Persistent allergic rhinitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients with persistent allergic rhinitis aged 18 years and above, regardless of gender; (2) Meet the Western medicine diagnostic criteria for persistent allergic rhinitis (symptom attacks =4 days/week and =4 consecutive weeks) and conform to the Traditional Chinese Medicine pattern of lung and spleen deficiency; (3) Voluntarily agree to participate in this clinical study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Pregnant or breastfeeding women, those planning to conceive within the next six months, or those unwilling to use effective contraception during the study period and for six months after discontinuation of the study drug; (2) Individuals with a history of allergy to components of the study drug; (3) Individuals deemed by the investigator as unsuitable for participation in this clinical study, including participants whose adherence to any aspect of the protocol (including visit schedules and completion of diary cards or questionnaires) may be affected due to reasons such as frequent changes in physical condition, educational level, or work environment (e.g., needing to travel for work or reside in different locations during the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean total nasal symptom score (TNSS) from baseline during the treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes and change rates of the weekly average total nasal symptom score from baseline;Weekly response rate of total nasal symptom score;Changes and change values of individual nasal/ocular symptom scores from baseline on a weekly basis;Change and change rate of total overall symptom score (TOSS) from baseline each week;Changes and change rates in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores from baseline;Patient Global Impression of Change (PGI-C) (4 weeks); | — |
Countries
China
Contacts
Shijiazhuang Hospital of Traditional Chinese Medicine