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

NCT05901532 | Completed Phase 2

• 1 other identifier: CF19289A
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic; Nasal Lavage; Medicine, Chinese Traditional

Keywords

Rhinitis, Allergic; Nasal Lavage; Medicine, Chinese Traditional

Outcome Measures

Primary Outcomes (2)

• 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

• Self-reported adverse events

  Any adverse events occurring during the study period

  Through study completion, an average of 2 months

Secondary Outcomes (5)

• Change of swollen degree of inferior turbinates

  Evaluated baseline and 2-month nasal lavage

• Change of the second minimal cross-sectional area of the nasal cavity

  Measured baseline and 2-month nasal lavage

• Change of total inspiratory resistance

  Measured baseline and 2-month nasal lavage

• Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire

  Evaluated baseline and 2-month nasal lavage

• Change of Eustachian Tube function test

  Evaluated baseline and 2-month nasal lavage

Study Arms (2)

Chinese herbal medicine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

Chinese herbal medicine

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.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Rong-San Jiang

Taichung, 40705, Taiwan

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

isoborneol

Condition Hierarchy (Ancestors)

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

Study Officials

• Rong-San Jiang, MD, PhD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 13, 2023
• Study Start: November 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: February 28, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-06

Locations

TW (1)