Herbal Tea Extract for Management of Rhinosinusitis

Deraya University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rhino Sinusitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Herbal Tea Extract for Management of Rhinosinusitis

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes