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The effect and safety of Qidan Bimin Wan in the treatment of seasonal allergic rhinitis with TCM sign Fei Pi Qixu: a randomized, blinded, parallel controlled multicenter phase II study

The effect and safety of Qidan Bimin Wan in the treatment of seasonal allergic rhinitis with TCM sign Fei Pi Qixu: a randomized, blinded, parallel controlled multicenter phase II study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002123
Enrollment
Unknown
Registered
2012-04-13
Start date
2012-03-05
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

seasonal allergic rhinitis (TCM sign Fei Pi Qixu)

Interventions

High dose:Qidan Bimin Wan giving by high dose
Mild dose:Qidan Bimin Wan giving by mild dose
Low dose:Qidan Bimin Wan giving by low dose

Sponsors

Dongfang Hospital, Beijing University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients to be confirmed as the reasonal allergic rhinitis or who worse with season with history longer than two years, onseted in March to October, and this onset no longer than one week; 2. The patients to be diagnosed as TCM sign Pi Fei Xu (spleen and lung deficiency); 3. Aged 18 to 60 years; 4. Skin prick test (Seasonal allergens) positive reaction and/or serum specifisic IgE positive reaction; 5. At least has midle grade nose symptom (>=2 scores); 6. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patient complicated with severe liver and renal disease or liver and renal function disorder obviously; 2. Patient complicated with upper respiratory infection, Chronic obstructive pulmonary disease, Pulmonary fibrosism asthma except mild intermittent asthma (NAEPP standard, 1977); 3. Chronic or intermittent used inhalation, oral, muscle injection, intravenous injection, and/or greater or super potent topical corticosteroids; 4. Using long-acting antihistamine drugs; 5. Using illegal drugs or deficiency of time of withdraw some drugs: Intranasal corticosteroids or system using shorter than one month; Intranasal cromolyn less than two weeks; Internal nasal decongestants or system using less than three days; Intranasal or system using antihistamines less than three days; Use of loratadine less than ten days. 6. Patient complicated with non allergic rhinitis, sinusitis, nasal polyps correlates, serious deviation of nasal septum and eye infection; 7. Patient complicated with diabetes mellitus history or blood sugar concentration higher than normal threshhold; 8. Long term us concomitant medication, for example, tricyclic antidepressants, may affect the assessment of effect of this study; 9. To be allergic for the drugs used in the study; 10. In recent three months attended other studies; 11. Patient complicated with mental or nervous system diseases; 12. Pregnant, lactating women or study period can not take effective measures to contraception in women of childbearing age; 13. Patient has a history of drug abuse; or a history of alcohol abuse, or a drunker cannot stop drinking during the test; 14. Who is recorgnized to be not suite for including in the study.

Design outcomes

Primary

MeasureTime frame
Change of the nose symptoms scores;Ocular symptoms scores;Local symptoms scores of examinations of the nasal;TCM signs scores;Single symptom disappearance rate;Remission time;

Countries

China

Contacts

Public ContactHua Dongfang
13903592082@163.com+86 022 65378067

Outcome results

None listed

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