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UnknownNCT01021475

Does Visceral Manipulation Works in Treating Functional Dyspepsia?

Does Visceral Manipulation Works in Treating Functional Dyspepsia? A Randomized Study

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
International College of Osteopathic Medicine · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The goal of this study is to determine if Visceral Manipulation (VM) is effective in treating Functional Dyspepsia in addition to drug therapy. Null hypothesis is that VM does not influence FD symptoms.

Detailed description

50 patients with Functional Dyspepsia (FD) diagnosed by General Practitioners are randomized in two therapy group: 1) drug only group and 2) drug + Visceral Manipulation group. Group 1 receive drug therapy for 4 weeks, Group 2 receive drug therapy for 4 weeks and 4 Visceral Manipulation visits with weekly frequency (visit 1 at day 1 of drug therapy). FD symptoms are recorded with VAS at baseline and after 1 and 4 weeks of therapy, and after 8 weeks (4 weeks after the finish of all therapies).

Conditions

Interventions

TypeNameDescription
PROCEDUREVisceral ManipulationUsual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks and 4 VM visits with weekly frequency with first VM visit at day 1 of drug therapy.
DRUGPPIs and/or DomperidoneUsual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks

Timeline

Start date
2009-11-01
Primary completion
2010-11-01
First posted
2009-11-30
Last updated
2009-11-30

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01021475. Inclusion in this directory is not an endorsement.