The combined effect of honey and zinc in treatment of acute diarrhea in children

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2016080312897N1
• Date of registration: 2016-10-05
• Prospective Registration: Yes
• Primary sponsor: Vice Chancellor for research of Qazvin University of Medical Sciences
• Public title: The combined effect of honey and zinc in treatment of acute diarrhea in children
• Scientific title: The comparison effect of honey accompanied zinc with zinc in treatment of acute diarrhea in children
• Date of first enrolment: 2016-10-22
• Target sample size: 80
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/12896
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Abolfazl mahyar
• Affiliation: Vice Chancellor for research of Qazvin University ofMedical sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: existence of acute diarrhea(watery or lose diarrhea 3 or more in 24 hour the last less than 14 days ; mild or moderate dehydration; age between 1 to 5 years. Exclusion criteria: chronic diarrhea ; accompanying diseases; severe dehydration( more than 9%).
Exclusion criteria:

Age minimum: 1 year
Age maximum: 5 years
Gender: Both

Health Condition(s) or Problem(s) studied

Acute diarrhea.
Intestinal infectious diseases

A00-A09

Intestinal infectious diseases

Intervention(s)

Intervention 1: The control group will receive only syrup zinc gluconate 5 cc (equal 5 mg) every 6 hour. The zinc gluconate syrup in control group will be flavored with authorized flavors. The bottle of solutions in 2 groups will be similar regarding shape, size, color and taste. Both groups will receive standard care for treatment of diarrhea including fluid therapy and antibiotics. Intervention 2: Case group will receive honey (1.5 cc every 6 hour for children with 1-3 years old and 2 cc every 6 hour for children with3-5 years old) plus syrup zinc gluconate 5 cc( equal 5 mg) every 6 hour. For easier eating of honey the honey will dissolve in 15 cc of water each time. Honey used will be branded Paajoohesh honey ( Daniz production company, under the license No. 12.12369 ,Takestan city, Iran). Syrup zinc gluconate used will be from Amin pharmacy company (license No. 7004300400003, Bach no: no:06260154967626, Esfehan city, Iran).

Case group will receive honey (1.5 cc every 6 hour for children with 1-3 years old and 2 cc every 6 hour for children with3-5 years old) plus syrup zinc gluconate 5 cc( equal 5 mg) every 6 hour. For easier eating of honey the honey will dissolve in 15 cc of water each time. Honey used will be branded Paajoohesh honey ( Daniz production company, under the license No. 12.12369 ,Takestan city, Iran). Syrup zinc gluconate used will be from Amin pharmacy company (license No. 7004300400003, Bach no: no:06260154967626, Esfehan city, Iran).

The control group will receive only syrup zinc gluconate 5 cc (equal 5 mg) every 6 hour. The zinc gluconate syrup in control group will be flavored with authorized flavors. The bottle of solutions in 2 groups will be similar regarding shape, size, color and taste. Both groups will receive standard care for treatment of diarrhea including fluid therapy and antibiotics.

Treatment - Drugs

Primary Outcome(s)

Frequency of diarrhea. Timepoint: Before intervention and after intervention. Method of measurement: Questionnaire.

Frequency of vomiting. Timepoint: Before and after intervention. Method of measurement: Questionnaire.

Secondary Outcome(s)

Complications. Timepoint: After intervention. Method of measurement: Questionnaire.

Source(s) of Monetary Support

Vice Chancellor for research of Qazvin University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Qazvin University of Medical Sciences