Nasal irrigation with licorice extract to treat inflammation of the nose and sinuses
| ISRCTN | ISRCTN51425529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51425529 |
| Secondary identifying numbers | CPRPG6H0011 |
- Submission date
- 13/02/2020
- Registration date
- 17/04/2020
- Last edited
- 14/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
Using nasal irrigation with a saline solution is often recommended by physicians to reduce symptoms of inflammation of the nose and sinuses. However, the effect of the procedure is not good enough and lasts for a short time. The salty, bitter taste after nasal irrigation often makes patients unwilling to use it as daily care. Additional medications, such as corticosteroid, have been proposed to enhance the effect of nasal irrigation, however, patients can be wary of using steroids.
Licorice, a very common natural material, and has been found to have anti-inflammatory and immunomodulatory effect. Its sweet taste and smell are generally well-liked. For this study, a nasal irrigant containing licorice extract was developed.
The aim of this study is to see if nasal irrigation with licorice extract is more effective than with saline.
Who can participate?
Adults with rhinitis or chronic rhinosinusitis
What does the study involve?
Participants will use either a licorice, corticosteriod or salt water nasal irrigation at home twice per day over 4 weeks. They will be assessed at the start, middle (2 weeks) and end (4 weeks) of the study for changes to their nose and sinus using a blood test, questionnaires and clinical examination.
What are the possible benefits and risks of participating?
Because we will teach those participants how to do nasal irrigation correctly by an expert before study, they will have the benefit to lean the skill for further nasal care. In addition, any kind of interventions (NILE, NICS or NIIS) would be supposed to improve their nasal symptoms by degrees. According to our preliminary study, nasal irrigation with licorice was considerably safe without significant side effect and only some irrigation-related adverse events, such as transient ear pain or stuff were encountered but those discomfort feelings could be self-limited in a short time.
Where is the study run from?
Chiayi Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
March 2018 to October 2021
Who is funding the study?
Chiayi Chang Gung Memorial Hospital (Taiwan)
Who is the main contact?
Dr Geng-He Chang
genghechang@gmail.com
Contact information
Public
Chiayi Chang Gung Memorial Hospital
No. 6
West Section
Jiapu Rd
Puzi City
Chiayi County
Chiayi
613
Taiwan
 ORCID ID |
0000-0001-5939-9747 |
|---|---|
| Phone | +886 5 362 1000 ext. 2076 |
| genghechang@gmail.com |
Study information
| Study design | Randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Investigating the effect of nasal irrigation with isotonic saline and extract of licorice on treatment of chronic rhinitis and sinusitis |
| Study acronym | NILE |
| Study hypothesis | The anti-inflammatory and immunomodulatory effects of licorice have been well-studied. We hypothesise that licorice will be a more effective nasal irrigant than saline |
| Ethics approval(s) | Approved 21/09/2018, the Chang Gung Medical Foundation Institutional Review Board (No. 199, Dunhua N. Rd., Songshan Dist., Taipei City 105, Taiwan (R.O.C.), troublefup6@cgmh.org.tw, 886-3-3196200 ext.3708), ref: 201800183A0C501A3. |
| Condition | allergic rhinitis, non-allergic rhinitis, chronic rhinosinusitis with polyposis, chronic rhinosinusitis without polyposis, nasopharyngeal carcinoma post-radiotherapy complicated with sinusitis |
| Intervention | The study includes five patient groups 1. Allergic rhinitis 2. Non-allergic rhinitis 3. Chronic rhinosinusitis with polyposis 4. Chronic rhinosinusitis without polyposis 5. Nasopharyngeal carcinoma post-radiotherapy complicated with sinusitis. AT recruitment, patient past medical records will be assessed to know if there is oral or intranasal antihistamine or steroid used one month before study (the enrollment should stop to use those medication for one month at least before study). Patient’s history will be taken to know if there is experience of sinonasal sugery (ex: turbinoplasty, septoplasty, rhinoplasty, sinus surgery, skull base surgery, etc.) or radiotherapy for nasal cavity, sinus or nasopharyngeal malignancy. Additionally, total IgE level and specific allergen test (MAST) will be checked on every participant to facilitate us to classify those patients (ex: allergic rhinitis or non-allergic rhinitis). The participants in each group will be assessed at baseline and randomized to receive one of the three following interventions. 1. Nasal irrigation with licorice extract (NILE) 2. Nasal irrigation with corticosteroid solution (NICS) 3. Nasal irrigation with isotonic saline solution (NIIS) The intervention is performed by patients at home twice per day over 4 weeks. Before the study, every participant will accept subjective evaluation with questionnaires, including the total symptom scores (TSS composed of rhinorrhea, pruritus, sneezing and blockage; none=0, mild=1, moderate=2, severe=3, summing scores range from 0 to 12), visual analogue scores (VAS) for rhinorrhea, pruritus, sneezing, blockage, postnasal drip and sleeping quality (0-100mm for each items) and Sino-nasal Outcome Test (SNOT-22). In addition, every patient will be evaluated objectively by flexible nasopharyngoscopy with Lund-Kenndy scores (scores: 0-12) and acoustic rhinometry to analyze the nasal resistance. We will collect patients' nasal discharge for analysis of inflammatory cytokines at our laboratory. Participants will return to the outpatient department for two follow up sessions during the intervention, at 2 weeks and 4 weeks. The above measurements will be done before the study and at 2 and 4 weeks of follow-up points. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Improvement in nasal obstruction measured by TSS (0-3), VAS (0-100) and SNOT22 at 0, 2 and 4 weeks 2. Improvement in rhinorrhea measured by TSS (0-3), VAS (0-100) and SNOT22 at 0, 2 and 4 weeks 3. Improvement in sneezing measured by TSS (0-3), VAS (0-100) and SNOT22 at 0, 2 and 4 weeks 4. Improvement in itchy nose measured by TSS (0-3), VAS (0-100) and SNOT22 at 0, 2 and 4 weeks 5. Improvement in postnasal drip measured by TSS (0-3), VAS (0-100) and SNOT22 at 0, 2 and 4 weeks 6. Improvement in sleep quality measured by TSS (0-3), VAS (0-100) and SNOT22 at 0, 2 and 4 weeks |
| Secondary outcome measures | 1. Nasal condition measured by nasal endoscopic examination, which is scored by using Lund Kennedy endoscopic scoring system, at 0, 2 and 4 weeks 2. Nasal resistance measured using acoustic rhinometry at 0, 2 and 4 weeks 3. Analysis of cytokines in the nasal discharge at 0, 2 and 4 weeks |
| Overall study start date | 01/03/2018 |
| Overall study end date | 31/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 (20 participants for each intervention and thus each arm will enroll 60 cases and total of five arms will have 300 cases)) |
| Total final enrolment | 60 |
| Participant inclusion criteria | 1. Diagnosis of allergic or non-allergic rhinitis 2. Diagnosis of chronic rhinosinusitis with or without nasal polyps |
| Participant exclusion criteria | 1. Aged <20 years 2. Antihistamine or corticosteroid (oral form or intranasal spray) use within 4 weeks of the intervention 3. Pregnancy 4. Planned sinonasal surgery within 4 weeks of the intervention 5. Allergy to licorice. |
| Recruitment start date | 04/12/2018 |
| Recruitment end date | 30/04/2021 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
No. 6
West Section
Jiapu Rd
Puzi City
Chiayi County
Chiayi
613
Taiwan
Sponsor information
Hospital/treatment centre
No. 6
West Section
Jiapu Rd
Puzi City
Chiayi County
Chiayi
613
Taiwan
| Phone | +886 5 362 1000 |
|---|---|
| a9244@cgmh.org.tw | |
| Website | https://www1.cgmh.org.tw/branch/jia/index.htm |
"ROR" |
https://ror.org/04gy6pv35 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Chia-Yi Chang-Gong Memorial Hospital, Chang Gung Memorial Hospital, Chia-Yi
- Location
- Taiwan
Results and Publications
| Intention to publish date | 30/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | This trial will run for 3 years (until 30/04/2021). If any patient group data collection is completed, we will analyze the part of data and publish it. The targets for publication would be journals of Chinese medicine, otolaryngology, and complementary and alternative medicine. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Allergic rhinitis | 15/07/2021 | 12/08/2022 | Yes | No |
| Results article | investigating nasal polps in a small number of treated patients | 29/11/2022 | 14/12/2022 | Yes | No |
Editorial Notes
14/12/2022: Publication reference and total final enrollment added.
12/08/2022: Publication reference added.
16/04/2020: Trial’s existence confirmed by the Chang Gung Medical Foundation Institutional Review Board.
