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A randomized controlled study on the treatment of lung Qi Deficiency and cold type allergic rhinitis with Lue Biyan Formula

A randomized controlled study on the treatment of lung Qi Deficiency and cold type allergic rhinitis with Lue Biyan Formula

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000589
Enrollment
Unknown
Registered
2025-03-25
Start date
2023-08-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Allergic rhinitis

Interventions

control group:Chlorpheniramine tablets 10mg/time, orally taken once a day for 14 days as a course of treatment, combined with placebo of Lu'e Biyan Formula (placebo is made by adding 5% positive drug

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age>18 years old and<60 years old; 2. Meet the diagnostic criteria of AR Western medicine; Severe or severe symptoms that have a significant impact on quality of life with symptoms occurring for more than 4 days per week and for = 4 consecutive weeks; The patient has at least three nasal symptoms (1) sneezing 2) watery nasal discharge 3) nasal itching 4) nasal congestion) and the daily average VAS score for each symptom is = 5 points; Or if there are 2 or more nasal symptoms (itching sneezing watery nose and nasal congestion) and at least one symptom scores = 2 points (on a four point scale); 3. Meet the traditional Chinese medicine syndrome differentiation criteria for nasal and lung qi deficiency and cold; 4. No history of asthma attacks or other allergic diseases within 3 months prior to enrollment; No use of glucocorticoids or antihistamines or leukotrienes within the week prior to enrollment; 5 voluntary signatories of informed consent form; 6. Patients who have not participated in AR clinical research in the past 3 months;

Exclusion criteria

Exclusion criteria: 1. Patients with combined rheumatic and autoimmune diseases; 2. Patients with nasal organic lesions such as sinusitis and nasal polyps bronchial asthma or other serious pulmonary complications; 3. Patients with combined tumors or severe impairment of heart liver kidney and other functions; 4. Those who are unable to cooperate due to mental illness or other reasons; 5. Pregnant or lactating individuals or those who have the ability to conceive and are unwilling/unable to take effective contraceptive measures; 6. History of smoking or drug abuse; 7. Those who have used local or systemic corticosteroids or other immunosuppressants in the past 3 months; 8. In the past week I have used mast cell membrane stabilizer anticholinergic drugs decongestants and other non drug treatments that have therapeutic effects on AR such as acupuncture and moxibustion and acupoint application; 9. Those who have used antihistamines and leukotrienes in the past week; 10. Those who have undergone nasal surgery within the past week; 11. Individuals with a history of allergies to the ingredients of the experimental drug

Design outcomes

Primary

MeasureTime frame
Clinical symptom scoring;

Secondary

MeasureTime frame
recurrence rate;Traditional Chinese Medicine Syndrome Score for Lung Qi Deficiency and Cold Syndrome;Quality of life score;Visual Analog Scale Score;

Countries

China

Contacts

Public ContactJia Mingyue

China-Japan Friendship Hospital

mingyue131415@163.com15210723090

Outcome results

None listed

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