PapillomaNCT05625308
Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions
A study testing Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid in people with Papilloma and Cervix Lesion, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
To test the efficacy of a newly-commercialized formula, 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia. Women in the study group took one tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Papilloma, Cervix Lesion
- What is being tested?
- Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 2 Dec 2022
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- HPV infections
- Occurrence of low-grade cervical lesions
Who cannot join
- Diagnosis of malignancy or severe cervical lesions
- Concurrent uterine pathologies
- Pregnancy or intended to seek pregnancy in the next three months
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
To test the efficacy of a newly-commercialized formula, 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia. Women in the study group took one tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. Women in the control group received no treatment.
- Conditions
- Papilloma, Cervix Lesion
- Being tested
- Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid
- Medical subject headings
- Papilloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic AcidDietary supplement
One tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid.
| Study group | Role | What they receive |
|---|---|---|
| Co-treatment with EGCG, FA, B12, and HA | Experimental | One tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. Receives: Dietary Supplement: Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid |
| Control | No intervention | Untreated women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of cervical lesions
The actual outcome was to measure the rate of regression of the lesions, from moderate to mild, from mild to none.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Jul 2022
- Primary completion9 Nov 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PapillomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cesare Aragona, MD, Principal investigator, Clinica Alma Res
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625308
- Sponsor's protocol ID
- HPV-NAT-COM
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions
- ClinicalTrials.gov ID
- NCT05625308
- Acronym / sponsor ID
- HPV-NAT-COM
- Conditions
- Papilloma, Cervix Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 22 Nov 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.
To test the efficacy of a newly-commercialized formula, 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia. Women in the study group took one tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. Women in the control group received no treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia.
| Arm | Type | Receives |
|---|---|---|
| Co-treatment with EGCG, FA, B12, and HA | Experimental | Dietary Supplement: Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic AcidOne tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. |
| Control | No intervention | –Untreated women. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- HPV infections
- Occurrence of low-grade cervical lesions
Key exclusion criteria (4 listed)
- Diagnosis of malignancy or severe cervical lesions
- Concurrent uterine pathologies
- Pregnancy or intended to seek pregnancy in the next three months
- Cancer
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 |
|---|---|---|
| Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic AcidOne tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid. | Dietary supplement | Co-treatment with EGCG, FA, B12, and HA |
Primary outcome
Regression of cervical lesions
Time frame: 12 weeks
The actual outcome was to measure the rate of regression of the lesions, from moderate to mild, from mild to none.
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 22 Dec 2022.
- Individual participant dataSharing planned: No
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A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1
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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.
Cesare Aragona, MD principal investigator
Clinica Alma Res
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid in people with Papilloma and Cervix Lesion, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
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 2 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 22 Dec 2022. 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 Italy. 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?
Regression of cervical lesions (time frame: 12 weeks). 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 22 Dec 2022.