Rhino Sinusitis
Conditions
Keywords
rhinosinusitis, Mango leaf, steroids, SNOT-16
Brief summary
The objective of this phase I controlled clinical trial is to determine the safety and efficacy of Berry leaves & Mango leaves mixture in symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute rhinosinusitis. Ten adult subjects, 18 to 70 years old, who meet the recommended criteria for acute rhinosinusitis, will be enrolled from Minia university ENT outpatient Clinic. Subjects will be advised to add Berry leaves & Mango leaves herbal tea mixture and followed for one month with their routine therapy (an oral decongestant, a nasal saline spray, and an antitussive agent except analgesic). Subject outcomes will be assessed by telephone interview at 0, 3, 7, 10, and 28 days. The Quality-of-life outcomes are measured on Day 3, 10 and 28 with SNOT-16, a validated evaluative instrument.
Interventions
DIETARY_SUPPLEMENTmango leaves extract
herbal tea 3 times/day
DRUGlocal steroids
local steroids once daily
OTHERnasal saline
nasal irrigation on need
DRUGamoxicillin clavulanates
500 mg 3 times a day
Sponsors
Deraya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject must have symptoms of acute bacterial rhinosinusitis. * The subject should be able to be self-assessed as moderate, severe, or very severe. * The subject must have access to a phone. * The subject must accept sharing and sign consent. * The subject should follow instructions carefully and not miss times of assessment
Exclusion criteria
* The subject has an allergy to: Flavonoids, phenolic acids, anthocyanins, carotenoids. * The subject has complications of sinusitis (facial edema, cellulitis, or orbital, meningeal or cerebral signs). * The subject is pregnancy. * The subject has a comorbidity that may impair their immune response (such as immunodeficiency disease, uncontrolled cancer, or chemotherapy or radiation treatment). * The subject has cystic fibrosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of SNOT 16 score after treatment | 14 days |
Countries
Egypt
Outcome results
None listed