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Berry Mango Leaves Extract for Acute Rhinosinusitis Phase I Trial, 10 Subjects

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Summary

ClinicalTrials.gov registered a Phase I controlled clinical trial (NCT07534280) studying the safety and efficacy of Berry leaves and Mango leaves herbal tea mixture for management of acute rhinosinusitis in adults. Ten subjects aged 18-70 will be enrolled from Minia University ENT outpatient clinic and followed for one month with telephone assessments at Days 0, 3, 7, 10, and 28.

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What changed

A new clinical trial registration was published on ClinicalTrials.gov for a Phase I controlled study evaluating Berry leaves and Mango leaves herbal tea mixture for symptomatic treatment of acute rhinosinusitis. The trial will enroll 10 adult subjects from Minia University ENT clinic in Egypt, who will receive the herbal tea alongside routine therapy (oral decongestant, nasal saline spray, and antitussive) for one month.

For clinical research organizations and trial sponsors, this registration indicates an early-stage investigation into herbal extract efficacy for sinus conditions. Quality-of-life outcomes will be measured using SNOT-16 at Days 3, 10, and 28. The trial does not include analgesic agents in the co-interventions. Compliance with clinical trial registration requirements under applicable regulations may apply to sponsors conducting similar research.

Archived snapshot

Apr 16, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Herbal Tea Extract for Management of Rhinosinusitis

N/A NCT07534280 Kind: NA Apr 16, 2026

Abstract

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.

Conditions: Rhino Sinusitis

Interventions: mango leaves extract, local steroids, nasal saline, amoxicillin clavulanates

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07534280

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Phase I research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals

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