Protocol summary
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Study aim
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Determining the effecacy of Golnar mocuadhesive on erythematous and erosive lesions of OLP
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized
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Settings and conduct
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Informed consent is obtained from the patients. Patients are randomly divided into two groups:
The first group is the control group, which includes 20 patients who receive triamcinolone mucoadhesive form 3 times a day.
The second group, the intervention group, includes 20 patients who receive the form of mucoadhesive containing Golnar 3 times a day.
Patients receive the medicine every two weeks to one month. Visits to check the symptoms of OLP are performed until the end of the second month. It will be explained to the patients used an amount that covers a thin layer onthe lesion. Nystatin drops will be prescribed to both groups.
The place of study is a private office specializing in oral and maxillofacial diseases.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Existence of clinical criteria and pathology of erythematous and erosive lesions of OLP
Non-entry criteria:
-Patients with a history of chronic diseases
- Active viral disease in the oral cavity
-Patients with a history of allergy to herbal medicines
-Received local treatments during the last 2 weeks or systemic treatments during the last 4 weeks for lesions of OLP
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Intervention groups
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Intervention group: including 31 patients who receive the form of glue containing Gelnar 3 times a day.
Control group: including 31 patients who receive triamcinolone 0.1% mucoadhesive form 3 times a day.
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Main outcome variables
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Formulation and standardization of mocuadhesive containing golnar (Punica granatum L.) and determining its effecacy in erythematous and erosive lesions of OLP and comparing it with the mocuadhesive form of triamcinolone during a randomized double-blind clinical study
General information
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Reason for update
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با توجه به شیوع پایین بیماری لیکن پلان دهانی و متعاقب آن شیوع کمتر ضایعات اروزیو، و با در نظر گرفتن محدودیت‌های موجود در دسترسی به بیماران واجد شرایط و همچنین مرور مطالعات و مقالات پیشین انجام‌شده در این زمینه، حجم نمونه مطالعه حاضر ۴۰ نفر تعیین گردید.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240212060964N1
Registration date:
2024-03-06, 1402/12/16
Registration timing:
prospective
Last update:
2025-12-28, 1404/10/07
Update count:
1
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Registration date
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2024-03-06, 1402/12/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-05-21, 1403/03/01
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Expected recruitment end date
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2026-09-22, 1405/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Formulation and standardization of mucoadhesive form of Golnar (Punica granatum L.) and its effectiveness in erythematous and erosive lesions of oral lichen planus and its comparison with mucoadhesive form of triamcinolone: a randomized double-blind clinical trial
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Public title
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The effectiveness of Pomegranate flower on oral lichen lesions
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Existence of clinical criteria and pathology of erythematous and erosive lesions of oral lichen planus
Exclusion criteria:
Patients with a history of chronic diseases such as hypertension, diabetes, etc.
Active viral disease in the oral mucosa
Patients with a history of allergy to herbal medicines-receiving local treatment in the last 2 weeks or systemic treatment in the last 4 weeks for lesions of oral lichen planus
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, the block randomization method will be used using blocks of 4. A person who is not involved in the process of taking patients and evaluating patients will create a random sequence using the site: https://www.sealedenvelope.com And based on the sample size, 15 blocks of 4 will be created. Each patient will be given a unique code that can be created on this site. Therefore, the concealment is observed and the patients and people involved in the study do not know in which group the next person will be placed and they will not know about the random sequence and only the statistics consultant will know about the random sequence and the codes will remain with them.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Medicines and placebo are in similar containers with the same shape, color and smell. Specific codes are inserted by a third person on the label of the medicine box and placebo. Patients and researchers do not know the concept of codes.با
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-02-07, 1402/11/18
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Ethics committee reference number
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IR.TUMS.TIPS.REC.1402.169
Health conditions studied
1
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Description of health condition studied
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Erythematous and erosive lesions of oral lichen planus
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ICD-10 code
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L43
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ICD-10 code description
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Lichen planus
Primary outcomes
1
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Description
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- Determining the formulation of the adhesive mucus form containing Golnar- Determining the pH of the form of glue containing Golnar- Determining the release of the extract from the adhesive mucus ointment containing Golnar- Determining the amount of adhesiveness of the adhesive mucus form containing Golnar- Determining the rheological properties of the form of glue containing Golnar- Determining the microbial stability of the adhesive mucus form containing Golnar- Comparison of the average pain score of lichen planus between two groups of adhesive mucus form containing Golnar and triamcinolone adhesive form- Comparison of the average lichen plan score between the two groups of adhesive mucus form containing Golnar and triamcinolone adhesive mucus- Comparison of the frequency of lichen planus lesions between the two groups of adhesive mucus form containing golnar and triamcinolone adhesive mucus- Comparison of the average score of response to lichen planus treatment between two groups of adhesive mucus form containing Golnar and triamcinolone adhesive mucus- Comparison of the average duration of treatment of lichen planus between two groups of adhesive mucus form containing Golnar and triamcinolone adhesive mucus- Comparison of the average Lichen Plan pain score within each group before and after treatment- Comparison of the average score of Lichen Plan within each group before and after treatment- Comparison of the frequency of lichen planus lesions in each group before and after treatment- Comparison of the mean response score to lichen planus treatment within each group before and after treatment
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Timepoint
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The beginning of the study, 2, 4, 6 and 8 weeks after the start of the study
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Method of measurement
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- Pain ruler or Visual Analog Scale (VAS): A scaled page from 0 to 10 is given to the patients and according to the pain intensity of the lesions, a numerical score between 0 (in the absence of pain) and 10 (the most severe) is given.- The largest diameter of each lesion is measured by a specialist using calipers and (or dental floss for lesions far from reach). The REU scoring system (reticular/hyperkeratotic, erosive/erythematous, ulcerative) will be used to evaluate lesions.- Side effects form based on (CTCAE) Common Terminology Criteria for Adverse Version 5 is completed for patients on days 7, 14, 28.
Intervention groups
1
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Description
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Intervention group: 20 patients who receive the mucoadhesive form containing Golnar 3 times a day
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Category
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Treatment - Drugs
2
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Description
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Control group: 20 patients who receive triamcinolone mucoadhesive form 3 times a day.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All non-personal data of participants without mentioning names; Information about the main messages and all the information obtained from the research is published in the article
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When the data will become available and for how long
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in the relevant article after its publication
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To whom data/document is available
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Everyone who has access to the published article
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Under which criteria data/document could be used
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After publication in the journal
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From where data/document is obtainable
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to the text of the published article
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What processes are involved for a request to access data/document
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send e-mail to zmoravej@razi.tums.ac.ir
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Comments
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