Trial | NCT01021475  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    domperidone ...

  • Study Participants

    50
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.
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).
Study Started
Nov 30
2009
Primary Completion
Nov 30
2010
Anticipated
Last Update
Nov 30
2009
Estimate

Procedure Visceral Manipulation

Usual 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.

Drug PPIs and/or Domperidone

Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks

Usual drug FD therapy + Visceral Manipulation Experimental

Usual drug FD therapy Active Comparator

Criteria 

Inclusion Criteria:

Clinical diagnosis of Functional Dyspepsia

Exclusion Criteria:

Diabetes Mellitus
Mental disturbance
Thyroid gland dysfunction
Intestinal, liver and biliary tract disease
Concurrent medications that could interact with GI function
Positive Helicobacter Pylori status
No Results Posted