Low-grade Cervical Intraepithelial NeoplasiaMODUCIN1NCT07379905
MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)
A study testing MODUCARE in people with Low-grade Cervical Intraepithelial Neoplasia and Moducare, run by Aristotle University Of Thessaloniki.
Trial summary
MODUCIN-1 (MODUcare for CIN1) is a prospective, single center, open-label, randomized trial that its purpose is to compare MODUCARE versus Wait-and-See Approach for the regression rate of histologically proven low-grade Cervical Intraepithelial Neoplasia (CIN1). Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low-grade Cervical Intraepithelial Neoplasia, Moducare
- What is being tested?
- MODUCARE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Mar 2028
- 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 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically proven CIN1
- Any HPV status (negative, positive: high or low risk)
- Any Pap test result
- Age 18 - 85 years old
- ECOG Performance status 0 - 1
Who cannot join
- Pregnancy
- Low likelihood of patient compliance to treatment protocol and follow-up
- Previous operation to the cervix
- Previous pelvic malignancy
- Pre-existing histologically proven CIN1 > 12 months
- Pre-existing histologically proven CIN2 and/or CIN3
- Hypersensitivity to trial medication
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Trial of MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)
MODUCIN-1 (MODUcare for CIN1) is a prospective, single center, open-label, randomized trial that its purpose is to compare MODUCARE versus Wait-and-See Approach for the regression rate of histologically proven low-grade Cervical Intraepithelial Neoplasia (CIN1).
Read the detailed description
Human Papillomavirus (HPV) is causally associated with cervical cancer and precancerous lesions (dysplasias) of the cervix. These lesions are detected mainly in the transformation zone and are diagnosed with colposcopy and biopsy confirmation. In high-grade lesions conization (surgical removal of a cone tissue form the cervix) is the therapy of choice, but in low-grade lesions monitoring and no-treatment is preferred. However, this wait-and-see approach can be assisted by pharmaceutical treatment, like MODUCARE.
MODUCARE is classified as a natural dietary supplement, specifically an immune support supplement containing a patented blend of plant sterols and sterolins, primarily beta-sitosterol and beta-sitosterol glucoside, derived from plant sources. It is taken orally, 2 capsules three times daily for the first month and then 1 capsule three times daily for next 5 months (in total 6 months).
- Being tested
- MODUCARE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MODUCAREDietary supplement
MODUCARE is classified as a natural dietary supplement, specifically an immune support supplement containing a patented blend of plant sterols and sterolins, primarily beta-sitosterol and beta-sitosterol glucoside, derived from plant sources.
| Study group | Role | What they receive |
|---|---|---|
| ARM A: Control Arm | No intervention | Wait-and-See approach |
| ARM B: Intervention Arm | Experimental | MODUCARE oral capsules., dosage 2 x 3 for 1 month and 1 x 3 for 5 months (total 6 months, as per instructions provided by the manufacturer) Receives: Dietary Supplement: MODUCARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression rate of CIN1
Measured: 6 months after randomization
Secondary outcomes (3)
Regression rate of CIN1
Measured: 12 months after randomization
Progression rate of CIN1
Measured: 6 & 12 months after randomization
Treatment related adverse events
Measured: : 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
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 Low-grade Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- * ARM A: Control Arm for Wait-and-See approach * ARM B: Intervation Arm for MODUCARE oral capsules, dosage 2 x 3 for 1 month and 1 x 3 for 5 months (total 6 months, as per instructions provided by the manufacturer)
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- INPA S.A.
- Responsible party
- Principal investigator, Dimitrios Zouzoulas, Aristotle University Of Thessaloniki
- Investigators
- Dimitrios Tsolakidis, Dr.Prof., Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379905
- Sponsor's protocol ID
- 2025-Β2015-518
- Acronym
- MODUCIN1
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of IPD only after contact with the principal investigator for the synthesis of future studies.
Publications
Zouzoulas D, Sofianou I, Chatzistamatiou K, Theodoulidis V, Grimbizis G, Tsolakidis D. Comparison of Moducare versus Wait-and-See approach for histologically proven Low-grade Cervical Intraepithelial Neoplasia (CIN1) (MODUCIN1 TRIAL) - Study protocol. PLoS One. 2026 Jul 13;21(7):e0353119. doi: 10.1371/journal.pone.0353119. eCollection 2026.
PubMed 42441577
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)
- ClinicalTrials.gov ID
- NCT07379905
- Acronym / sponsor ID
- MODUCIN1 / 2025-Β2015-518
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- INPA S.A.
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 2 Feb 2026 (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.
MODUCIN-1 (MODUcare for CIN1) is a prospective, single center, open-label, randomized trial that its purpose is to compare MODUCARE versus Wait-and-See Approach for the regression rate of histologically proven low-grade Cervical Intraepithelial Neoplasia (CIN1).
Detailed description
Human Papillomavirus (HPV) is causally associated with cervical cancer and precancerous lesions (dysplasias) of the cervix. These lesions are detected mainly in the transformation zone and are diagnosed with colposcopy and biopsy confirmation. In high-grade lesions conization (surgical removal of a cone tissue form the cervix) is the therapy of choice, but in low-grade lesions monitoring and no-treatment is preferred. However, this wait-and-see approach can be assisted by pharmaceutical treatment, like MODUCARE.
MODUCARE is classified as a natural dietary supplement, specifically an immune support supplement containing a patented blend of plant sterols and sterolins, primarily beta-sitosterol and beta-sitosterol glucoside, derived from plant sources. It is taken orally, 2 capsules three times daily for the first month and then 1 capsule three times daily for next 5 months (in total 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * ARM A: Control Arm for Wait-and-See approach * ARM B: Intervation Arm for MODUCARE oral capsules, dosage 2 x 3 for 1 month and 1 x 3 for 5 months (total 6 months, as per instructions provided by the manufacturer)
| Arm | Type | Receives |
|---|---|---|
| ARM A: Control Arm | No intervention | –Wait-and-See approach |
| ARM B: Intervention Arm | Experimental | Dietary Supplement: MODUCAREMODUCARE oral capsules., dosage 2 x 3 for 1 month and 1 x 3 for 5 months (total 6 months, as per instructions provided by the manufacturer) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven CIN1
- Any HPV status (negative, positive: high or low risk)
- Any Pap test result
- Age 18 - 85 years old
- ECOG Performance status 0 - 1
Key exclusion criteria (7 listed)
- Pregnancy
- Low likelihood of patient compliance to treatment protocol and follow-up
- Previous operation to the cervix
- Previous pelvic malignancy
- Pre-existing histologically proven CIN1 > 12 months
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 |
|---|---|---|
| MODUCAREMODUCARE is classified as a natural dietary supplement, specifically an immune support supplement containing a patented blend of plant sterols and sterolins, primarily beta-sitosterol and beta-sitosterol glucoside, derived from plant sources. | Dietary supplement | ARM B: Intervention Arm |
Primary outcome
Regression rate of CIN1
Time frame: 6 months after randomization
3 secondary outcomes
Regression rate of CIN1
Time frame: 12 months after randomization
Progression rate of CIN1
Time frame: 6 & 12 months after randomization
Treatment related adverse events
Time frame: : 6 months after randomization
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 5 Feb 2026.
- Derived from this study: PubMed 42441577Zouzoulas D, Sofianou I, Chatzistamatiou K, Theodoulidis V, Grimbizis G, Tsolakidis D. Comparison of Moducare versus Wait-and-See approach for histologically proven Low-grade Cervical Intraepithelial Neoplasia (CIN1) (MODUCIN1 TRIAL) - Study protocol. PLoS One. 2026 Jul 13;21(7):e0353119. doi: 10.1371/journal.pone.0353119. eCollection 2026.
- Individual participant dataSharing planned: No. Sharing of IPD only after contact with the principal investigator for the synthesis of future studies.
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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.
Dimitrios Tsolakidis, Dr.Prof. principal investigator
Aristotle University Of Thessaloniki
Questions about this trial
What is this clinical trial studying?
A study testing MODUCARE in people with Low-grade Cervical Intraepithelial Neoplasia and Moducare, run by Aristotle University Of Thessaloniki.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Dimitrios Zouzoulas, MD, MSc, PhD (+306946536065, dzouzoulas@hotmail.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression rate of CIN1 (time frame: 6 months after randomization). 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 NCT07379905, 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 5 Feb 2026.