Objective: evaluation of therapeutic effect of Descurainia sophia (L.) seeds on clinical symptoms of functional constipation in adults
Study design: single-center clinical trial
Study population: patients with chronic constipation referred to the gastroenterology clinic: Shariat Panahi clinic, School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Main inclusion criteria: adult patients with chronic constipation who fulfilled inclusion criteria ROMIII for chronic functional constipation, and has no sever disease in liver, kidney and cardiovascular systems and announced their agreement to participate in the program by signing a voluntary and informed consent.
Main exclusion criteria: Lack of durability of the above conditions; Unwillingness to continue participation in the study; Drug side effects or other threatening events.
Sample size: 35 people
Intervention Study: A warm syrup of Descurainia sophia (L.) seeds and sugar at fasting once daily
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030515408N2
Registration date:2016-03-29, 1395/01/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-29, 1395/01/10
Registrant information
Name
Anahita Ghourchian
Name of organization / entity
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Country
Iran (Islamic Republic of)
Phone
+98 26 3463 5198
Email address
dr.anahitaghourchian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-12-21, 1393/09/30
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial evaluating of effect of Descurainia sophia (L.) on clinical symptoms of adult patients with functional constipation
Public title
A clinical trial evaluating of effect of Descurainia sophia (L.) on clinical symptoms of adult patients with functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age: 70-20 years at the time of screening; Ability to participate in the study and there is no obvious behavioral disorders, speech and language diaeres; No major abdominal surgery; Lack of self and family history of thyroid disease; Colon cancer screening in people over 50 years; Lack of warning signs (rectal bleeding and weight loss and anemia); No underlying disease affecting constipation (Parkinson, Multiple sclerosis, stroke, hypothyroidism, cancer); Lack of pregnancy or lactation; Speaking ins; Avoiding the use of antibiotics in the past 5 weeks; Not taking medications causing constipation; No addiction; Complete the consent form; Having normal routine tests, including complete blood count, fecal occult blood test, alkaline phosphatase and TSH test, liver enzymes and Cr; No previous sensitivities to herbal medicines; Absence of severe cardiovascular disease, especially functional class 3 & 4 of chronic heart failure; Lack of proven malignancy; Absence of liver disease (esophageal varices and bleeding, encephalopathy, ascites); Absence of symptomatic gallstone disease (in history); Absence of severe kidney disease (creatinine more than 3 mg / dl); Having the criteria for functional constipation ROMIII.
Main exclusion criteria: Lack of durability of the above conditions; Unwillingness to continue participation in the study; Drug side effects or other threatening events.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Office of Research Affairs, Deputy of Research and Technology, Shahid Beheshti University of Medical
Street address
Sixth Floor, College Staff Building Number Two, Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Parvaneh st., Yemen st., Shahid Chamran Highway
City
Tehran
Postal code
Approval date
2014-05-04, 1393/02/14
Ethics committee reference number
150
Health conditions studied
1
Description of health condition studied
Relationship of Descurainia sophia L. with functional constipation in adults
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The proportion of patients reaching three or more spontanouse complete bowel movement/week
Timepoint
At the begining, before the intervention and 4 weeks after, at the end of study
Method of measurement
By interviews with patients and asking them
Secondary outcomes
1
Description
The number of laxatives used
Timepoint
At the begining, before the intervention and 4 weeks after, at the end of study
Method of measurement
By interviews with the patients and asking them
2
Description
The score of a check list of Patient Assessment of Constipation Symptoms (PAC-SYM) items
Timepoint
At the begining, before the intervention and 4 weeks after, at the end of study
Method of measurement
By interviews with the patients and asking them
3
Description
The type of stool according to Bristol chart
Timepoint
At the begining, before the intervention and 4 weeks after, at the end of study
Method of measurement
By interviews with the patients and asking them
Intervention groups
1
Description
Intervention: A spoonful of dry seeds of Descurainia sophia L. and a spoonful of sugar in a cup of boiling water are mixed and taken at fasting once a day. If the properties of defecation do not satisfy the patient , he is allowed to increase the dose of drug every three days to a maximum of 6 teaspoons / day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariat Panahi Clinic
Full name of responsible person
Dr. Rasool Choopani
Street address
No.8 Shams Alley, opposite St Tavanir, Vali Asr Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Be
Full name of responsible person
Dr. Rasool Choopani
Street address
No.8 Shams Alley, opposite St tavanir, Vali Asr Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Be
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
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Behe
Full name of responsible person
Dr. Anahita Ghourchian
Position
Ph.D student of Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Sttree Tavanir, Vali Asr Street