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Oral UlcerEarly Phase 1NCT04989049

Therapeutic Effect of Folic Acid in Healing of Oral Ulcers

A Early Phase 1 study testing Folic Acid 5 MG in people with Oral Ulcer, run by Dow University of Health Sciences.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

patients reporting at the department of oral medicine with the complain of oral ulceration will be asked to participate in this study. Read more about this study

Who is it for?
Ages 14 to 44 years
Conditions the study is for
Oral Ulcer
What is being tested?
Folic Acid 5 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
No sites listed yet
Study dates
Sep 2022to Dec 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 44 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • • Age of the participant will be between 14 to 44 years old
  • Both of the genders will be included
  • Patients with oral ulceration

Who cannot join

  • • Reluctant to participate
  • Non healing ulcerations, lasting for more than 14 days after removing the cause
  • Patients with neurological problems, psoriasis, rheumatoid arthritis.

Trial locations and contacts

No sites are listed yet.

Tahseen S Khooharo, MSc oral medicine contact

+923362533399

tahseen_shabbir@hotmail.com

About this study

Official title: Main Objective While Treating the Ulcers is to Reduce the Discomfort and Accelerate Healing. Thus the Purpose of the Study is to Find Out Therapeutic Role of Topical Folic Acid on Oral Ulcerations

patients reporting at the department of oral medicine with the complain of oral ulceration will be asked to participate in this study.

Read the detailed description

Oral ulcerations are usually reported with pain and discomfort while eating and drinking at times while talking. Ulcers are usually described as erythematous surroundings, raised margins, with yellowish-white necrotic pseudomembranous centre. Healing process of ulcers usually starts nearly after 24-48 h of its onset. The initial inflammatory stage is enriched by leukocytes, after 48 hours of injury, mature monocytes in connective tissue turn into macrophages which until day 3 tend to increase in numbers. Oral ulcers are one of the commonest lesions of oral cavity; around 83.6% people have suffered from the ulcers. Frequency of traumatic ulcers fluctuates from 3 to 34% around the globe. Traumatic ulcers are usually caused by mechanical irritaation. Various studies have been conducted till date for the treatment of oral ulcers such as anti-inflammatory gels, propolis extract gel, topical steroids such as triamcinolone acetonide paste and silver nanoparticle gel.

Folic acid (vitamin b9) belongs to the water soluble class of vitamins called B-complex. It is an essential component of metabolic pathways of carbohydrates, fats and proteins which are important compounds in various functions such as cardiovascular and nervous system. This vitamin is also important for DNA methylation and biosynthesis of nucleotide. Dietary foliate deficiency is a problem of developing country. Folic acid daily requirement of an adult is 400 mg/day whereas during pregnancy it's required up to 600mg and in nursing mother daily required dosage of foliate is 500mg/day.

The difference between folic acid and foliate is that the foliate is a natural form which is found in mushrooms, green leafy vegetables and livers whereas folic acid is synthetically produced and is used to fortify processed foods and supplements in a fully reduced biologically active form dihydrofolate reductase. Humans lack the enzyme which is required to produce foliate that is why they depend on dietary and supplemental form of this essential vitamin.

Main objective while treating the ulcers is to reduce the discomfort and accelerate healing. Thus the purpose of the study is to find out therapeutic role of topical folic acid on oral ulcerations.

Patients falling in the inclusion criteria will be asked to participate in the study, consent will be obtained from the patients. Demographic feature, history and examination will be noted on a research questionnaire. After examination patients will be given topical folic acid in tablet form to be applied by themselves twice a day on ulcers. Patients will be asked to visit the dental out patients department of oral medicine at Isra University Hyderabad on 7th day for follow up. Specific questions will be asked from the patients and examination will be done on the day of follow, the information will be recorded on a follow up form.

Conditions
Oral Ulcer
Being tested
Folic Acid 5 MG, placebo
Keywords
folic acid, oral ulcers, topical therapy
Medical subject headings
Oral Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Folic Acid 5 MGDrug

    Also called folacin

    folic acid tablet of 5mg will be placed on the ulcers 2 times per day for 7 days

  • placeboOther

    Also called inactive drug

    an inactive drug looking exactly like active drug will be given, patients will be asked to put it on ulcers 2 times per day

Study groups in NCT04989049
Study groupRoleWhat they receive
intervention group or case groupActive comparatortopical folic acid on oral ulcers will be applied for 7 days and patients will be asked to visit after 7 days for follow up
Receives: Drug: Folic Acid 5 MG
control groupPlacebo comparatorplacebo drug for oral ulcers
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. healing of ulcers

    patients will be examined to evaluate if the ulcers are healed completely, follow up questionnaire form will be filled by the examining dentist, describing the condition of the patient.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2021
  2. Study startSep 2022 (estimated)
  3. Primary completionNov 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
75 patients divided into two groups 35 in each
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04989049
Sponsor's protocol ID
folic acid for oral ulcers
Status last verified
Mar 2022
First submitted
7 Jul 2021
Last updated
24 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Folic Acid 5 MG in people with Oral Ulcer, run by Dow University of Health Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tahseen S Khooharo, MSc oral medicine (+923362533399, tahseen_shabbir@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

healing of ulcers (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.

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