NCT04046393

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

Chia Yi Chang Gung Memorial Hospital

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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

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

• Nasal Disease

Interventions

Type	Name	Description
DEVICE	Taiwan Scientific" noninvasive blood pressure meter TS-0411	measure autonomic nerve
DEVICE	Meridian Energy Analysis Device(MEAD)	measure meridian energy
PROCEDURE	bacteria culture	use culture swab to culture nasal discharge
PROCEDURE	nasopharyngoscopic examination	use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system
COMBINATION_PRODUCT	TCM nasal irrigation	Chinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle

Timeline

• Start date: 2019-12-31
• Primary completion: 2020-09-01
• Completion: 2022-02-14
• First posted: 2019-08-06
• Last updated: 2020-06-22

Locations

1 site across 1 country: Taiwan