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Trial record 40 of 167 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

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).

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: Triamcinolone Drug: Turmeric paste Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessor (CS) and statistician
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
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).
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

Active Comparator: Triamcenolone in orabase
Triamcenolone + na ploycarboxylate
Drug: Triamcinolone
Triamcenolone +napolycarboxylate
Other Name: Triamcenolone in orabase




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. IL-33 level in saliva [ Time Frame: base line and 4th week ]
    by ELISA



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Publications of Results:
Other Publications:
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Responsible Party: Mohamed salah abd-elhameed, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03877679     History of Changes
Other Study ID Numbers: OMED2:5:1
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All authors of this trial will have access to the final trial dataset.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: after study completion
Access Criteria: pubmed

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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
Keywords provided by Mohamed salah abd-elhameed, Cairo University:
oral lichen planus
curcumin
IL-33
corticosteroids
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Triamcinolone
Curcumin
Turmeric extract
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Antineoplastic Agents
Antioxidants
Protective Agents