Protocol summary

Summary
The goal of this trial is to study Effects off Rheum ribes L. syrup on bloody diarrhea in children aged 12 to 72 months. Inclusion criteria: (1) age between 12 to72 months; (2) history of passing loose stool (>3 times per day) mixed with blood and or mucus for ≤72 hours or>5 WBC in S/E, and (3) with or without the presence of fever, abdominal pain, anorexia, dehydration, and vomiting; (4) written, voluntary informed consents from the parent or legal guardians of the children were obtained at the time of admission. Exclusion criteria: (1) refusal of consent by parents; (2) treatment with an antimicrobial and or antidiarrheal agents within last 3 days; (3) fecal presence of erythrophagocytic trophozoite of Entameba histolytica or cyst/trophozoites of Giardia lamblia; (4) presence of concurrent illnesses (pneumonia, sepsis, meningitis, and toxic colitis). A Double - blind, Randomized, Controlled clinical trial. Ninety-four children aged 12 to 72 months with bloody dysentery caused by infection are either given a syrup base with or without Rheum ribes (n = 94) for 5 days; stool volume, frequency, excretion of blood/mucus, and relevant clinical and laboratory indices are determined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014070518356N1
Registration date: 2014-08-28, 1393/06/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-28, 1393/06/06
Registrant information
Name
Ali Khiveh
Name of organization / entity
Shahid sadoughei University of Medical Sciences of Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1724 0171
Email address
a-khiveh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research,Yazd Shahid Sadoghei University of Medical Sciences.
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects off Rheum ribes L. syrup on bloody diarrhea in children aged 12 to 72 months.
Public title
Effects off Rheum ribes L. syrup on bloody diarrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : (1) age between 12 to72 months; (2) history of passing loose stool (>3 times per day) mixed with blood and or mucus for ≤72 hours or>5 WBC in S/E, and (3) with or without the presence of fever, abdominal pain, anorexia, dehydration, and vomiting; (4) written, voluntary informed consents from the parent or legal guardians of the children were obtained at the time of admission. Exclusion criteria:(1) refusal of consent by parents; (2) treatment with an antimicrobial and or antidiarrheal agents within last 3 days; (3) fecal presence of erythrophagocytic trophozoite of Entameba histolytica or cyst/trophozoites of Giardia lamblia; (4) presence of concurrent illnesses (pneumonia, sepsis, meningitis, and toxic colitis).
Age
From 12 months old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 94
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
Vice Chancellor for research,Yazd Shahid sadoughei univesity of medical sciences
Street address
central department of Shahid sadoughei medical university.Shahid bahonar squer.Yazd
City
Yazd
Postal code
8916978477
Approval date
2014-06-25, 1393/04/04
Ethics committee reference number
17/1/65410

Health conditions studied

1

Description of health condition studied
Bloody diarrhoea
ICD-10 code
A03
ICD-10 code description
Shigellosis

Primary outcomes

1

Description
Blood in stool
Timepoint
Before intervention and eyery 8 hours after intervention
Method of measurement
Direct inspection and asking patient`s parents

2

Description
Fever
Timepoint
At the beginning and then every 8 hours
Method of measurement
Thermometer

3

Description
Daily numbers of stools
Timepoint
Every 8 hours
Method of measurement
Asking from nurse of pationt

4

Description
RBC in stool
Timepoint
In days 0, 3, 5
Method of measurement
Stool Exams

Secondary outcomes

empty

Intervention groups

1

Description
Ribes syrup children less than 15 KG 2,5 cc and more than 15 KG 5 cc every 6 houres fore 5 days
Category
Treatment - Drugs

2

Description
Placebo syrup( Basal ingredients of Ribes syrup with out Ribes ) children less than 15 KG 2,5 cc and more than 15 KG 5 cc every 6 houre for 5 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ziaei hospital of Ardakan
Full name of responsible person
Ali khiveh
Street address
Azadi squar, Ziaei hospital
City
Ardakan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ezoddini
Street address
Central Building of Shahid Sadoughei Medical University, Shahid Bahonar squer.Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Shahid Sadoughei 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
Traditional Medicine Faculty of Ardakan, Shahid Sadoughei University of Medical Sciences
Full name of responsible person
Ali Khiveh
Position
Ph.D candidate
Other areas of specialty/work
Street address
Traditional Medicine Faculty of Ardakan, Imam Khomeini ave.
City
Ardakan
Postal code
Phone
+98 35 2723 8917
Fax
+98 35 2724 6330
Email
ali.khiveh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Traditional Medicine Faculty of Ardakan, Shahid Sadoughei University of Medical Sciences
Full name of responsible person
Dr. Majid Emtiazy
Position
Assistant Professor
Other areas of specialty/work
Street address
Traditional Medicine Faculty of Ardakan, Imam Khomeini ave
City
Ardakan
Postal code
Phone
+98 35 2723 8917
Fax
Email
Dr.emtiazy@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Traditional Medicine Faculty of Ardakan, Shahid Sadoughei University of Medical Sciences
Full name of responsible person
Ali Khiveh
Position
Ph.D candidate
Other areas of specialty/work
Street address
Traditional Medicine Faculty of Ardakan, Imam Khomeini ave
City
Ardakan
Postal code
Phone
Fax
Email
ali.khiveh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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