Protocol summary

Study aim
Determination and comparison of the effect of Golghand majun and Polyethylene Glycol powder 4000 in the treatment of constipation in patients referred to Imam Hossein Hospital in 2019-2020.
Design
A simple randomized clinical trial (not blinded) using simple random table (phase 3), with control group (parallel groups) that 60 patients with functional constipation are randomly allocated to two groups (Intervention and control groups).
Settings and conduct
Sixty patients aged 2 to 15 years referred to Imam Hossein Hospital, whose functional constipation was confirmed by Cryitria Roman 4, (after obtaining written consent) are randomly allocated to two groups (receiving Golghand majun 500 mg / kg three times daily and receiving Polyethylene glycol (4000) Powder 0.7 g / kg three times daily). Both groups will be evaluated for 8 weeks after intervention. (Not blinded)
Participants/Inclusion and exclusion criteria
Inclusion criteria:Functional constipation confirmed by ROMAN criteria 4; Stool elimination twice a week or less; History of stool retention; Stiff or painful intestinal function; History of large stool diameter; History of large stool mass in rectum Exclusion criteria:Patients with causes of organic constipation; Patients with chronic illness who need special care; Pregnanccy; History of surgery involvig the gastrointestinal tract exept for appendectomy; History of allergies or drug allergies; Diagnosis of autism and major psychosis disorder; Use of some drugs; Weight loss over five percent in the past three months; Use of drugs that have an unknown delay in the gastrointestinal tract
Intervention groups
Intervention group: Golghand majun 500 mg / kg divided in three times daily, orally half an hour before meals for eight weeks Control group: Polyethylene glycol (4000) Powder 0.7 g / kg orally three times daily for eight weeks
Main outcome variables
Constipation improvement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190410043224N1
Registration date: 2020-02-20, 1398/12/01
Registration timing: registered_while_recruiting

Last update: 2020-02-20, 1398/12/01
Update count: 0
Registration date
2020-02-20, 1398/12/01
Registrant information
Name
Peiman Nasri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6331
Email address
peiman.nasri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation between the Golghand majun (Rosa damascena) and Polyethylene glycol (4000) in the pediatric functional constipation in chidren 2 to 15 years old referred to Emam Hossein hospital in 2019-2020
Public title
Comparison between the Golghand majun and Polyethylene glycol in the pediatric constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Functional constipation confirmed by ROMAN criteria 4 Stool elimination twice a week or less History of stool retention Stiff or painful intestinal function History of large stool diameter History of large stool mass in rectum
Exclusion criteria:
Patients with causes of organic constipation such as celiac disease, pseudo-obstruction, hypothyroidism, spinabifida, anorectal malformation, hirschsprung's disease Patients with chronic illness who need special care such as: stone kidney, sickle cell anemia, cereberal palsy, hepatitis, hematologic diseases, gastrointestinal bleeding, relapse fever or fever without locolized sign Pregnanccy History of surgery involvig the gastrointestinal tract exept for appendectomy History of allergies or drug allergies Diagnosis of autism, major psychosis disorder such as bipolar disorder, schizophrenia, children who have experienced physical abuse and sexual abuse Use of medication such as Metoclopyramide, Erythromycin, Butanol, Amoxiclav, Azithromycin, Domperidone, Amitriptyline, Hyoscyamine, Clonidine, Baclofen, Dicyclomine, Scopolamine Weight loss over five percent in the past three monthes Use of drugs that have an unknown delay in the gastrointestinal tract
Age
From 2 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into intervention and control groups using simple random number table (individual and simple randomization). The intervention group was allocated to the treatment of the Golghand majun and the control group was allocated to the proven treatment of constipation (administration of Polyethylene glycol powder).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Research and Technology Deputy of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.MUI.MED.REC.1398.330

Health conditions studied

1

Description of health condition studied
Functional constipation
ICD-10 code
K59.09
ICD-10 code description
Other constipation

Primary outcomes

1

Description
Constipation improvement
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Clinical Examination; Questionnaire of Constipation Evaluation

Secondary outcomes

1

Description
Treatment side effects
Timepoint
During the study and 8 weeks after the intervention
Method of measurement
Clinical Examination; Questionnaire of Constipation Evaluation

Intervention groups

1

Description
Golghand majun (Barij Pharmaceutical Company) 500 mg / kg divided in three times daily, orally half an hour before meals for eight weeks
Category
Treatment - Drugs

2

Description
Control group: Polyethylene glycol (4000) Powder (Sepidaj Pharmaceutical Company) 0.7 g / kg orally three times daily for eight weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Mehrdad Memarzadeh
Street address
Imam Hossein Hospital, Imam Khomeini Avenue, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
emamhossein_hospital@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Research and Technology Deputy of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3061
Fax
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Barij Medicinal Plant Research Center
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeedeh Ghaedi
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Imam Hossein Hospital, Imam Khomeini Avenue, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
Ghaedi_saeedeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Peiman Nasri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Hossein Hospital, Imam Khomeini Avenue, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
Peiman94157@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Peiman Nasri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Hossein Hospital, Imam Khomeini Avenue, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
Peiman94157@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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