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

Rhinitis, Allergic Clinical Trial

Official title:

Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis: Phase 2 Randomized, Double-blinded, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901532
• Other study ID #: CF19289A
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: June 2023
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 28, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medicine, Chinese Traditional
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• 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 plastic bottle 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 for 2 months.
• edible caramel
The bilateral nasal cavity was irrigated with a plastic bottle containing edible caramel dissolved in 240 ml of warm normal saline once a day for 2 months.

Locations

Country	Name	City	State
Taiwan	Rong-San Jiang	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of rhinitis symptom score	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.	Evaluated baseline and 2-month nasal lavage
Primary	Self-reported adverse events	Any adverse events occurring during the study period	Through study completion, an average of 2 months
Secondary	Change of swollen degree of inferior turbinates	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.	Evaluated baseline and 2-month nasal lavage
Secondary	Change of the second minimal cross-sectional area of the nasal cavity	The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.	Measured baseline and 2-month nasal lavage
Secondary	Change of total inspiratory resistance	Total inspiratory resistance was measured by rhinomanometry.	Measured baseline and 2-month nasal lavage
Secondary	Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire	Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian Tube function	Evaluated baseline and 2-month nasal lavage
Secondary	Change of Eustachian Tube function test	Performing a Eustachian Tube Function Test to evaluate Eustachian Tube function	Evaluated baseline and 2-month nasal lavage