Protocol summary

Study aim
Determination of the effect of Zizyphus Jujuba Fruit’s product compared to standard product in pediatric functional constipation
Design
Based on the statistical studies, sample size will be 110 people .they will use jujube extracts and PEG in two groups which be allocated by random blocked randomization. Treatment will take 4 weeks. and we will ask them by phone or verbal about effects in the end of 1,2,4 weeks.
Settings and conduct
This study is a randomized controlled clinical trial among patients referring to pediatric gastroenterology clinic of Rasool Akram Hospital.
Participants/Inclusion and exclusion criteria
1 - Children 2 to 12 years of age of both sexes who have been diagnosed with functional constipation based on ROMEIV criteria. 2. Absence of diseases such as: chronic and significant psychiatric disorders; - mental retardation; - history of chronic diseases; - history of developmental disorders in infancy and childhood; - moderate to severe traumatic history; - Chronic gastrointestinal disorders and congenital anomalies in the digestive tract - history of gastrointestinal surgery - IBS diagnosis based on ROMEIV criteria 3. Absence of chronic drug use history and medical treatment that has an effect on GI movement 4. no history of death or parental separation. 5.absence of symptoms of organic constipation 6. Fecal impaction in the physical examination, which can not be eliminated.
Intervention groups
Children aged 2-12 years with functional constipation with nutritional and behavioral instructions and PEG daily 0.4gr / kg Jujuba Fruit’s product 0.5cc/kg BD
Main outcome variables
number of defication per week Consistency of stool Number of incontinence times Painless defication Satisfaction of the drug Possible complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171213037866N1
Registration date: 2018-05-03, 1397/02/13
Registration timing: registered_while_recruiting

Last update: 2018-05-03, 1397/02/13
Update count: 0
Registration date
2018-05-03, 1397/02/13
Registrant information
Name
Nasim Behnoud
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0358
Email address
behnoud.n@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of tht effects of Zizyphus Jujuba Fruit’s product and Pidrolax in the Childhood Functional Constipation which referred to Rasoul Akram Clinic: a ra ndomized clinical trial
Public title
Effects of Zizyphus Jujuba Fruit’s product in the Childhood Functional Constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 2–12 years old and presence of Functional Constipation based on ROME IV
Exclusion criteria:
Any symptom of organic constipation in the history, physical examination or para clinics (such as hypothyroidism, Hirschsprung disease, chronic intestinal pseudo-obstruction) and the presence of other chronic diseases that lead to long-term use of drugs and long-term consumption of any drug that can cause constipation.
Age
From 2 years old to 12 years old
Gender
Both
Phase
1
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to intervention and control groups based on a randomized block method.
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
Research Committee of Iran University of Medical Sciences
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
IR.IUMS.REC 1396.9421309003

Health conditions studied

1

Description of health condition studied
Pediatric functional constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation

Primary outcomes

1

Description
Frequency of defecation per week
Timepoint
Before intervention, 1, 2, 3, 4 weeks after starting treatment
Method of measurement
Standard questionnaire

2

Description
The frequency of hard stool in a week
Timepoint
Before intervention, 1, 2, 3, 4 weeks after starting treatment
Method of measurement
Standard questionnaire

3

Description
Frequency of fecal incontinence per week
Timepoint
Before intervention, 1, 2, 3, 4 weeks after starting treatment
Method of measurement
Standard questionnaire

4

Description
The frequency of painful defecation in the week
Timepoint
Before intervention, 1, 2, 3, 4 weeks after starting treatment
Method of measurement
Standard questionnaire

5

Description
Frequency of drug adoption by the child per week
Timepoint
Before intervention, 1, 2, 3, 4 weeks after starting treatment
Method of measurement
Standard questionnaire

6

Description
The frequency of side effects in weeks
Timepoint
Before intervention, 1, 2, 3, 4 weeks after starting treatment
Method of measurement
Standard questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Nutritional and behavioral commands and PEG daily 0.4gr / kg
Category
Treatment - Drugs

2

Description
Control group: Nutritional and behavioral commands and Zizyphus Jujuba Fruit’s product
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
درمانگاه بیمارستان رسول اکرم
Full name of responsible person
نسیم بهنود
Street address
تهران - ستارخان - خ. نیایش - نبش خیابان منصوری - بیمارستان حضرت رسول اکرم (ص)
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6651 5001
Email
behnoud.n@tak.iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazem Malakouty
Street address
Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Iran University of Medical Sciences
Full name of responsible person
Nasim Behnoud
Position
Student in Iranian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Tehran, Behesht St., College of Iranian Medicine
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2191
Fax
Email
behnoud.n@tak.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Behnoud
Position
Student in Iranian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Tehran, Behesht St., College of Iranian Medicine
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2191
Fax
Email
behnoud.n@tak.iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Behnoud
Position
Student in Iranian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Tehran, Behesht St., College of Iranian Medicine
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2191
Fax
Email
behnoud.n@tak.iums.ac.ir

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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