Effect of Iranian traditional medicine on the basis of ARTEMISIA ABSINTHIUM on the improvement of symptoms of irritable bowel syndrome patients with constipation prevalence
The present study is a double-blind, randomized clinical trial that investigated the effect of Iranian traditional medicine on clinical signs and constipation in patients with constipated IBS. 70 patients with inclusion criteria were selected and randomly assigned to two groups of 35 intervention They are divided by medicine or placebo. Drugs and placebo are given as syrups three times a day, each 10 cc every 6 weeks for patients. To evaluate the symptoms, the IBS-SSS severity questionnaire (5 questions) and the severity of depression and anxiety (HADS) of 14 questions and Bristrol Stool Form Scale for stool consistency were used. The questionnaire is completed at the beginning of the study and after the end of the intervention, 6 and 4 weeks after the end of the treatment, the 10th week by the patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061034446N1
Registration date:2017-07-25, 1396/05/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-25, 1396/05/03
Registrant information
Name
Hamide Khorram Pajooh
Name of organization / entity
Mashhad Faculty of Traditional and Complementary Medicine
Country
Iran (Islamic Republic of)
Phone
+98 51 3876 4807
Email address
khorramh931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Mashhad University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Iranian traditional medicine on the basis of ARTEMISIA ABSINTHIUM on the improvement of symptoms of irritable bowel syndrome patients with constipation prevalence
Public title
The effect of Iranian traditional medicine on IBS disease
Purpose
Treatment
Inclusion/Exclusion criteria
The criteria for entry are based on the diagnostic criteria of IBS, namely, ROME IV, which is as follows:
(Recurrent abdominal pain at least one day a week in the last three months, with at least two of the following three characteristics: related to bowel movements - with a change in the frequency of bowel movements - accompanied by changes in the shape of the stool These symptoms start at least six months before the diagnosis.); constipation based on Bristrol Stool Form Scale; age between 18-50 years old; not having severe mental and behavioral disorders; no history of organic bowel disease; lack of pregnancy or breastfeeding; lack of drug addiction; no history of any major bowel surgery; serious and malignant systemic disease; the inability to use interfering chemical and vegetable medications with treatment.
Exit criteria:
pregnancy during the study; in the event of drug complications or other medical problems; unwillingness to continue treatment.
Age
From 18 years old to 50 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
University of Science and Technology, Faculty of Science and Technology, Mashhad University of Medical Sciences Mashhad Khorasan Razavi Iran
City
Mashhad
Postal code
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
IR.MUMS.REC.1396.48
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome with constipation prevalence
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Severity of disease, stool consistency,
Timepoint
At the beginning of the study and before starting treatment
Method of measurement
Illness severity questionnaire - IBS-SSS and Bristrol Stool Form Scale
Secondary outcomes
1
Description
anxiety and depression
Timepoint
6 weeks after starting treatment and 4 weeks after treatment
Method of measurement
questionnaire severity of depression and anxiety-HADS-
Intervention groups
1
Description
Control group: A similar medicinal product to the non-herbicide group was given as placebo for 6 weeks three times a day, each time 10 cc were given to the patients and the clinical manifestations of the patients at the beginning of the study and the week 6 treatments and 4 weeks after treatment discontinuation we do
Category
Placebo
2
Description
Intervention group: Syrup containing a certain amount of herbs of ARTEMISIA ABSINTHIUM, CUSCUTA EPITHYMUM, CASSIA FISTULA, ECHIUM AMOENIUM, MELLISA OFFICINALLIS weighing 10 cc three times a day for 6 weeks will be given at the start of the study and 6 weeks of treatment and 4 weeks after the follow-up treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology clinic of Ghaem Hospital
Full name of responsible person
Hamide Khorram Pajooh
Street address
Gastroenterology clinic, Ghaem Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of Science and Technology, Mashhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamide Khorram Pajooh
Position
Assistant Professor of Traditional Iranian Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, Second floor, Faculty of Medicine, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 3876 4807
Fax
Email
khorramh9312@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Noras M.D, Ph.D.
Position
Ph.D. In Persian Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, Second floor, Faculty of Medicine, Azadi Square
City
Mashhad
Postal code
Phone
+98 51385521889
Fax
Email
norasm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Traditional Medicine
Full name of responsible person
hamide khorram pajooh
Position
Assistant Professor of Traditional Iranian Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, Second floor, Faculty of Medicine, Azadi Square
City
mashhad
Postal code
Phone
+98 51 3876 4807
Fax
Email
khorramh931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)