Evaluation of Topical Pomegranate Extracts in Management... | NCT04193748

Studies
Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)

NCT04193748

Sponsor

Cairo University

Status

Completed

Last Update Posted

Feb 5, 2020Actual

Enrollment

42Actual

Phase

Phase 4

Conditions

Oral Lichen Planus

Interventions

Topical pomegranate seeds and peel extracts

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Nov 20, 2019Actual

Completion Date

Dec 13, 2019Actual

First Submitted Date

Dec 8, 2019

First Submission Date that Met QC Criteria

Dec 8, 2019

First Posted Date

Dec 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2020

Last Update Posted Date

Feb 5, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mai Zakaria Ibrahium Mohammed, Lecturer of Oral Medicine and Periodontology, Cairo University, Egypt, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus

Detailed Description

Lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been shown to affect 0.5% to 2.2% of various populations. The treatment options for OLP are numerous and include topical and systemic agents. Steroids were found effective in management of OLP with contraindicated use in some systemic diseases and with multiple side effects with its prolonged use. Pomegranates have been known for hundreds of years for their multiple health benefits, including anti-inflammatory activity. The recent surge indicates that pomegranates and their extracts may serve as natural alternatives to drugs which can offer a possible management of OLP decreasing pain and discomfort associated with this chronic condition.The aim of this study was the evaluation of the effect of topical pomegranate extracts in management of oral lichen planus lesions (OLP).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Active Comparator	Topical triamcinolone acetonide 0.1% available commercially (Kenacort- in orabase) has been used. Topical corticosteroid treatment has be repeated four times per day for four weeks.	Drug: Topical pomegranate seeds and peel extracts
Group S	Experimental	Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks.	Drug: Topical pomegranate seeds and peel extracts
Group P	Experimental	Topical pomegranate peel extract treatment has been repeated four times per day for four weeks.	Drug: Topical pomegranate seeds and peel extracts

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topical pomegranate seeds and peel extracts	Drug	Topical pomegranate seeds and peel extracts in the form of gel	Control group Group P Group S

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual analog scale (VAS)	Pain assessment scale	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Sign score	Score for clinical improvement of the signs	4 weeks
OHIP-14 questionnaire	evaluate the oral health related quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The study inclusion criteria were patients of both sexes with 18 to 60 years old in age with atrophic type OLP and signed the informed consent

Exclusion Criteria:

Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oral Medicine and Periodontology Department		Cairo			Egypt
Faculty of Dentistry, Cairo University

IPD Sharing Statement Module

Plan to Share IPD

Description

Because the research not published yet.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017676	Lichen Planus, Oral
D010146	Pain

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D008010	Lichen Planus
D017512	Lichenoid Eruptions

Browse Leaves

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Browse Branches

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