Clinical Efficiency of Natural Herbal Based Gel.

NCT06490289 | Completed

• 1 other identifier: SOD/ERB/2023/43-01
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Ulcer

Keywords

Ulcer; Herbel gel

Outcome Measures

Primary Outcomes (1)

• Reduction in size of Oral Ulcer and recovery of oral mucosa

  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"

  treatment of the ulcer 2-4 times a day for at least 2 weeks.

Study Arms (2)

Group A (Control Group)

NO INTERVENTION

No intervention was done

Group B

EXPERIMENTAL

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

Other: Denpro oral gel

Interventions

Denpro oral gel OTHER

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

Group B

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Afsheen Mansoor

Islamabad, 44080, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 19207485 BACKGROUND

MeSH Terms

Conditions

Oral Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Afsheen Mansoor, Ph.D

  Pakistan Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 8, 2024
• Study Start: June 15, 2023
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)