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Trial record 44 of 179 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
Sponsor:
Information provided by (Responsible Party):
Mohamed salah abd-elhameed, Cairo University

Tracking Information
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
 (submitted: March 14, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • clinical sign score [ Time Frame: Baseline , 2nd week and 4th week ]
    measured by Thongprasom from score 0 to 5 0= only white lesion 5=area of erosion more than 2 cm
  • IL-33 level in saliva [ Time Frame: base line and 4th week ]
    by ELISA
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.

  • Assess the efficacy of this preparation on pain, clinical parameter and the level of IL-33 in saliva.
  • Compare the outcome of new preparation with the gold standard treatment (corticosteroids).
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

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
Condition  ICMJE Oral Lichen Planus
Intervention  ICMJE
  • Drug: Triamcinolone
    Triamcenolone +napolycarboxylate
    Other Name: Triamcenolone in orabase
  • Drug: Turmeric paste
    Topical turmeric paste (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University
    Other Name: Curcumin
Study Arms  ICMJE
  • Experimental: turmeric paste
    Topical curcumin gel (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University traumeric extracted from Curcuma plant, it has anti-inflammatory, antioxidative and antineoplastic properties ((Nosratzehi et al., 2018), The curcumin is safe even in high doses, Since oxidative stress may play a role in pathophysiology of OLP, and by noting that OLP is a chronic inflammatory disease, the herbs which have both anti-inflammatory and antioxidant properties may efficiently control OLP (Kia et al., 2015).
    Intervention: Drug: Turmeric paste
  • Active Comparator: Triamcenolone in orabase
    Triamcenolone + na ploycarboxylate
    Intervention: Drug: Triamcinolone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
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:

  • Patients who will be clinically diagnosed as having atrophic &/or erosive oral lichen planus.
  • Patients with controlled diabetes and/or controlled hypertension will be included in the study.
  • Patients with no history of taking corticosteroids for the last 6 months
  • Patients who agrees to take medication.

Exclusion Criteria:

  • Pregnant and lactating ladies.
  • Patients with history of topical steroids during last 2 months & systemic steroids during last 6 months.
  • Patients with recent dental filling associated with the lesion or associated with recent drug administration.
  • Patient with uncontrolled diabetes, uncontrolled hypertension, or those with positive HCV ab or HBs Ag.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All authors of this trial will have access to the final trial dataset.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: after study completion
Access Criteria: pubmed
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