Compound Xinqi nasal spray:Research and development of an innovative traditional Chinese medicine preparation and randomized controlled single blind clinical trial

Phase 1

• Conditions: Allergic Rhinitis

• Registration Number: ITMCTR2000004154
• Lead Sponsor: Dongzhimen Hospital Affiliated to Beijing University of 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. Patients who meet the diagnostic criteria of allergic rhinitis or have previously been diagnosed with allergic rhinitis;
2. The average total nasal symptom score (TNSS) of 1 week before treatment was more than 4;
3. No other drugs (such as intranasal glucocorticoid nasal spray, antihistamines, decongestants and anticholinergic drugs) or surgical treatment (such as endoscopic pterygoid neurectomy, endoscopic cryoablation and inferior turbinectomy) in the past 6 months;
4. Patients who are able to correctly describe their wishes, voluntarily fill in the informed consent form and agree to participate in clinical trials.

Exclusion Criteria

1. Patients with serious diseases of heart, liver, kidney and other important organs;
2. Patients complicating with other respiratory diseases, acute/chronic sinusitis and other diseases;
3. Patients with organic lesions or nasal surgery;
4. Patients known or suspected to be allergic to the drugs used in this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Total nasal symptom scale (TNSS);

Secondary Outcome Measures

Name	Time	Method
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ);visual analogue scale (VAS);