Uterine FibroidsNCT05448365
Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid
A study testing Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol in people with Uterine Fibroids and D-chiro-inositol, run by Lo.Li.Pharma s.r.l at 2 sites in Italy.
Trial summary
The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6. The patients will be evaluated at baseline and after three months of treatment with placebo or product. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Uterine Fibroids, D-chiro-inositol, Inositol
- What is being tested?
- Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jul 2022to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
- eligible for surgery
- symptoms like menometrorrhagia or pelvic pain
Who cannot join
- BMI>30
- currently pregnant or breastfeeding
- diabetic
- suspect of malignancy
- diagnosis of cancer
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Dario camberlingo
Francavilla Fontana, Apulia, 72021
Massimo Stomati, Ph.D, mstomati@gmail.com
- Not yet recruiting
Ospedale Veris Delli Ponti
Scorrano, Apulia, 73020
Andrea Tinelli, Ph. D, andreatinelli@gmail.com
About this study
Official title: The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid
The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6.
The patients will be evaluated at baseline and after three months of treatment with placebo or product.
- Conditions
- Uterine Fibroids, D-chiro-inositol, Inositol, Epigallocatechin Gallate, Vitamin D, Vitamin B6
- Being tested
- Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol, Placebo
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositolDietary supplement
The patients will take for three months two tablets per day each containing 150mg epigallocatechin gallate, 25 mg D-chiro-inositol, 5mg Vitamin B6 and 25μg Vitamin D
PlaceboDietary supplement
Maltodextrines
| Study group | Role | What they receive |
|---|---|---|
| EGCG, Vit D, DCI, Vit B6 | Active comparator | Women with uterine fibroids randomized to treatment group Receives: Dietary Supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol |
| Placebo | Placebo comparator | Women with uterine fibroids randomized to placebo group Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter
Greater diameter of the diagnosed uterine fibroids
Measured: 3 months
Secondary outcomes (4)
Volume
Total volume of the diagnosed uterine fibroids
Measured: 3 months
Need for surgery
The percentage of patients that decide to avoid surgery
Measured: 3 months
pVEGF-R
the phosphorilation of VEGF receptor
Measured: 3 months
Marker of cellular proliferation
expression of ki67, ER, PR
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Jul 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies 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
- Model description
- Women with uterine fibroids
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448365
- Sponsor's protocol ID
- DELPHYS PLUS
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2022
- Last updated
- 12 Feb 2026
- Results posted
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid
- ClinicalTrials.gov ID
- NCT05448365
- Acronym / sponsor ID
- DELPHYS PLUS
- Conditions
- Uterine Fibroids, D-chiro-inositol, Inositol, Epigallocatechin Gallate, Vitamin D, Vitamin B6
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 7 Jul 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.
The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6.
The patients will be evaluated at baseline and after three months of treatment with placebo or product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Women with uterine fibroids
| Arm | Type | Receives |
|---|---|---|
| EGCG, Vit D, DCI, Vit B6 | Active comparator | Dietary Supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositolWomen with uterine fibroids randomized to treatment group |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboWomen with uterine fibroids randomized to placebo group |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
- eligible for surgery
- symptoms like menometrorrhagia or pelvic pain
Key exclusion criteria (5 listed)
- BMI>30
- currently pregnant or breastfeeding
- diabetic
- suspect of malignancy
- diagnosis of 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, Vitamin D, Vitamin B6, D-chiro-inositolThe patients will take for three months two tablets per day each containing 150mg epigallocatechin gallate, 25 mg D-chiro-inositol, 5mg Vitamin B6 and 25μg Vitamin D | Dietary supplement | EGCG, Vit D, DCI, Vit B6 |
| PlaceboMaltodextrines | Dietary supplement | Placebo |
Primary outcome
Diameter
Time frame: 3 months
Greater diameter of the diagnosed uterine fibroids
4 secondary outcomes
Volume
Time frame: 3 months
Need for surgery
Time frame: 3 months
pVEGF-R
Time frame: 3 months
Marker of cellular proliferation
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Life Study: Lifestyle Intervention in Fibroid Elimination
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol in people with Uterine Fibroids and D-chiro-inositol, run by Lo.Li.Pharma s.r.l at 2 sites 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massimo Stomati, Ph. D (0831851303, mstomati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter (time frame: 3 months). 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 12 Feb 2026.