. Severely ill patients need to be monitored in an ICU with appropriate anti-bacterial agents and early, aggressive and effective organ support. Antibiotic therapy consists of penicillins, macrolides or third generation cephalosporins.

Cost-effectiveness analysis of introducing malaria diagnostic testing in drug shops: A cluster-randomised trial in Uganda.

BACKGROUND: Private sector drug shops are an important source of malaria treatment in Africa, yet diagnosis without parasitological testing is common among these providers. Accurate rapid diagnostic tests for malaria (mRDTs) require limited training and present an opportunity to increase access to correct diagnosis. The present study was a cost-effectiveness analysis of the introduction of mRDTs in Ugandan drug shops. METHODS: Drug shop vendors were trained to perform and sell subsidised mRDTs and artemisinin-based combination therapies (ACTs) in the intervention arm while vendors offered ACTs following presumptive diagnosis of malaria in the control arm. The effect on the proportion of customers with fever 'appropriately treated of malaria with ACT' was captured during a randomised trial in drug shops in Mukono District, Uganda. Health sector costs included: training of drug shop vendors, community sensitisation, supervision and provision of mRDTs and ACTs to drug shops. Household costs of treatment-seeking were captured in a representative sample of drug shop customers. FINDINGS: The introduction of mRDTs in drug shops was associated with a large improvement of diagnosis and treatment of malaria, resulting in low incremental costs for the health sector at US$0.55 per patient appropriately treated of malaria. High expenditure on non-ACT drugs by households contributed to higher incremental societal costs of US$3.83. Sensitivity analysis showed that mRDTs would become less cost-effective compared to presumptive diagnosis with increasing malaria prevalence and lower adherence to negative mRDT results. CONCLUSION: mRDTs in drug shops improved the targeting of ACTs to malaria patients and are likely to be considered cost-effective compared to presumptive diagnosis, although the increased costs borne by households when the test result is negative are a concern.

Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

BACKGROUND: The common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; however, there is a lack of evidence to support the wide utility of this regimen. This protocol describes an ongoing phase II randomized controlled clinical trial, based on the theory of traditional Chinese medicine (TCM), with the objective of evaluating the efficacy and safety of Lian-Ju-Gan-Mao capsules (LJGMC), a Chinese patent medicine, compared with placebo in patients suffering from the common cold with wind-heat syndrome (CCWHS). METHODS/DESIGN: This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. A total of 240 patients will be recruited and randomly assigned to a high-dose group, medium-dose group, low-dose group, and placebo-matched group in a 1:1:1:1 ratio. The treatment course is 3 consecutive days, with a 5-day follow-up. The primary outcome is time to all symptoms' clearance. Secondary outcomes include time to the disappearance of primary symptoms and each secondary symptom, time to fever relief, time to fever clearance, and change in TCM symptom and sign scores. DISCUSSION: This trial is a well-designed study according to 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 LJGMC in treating CCWHS and help to optimize the dose for the next phase III clinical trial. Moreover, the protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on TCM. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IPR-15006504 . Registered on 4 June 2015.