Clinical trial NCT04046393: Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis
Official title: Chia Yi Chang Gung Memorial Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Nasal Disease
Keywords: rhinitis, sinusitis, nasal irrigation, TCM
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: WHOQOL-brief score (Taiwan version)
timeFrame: one month
Secondary outcomes:
measure: 22-item Sino-Nasal Outcome Test score (SNOT-22)
timeFrame: one month
measure: Total symptom score(TSS）
timeFrame: one month
measure: Autonomic nerve (HRV)
timeFrame: one month
measure: Meridian energy
timeFrame: one month
measure: Posttreatment culture negativity
timeFrame: one month
measure: Nasopharyngoscopic examination change
timeFrame: one month
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Pei-Rung Yang
role: STUDY_CHAIR
References: