To determine the safety and efficacy of tablets for patients with inflammation in mouth and lips.
- Conditions
- Recurrent oral aphthae,
- Registration Number
- CTRI/2020/08/026991
- Lead Sponsor
- RAJALAKSHMI HOSPITAL
- Brief Summary
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|**Study Title**
An open label, multi-center, single-arm treatment, clinical trial to determine the safety and efficacy of Muco-adhesive tablets with active ingredient sodium hyaluronate 0.5% manufactured by Tree of Life Pharma Ltd.in human adult, patients with Recurrent Aphthous Stomatitis (RAS).
|**Phase of development**
Final formulation, clinical testing for registration
|**Investigational MedicinalProducts**
**Test Product (T):** The product is a Muco-adhesive tablet with active Ingredient Sodium Hyaluronate 0.5% manufactured by Tree of Life Pharma Ltd.
|**Objectives**
**Primary Objective:**
To determine theefficacy ofthe muco-adhesive tablet with active ingredient Sodium Hyaluronate 0.5%manufactured by Tree of Life Pharma Ltd.in Human Adult, Patients with Recurrent Aphthous stomatitis (RAS).
**Secondary objective:**
To determine the safety and tolerability of the muco-adhesive tablet with active ingredient Sodium Hyaluronate 0.5%manufactured by Tree of Life Pharma Ltd.in Human Adult, Patients with Recurrent Aphthous stomatitis (RAS).
|**Study Design**
An open label, multi-center, single arm treatment, clinical trial in human adult,patient with Recurrent Aphthous Stomatitis (RAS).
|**Study population**
40 generally healthy patients with Recurrent Aphthous Stomatitis (RAS) with ONLY 1 aphthous wound will be enrolled in the study.
|**Primary Enrollment criteria**
Demographic data, medical and medication historyand this history includes duration, frequency of ulcer, physical examination includes size of ulcer, serology,biochemistry, Pain intensity scale(By Visual Analog Scale) and size of the ulcer and photography of the ulcerwill be performed prior to study enrolment as baseline.Diagnosis of Aphthous stomatitis will be made prior to study enrolment.
|**Study duration**
10 days
Duration will be from enrolment of the patient to until the visit completion day.The study treatment duration is 03 Days / 07-10 days for each patient.
|**Dose and Mode of Administration**
The product is a muco-adhesive tablet with active ingredient sodium hyaluronate 0.5%. One tablet will be attached to the Aphthous ulcer according to the instructions and the patient will be instructed to use 2 tablets per day for 3 days, one tablet every 12 hours.
The 1st dose will be applied in the clinical facility under the supervision of investigators (Daily doses till next visit will be dispensed and handed over to the patients). From the second dose onwards, patients will be instructed to use the products and apply it on their own. The patients will have more tablets than needed for the treatment in case the patient is having trouble adhering the tablets themselves. In any case the patient will not use more than 5 tablets of top of the first one used by the investigator (total of 6)
The product will firmly stick to the wound and within 4 hours it will becompletely dissolved. The patient will then be instructed to stick another muco-adhesive tablet after 12 hours from the first moment of the attachment of the first tablet.
|**Evaluation Schedule**
Totally 04 visits.
· Visit 01:Screening and enrollment (Day 01) and adhering the first tablet.
· Visit 02: On therapy Visit (Day 03) – after the last tablet has been dissolved.
· Visit 03: Follow up visit (Day 07)
· Visit 04: End of study visit (Day 10)
|**Patients Safety Measures**
· Biochemistry and serology will be done on the day of screening.
· At every visit, blood Pressure, radial pulse rate, oral temperature and wellbeing status will be enquired and recorded.
· Monitoring of healing will be monitored on visits 2, 3 and 4 and photographing the area on each visit.
· Another question that would be asked daily:"is the pain stronger or weaker than before the treatment?" This question will be asked on day 02, day 04, through telephone.
· Monitoring for adverse events will be done throughout the study period.
|**Efficacy assessment**
Primary Efficacy evaluations will be done as follows:
· On the first visit – adhering the tablet and a VAS questionnaire will be performed before the tablet (baseline) and immediately after sticking the tablets on the aphthous ulcer.
· On Therapy Visit – Visit 02 –72 hours (Day-03)
· Follow up visit – Visit 03 (Day – 07)
· End of Study -- Visit 04 (Day – 10)
Any adverse events would be noted during this evaluation period.
|**Clinical endpoint**
Primary end points· To determine the mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, Day 07 andDay 10.
· Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 1 before the treatment and after the first tablet, Day 03 or Day 07 or day 10
· Another question that would be asked daily:"is the pain stronger or weaker than before the treatment?" This question will be asked on day 02, day 04, through telephone
***Secondary end points***
· The assessment of Quality of Life by using a questionnaire subdivided into 3 domains:
-Functional level
-Medication limitation
-Treatment limitation of subjects during treatment period
· Monitoring of Adverse event throughout the study period.
|**Ethical Issues**
The study will be conducted as per the pertinent requirements of the Ethical guidelines for biomedical research on human participants, ICMR (2017), ICH (Step 5) ’Guidance on Good Clinical Practice’, ’Good Laboratory Practice’, ‘Good Clinical Practices for Clinical Research in India’ Guidelines, Good Clinical Laboratory Practice (GCLP), Declaration of Helsinki (Fortaleza, October 2013), New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E) dated 19 Mar 2019 and applicable regulatory requirements.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
- •Adult,non smoking, human above 18 years •Willing to comply with all requirements of this study protocol as well as instructed by the study personnel.
- •Mouth ulcer size >2 mm but <7mm at easily accessible location in the mouth allowing easy evaluation and treatment.
- •Only Ulcers that are present in the following anatomical spots will enroll in the study:superior and inferior inner lip, inner cheek (buccal), hard palate.(the place of the aphthous will be stated in the case report form.
- •Patients with only one Aphthous wound •Patients with start of mouth ulceration within 48 hours •Patients who agree not to use any othermedication for the ulcer during the study period.
- •No clinically significant abnormal finding on Medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems).
- 1.Patients with multiple aphthous in the mouth during the visit 2.The patient with Oral lesion suspected to be malignant 3.The patient with any Ulcerative oral lesion other than Aphthous stomatitis.
- 4.If the patient has undergone any experimental oral intervention within the last 24 hours.
- 5.History of alcohol addiction or abuse.
- 6.Patient who had participated in any other study within the 90 days of study 7.Patient who are not willing to enter the dosing details in their diary.
- 8.Females likely to become pregnant during conducting of the study 9.Pregnant and Lactating females.
- 10.Consumption of tobacco containing products Tobacco and tobacco products (like Khutkha, Pan/ Pan Masala, Beedi, Cigarettes) for at least 24.00 hours prior to screening and throughout the entire study 11.Consumption of vaping products 12.Any major illness in the last 03 months or any significant ongoing chronic medical illness.
- 13.Evidence of allergy or known hypersensitivity to Muco-Adhesive tablets and its components.
- 14.History of dehydration from diarrhea, vomiting or any other reason within a period of 48.00 hours prior to study check-in of each visit.
- 15.Use of any other medications for aphthous ulcer within 01 week prior to screening 16.Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion 17.Patients with Malignancy or a history of malignancy 18.Patients with Positive results for HIV or Hepatitis B or C 19.Immunocompromised patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To determine the mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, Day 07 andDay 10. 1.To determine the mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, Day 07 andDay 10. | 2.Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 1 before the treatment and after the first tablet, Day 03 or Day 07 or day 10 2.Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 1 before the treatment and after the first tablet, Day 03 or Day 07 or day 10 1.To determine the mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, Day 07 andDay 10. | 2.Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 1 before the treatment and after the first tablet, Day 03 or Day 07 or day 10
- Secondary Outcome Measures
Name Time Method N/AP N/AP
Trial Locations
- Locations (2)
ACSR GOVERNMENT COLLEGE
🇮🇳Nellore, ANDHRA PRADESH, India
RAJALAKSHMI HOSPITAL
🇮🇳Bangalore, KARNATAKA, India
ACSR GOVERNMENT COLLEGE🇮🇳Nellore, ANDHRA PRADESH, IndiaMr PhaneendraPrincipal investigator7660801861doddaga.phaneendra@gmail.com