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

• ClinicalTrials.gov Identifier: NCT05901532
• Recruitment Status: Completed
• First Posted: June 13, 2023
• Last Update Posted: October 26, 2023
• Sponsor: Taichung Veterans General Hospital
• Information provided by (Responsible Party): Taichung Veterans General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rhinitis, Allergic; Nasal Lavage; Medicine, Chinese Traditional	Drug: Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol; Drug: edible caramel	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis: Phase 2 Randomized, Double-blinded, Placebo-controlled Trial
• Actual Study Start Date: November 1, 2020
• Actual Primary Completion Date: April 30, 2022
• Actual Study Completion Date: February 28, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Chinese herbal medicine; 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.	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.
Placebo Comparator: Placebo; 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.	Drug: 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Taiwan

Rong-San Jiang

Taichung, Taiwan, 40705

Sponsors and Collaborators

Taichung Veterans General Hospital

Investigators

• Principal Investigator: Rong-San Jiang, MD, PhD; Taichung Veterans General Hospital

More Information

• Responsible Party: Taichung Veterans General Hospital
• ClinicalTrials.gov Identifier: NCT05901532
• Other Study ID Numbers: CF19289A
• First Posted: June 13, 2023
• Last Update Posted: October 26, 2023
• Last Verified: June 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taichung Veterans General Hospital:

Rhinitis, Allergic; Nasal Lavage; Medicine, Chinese Traditional

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases