Clinical Efficiency of Natural Herbal Based Gel.

NCT ID: NCT06490289

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2024-01-16

Brief Summary

This clinical trial was conducted in School of Dentistry, Islamabad from 15th June 2023 to 16th January 2024. A total 202 participants took part in study and were divided equally into two groups i.e Control group and Experimental group where Control group was not given any treatment for oral ulcer whereas Experimental group was given herbal based Denpro oral gel 2-4 times a day for at least 4 weeks topically on ulcer area. Mouth ulcer size in patients was measured on first day " Visit=0", second day " Visit=1", third day " Visit=2", fourth day " Visit=3", seventh day " Visit=4" and fourteenth day " Visit=5" for reduction and complete recovery. Data was analyzed by One way ANOVA and POST HOC Tukey test.

Detailed Description

This clinical trial was conducted in School of Dentistry, Shaheed Zulfiqar Ali Bhutto medical university for the period of six months from 15th June 2023 to 16th January 2024. Ethical approval was taken from the Ethical Review Board committee of the hospital with the Letter # SOD/ERB/2023/43-01. The participants volunteered in the study after the brief explanation about the aims and objectives study. These participants were enrolled in the study after receiving their informed written consents. Total 202 participants took part in the study and did show up during the entire follow up period of the study. 54 males and 148 females participated in this clinical trial after their confirmation of not having allergy to any type of medication. These patients were divided into two groups i.e Control group and Experimental group. Control group was not given anything but Experimental group was given Denpro oral gel (Gennec Health Sciences PVT, LTD, Karachi, Pakistan) for treating the ulcer 2-4 times a day for at least 2 weeks. They were instructed to apply the gel topically on the ulcer area with the help of finger or applicator after the meals or before sleeping. Moreover, they were forbidden to use any other medication for the treatment of the oral mouth ulcer to avoid the bias. Mouth ulcer size in both the control group and Experimental group was measured on the first day " Visit=0" which was taken as the baseline, again measured on second day " Visit=1" , third day " Visit=2" , fourth day " Visit=3" , seventh day " Visit=4" and finally, fourteenth day " Visit=5". These multiple visits were carried out for checking the reduction in its size and complete recovery of the oral mucosa without using anything in Control group and after the application of the gel in the Experimental group.

Conditions

Oral Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (Control Group)

No intervention was done

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group B

Denpro oral gel (Gennec Health Sciences PVT, LTD, Karachi, Pakistan) was administered.

Group Type: EXPERIMENTAL

Denpro oral gel

Intervention Type: OTHER

Experimental group was given Denpro oral gel (Gennec Health Sciences PVT, LTD, Karachi, Pakistan)

Interventions

Denpro oral gel

Experimental group was given Denpro oral gel (Gennec Health Sciences PVT, LTD, Karachi, Pakistan)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Mouth ulcer size greater than 2mm that appeared within 48 hours.

Exclusion Criteria

• Mouth ulcer size lesser than 2mm that did not appear within 48 hours.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Afsheen Mansoor

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Afsheen Mansoor, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Medical Sciences

Locations

Afsheen Mansoor

Islamabad, , Pakistan

Countries

Pakistan

References

Porter SR, Al-Johani K, Fedele S, Moles DR. Randomised controlled trial of the efficacy of HybenX in the symptomatic treatment of recurrent aphthous stomatitis. Oral Dis. 2009 Mar;15(2):155-61. doi: 10.1111/j.1601-0825.2008.01503.x.

Reference Type: BACKGROUND

PMID: 19207485 (View on PubMed)

Other Identifiers

SOD/ERB/2023/43-01

Identifier Type: -

Identifier Source: org_study_id