We want to show the efficacy of experimental drug in Treating Constipation (based on times of defecation in each weeks and difficulties in defection) and side effects of it in comparison with placebo and resistance to it during the research. Inclusion criteria: suffering from constipation based on rom III criteria. exclusion criteria: pregnancy, GI bleeding, liver & kidney & cardiac diseases.40 cases will be selected among the patient that suffering from constipation with randomization and divided to two groups A&B(placebo, lax-asab).during 4 weeks the severity of constipation will be detected in 14 times( times in each days).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105046388N1
Registration date:2011-06-03, 1390/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-03, 1390/03/13
Registrant information
Name
Mohamadhossein Somi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 7499
Email address
somimh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vive chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Herbal Medicine" Lax-asab" in treating constipation: a Randomised Control Trial
Public title
Efficacy of " Lax-asab" in Treating Constipation
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:suffering from constipation based on romIII criteria and non-use constiepation drugs in last month.(in selection of patients we try that cases similar in age and severity of disease)
exclusion criteria:secondary constipation beceause of drugs or other disease,quit the research,treatment with other antie constipation drugs,side effect of experiemental treatment.cases with hepatic,renal,cardiac,pulmonary,haematologicand brain disorder.cases with cancer,inflammatory bowel disease,hiestory of allergy to the herbals,alcholism,acetive addiction,pregnancy,breast feeding and history of gastrointestinal blleding.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tabriz University of Medical Sciences
Street address
tabriz/Tabriz University of Medical Sciences
City
tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
904
Health conditions studied
1
Description of health condition studied
constipation
ICD-10 code
K55-K63
ICD-10 code description
Constipation
Primary outcomes
1
Description
severity of constipation(based on number of defecation per week and defection difficulties)
Timepoint
befor intervention,every other day after intervention and 2 weeks after the end of intervention
Method of measurement
romIII criteria
Secondary outcomes
1
Description
probable side effect and toleration to the drug during the study
Timepoint
probable side effect and toleration to the drug during the study
Method of measurement
probable side effect and toleration to the drug during the study
Intervention groups
1
Description
dose of consumption:a glass of boiled water(0.25 liter)+a spoon of laxative herbal powder (1 gram)every other day before breakfast.
research will done in 4 weeks(1 month)and in 14 times( times in each days).
Category
Treatment - Drugs
2
Description
dose of consumption:a glass of boiled water(0.25 liter)+a spoon of Prepared placebo powder(1 gram)every other day before breakfast. research will done in 4 weeks(1 month)and in 14 times( times in each days).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
emam reza hospital of tabriz/subspecial clinic of sheikh-o-raeis of tabriz(doctor somi)
Full name of responsible person
doctor somi,digestional specialty,proffesor of university
Street address
tabriz/emam reza hospital of tabriz/Subspecialty clinic of sheikh-o-raeis of tabriz(doctor somi)
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. piruzpanah
Street address
Iran,Tabriz,Tabriz University of Medical Sciences,nutritional faculty
City
Tabriz
Grant name
904
Grant code / Reference number
904
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for Research of Tabriz 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
Inteligence room of Tabriz University of Medical Sciences/research room of Tabriz University of Medi