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

Chang Gung Medical Foundation

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Nasal Disease

Treatments: Combination Product: TCM nasal irrigation; Procedure: bacteria culture; Device: Meridian Energy Analysis Device(MEAD); Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411; Procedure: nasopharyngoscopic examination

Study type: Interventional

Funder types: Other

Identifiers

NCT04046393

201801970A3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups, including a placebo group

Traditional Chinese Medicine(TCM) group

Experimental group

Description:

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

Treatment:

Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411

Procedure: nasopharyngoscopic examination

Procedure: bacteria culture

Device: Meridian Energy Analysis Device(MEAD)

Combination Product: TCM nasal irrigation

Saline control group

Placebo Comparator group

Description:

nasal irrigation with saline isotonic solution

Treatment:

Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411

Procedure: nasopharyngoscopic examination

Procedure: bacteria culture

Device: Meridian Energy Analysis Device(MEAD)