Efficacy of Berry Leaves & Mango Leaves Mixture in Symptomatic Treatments on Disease-related Quality of Life in Adults With Clinically Diagnosed Acute Rhinosinusitis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Deraya University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Reduction of SNOT 16 score after treatment
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Routine therapy
Steroid plus oral antibiotics in their normal doses
Intervention: local steroids (Drug)
Routine therapy
Steroid plus oral antibiotics in their normal doses
Intervention: amoxicillin clavulanates (Drug)
Nasal irrigation Plus antibiotic
Nasal irrigation daily Plus oral antibiotics
Intervention: amoxicillin clavulanates (Drug)
Nasal irrigation Plus antibiotic
Nasal irrigation daily Plus oral antibiotics
Intervention: nasal saline (Other)
herbal tea group
Herbal tea 3 mgs three times a day plus oral antibiotic
Intervention: mango leaves extract (Dietary Supplement)
herbal tea group
Herbal tea 3 mgs three times a day plus oral antibiotic
Intervention: amoxicillin clavulanates (Drug)
Outcomes
Primary Outcomes
Reduction of SNOT 16 score after treatment
Time Frame: 14 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Soad Ali
associate professor
Deraya University