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

NCT06427577 | Recruiting

• 1 other identifier: 2024-SR-304 ZhenQiFuZheng
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (2)

• Rhinoconjunctivitis Quality of Life Questionnaire

  Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure

  12 weeks

• Visual Analog Score for pain

  Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure

  12 weeks

Study Arms (1)

Allergic rhinitis

EXPERIMENTAL

ZhenQi FuZheng granules (ShiDaiYangGuang) 1 bag at a time, twice a day. Oral for 4 weeks.

Drug: ZhenQi FuZheng granules (ShiDaiYangGuang)

Interventions

ZhenQi FuZheng granules (ShiDaiYangGuang) DRUG

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

Allergic rhinitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (5)

• Al-Digheari A, Mahboub B, Tarraf H, Yucel T, Annesi-Maesano I, Doble A, Lahlou A, Tariq L, Aziz F, El Hasnaoui A. The clinical burden of allergic rhinitis in five Middle Eastern countries: results of the SNAPSHOT program. Allergy Asthma Clin Immunol. 2018 Nov 19;14:63. doi: 10.1186/s13223-018-0298-x. eCollection 2018.

  PMID: 30473712 BACKGROUND

• Eifan AO, Durham SR. Pathogenesis of rhinitis. Clin Exp Allergy. 2016 Sep;46(9):1139-51. doi: 10.1111/cea.12780.

  PMID: 27434218 BACKGROUND

• Cheng L, Chen J, Fu Q, He S, Li H, Liu Z, Tan G, Tao Z, Wang D, Wen W, Xu R, Xu Y, Yang Q, Zhang C, Zhang G, Zhang R, Zhang Y, Zhou B, Zhu D, Chen L, Cui X, Deng Y, Guo Z, Huang Z, Huang Z, Li H, Li J, Li W, Li Y, Xi L, Lou H, Lu M, Ouyang Y, Shi W, Tao X, Tian H, Wang C, Wang M, Wang N, Wang X, Xie H, Yu S, Zhao R, Zheng M, Zhou H, Zhu L, Zhang L. Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis. Allergy Asthma Immunol Res. 2018 Jul;10(4):300-353. doi: 10.4168/aair.2018.10.4.300.

  PMID: 29949830 BACKGROUND

• Wang XD, Zheng M, Lou HF, Wang CS, Zhang Y, Bo MY, Ge SQ, Zhang N, Zhang L, Bachert C. An increased prevalence of self-reported allergic rhinitis in major Chinese cities from 2005 to 2011. Allergy. 2016 Aug;71(8):1170-80. doi: 10.1111/all.12874. Epub 2016 Apr 13.

  PMID: 26948849 BACKGROUND

• Li K, Chen Y, Jiang R, Chen D, Wang H, Xiong W, Li D, Liu Z, Li X, Li J, Yuan K. Protective effects of astragaloside IV against ovalbumin-induced allergic rhinitis are mediated by T-box protein expressed in T cells/GATA-3 and forkhead box protein 3/retinoic acid-related orphan nuclear receptor gammat. Mol Med Rep. 2017 Aug;16(2):1207-1215. doi: 10.3892/mmr.2017.6685. Epub 2017 Jun 6.

  PMID: 28586019 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lei Cheng

CONTACT

+8613776620807; chenglei@jsph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 24, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)