NCT07379905

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

A Randomized Trial of MODUCARE Versus Wait-and-See Approach for Histologically Proven Low-grade Cervical Intraepithelial Neoplasia (CIN1)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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).

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).

Conditions

• Low-grade Cervical Intraepithelial Neoplasia
• Moducare

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-01
• Completion: 2028-03-01
• First posted: 2026-02-02
• Last updated: 2026-02-05