Trial record 46 of 188 for:
curcumin
The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients
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ClinicalTrials.gov Identifier: NCT03877679 |
Recruitment Status :
Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
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Sponsor:
Cairo University
Information provided by (Responsible Party):
Mohamed salah abd-elhameed, Cairo University
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | September 24, 2018 | ||||||||||||||||
First Posted Date ICMJE | March 18, 2019 | ||||||||||||||||
Last Update Posted Date | March 18, 2019 | ||||||||||||||||
Estimated Study Start Date ICMJE | May 1, 2019 | ||||||||||||||||
Estimated Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Pain intensity [ Time Frame: 4 weeks ] measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | No Changes Posted | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients | ||||||||||||||||
Official Title ICMJE | The Effect of Topical Curcumin Versus Topical Corticosteroid on Pain, Clinical Parameters and Salivary Level of IL-33 in Oral Lichen Planus Patients: A Randomized Controlled Clinical Trial | ||||||||||||||||
Brief Summary | Introduce a new anti-inflammatory and antioxidant paste preparation (curcumin paste) in the management of Oral lichen planus.
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Detailed Description | Two groups will be prepared then decision of which one take curcumin paste will be selected according to randomized numbers in a sequentially numbered, opaque, sealed envelope 1 group will take topical corticosteroid and 1 will take curcumin paste then IL-33 level in saliva will be measured at the base line and at the end of 4th week pain and clinical parameters will be measured at 2nd and 4th week |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Masking Description: Outcome assessor (CS) and statistician Primary Purpose: Treatment
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Condition ICMJE | Oral Lichen Planus | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
40 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Estimated Study Completion Date ICMJE | June 1, 2020 | ||||||||||||||||
Estimated Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||
Contacts ICMJE | |||||||||||||||||
Listed Location Countries ICMJE | Not Provided | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT03877679 | ||||||||||||||||
Other Study ID Numbers ICMJE | OMED2:5:1 | ||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Mohamed salah abd-elhameed, Cairo University | ||||||||||||||||
Study Sponsor ICMJE | Cairo University | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE | Not Provided | ||||||||||||||||
PRS Account | Cairo University | ||||||||||||||||
Verification Date | March 2019 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |