Title: Assessment of the impacts of Traditional Persian Medicine measures on the functional chronic constipation compared to those of Allopathic Medicine.
Aims: To compare Lactulose+Traditional Persian Medicine with Lactulose (only) on the functional chronic constipation and assess clinical efficacy and side effects.
Design: The study is blocked randomized, double blind study.
Setting and conduct: After obtaining inform consent from the patients that refer to Motahari polyclinic, the patients divide into two parallel therapeutic groups through a block randomization. The sample size was determined based on similar studies. 20 patients, aged 18-80 years who meet the Rome-3 criteria are enrolled in this pilot study with a block randomization (10 in each group).
Major Inclusion and Exclusion criteria: Inclusion criteria: At least two criteria of ROM-3 Criteria should be observed; Chronic constipation should be confirmed via complete physical examination if needed. Exclusion criteria: Suspicious to organic disorders.
Intervention: Intervention group, will receive Lactulose and Persian traditional medicine as change of lifestyle with face to face interview and weekly follow up with standard questionnaire for 1 month and control group, will receive Lactulose only.
Main outcome measures (variables): Stool frequency, Hard stool, Painful defecation, Sensation of incomplete evacuation, Sensation of anorectal obstruction, Manual maneuvers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070915587N6
Registration date:2014-08-23, 1393/06/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-08-23, 1393/06/01
Registrant information
Name
Nasrin Naseri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4263
Email address
grc@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2014-10-07, 1393/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the impacts of Traditional Persian Medicine measures on the functional chronic constipation compared to those of Allopathic Medicine
Public title
Impacts of Traditional Persian Medicine on the constipation management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least two criteria of ROM-3 Criteria should be observed; Chronic constipation should be confirmed via complete physical examination if needed. Exclusion criteria: Suspicious to organic disorders; Obstructive disorders; Metabolic etiologies; Neurological problems.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz, Fars, Iran
City
Shiraz
Postal code
Approval date
2014-05-14, 1393/02/24
Ethics committee reference number
7210-13-01-93
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Frequency of bowel movements per week
Timepoint
Before intervention and at the end of every week, during intervention period (for one month)
Method of measurement
International questionnaire for diagnostic criteria of chronic constipation-ROM3
2
Description
Frequency of hard or lumpy stool in bowel movements per week
Timepoint
Before intervention and at the end of every week, during intervention period (for one month)
Method of measurement
International questionnaire for diagnostic criteria of chronic constipation-ROM3
3
Description
Frequency of strain during bowel movements per week
Timepoint
Before intervention and at the end of every week, during intervention period (for one month)
Method of measurement
International questionnaire for diagnostic criteria of chronic constipation-ROM3
4
Description
Frequency of incomplete emptying after bowel movements per week
Timepoint
Before intervention and at the end of every week, during intervention period (for one month)
Method of measurement
International questionnaire for diagnostic criteria of chronic constipation-ROM3
5
Description
Frequency of sensation of anorectal obstruction/blockage per week
Timepoint
Before intervention and at the end of every week, during intervention period (for one month)
Method of measurement
International questionnaire for diagnostic criteria of chronic constipation-ROM3
6
Description
Frequency of manually maneuvers usage per week
Timepoint
Before intervention and at the end of every week, during intervention period (for one month)
Method of measurement
International questionnaire for diagnostic criteria of chronic constipation-ROM3
Secondary outcomes
1
Description
symptoms of chronic constipation based on the international diagnostic criteria of ROM-3 chronic constipation
Timepoint
Before intervention and at the end of every week, during intervention period (for one month)
Method of measurement
International questionnaire for diagnostic criteria of chronic constipation-ROM3
Intervention groups
1
Description
Intervention group: Lactulose and measures recommended in Persian Traditional Medicine resources changing in lifestyle with face to face interview and weekly follow up with standard questionnaire for1 month.
Category
Lifestyle
2
Description
Control group: Lactulose [a disaccharide (double-sugar) formed from one molecule each of the simple sugars (monosaccharides) fructose and galactose, syrup, 10g/15ml, 10cc, 3times/day, for 1 month, Sobhan Co.] per se.