Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis

Phase 2

Completed

• Conditions: Nasal Lavage; Medicine, Chinese Traditional; Rhinitis, Allergic
• Interventions: Drug: Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol; Drug: edible caramel

• Registration Number: NCT05901532
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

In allergic rhinitis patients with severe symptoms, control of severe allergic reactions is limited with saline nasal irrigation. Therefore, there have been several attempts to use saline nasal irrigation in combination with other treatments to treat allergic rhinitis. This study tries to explore the effect of nasal irrigation with Chinese herbal medicines on allergic rhinitis.

Detailed Description

In this study, patients with allergic rhinitis over 20 years old were collected from the clinics of Otolaryngology and Traditional Chinese Medicine clinics. The subjects were randomly divided into two groups. They used the devices of NeiMed sinus rinse to irrigate the nose with 240 cc of Chinese herbal medicine solution or placebo each morning and evening for 2 months. Subjects in both groups filled questionnaires, and received acoustic rhinometry, rhinomanometry, and eustachian tube function tests before and after nasal irrigation. This study tries to explore the effect of nasal irrigation with Chinese herbal medicines on allergic rhinitis.

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2022-04-30
• Study Completion: 2023-02-28
• Study First Submitted: 2023-05-12
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-13
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Allergic rhinitis patients diagnosed based on the history and allergen test

Exclusion Criteria

• Those younger than 20 years old, Immunocompromised patients Pregnant women or breastfeeding women Those with a history of allergy to traditional Chinese medicine Those with liver and kidney insufficiency Those who cannot cooperate with nasal irrigation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese herbal medicine	Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol	The bilateral nasal cavity was irrigated with a bottle of NeilMed containing 1 gram of Szechwan Lovage Rhizome, 1 gram of Biod Magnolia Bud, 0.5 gram of Taiwan Angelica Root, 0.5 gram of Wild Mint Herb, 1.5 gram of Baikal Skullcap Root, and 0.5 gram of Borneol dissolved in 240 ml of warm normal saline once a day.
Placebo	edible caramel	The bilateral nasal cavity was irrigated with a bottle of NeilMed containing edible caramel dissolved in 240 ml of warm normal saline once a day.

Primary Outcome Measures

Name	Time	Method
Change of rhinitis symptom score	Evaluated baseline and 2-month nasal lavage	The effect of rhinorrhea, sneezing, nasal obstruction and itching on life quality was measuring by scores. Score 0 means no symptom, score 1 means symptomatic but not annoying, score 2 means troublesome symptoms and affecting part of daily activity or sleep and score 3 means annoying symptoms and affecting most daily activity or sleep.
Self-reported adverse events	Through study completion, an average of 2 months	Any adverse events occurring during the study period

Secondary Outcome Measures

Name	Time	Method
Change of swollen degree of inferior turbinates	Evaluated baseline and 2-month nasal lavage	The swollen degree of inferior turbinates was measuring by scores. Score 0 means inferior turbinates occupying less than 25% of nasal cavity, score 1 means inferior turbinates occupying 26 to 50 of nasal cavity, score 2 means inferior turbinates occupying 51 to 75 of nasal cavity and score 3 means inferior turbinates occupying more than 75% of nasal cavity.
Change of total inspiratory resistance	Measured baseline and 2-month nasal lavage	Total inspiratory resistance was measured by rhinomanometry.
Change of Eustachian Tube function test	Evaluated baseline and 2-month nasal lavage	Performing a Eustachian Tube Function Test to evaluate Eustachian Tube function
Change of the second minimal cross-sectional area of the nasal cavity	Measured baseline and 2-month nasal lavage	The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.
Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire	Evaluated baseline and 2-month nasal lavage	Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian Tube function

Trial Locations

Locations (1)

Rong-San Jiang; 🇨🇳 Taichung, Taiwan