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A multicenter, prospective, real-world study on the treatment of persistent allergic rhinitis with Qifang Bitong tablets

A multicenter, prospective, real-world study on the treatment of persistent allergic rhinitis with Qifang Bitong tablets

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026001608
Enrollment
Unknown
Registered
2026-06-26
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Persistent allergic rhinitis

Interventions

Treatment group:Conventional treatment supplemented with Qifang Bitong tablets
Control group:Conventional treatment

Sponsors

Shijiazhuang Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: (1) Patients with persistent allergic rhinitis aged 18 years and above, regardless of gender; (2) Meet the Western medicine diagnostic criteria for persistent allergic rhinitis (symptom attacks =4 days/week and =4 consecutive weeks) and conform to the Traditional Chinese Medicine pattern of lung and spleen deficiency; (3) Voluntarily agree to participate in this clinical study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Pregnant or breastfeeding women, those planning to conceive within the next six months, or those unwilling to use effective contraception during the study period and for six months after discontinuation of the study drug; (2) Individuals with a history of allergy to components of the study drug; (3) Individuals deemed by the investigator as unsuitable for participation in this clinical study, including participants whose adherence to any aspect of the protocol (including visit schedules and completion of diary cards or questionnaires) may be affected due to reasons such as frequent changes in physical condition, educational level, or work environment (e.g., needing to travel for work or reside in different locations during the study).

Design outcomes

Primary

MeasureTime frame
Change in the mean total nasal symptom score (TNSS) from baseline during the treatment period;

Secondary

MeasureTime frame
Changes and change rates of the weekly average total nasal symptom score from baseline;Weekly response rate of total nasal symptom score;Changes and change values of individual nasal/ocular symptom scores from baseline on a weekly basis;Change and change rate of total overall symptom score (TOSS) from baseline each week;Changes and change rates in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores from baseline;Patient Global Impression of Change (PGI-C) (4 weeks);

Countries

China

Contacts

Public ContactWei Pu

Shijiazhuang Hospital of Traditional Chinese Medicine

13393019259@163.com13393019259

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026