Herbal Tea Extract for Management of Rhinosinusitis

April 15, 2026 updated by: Soad Ali, Deraya University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 05673
        • Deraya university
    • Minya Governorate
      • Minya, Minya Governorate, Egypt, 05673
        • Soad A. Mohamad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: herbal tea group
Herbal tea 3 mgs three times a day plus oral antibiotic
Dietary supplement: mango leaves extract
herbal tea 3 times/day
Drug: amoxicillin clavulanates
500 mg 3 times a day
Active Comparator: Routine therapy
Steroid plus oral antibiotics in their normal doses
Drug: amoxicillin clavulanates
500 mg 3 times a day
Drug: local steroids
local steroids once daily
Placebo Comparator: Nasal irrigation Plus antibiotic
Nasal irrigation daily Plus oral antibiotics
Drug: amoxicillin clavulanates
500 mg 3 times a day
Other: nasal saline
nasal irrigation on need

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of SNOT 16 score after treatment
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deraya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2025

Primary Completion (Actual)

January 10, 2026

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3 April 2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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