[Efficacy and safety of Regan Syrup in treatment of common cold (wind-heat syndrome):a multicenter, randomized, double-blind, double-dummy, placebo and positive drug-controlled, parallel, phase â ¡b clinical trial].

Regan Syrup has the effect of clearing heat, releasing exterior, benefiting pharynx and relieving cough, and previous phase Ⅱ clinical trial showed that the efficacy of Regan Syrup high-dose and low-dose groups was better than that of the placebo group, and there was no statistically significant difference in the safety between the three groups. The present study was conducted to further investigate the efficacy and safety of the recommended dose(20 mL) of Regan Syrup in the treatment of common cold(wind-heat syndrome). Patients who met the inclusion and exclusion criteria were selected and divided into the test group(Regan Syrup+Shufeng Jiedu Capsules placebo), positive drug group(Regan Syrup placebo+Shufeng Jiedu Capsules) and placebo group(Regan Syrup placebo+Shufeng Jiedu Capsules placebo) at a 1∶1∶1 using a block randomization method. The course of treatment was 3 days. A total of 119 subjects were included from six study centers, 39 in the test group, 40 in the positive drug group and 40 in the placebo group. The onset time of antipyretic effect was shorter in the test group than in the placebo group(P≤0.01) and the positive drug group, but the difference between the test group and the positive drug group was not significant. The test group was superior to the positive drug group in terms of fever resolution(P<0.05), and had a shorter onset time of fever resolution than the placebo group, but without obvious difference between the two groups. Compared to the positive drug group, the test group had shortened disappearance time of all symptoms(P≤0.000 1). In addition, the test group was better than the positive drug group and the placebo group in relieving symptoms of sore throat and fever(P<0.05), and in terms of clinical efficacy, the recovery rate of common cold(wind-heat syndrome) was improved in the test group compared to that in the placebo group(P<0.05). On the fourth day after treatment, the total TCM syndrome score in both test group and positive drug group was lower than that in the placebo group(P<0.05). There was no significant difference in the incidence of adverse events between three groups and none of them experienced any serious adverse events related to the study drug. The results indicated that Regan Syrup could shorten the onset time of antipyretic effect, reduce the time of fever resolution, alleviate the symptoms such as sore throat and fever caused by wind-heat cold, reduce the total score of Chinese medicine symptoms, and improve the clinical recovery rate with good safety.

[Randomized double-blind placebo-controlled trial of Jingfang Granules in treatment of common cold(wind-cold syndrome)].

Jingfang Granules have the effects of inducing sweating to releasing exterior, dispersing wind and dispelling dampness. Modern studies have demonstrated that it has antipyretic and antiviral activities. Therefore, this trial was conducted to evaluate the efficacy and safety of Jingfang Granules in the treatment of common cold(wind-cold syndrome). A total of 138 common cold(wind-cold syndrome) patients meeting the inclusion and exclusion criteria were randomly assigned into the experimental group(n=92) and the placebo group(n=46) at a ratio of 2∶1 and respectively received Jingfang Granules and Jingfang Granules simulation agent. The treatment lasted for 5 d, and the follow-up time was 8 d. Recovery time was employed as the main indicator of efficacy. The median reco-very time of the experimental group was 3.33 d, shorter than that 7.00 d of the placebo group. The efficacy of the experimental group was better than that of the placebo group(P<0.000 1). The major symptom severity score-time AUC of the experimental group was 489.90±206.95, which was smaller than that of the placebo group(763.50±339.53). The recovery rate and marked effective rate of the experimental group were higher than those of the placebo group, The above outcomes were statistically significant between the two groups(P<0.05). The disappearance time and rate of single symptoms including aversion to cold, nasal congestion, runny nose, cough, headache, pharyngeal itching/pain, white sputum, and somatalgia also had significant differences between the two groups(P<0.05), indicating that Jingfang Granules had good performance in alleviating the above symptoms. During the study period, one case of the experimental group had a slight increase in serum creatinine, which returned to the normal level after re-examination. The incidence of adverse reactions was 1.10%, and no serious adverse reaction was found. The two groups had no significant difference in the incidence of adverse reactions. In conclusion, Jingfang Granules can significantly shorten the course of common cold(wind-cold syndrome) and quickly alleviate the clinical symptoms, demonstrating good safety and clinical advantages.

Binafuxi granules in the treatment of common cold with heat syndrome based on traditional Uighur medicine: study protocol for a multicenter randomized controlled trial.

BACKGROUND: The common cold is a highly prevalent illness with significant impact on society and health care. Common cold with heat syndrome (CCHS) is one of the most common types based on syndrome differentiation by traditional Uighur medicine (TUM), which is widely used in Central Asia. The study is designed to explore the efficacy, safety and optimal therapeutic dosage of Binafuxi granules in treating CCHS. METHODS: This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Participants (n = 240) will be enrolled from five centers across China and randomly assigned to the high-dose group, low-dose group or placebo control group in a 1:1:1 ratio. All eligible patients will receive test drugs twice daily for 3 days. The primary outcome is the time to fever relief. Secondary outcomes include the time to fever clearance, duration of primary symptoms and each symptom and change in TUM symptom score. DISCUSSION: This is the first placebo-controlled randomized clinical trial of a Uighur medicine in treating common cold. It will provide robust evidence on the efficacy and safety of Binafuxi granules in the treatment of CCHS. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IIR-17013379 . Registered on 14 November 2017.

Agreement Between Integrated Management of Childhood Illness and Final Diagnosis in Acute Respiratory Tract Infections.

OBJECTIVE: To evaluate the agreement between integrated management of childhood illness (IMCI) and final diagnosis in patients presenting with cough at the second and third level health institutions. METHODS: This cross-sectional study included 373 children aged 2-60 mo who presented with cough at the pediatric emergency and outpatient clinics in the Department of Pediatrics. After clinical examination of children, body temperature, respiratory rate, saturation, presence or absence of the chest indrawing, rales, wheezing and laryngeal stridor were recorded. Cases were categorized according to IMCI algorithm regarding the severity using the color code, such as red (urgent treatment), yellow (treatment in the hospital), or green (treatment at home). Final diagnosis after physical examination, laboratory analysis and chest X-ray was compared with the IMCI algorithm. RESULTS: Study agreement between IMCI classification and final diagnosis was 74.3% with kappa value 0.55 (moderate agreement). Similar agreement values were detected in both the second and third level health institutions. Health condition and gender did not affect agreement value. Agreement were found to be high in patients <24 mo of age (ĸ = 0.67), presence of fever and cough (ĸ = 0.54), tachypnea (ĸ = 0.93), chest indrawing (ĸ = 1.00) and oxygen saturation of <94%(ĸ = 0.90). CONCLUSIONS: Adding saturation level to the IMCI algorithmic diagnosis may increase agreement between IMCI classification and final diagnosis.

Propolis nasal spray effectively improves recovery from infectious acute rhinitis and common cold symptoms in children: a pilot study.

Currently, treatment for acute rhinitis (AR) is symptomatic but no clear agreement exists to control its development. Propolis extract may appear as a promising natural treatment for AR, but its beneficial effects have not yet been fully tested. Forty children suffering from AR and common cold symptoms aged between 2-12 years were enrolled in a prospective epidemiological multicentre study. A 7-day treatment with propolis nasal spray (3 times/day) was applied and a comparison of symptomatology, subjective global improvement and quality of life (QoL) between baseline (day 1) and final (day 7) visits were performed. The main goal was to evaluate the changes in symptom intensity using the Jackson’s scoring test. After 7 days of treatment there was a significant decrease of symptoms both in the total score (p less than 0.0001) and in regard to each AR symptom (p less than 0.01). On the whole, the sample reported no symptoms by day 7, and the resolution of symptoms occurred approximately at day 4. Furthermore, there was no need for supplementary treatment. Both the subjective global improvement impression and the QoL of patients appeared to significantly improve after treatment. No adverse events (AEs) were found globally. It can be concluded that propolis nasal spray effectively improves recovery from infectious AR and common cold symptoms in children and is an optimal alternative in the treatment of this disease without need for any adjuvant treatment.

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.

Efficacy and safety of Gantong Granules in the treatment of common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

BACKGROUND: Although the common cold is generally mild and self-limiting, it is a leading cause of consultations with doctors and missed days from school and work. In light of its favorable effects of relieving symptoms and minimal side-effects, Traditional Chinese Medicine (TCM) has been widely used to treat the common cold. However, there is a lack of robust evidence to support the clinical utility of such a treatment. This study is designed to evaluate the efficacy and safety of Gantong Granules compared with placebo in patients with the common cold with wind-heat syndrome (CCWHS). METHODS/DESIGN: This is a multicenter, phase IIb, double-blind, placebo-controlled and randomized clinical trial. A total of 240 patients will be recruited, from 5 centers across China and randomly assigned to the high-dose group, medium-dose group, low-dose group or placebo control group in a 1:1:1:1 ratio. All subjects will receive the treatment for 3 to 5 days, followed by a 7-day follow-up period. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary symptoms and each symptom, time to fever relief and time to fever clearance, change in TCM symptom score, and change in Symptom and Sign Score. DISCUSSION: This trial will provide high-quality evidence on the efficacy and safety of Gantong Granules in treating CCWHS, and help to optimize the dose selection for a phase III clinical trial. TRIAL REGISTRATION: The registration number is ChiCTR-TRC-14004255 , which was assigned by the Chinese Clinical Trial Registry on 12 February 2014.

Gripe ou resfriado? Sinusite ou rinite? / Influenza or cold? Sinusitis or rhinitis?

Resfriado comum e gripe são habitualmente confundidos, principalmente se o resfriado for mais intenso. Coriza é rotulada tanto como alergia como sinusite. Os processos inflamatórios das vias aéreas superiores envolvidos nessas entidades clínicas conjugam fatores comuns, embora tenham etiologias diferentes. Graças a isso, diagnósticos equivocados geram tratamento inadequado, geralmente com emprego desnecessário de antibióticos. O resfriado comum e a gripe (influenza) são infecções virais do trato respiratório, assim como a maioria das rinossinusites. Já a rinite é, em sua maior parte, manifestação da atopia respiratória.

Common cold and flu are usually confused, especially if the cold is more intense. Many times, coryza is labeled as being allergy or sinusitis. The inflammation of the upper airways involved in these clinical entities combine common factors, although they have different etiologies. As a result, misdiagnosis generates inadequate treatment, usually with unnecessary use of antibiotics. The common cold and the flu (influenza) are viral infections of the respiratory tract, as well as most cases of rhinosinusitis. On the other hand, rhinitis is, most of the time, a manifestation of respiratory atopy.

Guidelines on common cold for traditional Chinese medicine based on pattern differentiation.

OBJECTIVE: To establish the guidelines on common cold treated with Traditional Chinese Medicine (TCM) in terms of pattern identification. METHODS: The guidelines were formulated by using the basic patterns common cold in China Pharmacopeia integrated with findings from systematic literature review and the experts' consensus on the issue in question. RESULTS: Common cold was divided into four patterns in the guidelines. The medications were recommended respectively: Ganmaoqingre granule for wind-cold exterior syndrome, Yinqiaojiedu granule for wind-heat exterior syndrome, Huoxiangzhengqi Wan for summer-heat dampness exterior syndrome and Shensu Wan for wind-cold exterior syndrome accompanied with Qi deficiency. CONCLUSION: The guidelines were primarily derived from the practice experience of TCM and the experts' consensus. The process was not strictly evidence-based because of lacking enough clinical studies. Further refinement of the guidelines should be needed as more studies are available.

Safety and tolerability of North American ginseng extract in the treatment of pediatric upper respiratory tract infection: a phase II randomized, controlled trial of 2 dosing schedules.

BACKGROUND: Upper respiratory tract infections are the most common childhood illness. Panax quinquefolius (American ginseng root extract) standardized to contain 80% poly-furanosyl-pyranosyl-saccharides is purported to be effective in adult upper respiratory tract infection but has not been evaluated yet in a pediatric population. OBJECTIVES: Our primary objective was to document the safety and tolerability of 2 weight-based dosing schedules (standard dose versus low dose versus placebo) in children. We also used the Canadian Acute Respiratory Infection Flu Scale, a quantitative scoring sheet for measuring the severity and duration of upper respiratory symptoms, to establish the SD of the treatment effect to allow sample-size calculations for future clinical trials. METHODS: We conducted a randomized, double-blind dose-finding 3-arm trial (2 dosing schedules of American ginseng extract with 1 placebo control) during the winter months (November 2005 to March 2006) in children 3 to 12 years of age. RESULTS: Seventy-five subjects were prerecruited from the general population in Edmonton. Of these, 46 subjects developed an upper respiratory tract infection and were randomly assigned (15 standard dose, 16 low dose, and 15 placebo), with 1 subject withdrawing from the low-dose arm before beginning the intervention. No serious adverse events were reported. The frequency, severity, and degree of association between the intervention and reported adverse events were not significantly different among each of the 3 treatment arms. CONCLUSIONS: Standard doses of ginseng were well tolerated and merit additional evaluation with regard to treatment of pediatric upper respiratory tract infection.

Lessons learned from the 2007-2008 cold and flu season: what worked and what was worthless.

The 2007-2008 cold and flu season had a feeble beginning but a dramatic end. Most states in the U.S. were reporting their highest number of flu cases well into February and March. It is concerning that not only the public but health care professionals have not embraced widespread vaccination because approximately 200,000 hospitalizations and 36,000 deaths a year continue to make this condition one of the leading preventable causes of morbidity and mortality. The real question that needs to be asked next year is who should not be vaccinated rather than who needs to be vaccinated. Preventive measures with soap and water and 62% ethyl alcohol hand gels continue to make sense, whereas the antibacterial soaps seem to provide no added protection and theoretically increase the risk of bacterial resistance. A few dietary supplements garnered some attention. Among products with clinical research, an oral 500 mg qd immunogenic fermentate (Epicor) reduced the risk and duration of cold and flu symptoms in subjects vaccinated for seasonal influenza. Two novel prescription medications (zanamivir [Relenza], and oseltamivir [Tamiflu]) are available for the prevention and/or treatment of influenza and also have demonstrated minimal resistance compared to the older medications. These FDA-approved medications should receive more attention because of their overall effectiveness in treating the flu during the first stages of the disease process.

Current and future therapeutic approaches to the common cold.

For decades, investigators have strived to elucidate the pathogenesis, and hence a treatment, for the common cold. Therapy has been tried with a variety of agents, ranging from anecdotal folk remedies, to well-designed medications. Measures primarily directed to relieve the symptoms of the common cold, rather than specific antimicrobial agents, are the current main stay of therapy. Millions of patients would benefit from an easy-to-perform diagnostic test and specific therapy that works quickly, shortening the duration of illness and preventing further spread of infection.

[Expired nitric oxide concentration derived from nasal cavity and that derived from airway and lung in Japanese cedar pollinosis].

AIM: Japanese cedar pollinosis (Type I allergy to Japanese cedar pollen) shows a high incidence in spring in Japan, demonstrating symptoms such as pituita, rhinostenosis, lacrimation and sometimes pharyngeal pain. The following study investigated whether expired nitric oxide (NO) concentration is increased in Japanese cedar pollinosis, and whether expired NO concentration can be used to discriminate from cold syndrome which symptoms are similar to Japanese cedar pollinosis. SUBJECTS AND METHODS: In 20 healthy subjects, 20 patients with Japanese cedar pollinosis and 20 patients with cold syndrome, expired NO concentrations derived from nasal cavity and those derived from airway and lung were measured. Expired NO concentrations derived from nasal cavity and those derived from airway and lung were compared among the groups. RESULTS: In patients with Japanese cedar pollinosis expired NO concentrations derived from nasal cavity and those derived from airway and lung markedly increased. In patients with cold syndrome there were no significant increases in these concentrations. DISCUSSION: It is considered that expired NO concentration is useful for discriminating Japanese cedar pollinosis from cold syndrome. It seems interesting that not only expired NO concentrations derived from nasal cavity but also those derived from airway and lung were clevated. Generalized airway inflammation may be present, even without clinical asthma, in patients with Japanese cedar pollinosis.

ARI concepts of mothers in Punjabi villages: a community-based study.

Pneumonia is a major child killer in the developing world; to prevent such deaths, mothers must be able to differentiate pneumonia from common cold. Local concepts regarding these illnesses were studied by interviewing 315 mothers of young children in their homes in Punjabi villages. Mothers described pneumonia differently from cough-and-cold but only a few volunteered fast breathing as a sign of pneumonia. Both illnesses were thought to be caused by "coldness," and were initially treated with "heat-producing" home remedies and feeding was continued in both. Spiritual healers were not consulted for cough-and-cold or pneumonia. Virtually all mothers said that allopathic medicines were necessary for both illnesses and 2/3rd said that if a child did not improve after 2 days of a given medicine, they would change the medicine and/or the doctor.