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Clinical study on the efficacy and safety of Xiangju tablets in the treatment of seasonal allergic rhinitis

Clinical study on the efficacy and safety of Xiangju tablets in the treatment of seasonal allergic rhinitis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075873
Enrollment
Unknown
Registered
2023-09-18
Start date
2023-09-15
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal allergic rhinitis

Interventions

Experimental Group:Xiangju tablets

Sponsors

Inner Mongolia Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18 years old to 65 years old, gender is not limite; (2) Meet the diagnostic criteria for seasonal allergic rhinitis (refer to the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (Revised Edition 2022)), and meet all of the following conditions on a random day: ? Symptoms: Symptoms such as paroxysmal sneezing, watery rhinorrhea, nasal itching, and nasal congestion occur 2 or more times, and the symptoms last or accumulate for more than 1 hour every day, and may be accompanied by eye symptoms such as tearing, itchy eyes, and red eyes; ? Signs: Nasal mucosa is commonly pale, edematous, and watery nasal secretions;

Exclusion criteria

Exclusion criteria: (1) Combined with severe nasal septal deviation, nasal polyps, sinusitis, hypertrophic rhinitis and other organic nasal diseases, or large-scale trauma to the nasal cavity; (2) Combined with various types of asthma such as bronchial asthma and cough variant asthma; (3) Combined with serious diseases of the heart, brain, liver, kidney, respiratory system, circulatory system, endocrine system, immune system, hematopoietic system and other major organs or systems (such as acute myocardial infarction, malignant tumor, tuberculosis, severe hypertension, diabetic ketosis Diabetic complications such as acidosis, immunodeficiency diseases such as HIV, autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, leukemia, etc.); (4) Pregnant or lactating women, or unwilling to take effective contraceptive measures during the trial; (5) Have a history of allergy to the ingredients of the experimental drugs; (6) Have a history of any disease that affects regimen compliance (such as severe mental disorder, cognitive dysfunction, drug abuse or addiction, long-term alcoholism, etc.); (7) Participated in clinical trials of other drugs or medical devices in the past month; (8) The researcher believes that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Nasal symptom score (TNSS) ;

Secondary

MeasureTime frame
Eye symptom score (TOSS);Nasal/eye single symptom scores;Overall nasal/eye symptom score and single symptom score-time AUC;Time to improve overall and single nasal/eye symptoms;Improvement rate of overall and single nasal/eye symptoms;Time for nasal/eye symptoms and single symptoms to disappear;Disappearance rate of nasal/eye symptom and single symptom scores;Local sign score (anterior rhinoscopy);

Countries

China

Contacts

Public ContactHuang Yan

Inner Mongolia Hospital of Traditional Chinese Medicine

huangyansuhe@Aliyun.com+86 135 1481 9385

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026