NCT06836102

Brief Summary

Efficacy of orange peel extract in treatment of epistaxis in children

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 15, 2025

Last Update Submit

February 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The potential of nano-based gel of Orange peel extract in management of epistaxis

    assessment of epistaxis ( amount, severity and frequency ) according to ESS ( Epistaxis Severity Score ) between patients in study groups

    From enrollment to the end of treatment at 4 weeks

Study Arms (3)

gel of Orange peel extract

ACTIVE COMPARATOR

usage of gel of Orange peel extract as a local treatment of epistaxis

Dietary Supplement: Orange

nano-based gel of Orange peel extract

ACTIVE COMPARATOR

usage of nano-based gel of Orange peel extract as a local treatment of epistaxis

Dietary Supplement: Orange

placebo

PLACEBO COMPARATOR

usage of placebo in control cases

Dietary Supplement: Orange

Interventions

OrangeDIETARY_SUPPLEMENT

usage of orange peel extract in gel layer in treatment of epistaxis

gel of Orange peel extractnano-based gel of Orange peel extractplacebo

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children with anterior epistaxis from little's area

You may not qualify if:

  • patient with nasal polyp.
  • patients with hematological abnormalities.
  • patients with general diseases affecting coagulation system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Andrade MA, Barbosa CH, Shah MA, Ahmad N, Vilarinho F, Khwaldia K, Silva AS, Ramos F. Citrus By-Products: Valuable Source of Bioactive Compounds for Food Applications. Antioxidants (Basel). 2022 Dec 25;12(1):38. doi: 10.3390/antiox12010038.

    PMID: 36670900BACKGROUND

Related Links

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Central Study Contacts

Mostafa Nasr Ahmed, consultant

CONTACT

Hanaa Bahaa El-khouly, consultant of pharmacognosy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of otorhinolaryngology Minia university

Study Record Dates

First Submitted

February 15, 2025

First Posted

February 20, 2025

Study Start

February 1, 2025

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

result

Shared Documents
ICF, CSR
Time Frame
3 months
Access Criteria
contact by emailing
More information

Available IPD Datasets

Study Protocol (drmostafanasr1988@gmail.com)Access