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Evaluation of efficacy of flaxeed oil capsule in comparison with olive oil in patients with chronic idiopathic constipation referred to clinic and teachy hospitals of Shahrekord Univercity of Medical Sciences

Protocol summary

Study aim
Determining the effectiveness of flaxseed oil capsule in comparison with olive oil capsule in patients with chronic constipation
Design
Patients randomly assigned to one of three groups A, B, and C. Group C is the control group. In this group, the lifestyle change method is used and explanations are provided them in the form of brochure. In group A ( intervention) in addition to lifestyle changes, capsules labeled A and in group B ( intervention) ,capsules labeled B are used. Each herbal capsule contains one gram of olive oil or one gram of oil.It is flaxseed (with a completely similar shape) and is prescribed in a daily dose of 5 grams (5 pearls).
Settings and conduct
In this study, the effect of flaxseed oil herbal capsules in the treatment of chronic idiopathic constipation and its comparison with the effect of olive oil herbal capsules in patients referred to Hajar Hospital in Shahrekord and training clinic. The capsules of both intervention groups are similar.The researcher and the patient are not aware of the contents of the capsule. Patients are randomly divided into one of three groups: A (intervention group), B (intervention group) or C (control group).
Participants/Inclusion and exclusion criteria
Entry requirements:Patients in the age group of 25 to 70 years who have had constipation for at least 3 months and the frequency of defecation is a maximum of twice a week. No entry:History of constipation medications (such as calcium channel blockers),Underlying diseases (such as diabetes, hypothyroidism, Parkinson's), pregnancy, drug addiction, history of any type of abdominal surgery, not taking medication as prescribed by a doctor
Intervention groups
Flaxseed oil herbal capsule group and olive oil herbal capsule group
Main outcome variables
Effect on constipation symptoms (stool consistency, number of defication) and effect on fasting blood sugar and lipid profile

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210312050678N1
Registration date: 2021-03-16, 1399/12/26
Registration timing: prospective

Last update: 2021-03-16, 1399/12/26
Update count: 0
Registration date
2021-03-16, 1399/12/26
Registrant information
Name
Mahnosh Salem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3242 2473
Email address
st-salem.m@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-03, 1400/01/14
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of flaxeed oil capsule in comparison with olive oil in patients with chronic idiopathic constipation referred to clinic and teachy hospitals of Shahrekord Univercity of Medical Sciences
Public title
Evaluation of efficacy of flaxeed oil capsule in comparison with olive oil in patients with chronic idiopathic constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 25 to 70 years with a history of chronic idiopathic constipation Patients with constipation for at least 3 months and defecation up to twice a week
Exclusion criteria:
Age
From 25 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into one of three groups: A (patient 1 to 35), group B (36 to 70), and group C (71 to 105).
Blinding (investigator's opinion)
Double blinded
Blinding description
In the two intervention groups, drugs with similar appearance and method of use are used.The patient is explained that the herbal capsule contains olive oil or flaxseed oil.The researcher and the patient are not aware of the contents of the capsule and are distinguished by labels A and B.The Data Safety and Monitoring Committee is aware of the contents of each capsule.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2020-10-20, 1399/07/29
Ethics committee reference number
IR.SKUMS.REC.1399.168

Health conditions studied

1

Description of health condition studied
Chronic idiopathic constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation

Primary outcomes

1

Description
Difficulty of defecation
Timepoint
2 months
Method of measurement
questionnaire

Secondary outcomes

1

Description
Number of bowel movements
Timepoint
2 months
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: Group A: Recipient of olive oil herbal capsules.Each capsule contains 1 gram of olive oil. It is recommended to consume 5 grams per day (two before breakfast, two before lunch and one before dinner) for two months.Barij Pharmacy Essential oil is prepared this pearl. Also, lifestyle changes are presented to the patient as a tract.
Category
Treatment - Drugs

2

Description
Intervention group: Group B: Recipient of flaxseed herbal oil capsules.Each capsule contains 1 gram of flaxseed vegetable oil. It is recommended to consume 5 grams per day (two before breakfast, two before lunch and one before dinner) for two months.Barij Pharmacy Essential oil is prepared this pearl. Also, lifestyle changes are presented to the patient as a tract.
Category
Treatment - Drugs

3

Description
Control group: Group C: Lifestyle changes.Necessary recommendations are provided to the patient in the form of tract: do not eat the main meals irregularly and eat them at a specific time. Eat breakfast within an hour after waking up, drink two glasses of warm water on an empty stomach. Consume one and a half Up to liters of water per day (6 to 8 glasses), consumption of 20 to 25 grams of fiber per day (table of high-fiber foods and the amount of fiber per unit of food is provided to patients).
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital, Shahrekord
Full name of responsible person
Ghorbanali Rahimian
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
mahnoshsalem@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghy
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
mahnoshsalem@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Mahnosh Salem
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar aven
City
Sahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
mahnoshsalem@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mahnosh Salem
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
mahnoshsalem@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mahnosh Salem
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
mahnoshsalem@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
2022-2023
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
I have not decided yet
From where data/document is obtainable
I have not decided yet
What processes are involved for a request to access data/document
I have not decided yet
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