Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis

NCT ID: NCT04046393

Last Updated: 2020-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2022-02-14

Brief Summary

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This study investigate the nasal irrigation with Traditional herbal medicine extract-saline isotonic solution in the treatment of chronic rhinitis and sinusitis. Half of participants will receive Traditional herbal medicine extract-saline isotonic solution nasal irrigation, while the other half will receive saline alone nasal irrigation.

Detailed Description

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In the program, the investigators plan to investigate a clinical triad to research the outcomes of nasal irrigation with Traditional herbal medicine extract-saline isotonic solution for treatment of chronic rhinitis and sinusitis. The aims of this study are listed below:

Aim 1: evaluating the outcomes and quality of life of nasal irrigation with Traditional herbal medicine extract-saline isotonic solution to treat enrolled patients with chronic rhinitis or sinusitis. The investigators use modern devices to evaluate the autonomic nerve, meridian energy and pulse. The questionnaires of quality of life and symptoms will be recorded. Nasal irrigation with saline alone will be conducted during the clinical triad to compare the effectiveness and quality of life with Traditional herbal medicine extract.

Aim 2: analyzing the changes of bacteria culture in nasal discharge collected during the clinical triad before and after nasal irrigation for investigating the microenvironment of Traditional herbal medicine extract-saline isotonic solution.

According to the research, the investigators will realize the improvement of using Traditional herbal medicine extract-saline isotonic solution for nasal irrigation to treat sino-nasal diseases, by investigating the changes of quality of life and microenvironment of nasal cavity. The nasopharyngoscopic examination, autonomic nerve, meridian energy and pulse were record to compare the effectiveness of Traditional herbal medicine extract-saline isotonic solution with nasal irrigation with saline alone.

Conditions

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Nasal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Traditional Chinese Medicine(TCM) group

nasal irrigation with Traditional herbal medicine(licorice) extract-saline isotonic solution

Group Type EXPERIMENTAL

Taiwan Scientific" noninvasive blood pressure meter TS-0411

Intervention Type DEVICE

measure autonomic nerve

Meridian Energy Analysis Device(MEAD)

Intervention Type DEVICE

measure meridian energy

bacteria culture

Intervention Type PROCEDURE

use culture swab to culture nasal discharge

nasopharyngoscopic examination

Intervention Type PROCEDURE

use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system

TCM nasal irrigation

Intervention Type COMBINATION_PRODUCT

Chinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle

Saline control group

nasal irrigation with saline isotonic solution

Group Type PLACEBO_COMPARATOR

Taiwan Scientific" noninvasive blood pressure meter TS-0411

Intervention Type DEVICE

measure autonomic nerve

Meridian Energy Analysis Device(MEAD)

Intervention Type DEVICE

measure meridian energy

bacteria culture

Intervention Type PROCEDURE

use culture swab to culture nasal discharge

nasopharyngoscopic examination

Intervention Type PROCEDURE

use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system

Interventions

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Taiwan Scientific" noninvasive blood pressure meter TS-0411

measure autonomic nerve

Intervention Type DEVICE

Meridian Energy Analysis Device(MEAD)

measure meridian energy

Intervention Type DEVICE

bacteria culture

use culture swab to culture nasal discharge

Intervention Type PROCEDURE

nasopharyngoscopic examination

use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system

Intervention Type PROCEDURE

TCM nasal irrigation

Chinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

1. Diagnostic criteria for chronic rhinitis and sinusitis male and female volunteers.
2. Stop using oral and topical steroid and anti-histamine treatments \>2 weeks prior to enrollment.
3. \>20 years of age.

Exclusion Criteria

1. Allergy to herbal medicine.
2. Presence of a sinus tumor.
3. Significant immune dysfunction.
4. Pregnancy and breast-feeding women.
5. Undergone nasal surgery \<1 week prior to enrollment.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pei-Rung Yang

Role: STUDY_CHAIR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Chiayi City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Pei-Rung Yang

Role: CONTACT

+886-5-3621000 ext. 2069

Facility Contacts

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Pei-Rung Yang

Role: primary

+886-5-3621000 ext. 2069

Other Identifiers

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201801970A3

Identifier Type: -

Identifier Source: org_study_id

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