J30.1
Conditions
Interventions
Group 1: Galphimia Glauca (synonyme Thryallis Glauca) D6, Liquid dilution, 20 ml 43% Ethanol solution, DHU-Arzneimittel GmbH & Co: PZN 02114676, 3x5 drops daily
Group 2: Individual homeopathic remedy,
Sponsors
Charité - Universitätsmedizin BerlinInstitut für Sozialmedizin, Epidemiologie und Gesundheitsokönomie
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study has two co-primary objectives: The two co-primary objectives are - to investigate the efficacy of standardised treatment with Galphimia glauca (potency D6) in comparison to placebo and - to investigate the efficacy of individualised homeopathic treatment (potency D6) in comparison to placebo regarding disease-specific quality of life in patients with SAR. The study has one explorative objective: The explorative objective is - to investigate the efficacy of standardised homeopathic treatment with Galphimia glauca (potency D6) in comparison to individualised homeopathic treatment (potency D6) regarding disease-specific quality of life in patients with SAR. 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
| Measure | Time frame |
|---|---|
| - RQLQ score measured at the end of weeks 2, 3, 4, 7 and 8 - Responders, defined as patients with a decrease in RQLQ score (mean scores at weeks 3 and 4) of at least 0.5 point compared to the baseline value. The responder criterion is the threshold for the clinical relevance. - Rescue Medication Score (RMS) measured daily between baseline and the end of week 4, and daily in week 7 and 8 - Intensity of total SAR symptoms and individual SAR symptoms (nasal and non-nasal) at the end of weeks 2, 4 and 8 using a Visual Analogue Scale (VAS) - Nasal and eye-symptoms, extracted from the RQLQ assessments and analysed separately. These two questions from the RQLQ are equivalent to the Total Nasal Symptom Score (TNSS) and will be assessed at the end of weeks 2, 3, 4, 7 and 8. - Generic health-related quality of life (SF-12) at the end of weeks 2, 4 and 8 - Safety assessment: number of patients who report, and number of, adverse events (AE) and serious adverse events (SAE) or number of patients who discontinue treatment due to AE or SAE between baseline and the end of week 8. - Resource utilisation and costs measured at the end of weeks 2, 4 and 8 - Qualitative data collection: subjective experiences of treatment, obtained from interviews after week 8 and between weeks 8 and 12 | — |
Countries
Germany
Contacts
Public ContactMargit Cree
Charité - Universitätsmedizin Berlin Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie Projektbereich Komplementäre und Integrative Medizin
Outcome results
None listed