Therapeutic Effect of Folic Acid in Healing of Oral Ulcers

NCT04989049 | Unknown Early Phase 1 DMC

• 1 other identifier: folic acid for oral ulcers
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Oral Ulcer

Keywords

folic acid; oral ulcers; topical therapy

Outcome Measures

Primary Outcomes (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.

  7 days

Study Arms (2)

intervention group or case group

ACTIVE COMPARATOR

topical folic acid on oral ulcers will be applied for 7 days and patients will be asked to visit after 7 days for follow up

Drug: Folic Acid 5 MG

control group

PLACEBO COMPARATOR

placebo drug for oral ulcers

Other: placebo

Interventions

Folic Acid 5 MG DRUG

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

Also known as: folacin

intervention group or case group

placebo OTHER

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

Also known as: inactive drug

control group

Eligibility Criteria

• Age: 14 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

MeSH Terms

Conditions

Oral Ulcer

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Tahseen S Khooharo, MSc oral medicine

CONTACT

+923362533399; tahseen_shabbir@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post graduate trainee

Model Details: 75 patients divided into two groups 35 in each

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: August 4, 2021
• Study Start: September 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share