Does Visceral Manipulation Works in Treating Functional Dyspepsia?
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by International College of Osteopathic Medicine.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
International College of Osteopathic Medicine
Information provided by:
International College of Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT01021475
First received: November 27, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Functional Dyspepsia |
Procedure: Visceral Manipulation Drug: PPIs and/or Domperidone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Does Visceral Manipulation Works in Treating Functional Dyspepsia? A Randomized Study |
Resource links provided by NLM:
MedlinePlus related topics:
Indigestion
Drug Information available for:
Domperidone
U.S. FDA Resources
Further study details as provided by International College of Osteopathic Medicine:
Primary Outcome Measures:
- FD symptoms: Bothersome postprandial fullness
/ Early satiation / Epigastric pain / Epigastric burning [ Time Frame: baseline, 1, 4 and 8 weeks after therapy start ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Usual drug FD therapy + Visceral Manipulation |
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.
|
| Active Comparator: Usual drug FD therapy |
Drug: PPIs and/or Domperidone
Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021475
Contacts
| Contact: Massimo Rossi, DO B.Sc (Student) | 00393929517349 | massimo@rossimassimo.com |
Locations
| Italy | |
| Ambulatori Comunali di Cavenago Brianza | Recruiting |
| Cavenago Di Brianza, Milano, Italy, 20040 | |
| Contact: Massimo Rossi, DO B.Sc (student) 0039 3929517349 massimo@rossimassimo.com | |
Sponsors and Collaborators
International College of Osteopathic Medicine
Investigators
| Principal Investigator: | Rossi Massimo, DO B.Sc (student) | International College of Osteopathic Medicine |
More Information
No publications provided
| Responsible Party: | Massimo Rossi DO BSc (student), ICOM |
| ClinicalTrials.gov Identifier: | NCT01021475 History of Changes |
| Other Study ID Numbers: | VM-01 |
| Study First Received: | November 27, 2009 |
| Last Updated: | November 27, 2009 |
| Health Authority: | Italy: Ministero della Sanità |
Keywords provided by International College of Osteopathic Medicine:
|
Functional Dyspepsia, Visceral Manipulation |
Additional relevant MeSH terms:
|
Dyspepsia Gastritis Signs and Symptoms, Digestive Signs and Symptoms Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Domperidone Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013