Effect of Propolis on moderate asthma

Phase 2

• Conditions: asthma.; asthma , unspecified

• Registration Number: IRCT201209302695N4
• Lead Sponsor: Islamic Azad University of Mashhad

Brief Summary

Introduction: Propolis is produced by honey bee, but it seems that its constituent is different from honey. Propolis was used by folk medicine for treatment of asthma but most of the studies were experimental. The objective of this study was to determine the effect of Propolis on clinical and physiological findings of moderate persistent asthma.<br /> Design: Prospective, randomized, double blind, placebo-controlled, clinical trial. <br /> Participants including major eligibility criteria: We enrolled patients aged 15-90 years with moderate asthma and FEV1 of 60-79% of predicted at a sub-specialty clinic of pulmonary medicine. We randomly allocated subjects to receive either Propolis (75 mg three times a day) or matched placebo for one month.<br /> Primary outcome was ACT (Asthma control test) score and secondary outcomes included dyspnea, Spirometry, FENO (Fractional Exhaled Nitric Oxide) and Sputum cytology including inflammatory cell. Sputum induction was made by hypertonic saline and cytology slides were stained by Papa Nicolaou stain.<br /> Results: Fifty two subjects were enrolled in this study and completed the course of therapy. Clinical findings including cough, dyspnea, wheezing, Sputum, post nasal drip, Nocturnal symptoms, Acute attack and wheezing were significantly improved after the treatment. ACT score was also significantly increased by Propolis (12.8±5.5 before and 18.1±4.99 after the trial) which was significantly higher than placebo (14.4±6.6 after the trial). The most significant physiological improvements were significant increase of FEV1, FEFV1/FVC, FEF25-75 and PEFR. FENO showed significant decrease in Propolis group, on the contrary it was increased in placebo group. Cytological examination of sputum showed that the pattern of inflammation was eosinophilic in 44% of subjects with average eosinophil of 7.2±1.01%. The eosinophilia was significantly decreased by Propolis after the trial (4.3±3.1%), but it was significantly increased in placebo group (11.1±6.6%).<br /> Conclusion: Propolis improved the clinical and physiological findings of moderate persistent of asthma, and it was also able to suppress the eosinophilic inflammation.<br />

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

inclusion criteria: New subjects suffering from cough or dyspnea with an intermittent course and history of airway hyper responsiveness; controller drugs was not started; spirometry of the patients showing moderate asthma (forced expiratory volume in the first second between 60 to 80%).
Exclusion criteria: mild (FEV1 mare than 80%); severe asthma (FEV1<60%); respiratory infection; treatment with systemic corticosteroid; rhinosinusitis; gastroesophageal reflux disease; other obstructive lung disease; Churg–Strauss syndrome; smokers; vocal cord dysfunction; reactive airway dysfunction syndrome.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fractional exhaled Nitric Oxide (FENO). Timepoint: at the beginning of the study and at the end of the three weeks treatment. Method of measurement: expiratory nitric oxide test with NObreath equipment.;ACT score test. Timepoint: At the beginning of the study and at the end of the three weeks treatment. Method of measurement: ACT questionnaire.