MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1) (MODUCIN1)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Low-grade Cervical Intraepithelial Neoplasia; Moducare
• Intervention / Treatment: Dietary supplement: MODUCARE

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 Type: Interventional
• Enrollment (Estimated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dimitrios Zouzoulas, MD, MSc, PhD; Phone Number: +306946536065; Email: dzouzoulas@hotmail.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: ARM A: Control Arm; Wait-and-See approach
Experimental: ARM B: Intervention Arm; 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)	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Regression rate of CIN1	6 months after randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Regression rate of CIN1	12 months after randomization
Progression rate of CIN1	6 & 12 months after randomization
Treatment related adverse events	: 6 months after randomization

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Collaborators: INPA S.A.
• Investigators: Principal Investigator: Dimitrios Tsolakidis, Dr.Prof., Aristotle University of Thessaloniki

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-Β2015-518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing of IPD only after contact with the principal investigator for the synthesis of future studies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No