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A randomized controlled clinical study evaluating the effectiveness and safety of Tongqiao Biyan Granules in the treatment of moderate to severe persistent allergic rhinitis

A randomized controlled clinical study evaluating the effectiveness and safety of Tongqiao Biyan Granules in the treatment of moderate to severe persistent allergic rhinitis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042391
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-02-15
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

Allergic rhinitis

Interventions

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
10 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged from 10 to 60 years, regardless of gender; 2. For patients with allergic rhinitis, the diagnostic criteria (ARIA) are as follows: Symptoms: sneezing, clear water like runny nose, itchy nose and stuffy nose appeared 2 or more symptoms, lasting or accumulating for more than 1 hour every day; Signs: common nasal mucosa pale, edema, nasal water secretion; Allergen test: at least one allergen SPT and / or serum specific IgE positive (all results within one year are valid); 3. Patients with lung qi deficiency syndrome, spleen qi deficiency syndrome or lung spleen qi deficiency syndrome; 4. Patients with symptom onset >= 4 days / week, and >= 4 consecutive weeks; 5. Patients with moderate to severe allergic rhinitis have a significant impact on the quality of life (including sleep, daily life, study or work); 6. Patients with nasal symptom score (TNSS) >= 8 within 12 hours, nasal congestion score >= 2; 7. Patients and guardians informed and agreed to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with nasal space occupying lesions and structural abnormalities, including but not limited to: nasal polyps, nasal masses, meningeal encephalocele, congenital nostril atresia, congenital piriform foramen stenosis, thickening and internal displacement of maxillary frontal process, deviation of nasal septum, gasification of middle turbinate, etc; 2. Patients with known poor overall physical condition include but are not limited to: (1) Malignant tumor; (2) Uncontrolled systemic infection; (3) Severe malnutrition (BMI = 7.0 mmol / L or 2-hour postprandial glucose >= 11.1 mmol / L after standardized treatment) was found in diabetic patients; (5) The blood pressure of hypertension patients was poorly controlled (systolic blood pressure >= 160 mmHg and / or diastolic blood pressure >= 100 mmHg after standardized treatment); (6) Moderate to severe anemia (HB = 1.5unl, creatinine >= 1.5unl, AST, ALT >= 1.5unl; 3. Pregnant or lactating women; 4. Subjects who are known or suspected to be allergic to the components of Tongqiao Biyan granules; 5. Subjects with a history of nose or eye injury or surgery in the past three months; 6. Subjects dependent on nasal, oral or ocular decongestants, antihistamines and hormones; 7. Subjects with a history of mental illness (except mild mood disorders); 8. The subjects with dyslexia or communication difficulties can not cooperate to complete the study; 9. Subjects who can't guarantee medication compliance or can't return visit on time; 10. Situations that other researchers believe may seriously affect the research results.

Design outcomes

Primary

MeasureTime frame
TNSS;

Secondary

MeasureTime frame
TOSS;Effective after 3 weeks of treatment;RQLQ;Anterior rhinoscopy score;IL4;IL5;TGF-ß;AE;

Countries

china

Contacts

Public ContactTian Li

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

18980880129@qq.com+86 18980880129

Outcome results

None listed

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