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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06427577
Enrollment
40
Registered
2024-05-24
Start date
2024-06-01
Completion date
2028-06-01
Last updated
2024-12-09

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

Conditions

Rhinitis, Allergic

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.

Interventions

DRUGZhenQi FuZheng granules (ShiDaiYangGuang)

1 bag at a time, twice a day. Oral orally for 4 weeks.

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Rhinoconjunctivitis Quality of Life Questionnaire12 weeksPatients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure
Visual Analog Score for pain12 weeksPatients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure

Countries

China

Contacts

Primary ContactLei Cheng
chenglei@jsph.org.cn+8613776620807

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026