Investigating the Effect of Simultaneous Consumption of “Grape molasses with Ferrus Sulfat Compared with Ferrus Sulfat on Iron Deficiency Anemia in 15-49 years womens .
Investigating the Effect of Simultaneous Consumption of “Grape molasses with Ferrus Sulfat Compared with Ferrus Sulfat on Iron Deficiency Anemia .
Design
A double-blind clinical trial. From patients with anemia confirmed by blood test, eligible individuals are selected and then randomly assigned to one of two intervention or control groups. Intervention group: Iron tablets with grape juice and Control group: Iron tablets with placebo. Sample size: 80 phase of clinical trial
Settings and conduct
Location: Hematology Specialty Clinic of Imam Khomeini Hospital in Urmia. The patient's general tendency at week 0 and 4, severity of anemia based on blood hemoglobin at week 0 and 4, and drug side effects at week 4, are assessed. The types of medicines are blind.
Participants/Inclusion and exclusion criteria
Completion of informed consent form by women with anemia with hemoglobin 10-12 and age 15-49 years
Intervention groups
The intervention group received iron tablets (3 times a day fasting) and grape juice (10 cc three times a day in warm water) three times a day. (1 hour before breakfast, lunch, and dinner) and the control group received iron tablets (fasting 3 times daily) and placebo syrup (10 cc three times daily in warm water). (1 hour before breakfast, lunch and dinner).
Main outcome variables
blood hemoglobin
General information
Reason for update
Acronym
GMAS
IRCT registration information
IRCT registration number:IRCT20200120046205N1
Registration date:2020-01-30, 1398/11/10
Registration timing:prospective
Last update:2020-01-30, 1398/11/10
Update count:0
Registration date
2020-01-30, 1398/11/10
Registrant information
Name
Rasoul Pourhakim rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3343 1734
Email address
rasoul.pourhakim@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-08, 1398/11/19
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Simultaneous Consumption of “Grape molasses with Ferrus Sulfat Compared with Ferrus Sulfat on Iron Deficiency Anemia in 15-49 years womens .
Public title
Investigating the Effect of “Grape molasses on Iron Deficiency Anemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iron Deficiency Anemia mild type
age 15-49 years
Exclusion criteria:
Diabetic Individuals
pregnancy
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study participants are dividing into two groups of grape molasses and placebo with simple random method by using the random number table.For randomization, each drug or placebo is assigned a specific code computer program and is included in the label containing the consumption information. The researcher and patients are not aware of any drug or placebo codes
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and study participants (patients) are unaware that they have been given Grape molasses or placebo.(double blind trial)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahed University
Street address
Shahed University, Opposite to Imam Khomeini holy shrine, Persian Gulf highway (Tehran-Qom)
City
Tehran
Province
Tehran
Postal code
331911865
Approval date
2019-12-23, 1398/10/02
Ethics committee reference number
IR.SHAHED.REC.1398.108
Health conditions studied
1
Description of health condition studied
iron Deficiency Anemia
ICD-10 code
D50
ICD-10 code description
Iron deficiency anemia
Primary outcomes
1
Description
Blood hemoglobin
Timepoint
At the beginning of the study and one month after the intervention
Method of measurement
blood test
Secondary outcomes
1
Description
Side effects of the drug
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Medication Complications Questionnaire
Intervention groups
1
Description
The intervention group: this group receives iron tablets with grape molasses (10 cc in a glass of lukewarm water) three times a day (1 hour before breakfast, lunch, and dinner) for one month.
Category
Treatment - Drugs
2
Description
Control group: this group receives iron tablets with placebo syrup (10 cc in a glass of lukewarm water) three times a day (1 hour before breakfast, lunch, and dinner) for one month.