Oral UlcerNCT06490289
Clinical Efficiency of Natural Herbal Based Gel.
A study testing Denpro oral gel in people with Oral Ulcer, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Ulcer
- What is being tested?
- Denpro oral gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2023to 16 Jan 2024
- Phase
- Interventional
- 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 18 to 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mouth ulcer size greater than 2mm that appeared within 48 hours.
Who cannot join
- Mouth ulcer size lesser than 2mm that did not appear within 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficiency of Psidium Guajava-based Herbal Gel in the Management of Recurrent Aphthous Stomatitis: a Randomized Clinical Trial
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.
Read the 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
- Being tested
- Denpro oral gel
- Keywords
- Ulcer, Herbel gel
- Medical subject headings
- Oral Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denpro oral gelOther
Experimental group was given Denpro oral gel (Gennec Health Sciences PVT, LTD, Karachi, Pakistan)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Denpro oral gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: treatment of the ulcer 2-4 times a day for at least 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start15 Jun 2023
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Afsheen Mansoor, Pakistan Institute of Medical Sciences
- Investigators
- Afsheen Mansoor, Ph.D, Principal investigator, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490289
- Sponsor's protocol ID
- SOD/ERB/2023/43-01
- Status last verified
- Sep 2024
- First submitted
- 30 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19207485
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficiency of Psidium Guajava-based Herbal Gel in the Management of Recurrent Aphthous Stomatitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06490289
- Acronym / sponsor ID
- SOD/ERB/2023/43-01
- Conditions
- Oral Ulcer
- Keywords
- Ulcer, Herbel gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Control Group) | No intervention | –No intervention was done |
| Group B | Experimental | Other: Denpro oral gelDenpro oral gel (Gennec Health Sciences PVT, LTD, Karachi, Pakistan) was administered. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mouth ulcer size greater than 2mm that appeared within 48 hours.
Key exclusion criteria (1 listed)
- Mouth ulcer size lesser than 2mm that did not appear within 48 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denpro oral gelExperimental group was given Denpro oral gel (Gennec Health Sciences PVT, LTD, Karachi, Pakistan) | Other | Group B |
Primary outcome
Reduction in size of Oral Ulcer and recovery of oral mucosa
Time frame: treatment of the ulcer 2-4 times a day for at least 2 weeks.
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 19207485Porter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afsheen Mansoor, Ph.D principal investigator
Pakistan Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Denpro oral gel in people with Oral Ulcer, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in size of Oral Ulcer and recovery of oral mucosa (time frame: treatment of the ulcer 2-4 times a day for at least 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06490289, which also lists 1 linked publication.
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 19 Sep 2024.