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Does Visceral Manipulation Works in Treating Functional Dyspepsia?

Primary Purpose

Functional Dyspepsia

Status
Unknown status
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Visceral Manipulation
PPIs and/or Domperidone
Sponsored by
International College of Osteopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional Dyspepsia, Visceral Manipulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ambulatori Comunali di Cavenago BrianzaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Usual drug FD therapy + Visceral Manipulation

Usual drug FD therapy

Arm Description

Outcomes

Primary Outcome Measures

FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning

Secondary Outcome Measures

Full Information

First Posted
November 27, 2009
Last Updated
November 27, 2009
Sponsor
International College of Osteopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01021475
Brief Title
Does Visceral Manipulation Works in Treating Functional Dyspepsia?
Official Title
Does Visceral Manipulation Works in Treating Functional Dyspepsia? A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
International College of Osteopathic Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
Functional Dyspepsia, Visceral Manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual drug FD therapy + Visceral Manipulation
Arm Type
Experimental
Arm Title
Usual drug FD therapy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Visceral Manipulation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PPIs and/or Domperidone
Intervention Description
Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks
Primary Outcome Measure Information:
Title
FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning
Time Frame
baseline, 1, 4 and 8 weeks after therapy start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massimo Rossi, DO B.Sc (Student)
Phone
00393929517349
Email
massimo@rossimassimo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rossi Massimo, DO B.Sc (student)
Organizational Affiliation
International College of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulatori Comunali di Cavenago Brianza
City
Cavenago Di Brianza
State/Province
Milano
ZIP/Postal Code
20040
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Rossi, DO B.Sc (student)
Phone
0039 3929517349
Email
massimo@rossimassimo.com

12. IPD Sharing Statement

Learn more about this trial

Does Visceral Manipulation Works in Treating Functional Dyspepsia?

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