Evaluation the effect of Psyllium powder (oral herbal laxative) in prevention of constipation, hemorrhoids and anal fissure during pregnancy in pregnant women (3rd trimester) who will refer to Pregnancy Care Clinics in Shiraz, Iran during 1 year.
During gestational period, constipation results from change in diet, decline in physical activity and decrease digestive system activity. Recently, some herbs have been taken into account to deal with this problem. Psyllium is one of these herbs whose effect appears by absorbing of water and providing additional bulk to the stool.
This study is conducted to evaluate probable preventive effects of psyllium powder on constipation and occurrence anal fissure and hemorrhoidal disease in pregnant women. So pregnant women who are at the beginning of 3rd trimester of gestational period will be randomly divided into two groups. Group A will be received psyllium powder twice daily and group B will be received placebo (no intervention). All cases will be visited two times. First time in designed to be 45 days after starting the program (receiving psyllium and placebo) and second time, 7 days before predicted delivery date. Both groups will be evaluated on the base of history and physical examination and results will be analized.
General information
Acronym
N/A
IRCT registration information
IRCT registration number:IRCT201212119936N3
Registration date:2013-01-15, 1391/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-15, 1391/10/26
Registrant information
Name
Leila Ghahramani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 5586
Email address
lghahraman@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2010-08-31, 1389/06/09
Expected recruitment end date
2011-08-31, 1390/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Psyllium powder (oral herbal laxative) in prevention of constipation, hemorrhoids and anal fissure during pregnancy in pregnant women (3rd trimester) who will refer to Pregnancy Care Clinics in Shiraz, Iran during 1 year.
Public title
Evaluation the effect of Psyllium powder (oral herbal laxative) in prevention of constipation, hemorrhoids and anal fissure during pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
pregnant women at the onset of 3rd trimester; age between 20 and 30 years; primi para; negative history of anorectal diseases; absence of signs suggestive of anorectal disease based on clinical examination at baseline.
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
3136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2010-04-21, 1389/02/01
Ethics committee reference number
2220
Health conditions studied
1
Description of health condition studied
constipation
ICD-10 code
K59.0
ICD-10 code description
constipation
Primary outcomes
1
Description
Preventing constipation
Timepoint
7 days before the expected date of delivery
Method of measurement
History of less than 3 times defecation per week or uncomfortable defecation is considered as constipation
Secondary outcomes
1
Description
Fissure
Timepoint
7 days before the expected date of delivery
Method of measurement
History and physical examination
2
Description
hemorrhoid
Timepoint
7 days before the expected date of delivery
Method of measurement
History and physical examination
Intervention groups
1
Description
Psyllium powder will be used twice daily as intervention.
Category
Treatment - Drugs
2
Description
Control group received placebo which was similar to psyllium powder in appearance and taste. Placebo was prepared by Shiraz School of Pharmacy by the order of Colorectal Research Center. According to pharmacists it had neutral effect considering the objects of the study.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Prenatal care clinics in the city of Shiraz, Shiraz University of Medical Sciences
Full name of responsible person
Leila Ghahramani, MD
Street address
Faghihi hospital, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice-Chancellery of Research, Chairman of the Supreme Council for Research Centers ofShiraz Universi
Street address
Shiraz University of Medical Sciences, shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Colorectal Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Leila Ghahramani, MD
Position
Assistant professor of surgery
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz