Study on the Mechanism of ZhenQiFuZheng in the Treatment of Allergic Rhinitis Based on Intestinal Flora and Metabolites

Not Applicable

Recruiting

• Conditions: Rhinitis, Allergic
• Interventions: Drug: ZhenQi FuZheng granules (ShiDaiYangGuang)

• Registration Number: NCT06427577
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

ZhenQi FuZheng granules has been used to improve the immune function of human body, protect the bone marrow and adrenal cortex function and promote the recovery of positive function in traditional Chinese medicine care, especially with the immune imbalance diseases like post-surgery, chemotherapy and rhinitis. This project intends to establish AR（allergic rhinitis）specimen library, cell and animal model experiment, combining clinical cohort research with applied basic research, further assess the therapeutic mechanism of ZhenQiFuZheng granules in AR. We assume that ZhenQi FuZheng granules could cause the metabolic omics changes of nasal inflammatory factors and nasal secretions in AR patients, thus improving the type 2 inflammation level of allergic rhinitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-05-19
• Study First Posted: 2024-05-24
• Study Start: 2024-06-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult patients (18-65 years).
• Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and are diagnosed as allergic rhinitis .

Exclusion Criteria

• Patients who refused to accept specimen and questionnaire collection.
• Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allergic rhinitis	ZhenQi FuZheng granules (ShiDaiYangGuang)	ZhenQi FuZheng granules (ShiDaiYangGuang) 1 bag at a time, twice a day. Oral for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Visual Analog Score for pain	12 weeks	Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure
Rhinoconjunctivitis Quality of Life Questionnaire	12 weeks	Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China