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A comparison between Polyethylene Glycol , Aabdominal Massage and combination of Poly ethylene glycol with abdominal massage in symptom and quality of life improvement in Functional Constipation.

Protocol summary

Study aim
The efficacy of abdominal massage, Polyethylene Glycol and Combination of Polyethylene Glycol with abdominal massage in symptom relief and quality of life improvement of patients with functional constipation
Design
This study is not a blinded randomized clinical trial. All patients with chronic functional constipation based on ROM 4 criteria and age 18-65 years who do not have exclusion criteria are randomly assigned in one of the three treatment groups. Each group consists of 44 patients.Group (A) Polyethylene Glycol 20 gr powder(2 sachet of Cololax,Darian Tejarat Company,Iran ) of dissolved in a glass of water, after breakfast ,Once daily . Group (B): Abdominal massage for 15 minutes with Polyethylene glycol 20 gr powder dissolved In a glass of water, after breakfast, Once daily . Group (C): Abdominal massage for 15 minutes daily. Western Abdominal massage therapy will be performed for a period of 2 weeks and will be semi-supervised. The course is performed at least 5 days a week, which is semi-supervised method 2 times a week, by a Physical Medicine and Rehabilitation Specialist and 3 other days of the week will be treated by the same person at home in the same way. Each session will consist of 10 to 15 minutes. In the first visit , after complete explanation for patients,the patients complete the consent form . Demographic data ,validated persian version of the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) and stool consistency ( BRISTOL SCORE ) are recorded.After completing a 2-week treatment dration,all patients discontinue the treatment for 2 weeks, and again,the questionnaires will be completed.
Settings and conduct
This study is not a blinded randomized clinical trial. All patients with chronic functional constipation ,who referred to gastroenterology clinic of Rasoul Akram hospital in 2016-2017( based on ROM4 and whitout any exclusion criteria) are randomly assigned into one of the three treatment groups. Each group consists of 44 patients
Participants/Inclusion and exclusion criteria
Inclusion criteria: Functional constipation based on Rome 4;age 18-65 years Exclusion criteria: History of usage of Opiod ,Tricyclic antidepressant, Anti-hypertension,Anti-convulsant, Analgesic,Hypnotic; Systemic disease(Diabetes Melitous,Hypertention, Cardiac ,Pulmonary ,Renal,liver,Thyroid disease, Cancer,Myopathy, Neuropathy, Sclerodermea); Pregnancy; Breast feeding; Abdominal pain; Irritable Bowel Syndrome; History of Abdominal surgery; Abdominal hernia(Umbilical and /or Inguinal); History of allergy to prescribed medication; Non-compliant and uncooperative; Mechanical and/or Pseudo - intestinal obstruction
Intervention groups
Group A: Polyethylene Glycol 20 gr powder(2 sachet of Cololax ) that dissolved in a glass of water, after breakfast ,Once daily . Group B : Abdominal massage for 15 minutes with Polyethylene Glycol 20 gr powder(2 sachet of Cololax ) dissolved In a glass of water, after breakfast, Once daily . Group C: Abdominal massage for 15 minutes daily
Main outcome variables
Quality of life and symptoms of patients with functional constipation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141201020178N8
Registration date: 2018-03-02, 1396/12/11
Registration timing: registered_while_recruiting

Last update: 2018-03-02, 1396/12/11
Update count: 0
Registration date
2018-03-02, 1396/12/11
Registrant information
Name
Marjan Mokhtare
Name of organization / entity
Iran University of Medical sciences,Rasoul Akram Hospital,Colorectal Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 2845
Email address
mokhtare.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-14, 1396/07/22
Expected recruitment end date
2018-05-12, 1397/02/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between Polyethylene Glycol , Aabdominal Massage and combination of Poly ethylene glycol with abdominal massage in symptom and quality of life improvement in Functional Constipation.
Public title
Effect of abdominal massage ,Polyethylene Glycol and combined together in symptom and quality of life improvement in Functional Constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with functional constipation based on Rome 4 who have frequently ,2 or more of the following criteria: fewer than 3 defecation per week , hard stool, straining, blockage sensation , sensation of incomplete evacuations, manual maneuvers of evacuation. Age 18-65 years
Exclusion criteria:
History of usage of Opiod ,Tricyclic antidepressant, Anti-hypertension,Anti-convulsant, Analgesic,Hypnotic Systemic disease(Diabetes Melitous,Hypertention, Cardiac ,Pulmonary ,Renal,liver,Thyroid disease, Cancer,Myopathy, Neuropathy, Sclerodermea) Pregnancy Breast feeding Abdominal pain Irritable Bowel Syndrome History of Abdominal surgery Abdominal hernia(Umbilical and /or Inguinal) History of allergy to prescribed medication Non-compliant and uncooperative Mechanical and/or Pseudo - intestinal obstruction
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
All patients based on computerized random table ,assigned in one of treatment group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
West Shahid Hemmat Highway,Intersection of Chamran and Sheikh Fazlollah Noori
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-10-14, 1396/07/22
Ethics committee reference number
IR.IUMS.FMD.REC.1396.26277

Health conditions studied

1

Description of health condition studied
Functional Constipation
ICD-10 code
K59.00
ICD-10 code description
Constipation, unspecified

Primary outcomes

1

Description
Quality of life in patients with functional constipation and symptom in patients with functional constipation
Timepoint
Before Intervention ,2 Weeks after Intervention
Method of measurement
Persian version of patient assessment constipation quality of life(PAC-QOL) questionnaire

2

Description
symptom in patients with functional constipation
Timepoint
Before Intervention ,2 and 4 Weeks after Intervention
Method of measurement
BRISTOL SCORE

Secondary outcomes

1

Description
Patient Compliance Rate
Timepoint
Two Weeks after starting treatment
Method of measurement
Data gathering sheet

2

Description
Adverse effects rate
Timepoint
Two Weeks after starting treatment
Method of measurement
Data gathering sheet

Intervention groups

1

Description
Group (A) Treatment with Polyethylene Glycol 20 gr powder(2 sachet of Cololax) of dissolved in a glass of water, after breakfast, Once daily
Category
Treatment - Drugs

2

Description
Group (B): Abdominal massage for 15 minutes with Polyethylene Glycol 20 gr powder(2 sachet of Cololax)of dissolved in a glass of water, after breakfast, Once daily.
Category
Treatment - Other

3

Description
Group (C): Abdominal massage for 15 minutes daily.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Colorectal Research Center,Rasoul Akram Hospital
Full name of responsible person
Marjan Mokhtare
Street address
Niayesh Street ,Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Email
marjanmokhtare@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakooti
Street address
Niayesh Street ,Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Email
kmalakouti@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marjan Mokhtare
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology and Hepatology
Street address
Niayesh Street ,Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Email
marjanmokhtare@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marjan Mokhtare
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology and Hepatology
Street address
Colorectal Research Center, Rasoul Akram Hospital, Niayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Fax
Email
marjanmokhtare@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marjan Mokhtare
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology and Hepatology
Street address
Colorectal Research Center,Rasoul akram Hospital,Niayesh Street,Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Email
marjanmokhtare@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD collected for primary outcome
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Just analyzed data
From where data/document is obtainable
Research Administrator of Colorectal Research Center, Marjan Mokhtare
What processes are involved for a request to access data/document
After applying by email, it will be reviewed and answered.
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