Health TrialsbyHealthPanel

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

ConditionsLow-grade Cervical Intraepithelial NeoplasiaModucare
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorAristotle University Of Thessaloniki

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Histologically proven CIN1

Any HPV status (negative, positive: high or low risk)

Any Pap test result

Age 18 - 85 years old

Disqualifiers

Pregnancy

Low likelihood of patient compliance to treatment protocol and follow-up

Previous operation to the cervix

Previous pelvic malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • MODUCARE

    Dietary 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.

Treatment groups

182 Participants
are divided into 2 treatment groups
Group A: ARM A: Control ArmNo intervention 0 interventions
Group B: ARM B: Intervention ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Regression rate of CIN1

Time frame
6 months after randomization

Secondary outcomes

1

Regression rate of CIN1

Time frame
12 months after randomization
2

Progression rate of CIN1

Time frame
6 & 12 months after randomization
3

Treatment related adverse events

Time frame
: 6 months after randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aristotle University Of Thessaloniki

Lead sponsor

INPA S.A.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: