A randomized, double-blind, placebo-controlled multicenter clinical trial of Xiehuang Jiejing granule in the treatment of cough variant asthma in children.

BACKGROUND: Cough variant asthma (CVA), also called concealed asthma or allergic asthma, is the most common cause of chronic cough in children. The disorder is mainly characterized by a nonproductive dry cough associated with a high recurrence rate that is conventionally treated with antibiotics, anti-inflammatory medications, cough suppressants, or expectorants. For millennia, Chinese herbal medicine (CHM) has been used widely in China to treat pediatric CVA cases, although high-quality evidence of CHM efficacy is lacking. In this study, the effectiveness and safety of Xiehuangjiejing (XHJJ) granule will be evaluated when used alone to treat children with CVA. METHODS AND ANALYSIS: A randomized, double-blind, parallel, placebo-controlled multicenter trial will be conducted over the course of 2 weeks. A total of 180 CVA patients of ages between 4 and 7 years old will be randomly assigned to the experimental group (XHJJ granules, 4.5 g administered 3 times daily) or control group (matched placebo, 4.5 g administered 3 times daily) in a 2:1 ratio based on subject number per group, respectively. The trial will consist of a 7-day medical interventional stage and a 7-day follow-up stage. On day 7 of the follow-up stage, an evaluation of all subjects will be carried out to assess cough symptom score as the primary outcome and several secondary outcomes, including TCM (traditional Chinese medicine) syndrome score, lung function, and dosage of salbutamol aerosol inhaler therapy. Safety assessments will also be evaluated during the trial. DISCUSSION: The aim of this study was to examine the effectiveness and safety of Xiehuangjiejing (XHJJ) granule using a trial protocol designed to yield high-quality, statistically robust results for use in evaluating CHM as a treatment for CVA in children.

Anti-fatigue effects of proteins isolated from Panax quinquefolium.

ETHNOPHARMACOLOGICAL RELEVANCE: American ginseng (Panax quinquefolium) is an obligate shade perennial plant that belongs to Araliaceae ginseng species, and is native to eastern USA and Canada. Ginseng proteins are reported to have several pharmaceutical properties. However, such properties of American ginseng proteins (AGP) have seldom been reported. Also, anti-fatigue properties of AGP have not been studied. Therefore, we examined the anti-fatigue effects of AGP in mice. MATERIALS AND METHODS: The molecular weight and protein contents of AGP were determined by SDS-PAGE, while the amino acid composition was analyzed by HPLC. The mice were divided into four groups. The control group was administered distilled water by gavage every day for 28 days. The other groups, designated as AGP treatment groups, were administered 125, 250 and 500 mg/kg of body weight, respectively of AGP by gavage every day for 28 days. Anti-fatigue activity was estimated using forced swimming test, and biochemical indices were determined using available kits. RESULTS: The subunit molecular weight of AGP ranged from 8-66 kD and the protein content measured by Bradford assay was 1.86 mg/mL. The forced swimming time of low, intermediate and high groups were found to be longer as compared to the control group. AGP significantly decreased blood lactate (BLA) and serum urea nitrogen (SUN) levels, and increased hepatic glycogen (GLU) level. Additionally, AGP lowered malondialdehyde (MDA) content and increased the levels of glutathione peroxidase (GPx) and superoxide dismutase (SOD). CONCLUSION: AGP shows anti-fatigue activity in mice, as measured by the physiological indices for fatigue.