Effect of Chinese Herbal Medicine Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorTaichung Veterans General Hospital
About this trial
Investigators tried to evaluate the efficacy and safety of Chinese herbal medicine nasal irrigation as an adjuvant therapy after FESS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Patients with chronic rhinosinusitis who failed medical treatment 2.Patients underwent bilateral primary functional endoscopic sinus surgery.
Disqualifiers
1. Patients with a history of immunodeficiency 2.Patients with a history of sinus surgery 3.Patients who receiving antibiotic treatment within a week before functional endoscopic sinus surgery 4.Patients with a pathological diagnosis of fungal sinusitis 5.Patients with a pathological diagnosis of sinonasal tumor
Trial design
Design model
Parallel
Treatments tested in this trial
Chinese herbal medicine Powder
DrugThe bilateral nasal cavity was irrigated by using a NeilMed® SINUS RINSE™ Squeeze Bottle containing 240ml of Chinese herbal medicine solution twice a day for 2 months.
Salt Powder
DrugThe bilateral nasal cavity was irrigated by using a NeilMed® SINUS RINSE™ Squeeze Bottle containing 240ml of of normal saline twice a day for 2 months.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Chinese herbal medicineExperimental treatment 1 intervention
Group B: SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Taiwanese version of the 22-item Sino-Nasal Outcome Test
The Taiwanese version of the 22-item Sino-Nasal Outcome Test contains 22 items of symptoms and social/emotional consequences from nasal disorder. Patients are asked to rate their problems based on how they have been over the past two weeks. Each item is graded from 0 (no problem) to 5 (as bad as it can be) according to its severity and frequency.
Time frame
From before operation to 3 months after surgery2
Self-reported adverse events
Any adverse events occurring during the 2 months period of nasal irrigation
Time frame
From before nasal irrigation to after 2-month nasal irrigationSecondary outcomes
1
Change of the second minimal cross-sectional area of the nasal cavity
The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.
Time frame
From before operation to 3 months after surgery2
Change of endoscopic score
The endoscopic appearances were categorized into polyps (0: no polyps; 1: polyps present within the middle meatus; 2: polyps beyond the middle meatus); nasal secretion (0: no secretion; 1: clear, thin secretion; 2: thick, purulent secretion); mucosal edema; scarring; crusting; (0: absent; 1: mild; 2: severe). The score ranged from 0 to 20 for both nostrils together.
Time frame
From before operation to 3 months after surgery3
Change of saccharine transit time
The saccharine transit test involved placing saccharine granules under the head of the inferior turbinate in the more severely affected nostril. The time interval (minute) between placement of saccharine granules and sensation of sweetness in the throat was recorded.
Time frame
From before operation to 3 months after surgerySponsors and contacts
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Source ClinicalTrials.gov