Effect of SYN-AR on alleviation of grass pollen allergy associated symptoms

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: Treatment: three capsules (oral administration) of SYN‐AR in one of three compositions (SYN‐AR‐A, SYN‐AR‐B or SYN‐AR‐C) per day for 3 days per week for the duration of 3 weeks Control: three capsules of placebo (oral administration) per day for 3 days per week for the duration of 3 weeks Randomisation: 1:1 block randomisation by sealed envelope. Placebo and the three verum prepatations are indistinguishable from each other. Study Design: 1. Screening 2. Baseline exposure in an allergen exposure chamber 3. Post‐intervention exposure in an allergen exposure chamber CONDITION: Allergic rhinoconjunctivitis caused by grass pollen ; Eye Diseases PRIMARY OUTCOME: Symptoms are measured using the Total Symptom Score (TSS, max. 24 Points) = Total Nose Symptom Score (TNSS, max. 12 Points) + Total Eye Symptom Score (TESS, max. 12 Points) at baseline and after the 3‐week‐intervention SECONDARY OUTCOME: Measured at baseline and at the post‐intervention exposure:; 1. Eye symptoms measured using the Max. Total Eye Symptom Score (TESS); 2. Nasal symptoms measured using the Max. Total Nasal Symptom Score (TNSS); 3. Bronchial symptoms measured using the Max. Total Bronchial Symptom Score (TBSS); 4. Other symptoms measured using the Total Other Symptom Score (TOSS); 5. Peak Nasal Inspiratory Flow (PNIF) measured before and after each exposure; 6. Spirometry (FEV1, FEV1/FVC, MEF25‐75) measured before and after each exposure; 7. Use of emergency medications and/or emergency case management; 8. Number of incidents and number of subjects with adverse events related to ingestion of the dietary supplement SYN‐AR; 9. Number of incidents and number of individuals with late reactions and/or adverse events related to exposure after each exposure; 10. Post‐treatment follow‐up questionnaire at 4 weeks after post‐intervention exposure INCLUSION CRITERIA: 1. Persons of either se Xbetween 18 and 65 years of age 2. Oral and written consent 3. Patients with clinically relevant sensitization to grass pollen and allergic symptoms for at least 2 years 4. Positive skin prick test (SPT) to grass pollen 5. Proven response to exposure to grass pollen in the allergen exposure chamber 6. Patients who agree to undergo all examinations and procedures mentioned in the study protocol 7. Patients who are fully conversant with the German language
Epistemonikos ID: 711b90be83b633c583891c8b45913e88558debe4
First added on: Aug 28, 2024