Objectives: To assess the effect of Achillea millefolium on the duration of diarrhea in patients with gastroenteritis. Design: A double blind randomized clinical trial. Setting and conduct: The eligible patients with complaints of diarrhea referred to Shahid Beheshti Hospital will be enrolled into the trial. Inclusion criteria: Age more than 2 years, gastroenteritis, PO. Exclusion criteria: NPO, Drug intolerance, Severe malnutrition, Immune deficiency, Diabetes, Heart disease, Using of anti-diarrheal drugs. Intervention group: Oral administering of Achillea millefolium 5 milliliters every 8 hours for 3 days. Control group: Oral administering of placebo 5 milliliters every 8 hours for 3 days. Primary outcome: Duration of diarrhea by asking from patient or mother, frequency of diarrhea by asking from patient or mother.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070817985N3
Registration date:2015-07-20, 1394/04/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-20, 1394/04/29
Registrant information
Name
Alireza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Achillea millefolium on the duration of diarrhea in patients with gastroenteritis
Public title
The effect of Achillea millefolium on improvement of gastroenteritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 2 years; gastroenteritis; PO Exclusion criteria: NPO; Drug intolerance; Severe malnutrition; Immune deficiency; Diabetes; Heart disease; Using of anti-diarrheal drugs
Age
From 2 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2015-07-06, 1394/04/15
Ethics committee reference number
IR.KAUMS.REC.1394.55
Health conditions studied
1
Description of health condition studied
Gastroenteritis
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
Duration of diarrhea
Timepoint
Daily
Method of measurement
Asking from patient or mother
2
Description
Frequency of diarrhea
Timepoint
Daily
Method of measurement
Asking from patient or mother
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral administering of Achillea millefolium 5 milliliters every 8 hours for 3 days.
Category
Treatment - Drugs
2
Description
Control group: Oral administering of placebo 5 milliliters every 8 hours for 3 days.