NCT07534280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 9, 2026

Last Update Submit

April 15, 2026

Conditions

Rhino Sinusitis

Keywords

rhinosinusitisMango leafsteroidsSNOT-16

Outcome Measures

Primary Outcomes (1)

  • Reduction of SNOT 16 score after treatment

    14 days

Study Arms (3)

herbal tea group

EXPERIMENTAL

Herbal tea 3 mgs three times a day plus oral antibiotic

Dietary Supplement: mango leaves extractDrug: amoxicillin clavulanates

Routine therapy

ACTIVE COMPARATOR

Steroid plus oral antibiotics in their normal doses

Drug: local steroidsDrug: amoxicillin clavulanates

Nasal irrigation Plus antibiotic

PLACEBO COMPARATOR

Nasal irrigation daily Plus oral antibiotics

Other: nasal salineDrug: amoxicillin clavulanates

Interventions

mango leaves extractDIETARY_SUPPLEMENT

herbal tea 3 times/day

herbal tea group
local steroidsDRUG

local steroids once daily

Routine therapy
nasal salineOTHER

nasal irrigation on need

Nasal irrigation Plus antibiotic
amoxicillin clavulanatesDRUG

500 mg 3 times a day

Nasal irrigation Plus antibioticRoutine therapyherbal tea group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Soad A. Mohamad

Minya, Minya Governorate, 05673, Egypt

Location

Deraya university

Minya, 05673, Egypt

Location

MeSH Terms

Conditions

Rhinosinusitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

November 20, 2025

Primary Completion

January 10, 2026

Study Completion

March 1, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)