Comparison of Pidrolax plus paraffin versus Pidrolaxin the treatment of pediatric functional constipation
Design
The study will be double blind and clinical trial.74 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients candidate for cpediatric functional constipation in Amirkabir Hospital in Arak are divided into 2 groups by simple randomization with blocks.The study is one-blind in which participant is kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Outpatients with a history of functional constipation (at least 3 months), 2 to 18 years
Exclusion criteria:Non-functional constipation, resistance to treatment in the first month, hypothyroidism,Hirschsprung's disease, Known disorders cardiac, renal and neurological, colon surgery history,patients with secondary constipation due to chronic disease such as endocrine, metabolic or neurological diseases
Intervention groups
Intervention group 1: will receive 0.7 geram in kilogeram Pidrolaxin in day for 3 months.
Intervention group 2: will receive 0.7 geram in kilogeram in day of Pidrolaxin with liquid paraffin orally for 3 months.
Main outcome variables
Frequency of defecation , painful defecation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N179
Registration date:2023-01-01, 1401/10/11
Registration timing:prospective
Last update:2023-01-01, 1401/10/11
Update count:0
Registration date
2023-01-01, 1401/10/11
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Pidrolax plus paraffin versus Pidrolaxin the treatment of pediatric functional constipation
Public title
Comparison of Pidrolax plus paraffin versus Pidrolaxin the treatment of pediatric functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Outpatients with a history of functional constipation (at least 3 months)
2 to 18 years
Exclusion criteria:
Non-functional constipation
Resistance to treatment in the first month
hypothyroidism
hyreshprong disease
Known disorders cardiac, renal and neurological
Colon surgery history
Patients with secondary constipation due to chronic disease such as endocrine, metabolic or neurological diseases
Age
From 2 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this controlled intervention trial, a blinding stage will be performed. In this way, two ready-to-use bottles of medicine labeled A and B will be prepared by the researcher: a bottle containing Pidrolox labeled (A) and a bottle containing liquid paraffin labeled (B). After randomization and grouping by the researcher, with the reference of each Which of the qualified patients will be delivered labeled bottles without the name of the drug (according to the grouping done) and the patient will not be informed of the type of drug treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2022-07-03, 1401/04/12
Ethics committee reference number
IR.ARAKMU.REC.1401.109
Health conditions studied
1
Description of health condition studied
Pediatric functional constipation
ICD-10 code
K59.9
ICD-10 code description
Functional intestinal disorder, unspecified
Primary outcomes
1
Description
Frequency of defecation
Timepoint
In week
Method of measurement
Physical examination
2
Description
Painful defecation
Timepoint
In week
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: will receive 0.7 geram in kilogeram Pidrolaxin in day for 3 months.
Category
Treatment - Drugs
2
Description
Intervention group 2: will receive 0.7 geram in kilogeram in day of Pidrolaxin with liquid paraffin orally for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Noshin Sajadi
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3417 3645
Email
sajadi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
dr Mahdi salehi
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
salehi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?