Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

TERMINATED

NCT07899515

Efficacy and Safety of Xinyi Powder in Patients With Allergic Rhinitis and the Lung Deficiency and Cold Syndrome

Sponsor: Nanjing University of Traditional Chinese Medicine

View on ClinicalTrials.gov

Summary

By observing the improvement of Xinyi Powder powder and simulated agent on the symptoms, symptom and sign scores, nasal symptom VAS scores, and quality of life of patients with allergic rhinitis due to lung deficiency and cold, the clinical efficacy of Xinyi Powder in the treatment of allergic rhinitis due to lung deficiency and cold is evaluated. It fully embodies the characteristics and advantages of traditional Chinese medicine treatment, provides new treatment methods for the clinical treatment of allergic rhinitis due to lung deficiency and cold, and provides objective basis for the development of new drugs.

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Xinyi Powder in the Treatment of Allergic Rhinitis With Lung Deficiency and Cold Syndrome

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

228

Start Date

2024-10-23

Completion Date

2026-07-25

Last Updated

2026-10-27

Healthy Volunteers

Conditions

Allergic Rhinitis

Interventions

DRUG

Xinyi Powder

Xinyi Powder is a fixed Chinese herbal formula manufactured by the pharmaceutical preparation department of Jiangsu Province Hospital of Chinese Medicine. It consists of ten Chinese herbal medicines-Xinyi, Xixin, Gaoben, Shengma, Chuanxiong, Mutong, Fangfeng, Qianghuo, Baizhi, and Gancao-in equal proportions. The herbs are ground into a fine powder. The powdered herbs passed through an 80-mesh sieve, with at least 95% of the powder passing through a 100-mesh sieve. The preparation is packaged in 6-g sachets. Participants will take one sachet (6 g) orally twice daily, in the morning and evening after meals, with green tea for 14 consecutive days.

DRUG

Xinyi Powder placebo

The Xinyi Powder placebo was manufactured by the pharmaceutical preparation department of Jiangsu Province Hospital of Chinese Medicine. It was prepared from a base material, colorant, and solvent through mixing, drying, grinding, and sieving. The placebo was designed to closely match Xinyi Powder in appearance, color, odor, and packaging. It was packaged in 6-g sachets and administered orally at one sachet twice daily, in the morning and evening after meals, with green tea for 14 consecutive days.

Inclusion Criteria: To be eligible for inclusion, patients must meet all of the following criteria: 1. Meet the diagnostic criteria for allergic rhinitis (Western medicine), with a Total Nasal Symptom Score (TNSS) \> 4; have a confirmed diagnosis of Seasonal Allergic Rhinitis (SAR) or Perennial Allergic Rhinitis (PAR) with seasonal exacerbation; and have an onset of the current episode within the past 4 weeks; 2. Allergen testing: Positive results on skin prick test and/or serum-specific IgE assay; 3. Meet the Traditional Chinese Medicine (TCM) syndrome diagnostic criteria for "Lung Deficiency with Cold Invasion"; 4. Aged 18 to 65 years (inclusive), regardless of gender; Voluntary participation in the trial and signing of a written informed consent form. Exclusion Criteria: Patients meeting any of the following criteria must be excluded: 1. Patients found to have nasal mucosal erosion, ulceration, or nasal septal perforation during the pre-enrollment nasal examination; 2. Patients with other nasal conditions that might cause intranasal drug deposition, such as sinusitis, rhinitis medicamentosa, nasal polyps, or structural abnormalities of the nasal cavity; 3. Patients who have undergone nasal surgery within the 12 months prior to screening; 4. Patients currently receiving treatment for allergic conditions such as allergic rhinitis, allergic eczema, conjunctivitis, or asthma; 5. Patients using systemic corticosteroids, those who have used intranasal glucocorticoids within 15 days prior to the study, or those undergoing long-term immunotherapy (exceeding 2 years); 6. Patients with abnormal liver or renal function (ALT or AST ≥ 1.5 times the upper limit of normal; Cr \> upper limit of normal); 7. Patients with severe underlying diseases, such as cardiovascular or cerebrovascular disease, or disorders affecting the liver, kidneys, respiratory system, or hematopoietic system; 8. Pregnant or lactating women, or patients with psychiatric disorders; 9. Patients with a known allergy to the investigational drug or its components; 10. Patients who have participated in other clinical trials within the 3 months prior to screening; 11. Other patients deemed unsuitable for enrollment by the investigator.

Locations (2)

Jiangsu Provincial Second Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, China

Jiangsu Province Hospital of Chinese Medicine