Rhinitis, AllergicPhase 2NCT05901532
Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis
A Phase 2 study testing Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol and edible caramel in people with Rhinitis, Allergic and Nasal Lavage, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rhinitis, Allergic, Nasal Lavage, Medicine, Chinese Traditional
- What is being tested?
- Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol and edible caramel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2020to 28 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Allergic rhinitis patients diagnosed based on the history and allergen test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis: Phase 2 Randomized, Double-blinded, Placebo-controlled Trial
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.
Read the 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.
- Being tested
- Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol, edible caramel
- Keywords
- Rhinitis, Allergic, Nasal Lavage, Medicine, Chinese Traditional
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and BorneolDrug
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 caramelDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: edible caramel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluated baseline and 2-month nasal lavage
Self-reported adverse events
Any adverse events occurring during the study period
Measured: Through study completion, an average of 2 months
Secondary outcomes (5)
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.
Measured: Evaluated baseline and 2-month nasal lavage
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: Measured baseline and 2-month nasal lavage
Change of total inspiratory resistance
Total inspiratory resistance was measured by rhinomanometry.
Measured: Measured baseline and 2-month nasal lavage
Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire
Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian Tube function
Measured: Evaluated baseline and 2-month nasal lavage
Change of Eustachian Tube function test
Performing a Eustachian Tube Function Test to evaluate Eustachian Tube function
Measured: Evaluated baseline and 2-month nasal lavage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Nov 2020
- Primary completion30 Apr 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rong-San Jiang, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901532
- Sponsor's protocol ID
- CF19289A
- Status last verified
- Jun 2023
- First submitted
- 12 May 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis: Phase 2 Randomized, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05901532
- Acronym / sponsor ID
- CF19289A
- Keywords
- Rhinitis, Allergic, Nasal Lavage, Medicine, Chinese Traditional
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese herbal medicine | Experimental | Drug: Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and BorneolThe 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. |
| Placebo | Placebo comparator | Drug: edible caramelThe bilateral nasal cavity was irrigated with a bottle of NeilMed containing edible caramel dissolved in 240 ml of warm normal saline once a day. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Allergic rhinitis patients diagnosed based on the history and allergen test
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and BorneolThe 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 | Chinese herbal medicine |
| edible caramelThe 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. | Drug | Placebo |
Primary outcome
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
5 secondary outcomes
Change of swollen degree of inferior turbinates
Time frame: Evaluated baseline and 2-month nasal lavage
Change of the second minimal cross-sectional area of the nasal cavity
Time frame: Measured baseline and 2-month nasal lavage
Change of total inspiratory resistance
Time frame: Measured baseline and 2-month nasal lavage
Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire
Time frame: Evaluated baseline and 2-month nasal lavage
Change of Eustachian Tube function test
Time frame: Evaluated baseline and 2-month nasal lavage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong-San Jiang, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol and edible caramel in people with Rhinitis, Allergic and Nasal Lavage, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of rhinitis symptom score (time frame: Evaluated baseline and 2-month nasal lavage). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.