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NCT Number: NCT05901532

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

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.

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Key information

Conditions

Rhinitis, Allergic Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Medicine, Chinese Traditional Nasal Lavage Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rong-San Jiang

Taichung, 40705, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol

Drug

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

Drug

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.

Primary outcomes

  1. Change of rhinitis symptom score

    Time frame: 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.

  2. Self-reported adverse events

    Time frame: Through study completion, an average of 2 months

    Any adverse events occurring during the study period

Secondary outcomes

  1. Change of swollen degree of inferior turbinates

    Time frame: 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.

  2. Change of the second minimal cross-sectional area of the nasal cavity

    Time frame: Measured baseline and 2-month nasal lavage

    The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.

  3. Change of total inspiratory resistance

    Time frame: Measured baseline and 2-month nasal lavage

    Total inspiratory resistance was measured by rhinomanometry.

  4. Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire

    Time frame: Evaluated baseline and 2-month nasal lavage

    Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian Tube function

  5. Change of Eustachian Tube function test

    Time frame: Evaluated baseline and 2-month nasal lavage

    Performing a Eustachian Tube Function Test to evaluate Eustachian Tube function

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 13, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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