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NCT Number: NCT06427577

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

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.

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Key information

Conditions

Rhinitis, Allergic Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Cheng Lei, Chief physician

CONTACT

[email protected]

0086-13776620807

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZhenQi FuZheng granules (ShiDaiYangGuang)

Drug

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

Primary outcomes

  1. Rhinoconjunctivitis Quality of Life Questionnaire

    Time frame: 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

  2. Visual Analog Score for pain

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Cheng

CONTACT

[email protected]

+8613776620807

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
May 24, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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