A Randomized Controlled Study on the Effect of Acupuncture Intervention in Advance on the Efficacy of Moderate to Severe Seasonal Allergic Rhinitis

Phase 1

• Conditions: Seasonal Allergic Rhinitis

• Registration Number: ITMCTR2200005812
• Lead Sponsor: Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Meet the diagnostic criteria of moderate and severe seasonal allergic rhinitis;
(2) Subjects with positive reactions to seasonal inhalation allergens such as pollen and fungi in skin prick test;
(3) Subjects with a history of seasonal allergic rhinitis for at least 2 yearswho have a fixed onset time each year and are currently in remission;
(4) The average total nasal symptom score(TNSS)=4 during the episode in the past year;
(5) Subjects aged between 18-65 years old;
(6) Subjects who volunteer to participate in the clinical study, and are able to answer relevant scale questions truthfully as required, recorded the use of anti-allergy drugs, and signed informed consent.
Only those who meet the above six items can be included.

Exclusion Criteria

(1) Subjects who have a history of chronic paranasal sinusitis, or who are found to have chronic paranasal sinusitis by paranasal sinus X-ray examination;
(2) Subjects who have organic lesions in the nasal cavity or who have undergone nasal surgery;
(3) Subjects with respiratory tract infection or acute sinusitis within the past 2 weeks; patients with inflammation on chest X-ray;
(4) Subjects who have received western medicine (H1-antihistamines, glucocorticoids, leukotriene receptor antagonists, mast cell membrane stabilizers, decongestants and anticholinergics, etc.), traditional Chinese medicines, etc. via nasal cavity, oral cavity or systemic route in the past 2 weeks which may affect the results of clinical study;
(5) Subjects who have received physical therapy within the range of traditional medicine such as acupuncture, moxibustion, cupping, and intranasal Chinese medicine inhalation in the past 2 weeks;
(6) Subjects who have received specific immunotherapy or systemic hormone therapy within the past 1 year;
(7) Subjects complicated with other respiratory diseases, such as asthma, etc.;
(8) Subjects complicated with severe liver or kidney dysfunction or other serious diseases, who cannot receive treatment;
(9) People with serious mental illness or violent tendencies;
(10) Pregnant or lactating women, and women who are planning to become pregnant during the trial;
(11) Concurrently participating in other clinical trials.
Those who meet any of the above items will be excluded.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total nasal symptom scores (TNSS);

Secondary Outcome Measures

Name	Time	Method
Patient acceptance;attack rate;Rhinoconjunctivitis quality of life questionnaire(RQLQ);Rescue medication score (RMS);Total nonnasal symptom score (TNNSS);Patient satisfaction;