Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490289
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-06-30
Brief Title:
Clinical Efficiency of Natural Herbal Based Gel
Sponsor:
Pakistan Institute of Medical Sciences
Organization:
Pakistan Institute of Medical Sciences
Study Overview
Official Title:
Clinical Efficiency of Psidium Guajava-based Herbal Gel in the Management of Recurrent Aphthous Stomatitis a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 Visit0 second day Visit1 third day Visit2 fourth day Visit3 seventh day Visit4 and fourteenth day Visit5 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 SODERB202343-01 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 ie 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 Visit0 which was taken as the baseline again measured on second day Visit1 third day Visit2 fourth day Visit3 seventh day Visit4 and finally fourteenth day Visit5 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None