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Administration of a Natural Molecular Complex in Functional Chronic Constipation

NCT05192317 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2023-07-14

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blinded placebo controlled trial to evaluate the efficacy and safety of the substance-based medical device (Sollievo Fisiolax) in the treatment of Chronic Constipation.

Treatment period for each patient is 28 days.

Conditions

  • Chronic Constipation

Interventions

DEVICE

Sollievo Fisiolax

Class IIb Medical Device

OTHER

Sollievo Fisiolax Placebo

Placebo

Sponsors & Collaborators

  • JSB Solutions S.R.L.

    collaborator UNKNOWN

  • Aboca Spa Societa' Agricola

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-09
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05192317 on ClinicalTrials.gov