Plantar WartEarly Phase 1NCT05592041
Studying of Natural Constituents' Treatment of Plantar Warts
A Early Phase 1 study testing Banaba Leaf Extract in people with Plantar Wart, run by Deraya University at 1 site in Egypt.
Trial summary
Moringa banana nigella and Banna coat extract were prepared and formulated in the form of bi gel for transdermal delivery of these plant extracts. The formulation was prepared and charterized for organoleptic charters, morphology, and penetration efficacy. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Plantar Wart
- What is being tested?
- Banaba Leaf Extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2022to 10 Jan 2023
- Phase
- Early Phase 1
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patient aged 18 years or more.
- Clinical evaluation
- Number of warts lower than 10 on the 2 feet and total diameter of warts lower than 10 cm
Who cannot join
- Patient suspected to be immunocompromised
- Patient aged under 18 years
- Patient refusing to sign the consent
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In-vitro and Randomized Controlled Clinical Studying of Natural Constituents' Anti-HPV Potential for Treatment of Plantar Warts Supported With in Silico Studies
Moringa banana nigella and Banna coat extract were prepared and formulated in the form of bi gel for transdermal delivery of these plant extracts. The formulation was prepared and charterized for organoleptic charters, morphology, and penetration efficacy. The optimised formulation was assessed clinically on patients suffering from plantar warts. The clinical study was phase 1 and interventional randomised allocation.
- Conditions
- Plantar Wart
- Being tested
- Banaba Leaf Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banaba Leaf ExtractDrug
Also called moringa banna nigella
a herbal extract in the form of Bigel
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (Group I) | Experimental | Not described Receives: Drug: Banaba Leaf Extract |
| Control group (Group II) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical remission of the warts
Number of warts (counts)
Measured: 30 days
Clinical assessment of warts curement
Diameter of wart in cm
Measured: 30 days
Secondary outcomes (1)
Pain asssesment
pain was assesed by VAS scoring (0) the least to (5) highest
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start20 Oct 2022
- Primary completion18 Dec 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar WartStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soad Ali, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592041
- Sponsor's protocol ID
- Anti-HPV
- Status last verified
- May 2024
- First submitted
- 17 Oct 2022
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vitro and Randomized Controlled Clinical Studying of Natural Constituents' Anti-HPV Potential for Treatment of Plantar Warts Supported With in Silico Studies
- ClinicalTrials.gov ID
- NCT05592041
- Acronym / sponsor ID
- Anti-HPV
- Conditions
- Plantar Wart
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 24 Oct 2022 (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.
Moringa banana nigella and Banna coat extract were prepared and formulated in the form of bi gel for transdermal delivery of these plant extracts. The formulation was prepared and charterized for organoleptic charters, morphology, and penetration efficacy. The optimised formulation was assessed clinically on patients suffering from plantar warts. The clinical study was phase 1 and interventional randomised allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group (Group I) | Experimental | Drug: Banaba Leaf Extract |
| Control group (Group II) | No intervention | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female patient aged 18 years or more.
- Clinical evaluation
- Number of warts lower than 10 on the 2 feet and total diameter of warts lower than 10 cm
Key exclusion criteria (4 listed)
- Patient suspected to be immunocompromised
- Patient aged under 18 years
- Patient refusing to sign the consent
- Pregnant or lactating women
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 |
|---|---|---|
| Banaba Leaf ExtractAlso: moringa banna nigellaa herbal extract in the form of Bigel | Drug | Treatment group (Group I) |
Primary outcome
Complete clinical remission of the warts
Time frame: 30 days
Number of warts (counts)
Clinical assessment of warts curement
Time frame: 30 days
Diameter of wart in cm
1 secondary outcome
Pain asssesment
Time frame: 30 days
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 16 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Banaba Leaf Extract in people with Plantar Wart, run by Deraya University at 1 site in Egypt.
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 3 inclusion and 4 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 16 May 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 Egypt. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Complete clinical remission of the warts (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.