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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05901532
Other study ID # CF19289A
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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