Comparative assessment the effect of Golghand and Psyllium on constipation in elderly referred to Traditional Medicine School Clinic of Ardakan affiliated to Yazd University of Medical Sciences, 2016
The aim of this study is to compare the effect of two products, namely, Psyllium and Golghand on the constipation of elder patients who are referred to Traditional Medicine School Clinic of Ardakan. The research population includes the old people (above 60 years) who are suffering from constipation based on ROME III reference and referred to Traditional Medicine School Clinic of Ardakan . These people are recognized based on at least two terms of the ROME III questioning form. The sample size is 35 that is chosen based on the previous studies. The patients under study are assigned into two groups using the Minimization stratification method. Each group receives a certain amount of the products, Psyllium or Golghand. Each group is asked to write a daily report of their bowel movements (defecation, bloating, abdominal pain, vomiting). The data collected weekly by a researcher for a period of two weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012423190N2
Registration date:2016-03-07, 1394/12/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-07, 1394/12/17
Registrant information
Name
Tabandeh Sadeghi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.sadeghi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2016-02-29, 1394/12/10
Expected recruitment end date
2016-07-31, 1395/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment the effect of Golghand and Psyllium on constipation in elderly referred to Traditional Medicine School Clinic of Ardakan affiliated to Yazd University of Medical Sciences, 2016
Public title
Comparison the effect of Golghand and Psyllium on constipation in elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: minimum age will be sixty years old; diagnosis constipation according to ROME III criteria; consent for participation in study.
Exclusion Criteria: no ability for movement and activity; addiction; metabolic disorders such ac diabetes; consumption of specific drug; consumption of drug for psychiatric disorders; no consumption of drugs according to schedul(forget consumption for 4 time in week); treatment for constipation 2week before study; syptoms of gastroenteritis(nasea,vomiting,diarrehea); reluctance for cooperation.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Emam Ali Street, Organization Center of Rafsanajn University of Medical Sciences, Rafsanjan, Iran.
City
Rafsanjan
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.RUMS.REC.1394.177
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
k59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
number of defecation per week
Timepoint
before intervention, during intervention and 2 week after intervention
Method of measurement
bowel habities check list
Secondary outcomes
1
Description
Abdominal bloating
Timepoint
before intervention, during intervention and 2 week after intervention
Method of measurement
Bowel habities check list
2
Description
Vomiting
Timepoint
before intervention, during intervention and 2 week after intervention
Method of measurement
Bowel habities check list
3
Description
Abdominal Pain
Timepoint
before intervention, during intervention and 2 week after intervention
Method of measurement
Bowel habities check list
Intervention groups
1
Description
Goleghand group: receive one spoon of Goleghand 3 times a day half hour after meals for 2 weeks
Category
Treatment - Drugs
2
Description
Psyllium group: receive a sachet of Psyllium plant powder with a glass of water 3 times a day after meals for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional Medicine School Clinic of Ardakan affiliated to Yazd University of Medical Sciences
Full name of responsible person
Asieh Hatefi
Street address
Ziaee Hospital- Ardakan
City
Ardakan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad Reza Mirzaee
Street address
Emam Ali Street, Organization Center of Rafsanjan University of Medical Sciences, Rafsanjan, Iran.
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
PhD/ faculty member
Other areas of specialty/work
Street address
Gomhori Street, Nursing and Midwifery School, Rafsanjan, Iran
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
t.sadeghi@rums.ac.ir, t.b_sadeghi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
PhD
Other areas of specialty/work
Street address
Gomhori Street, Nursing and Midwifery School, Rafsanjan, Iran
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
t.sadeghi@rums.ac.ir, t.b_sadeghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
PhD
Other areas of specialty/work
Street address
Gomhori Street, Nursing and Midwifery School, Rafsanjan, Iran
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
t.sadeghi@rums.ac.ir, t.b_sadeghi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)