Providing a complementary medicine solution along with other treatments to reduce drug dependence and a safe, easy and acceptable solution for improvement and prevention in elderly patients with functional constipation
Design
Clinical trial with control group, with parallel groups, one blind, randomized
Settings and conduct
The researcher and analyst assistants are both blind. The site of the study is the Social Security Hospital Clinic. After the samples are selected, the questionnaire is filled in by the researcher's assistance. The training is given to each group by the researcher. The questionnaire is then re-filled up with the help of a researcher It will be analyzed by expert statistician
Participants/Inclusion and exclusion criteria
Criteria for entering the study include:
Patients are in the age group of 50-70؛able to answer questions؛postmenopausal؛Constipation according to Rome III؛Not having the history of the diseases listed in the study؛Not having drug and alcohol addiction؛Not living in the nursing home.
Exit criteria:
Emergency and side effects during the intervention؛Diet change to relieve constipation during the intervention period؛Do not use dung more than 3 consecutive times a week؛Critical and mental crisis, mourning, divorce, travel, illness
Intervention groups
Any one of the test group, 28 packs, 30 grams of husk will be delivered. Take one packet with two glasses of lukewarm water, take a glass of 30 minutes before breakfast and a glass for 30 minutes before dinner for four weeks. In the control group, they will drink a glass of water for four weeks in the morning and at night
Main outcome variables
Non-drug strategy for the treatment and prevention of constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190220042774N1
Registration date:2019-06-08, 1398/03/18
Registration timing:retrospective
Last update:2019-06-08, 1398/03/18
Update count:0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Neda Khevegi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3223 8901
Email address
neda.kh232@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Descurainia sophia (L.) seed Webb ex Prantl on the severity of functional constipation in Women 50-70 years old .
Public title
Effect of Descurainia sophia (L.) seed Webb ex Prantl on the severity of functional constipation in Women 50-70 years old .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the age range of 50-70 years
Mentally minded and able to answer questions.
Postmenopause.
Constipation according to Roman criteria III
Exclusion criteria:
The presence of diseases that the specialist confirms
drug and alcohol addiction
Attending the nursing home
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
After identifying the subjects, to randomize the samples after the visit to the specialty of digestion and confirmation by him if the sample is approved for inclusion in the study, according to the 2nd bloc by the statistics expert, to the sample of the envelope (code Without name).(With random allocation based on patient referral) and the subjects were randomly assigned to control and intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assistant researcher, statistician
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bojnourd University of Medical Sciences
Street address
South Hospital Imam Ali Hospital,Shahriar Street
City
Bojnord
Province
North Khorasan
Postal code
9678694176
Approval date
2018-12-04, 1397/09/13
Ethics committee reference number
IR.NKUMS.REC.1397.070
Health conditions studied
1
Description of health condition studied
Functional Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Frequency of bowel movements per week
Timepoint
Measure the severity of constipation at the beginning of the study (before the intervention) and the end of week 4 after the start of the descurainia sophia.
Method of measurement
Constipation Assessment Questionnaire( CAS )
Secondary outcomes
empty
Intervention groups
1
Description
he 30-gram descurainia sophia packs are placed in the test group. Every night a packet with a glass of water is provided, the next day a glass of 30 minutes before breakfast and a glass of 30 minutes before dinner for 4 weeks will be consumed by the research unit.
Category
Treatment - Drugs
2
Description
Control group: Take 2 glasses of water, a glass 30 minutes before breakfast and a glass 30 minutes before dinner for 28 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Social Security Hospital in Bojnourd
Full name of responsible person
Dr. Behzad Ramezani Farokhani
Street address
Chamran street
City
Bojnord
Province
North Khorasan
Postal code
9413923874
Phone
+98 58 3223 1851
Email
neda.kh232@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr.Seyed Kaveh Hojjat
Street address
Central building of North Khorasan University of Medical Sciences,Government Boulevard
City
Bojnord
Province
North Khorasan
Postal code
7487797149
Phone
+98 58 7095 3229
Email
S.Kavehhojjat1@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Neda Khayahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Southern side of Imam Ali Hospital.,Shahriar Street
City
Bojnord
Province
North Khorasan
Postal code
9415954355
Phone
+98 58 3223 8901
Email
neda.kh232@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mahbubeh Tabatabaei Chehr
Position
Collegian
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Southern side of Imam Ali Hospita, Shahriar Street
City
Bojnord
Province
North Khorasan
Postal code
9678694176
Phone
+98 58 3229 7096
Email
Chehr192@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mahbubeh Tabatabaei Chehr
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Southern side of Imam Ali Hospital,Shahriar Street
City
Bojnord
Province
North Khorasan
Postal code
9678694176
Phone
+98 58 3229 7096
Email
Chehr192@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD