Evaluation of Topical Chamomile Versus Topical Triamcinol... | NCT03793634

Studies
Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus

NCT03793634

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jan 4, 2019Actual

Enrollment

37Estimated

Phase

Phase 1

Conditions

Oral Lichen Planus

Interventions

topical chamomile

Countries

Not provided

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 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2019Estimated

Primary Completion Date

Dec 1, 2019Estimated

Completion Date

Mar 1, 2020Estimated

First Submitted Date

Jan 3, 2019

First Submission Date that Met QC Criteria

Jan 3, 2019

First Posted Date

Jan 4, 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 3, 2019

Last Update Posted Date

Jan 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Using of herbal medications as topical chamomile which has antioxidant, anti-inflammatory and anticarcinogenesis effect with little side effects is the aim for the future treatment of OLP.

Detailed Description

Oral lichen planus (OLP) is a chronic inflammatory T cell mediated autoimmune disease that affects skin and any mucous membrane particularly oral mucosa.The patient complains of burning sensation, pain; interference with eating, swallowing and speech leading to worsening of quality of life.Oxidative stress plays a role in pathomechanism of OLP disease. Enzymatic and non- enzymatic anti-oxidants act as a physiological guard against reactive oxygen species (ROS) and cytokine-mediated toxicity.Herbal treatment is the aim of the future therapy.Chamomile has anti-oxidant , anti-inflammatory effect and accelerate healing.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
topical chamomile	Experimental	herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect.	Drug: topical chamomile
Topical Triamcinolone Acetonide	Active Comparator	topical triamcinolone acetonide is the gold standard treatment of oral lichen planus.	Drug: topical chamomile

Interventions

Name	Type	Description	Arm Group Labels	Other Names
topical chamomile	Drug	herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect	Topical Triamcinolone Acetonide topical chamomile

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain using Numerical rating scale	Pain measure using Numerical rating scale	1 month

Secondary Outcomes

Measure	Description	Time Frame
clinical sign score	Reduction in clinical sign score using Thongprasom et al	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic OLP.
Patients with no history of taking corticosteroids for the last 6 months.
Patients who agree to take medication.
Medically free

Exclusion Criteria:

Patients with oral lesions other than OLP.
Lichenoid reaction .
Pregnant females and lactation.
Smokers

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017676	Lichen Planus, Oral

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000713170	Chamomile extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

The supervisor(AA) will be blind. The principle investigator(EN) will supply the patient with the treatment.

The supervisor (AA) will assess the clinical parameters before treatment , between visits and at the end of the treatment.

Statistician will be blind. Double - blind study.

Who Masked

Outcomes Assessor