Homeopathy for Seasonal Allergic Rhinitis (HOMEOSAR) – A Randomised Controlled Trial
- Conditions
- J30.1Allergic rhinitis due to pollen
- Registration Number
- DRKS00018081
- Lead Sponsor
- Charité - Universitätsmedizin BerlinInstitut für Sozialmedizin, Epidemiologie und Gesundheitsokönomie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 62
•Patients aged = 18 and = 75 years
•On average, moderate to severe seasonal allergic rhinitis (SAR) symptoms over a period of at least 2 pollen seasons
•Visual analogue scale (VAS) score = 40mm and = 80mm for SAR symptoms as assessed by the patients for the week before the inclusion
•Positive skin prick test and/or radioallergosorbent (RAST) test positive for both, birch and grass pollen
•Use of, or indication for, oral antihistamines as anti-allergic medication
•Written informed consent (obtained before the first assessment is performed)
•Availability for the entire duration of the study
•Ability to adhere to the study procedures and visit schedule
•Perennial allergic rhinitis or other types of chronic rhinitis
•History of anaphylactic reactions
•In accordance to GINA criteria asthma with the following criteria: a.) occurrence of asthma symptoms more than twice per week, b) any night waking due to asthma, c) reliever (beta-2-sympathomimetic drug) needed more than twice per week, excluded reliever taken before exercise, d) activity limitation due to asthma. The patient is excluded if more than one criterion is met.
•Moderate to severe atopic dermatitis
•Current daily use of topical or systemic corticosteroids
•Known hypersensitivity to Galphimia glauca or other homeopathic drugs
•Allergen-specific immunotherapy currently or within the past 3 years
•Homeopathic therapy currently or within the past 6 weeks
•Use of other complementary and integrative medicine treatments for SAR currently or within the past 6 weeks
•Alcohol addiction
•Pregnancy or breastfeeding
•Serious acute or chronic organic disease or serious mental disorder
•Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian), or other vulnerable patients (e.g. under arrest)
•Simultaneous participation in any other clinical trial
•Employees or family members of the sponsor or investigators
• Acute infection with SARS-COV-2 virus
• Long-COVID-syndrome
• Positive SARS-COV-2 PCR or antigen rapid test within the last 24 hours
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The study has two co-primary objectives:<br>The two co-primary objectives are<br>- to investigate the efficacy of standardised treatment with Galphimia<br>glauca (potency D6) in comparison to placebo<br>and<br>- to investigate the efficacy of individualised homeopathic treatment<br>(potency D6) in comparison to placebo<br><br>regarding disease-specific quality of life in patients with SAR.<br><br>The study has one explorative objective:<br>The explorative objective is<br>- to investigate the efficacy of standardised homeopathic treatment<br>with Galphimia glauca (potency D6) in comparison to individualised<br>homeopathic treatment (potency D6)<br><br>regarding disease-specific quality of life in patients with SAR.<br><br>The primary endpoint is the mean of the Rhinitis Quality of Life Questionnaire (RQLQ) total scores, measured at the end of week 3 and 4.
- Secondary Outcome Measures
Name Time Method