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
Determining the effecacy of Golnar mocuadhesive on erythematous and erosive lesions of OLP
Design
Clinical trial with control group, with parallel groups, double-blind, randomized
Settings and conduct
Informed consent is obtained from the patients. Patients are randomly divided into two groups:
The first group is the control group, which includes 31 patients who receive triamcinolone mucoadhesive form 3 times a day.
The second group, the intervention group, includes 31 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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240212060964N1
Registration date:2024-03-06, 1402/12/16
Registration timing:prospective
Last update:2024-03-06, 1402/12/16
Update count:0
Registration date
2024-03-06, 1402/12/16
Registrant information
Name
Seyede Zahra Moravej
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 4535
Email address
zmoravej@razi.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2026-09-22, 1405/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effectiveness of Pomegranate flower on oral lichen lesions
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Biomedical Research Ethics Committee
Street address
6th floor, Central Organization of Tehran University of Medical Sciences, corner of Qods St, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-02-07, 1402/11/18
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.169
Health conditions studied
1
Description of health condition studied
Erythematous and erosive lesions of oral lichen planus
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
- 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
Timepoint
The beginning of the study, 2, 4, 6 and 8 weeks after the start of the study
Method of measurement
- 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.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 31 patients who receive the mucoadhesive form containing Golnar 3 times a day
Category
Treatment - Drugs
2
Description
Control group: 31 patients who receive triamcinolone mucoadhesive form 3 times a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
private clinic
Full name of responsible person
Hooman Ebrahimi
Street address
No. 7, Yazdan Alley, West Zaratasht St., Tehran
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 8890 8128
Email
hooman.ebrahimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roja Rahimi
Street address
No. 27, North Sarparast St., West Taleghani St.
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 8378
Email
rojarahimi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyede Zahra Moravej
Position
Ph.D candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 27, North Sarparast St., West Taleghani St
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 8378
Email
szm1376@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyede Zahra Moravej
Position
Ph.D candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 27, North Sarparast St., West Taleghani St
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 8378
Email
szm1376@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyede Zahra Moravej
Position
Ph.D candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 27, North Sarparast St., West Taleghani St
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 8378
Email
szm1376@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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
When the data will become available and for how long
in the relevant article after its publication
To whom data/document is available
Everyone who has access to the published article
Under which criteria data/document could be used
After publication in the journal
From where data/document is obtainable
to the text of the published article
What processes are involved for a request to access data/document