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

Tracking Information

• First Submitted Date: May 12, 2023
• First Posted Date: June 13, 2023
• Last Update Posted Date: October 26, 2023
• Actual Study Start Date: November 1, 2020
• Actual Primary Completion Date: April 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 12, 2023)

• 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.
• Self-reported adverse events [ Time Frame: Through study completion, an average of 2 months ]
  Any adverse events occurring during the study period

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 12, 2023)

• 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.
• 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.
• Change of total inspiratory resistance [ Time Frame: Measured baseline and 2-month nasal lavage ]
  Total inspiratory resistance was measured by rhinomanometry.
• 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
• 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

Original Secondary Outcome Measures (submitted: June 12, 2023)

• Chage of swollen degree of inferior turbinates [ Time Frame: Evaluated baseline and 2-month nasal lavage ]
  The swollen degree of inferior trubinates was measuring by scores. Score 0 means inferior turbinates occupying less than25% 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 than75% of nasal cavity.
• 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.
• Change of total inspiratory resistance [ Time Frame: Measured baseline and 2-month nasal lavage ]
  Total inspiratory resistance was measured by rhinomanometry.
• 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
• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis
• Official Title: Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis: Phase 2 Randomized, Double-blinded, Placebo-controlled Trial
• 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.
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Rhinitis, Allergic
• Nasal Lavage
• Medicine, Chinese Traditional

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.
• 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.

Study Arms

• 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.
  Intervention: Drug: Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol
• 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.
  Intervention: Drug: edible caramel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 12, 2023): 38
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 28, 2023
• Actual Primary Completion Date: April 30, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT05901532
• Other Study ID Numbers: CF19289A
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Taichung Veterans General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Taichung Veterans General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Taichung Veterans General Hospital
• Verification Date: June 2023