Dataset Information

Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial.

ABSTRACT:

Background

The common cold is the most frequent acute respiratory illness that places a burden on society, both personally and economically. There is no standard therapy; only symptomatic therapy remains the mainstay of common cold treatment. Thus, interest in herbal medicines is on the rise. Eunkyosan and Samsoeum are used for the common cold in East Asian countries. Although Eunkyosan and Samsoeum are clinically used for the treatment of the common cold, their effectiveness and safety have yet to be studied. Therefore, we aimed to evaluate their effectiveness and safety.

Methods

This study is a randomized, patient-assessor blind, controlled, parallel, and multicenter clinical trial. A total of 375 participants diagnosed with the common cold will be enrolled via four hospitals. The common cold patients will take a daily dose of Eunkyosan or Samsoeum or a placebo, three times a day for eight days. The primary outcome is the change in total Wisconsin Upper Respiratory Symptom Scale-21-Korean version (WURSS-21-K) score between baseline and six days. The secondary outcome includes the visual analogue scale (VAS). Safety is evaluated and adverse events are assessed throughout the trial. Written informed consent will be obtained from all study participants before enrollment.

Discussion

This results will be published in a peer-reviewed journal and disseminated in related conferences.

Trial registration

ClinicalTrials. gov, registration number: NCT04073511.

SUBMITTER: Kim KI

PROVIDER: S-EPMC7016249 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Publications

Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial.

Kim Kwan-Il KI Hong Minna M Park Yang-Chun YC Lee Beom-Joon BJ Kim Kitae K Kang Byung Kab BK Choi Jun-Yong JY

Integrative medicine research 20200122 1

<h4>Background</h4>The common cold is the most frequent acute respiratory illness that places a burden on society, both personally and economically. There is no standard therapy; only symptomatic therapy remains the mainstay of common cold treatment. Thus, interest in herbal medicines is on the rise. Eunkyosan and Samsoeum are used for the common cold in East Asian countries. Although Eunkyosan and Samsoeum are clinically used for the treatment of the common cold, their effectiveness and safety ...[more]

PMID: 32071868

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Project description:BackgroundThere is no clear evidence-based medicine that points to the most effective drug treatments for the common cold. In view of its ability to relieve symptoms and shorten the disease course, as well as its minimal side effects, traditional Chinese medicine (TCM) has been widely used to treat the common cold. However, there is a lack of strong evidence to support the clinical efficacy of TCM. This study aimed to evaluate the efficacy and safety of Ganduqing granules in the treatment of the common cold based on the network pharmacology analysis.MethodsIn this multicenter, randomized, double-blind, placebo-controlled trial, 60 eligible subjects will be randomly assigned to either the intervention group or the placebo group. The intervention group will be treated with Ganduqing granules, while the placebo group will be treated with placebo. After 5 days of intervention, the efficacy and safety of Ganduqing granules in the treatment of the common cold will be observed. The primary outcome is the time to clearance of all symptoms. The secondary outcomes included the levels of IL-6, TNF-α, SOD, and MDA in the peripheral blood, time to disappearance of primary symptoms and secondary symptoms, clinical symptom remission rate, and change in TCM syndrome score.ResultsSixty participants completed the study. Ganduqing granules showed a greater effect on the time to clearance of all symptoms (P < 0.0001), nasal discharge (P=0.0124), fatigue and lack of strength (P=0.0138), dryness of the pharynx (P < 0.0001), pharyngalgia or dysphagia (P < 0.0001), and expectoration (P < 0.0431) compared with the placebo group. Participants in the intervention group had a greater decrease of IL-6 levels compared with the placebo group (P < 0.007); similar results were observed for the SOD (P < 0.033). However, the change in TNF-α and MDA levels in the intervention group was not significantly different from the placebo group. In addition, participants in the intervention group had a greater decrease of TCM syndrome score compared with the placebo group (P < 0.040).ConclusionGanduqing granules could improve common cold symptoms, shorten the disease course, attenuated inflammation and oxidative stress, and provided objective evidence for the efficacy and safety of a Chinese herbal medicine in treating the common cold.

Project description:BackgroundImpulsivity and compulsivity are related to emotional and social maladjustment and often underlie psychiatric disorders. Recently, alterations in microbiota composition have been shown to have implications for brain development and social behavior via the microbiota-gut-brain axis. However, the exact mechanisms are not fully identified. Recent evidence suggests the modulatory effect of synbiotics on gut microbiota and the contribution of these agents in ameliorating symptoms of many psychiatric diseases. To date, no randomized controlled trial has been performed to establish the feasibility and efficacy of this intervention targeting the reduction of impulsivity and compulsivity. We hypothesize that supplementation with synbiotics may be an effective treatment in adults with high levels of impulsivity and/or compulsivity.Methods/designThis is a prospective, multicenter, double-blind, randomized controlled trial with two arms: treatment with a synbiotic formula versus placebo treatment. The primary outcome is the response rate at the end of the placebo-controlled phase (response defined as a Clinical Global Impression-Improvement Scale score of 1 or 2 = very much improved or much improved, plus a reduction in the Affective Reactivity Index total score of at least 30% compared with baseline). A total of 180 participants with highly impulsive behavior and a diagnosis of attention deficit/hyperactivity disorder (ADHD) and/or borderline personality disorder, aged 18-65 years old, will be screened at three study centers. Secondary outcome measures, including changes in general psychopathology, ADHD symptoms, neurocognitive function, somatic parameters, physical activity, nutritional intake, and health-related quality of life, will be explored at assessments before, during, and at the end of the intervention. The effect of the intervention on genetics, microbiota, and several blood biomarkers will also be assessed. Gastrointestinal symptoms and somatic complaints will additionally be explored at 1-week follow-up.DiscussionThis is the first randomized controlled trial to determine the effects of supplementation with synbiotics on reducing impulsive and compulsive behavior. This clinical trial can contribute to explaining the mechanisms involved in the crosstalk between the intestinal microbiome and the brain. If effects can be established by reducing impulsive and compulsive behavior, new cost-effective treatments might become available to these patients.Trial registrationClinicalTrials.gov, NCT03495375. Registered on 26 February 2018.

Dataset Information

Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial.

Background

Methods

Discussion

Trial registration

Publications

Herbal medicines (Eunkyosan and Samsoeum) for treating the common cold: a protocol for a randomized, placebo-controlled, multicenter clinical trial.

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