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Completed

NCT Number: NCT07534280

Herbal Tea Extract for Management of Rhinosinusitis

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.

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Key information

Conditions

Rhino Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinosinusitis Sinusitis

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soad A. Mohamad, Minya, Minya Governorate, Egypt

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mango leaves extract

Dietary Supplement

herbal tea 3 times/day

local steroids

Drug

local steroids once daily

nasal saline

Other

nasal irrigation on need

amoxicillin clavulanates

Drug

500 mg 3 times a day

Primary outcomes

  1. Reduction of SNOT 16 score after treatment

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Deraya University

Other

Registry information

Official study title

Efficacy of Berry Leaves & Mango Leaves Mixture in Symptomatic Treatments on Disease-related Quality of Life in Adults With Clinically Diagnosed Acute Rhinosinusitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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