Evaluation of the effect of oral traditional Persian medicine product of soft pistachio hull on children with acute gastroenteritis, compared with routine treatment
General Objective:
Determining the effect of the oral product of Iranian traditional medicine obtained from the dried soft hull of pistachio on children with acute gastroenteritis, compared with routine treatment.
Design
Clinical trial with control and intervention groups, single blind. phase 3.60 patients. Randomization using cards
Settings and conduct
The research will be carried out in medical sciences hospitals of Qom. Patients will be unaware of the groups and drugs in the containers.
Participants/Inclusion and exclusion criteria
Entering:
• Children aged 5 to 12 with acute gastroenteritis, which has been confirmed by a pediatric specialist due to the symptoms of diarrhea, vomiting, abdominal pain and dehydration, and need hospitalization and intravenous treatment.
• Not receiving drug treatment before entering the study
• Obtaining written consent from parents to participate in the research
Not entering:
• Duration of diarrhea more than two weeks
• Diarrhea following other diseases such as sepsis, respiratory and urinary infections, metabolic causes, endocrine causes
• Diarrhea following the use of drugs and antibiotics
• Gastroenteritis following autoimmune disease
Intervention groups
The oral product of Iranian traditional medicine obtained from the dried soft hull of pistachio will be prescribed to the patients at the rate of 5 grams per day in divided doses three times a day until the symptoms are resolved along with routine treatment.
Main outcome variables
Acute gastroenteritis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221017056213N2
Registration date:2024-11-09, 1403/08/19
Registration timing:prospective
Last update:2024-11-09, 1403/08/19
Update count:0
Registration date
2024-11-09, 1403/08/19
Registrant information
Name
fatemeh jahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3776 4075
Email address
fjahani@muq.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral traditional Persian medicine product of soft pistachio hull on children with acute gastroenteritis, compared with routine treatment
Public title
The effect of soft pistachio hull on acute gastroenteritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 5 to 12 years with acute gastroenteritis who have been confirmed by a pediatric specialist due to the symptoms of diarrhea, vomiting, abdominal pain and dehydration and need hospitalization and intravenous treatment.
Not receiving drug treatment before entering the study
Obtaining written consent from parents to participate in the research
Exclusion criteria:
Duration of diarrhea more than two weeks
Diarrhea caused by other diseases such as sepsis, respiratory and urinary infection, metabolic causes, endocrine causes
Diarrhea caused by taking medicine and antibiotics
Gastroenteritis caused by autoimmune disease
Change diagnosis
Refusal to continue cooperation
Age
From 5 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization using cards: intervention group letter A and control group letter B. Letter A is written on one card and letter B is written on the other, and they are closed and placed inside a covered container. In order of arrival of patients, if they are eligible, patients will choose one of the cards and be placed in that group. This work will be done until the sample volume of both groups is completed. The classification is done in order to match the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
A single blinded clinical trial. Since the control group will be given routine medication and the intervention group will be given routine medication along with the studied medication, the researcher and the therapist will know the type of treatment of each group. Therefore, after randomization, the patients will be unaware of the groups and drugs in the containers, which causes a blinding of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Qom University of Medical Sciences
Infectious gastroenteritis and colitis, unspecified
Primary outcomes
1
Description
Gastroenteritis
Timepoint
The beginning of the intervention and the end of symptoms
Method of measurement
Through history and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The oral product of Iranian traditional medicine obtained from the dried soft hull of pistachio will be prescribed to the patients at the rate of 5 grams per day in divided doses three times a day until the symptoms are resolved along with routine treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital affiliated to Qom University of Medical Sciences
Full name of responsible person
Fatemeh Jahani
Street address
Qom Faculty of Persian Traditional Medicine , next to Alley 44, 15 Khordad Blvd