The Comparison of the effects of traditional remedy of Foeniculum vulgare and Rosa Damascena on clinical symptoms of elderly patients with functional constipation
Determination of the effect Traditional remedy of Foeniculum vulgare and Rosa domascena on Clinical Symptoms of Elderly Patients with Functional Constipation
Design
Patients were randomly assigned to either an intervention or a control group. included 30 people who were blocked randomly assigned to the each group.Intervention group,patients with functional constipation treated with combination of Rosa domascena and Foeniculum vulgare extract. The control group includes Patients who mix and consume of Poly Ethylene Glycol powder
Settings and conduct
This double blind study will perform on elderly patients with constipation on urban health service centers in Kerman city.Medicines are manufactured by a traditional pharmacist and packaged and coded in the same way.One who performs coding until the end of the intervention has no role in the study. Patients by someone who is unaware of how the drugs are coded,Until the end of the intervention, there was no role in the study. Patients are randomly assigned to one of the two groups studied, followed and followed up by a person who does not know how the medication is coded
Participants/Inclusion and exclusion criteria
Inclusion criteria:Elderly patients over 60 years of age who are mentally alert and able to answer questions and have constipation based on the approved Rome IV criteria.
Exclusion criteria:
History of gastrointestinal obstructive diseases, psychiatric disorders, history of drug abuse, patient's unwillingness to continue the plan.
Intervention groups
Case group: 10 gr traditional remedy (5 gr Foeniculum vulgare and 5 gr Rosa domascena), two times a day
Control group: 10 gr PEG, two times a day
Main outcome variables
Constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200108046056N1
Registration date:2020-02-25, 1398/12/06
Registration timing:registered_while_recruiting
Last update:2020-02-25, 1398/12/06
Update count:0
Registration date
2020-02-25, 1398/12/06
Registrant information
Name
Sedigheh khodabandeh Shahrki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5218
Email address
s_khodabandeh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the effects of traditional remedy of Foeniculum vulgare and Rosa Damascena on clinical symptoms of elderly patients with functional constipation
Public title
Traditional remedy of Foeniculum vulgare and Rosa Damascena on clinical symptoms of elderly patients with constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The elderly over 60 years of age mentally alert and able to answer questions
constipation approved in accordance with Rome IV diagnostic criteria. informed consent.
Having informed consent
no history of gastrointestinal obstructive disorders.
No history of gastrointestinal inflammatory diseases.
Exclusion criteria:
unwillingness to continue participation in the study at any time of the study.
The occurrence of acute complications during the intervention.
use of laxatives for constipation during the study.
Reporting any signs suggesting an allergic reaction to Foeniculum vulgare and Rosa Damascena.
Not taking regular medication
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 people aged 60 years Community Health Centers who suffer from constipation each person has a proprietary code given by A statistic consultant is provided in blocks 4 and unaware of which code belongs to which group is placed in the envelope (with random allocation based on the referral of patients) and the subjects are randomly assigned to two groups of control and intervention. Questionnaires are completed before and after the intervention by a researcher who is unaware of the intervention and control group. Constipation is the main variable in this studyp also performs the usual treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind study. Medicines are manufactured by a traditional pharmacist and packaged and coded uniformly. The person doing the coding has no role in the study until the end of the intervention. Patients are randomly assigned to one of the two study groups by a person who has no knowledge of how the drugs are coded. Statistical analysis of the study is performed by a third person who is unaware of how the groups are coded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences and Health Services
Street address
Jahad Blvd. Ebn Sina Avenue, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2020-01-13, 1398/10/23
Ethics committee reference number
IR.KMU.REC.1398.470
Health conditions studied
1
Description of health condition studied
constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
People with constipation who have 2 or more grade according to Rome 4 criteria
Timepoint
All of the above groups meet weekly on a weekly basis: initial visit and diagnosis before the intervention, one month after intervention and two month after the intervention intervention
Method of measurement
Questionnaire based on the international diagnostic criteria of chronic constipation-ROMIV
Secondary outcomes
1
Description
Quality Of Life
Timepoint
Before the intervention. one month after intervantion, two month after the interventionintervention
Method of measurement
Patient Assessment of Constipation Quality of Life Questionnaire
Intervention groups
1
Description
Intervention group: Patients with chronic constipation treated with sachet of Roses Damascena and Foeniculum vulgare which was produced at the Kereman university of Medical Science, faculty of Persian medicine, as a sachet and dosed with the desired dosage . 10 grams of sachets (containing 5 grams of Foeniculum vulgare powder and 5 grams of Rosa domascena powder), two times a day, in the morning and evening before meals and mix with a glass of warm water.
Category
Treatment - Drugs
2
Description
Control group: 10 gr sachet of PEG powder, two times a day, in the morning and evening before meal, with one glass of warm water
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Service Centers
Full name of responsible person
Sedighe Khodabandeh Shahraki
Street address
Nursing Research Center, Iran, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
Email
S_Khodabandeh@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Pardakhti Abbas
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
S_khodabandeh@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Sedigh Khodabandeh Shahrki
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
S_khodabandeh@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Azimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0119
Email
dr.azimm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sedigh Khodabandeh Shahrki
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
s_khodabandeh@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only, information about the outcome of the study will be published.
When the data will become available and for how long
The publication time after the publication of the results will be in a journal.
To whom data/document is available
Anyone who wants to have access to information after publishing in a journal.
Under which criteria data/document could be used
Analysis of data based on statistical software.
From where data/document is obtainable
Kerman University of Medical Sciences.After publication in a journal can go to the website of the journal. Refer to this email:s_khodabandeh@kmu.ac.ir
What processes are involved for a request to access data/document
After the publication of the study information in a journal, it can immediately access the information.