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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201708026888N19 |
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Date of registration:
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2017-08-19 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Ondansetron, Vitamin B6 and Rhizome in Nausea and Vomiting of Pregnancy in pregnant women referred to health centers in Hamadan city
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Scientific title:
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The Effect of Ondansetron, Vitamin B6 and Rhizome in Nausea and Vomiting of Pregnancy in pregnant women referred to health centers in Hamadan city |
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Date of first enrolment:
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2017-08-10 |
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Target sample size:
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120 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/7329 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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2-3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Fatemeh Shobeiri
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Address:
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Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery, No. 137, Shahid Fahmideh street, Hamadan
Hamadan
Iran (Islamic Republic of) |
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Telephone:
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+98 81 3827 6051 |
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Email:
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shobeiri@umsha.ac.ir |
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Affiliation:
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Hamadan University of Medical Sciences |
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Name:
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Fatemeh Shobeiri
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Address:
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Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery, No. 137, Shahid Fahmideh street, Hamadan
Hamadan
Iran (Islamic Republic of) |
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Telephone:
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+98 81 3838 0150 |
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Email:
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shobeiri@umsha.ac.ir |
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Affiliation:
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Hamedan University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: Age of 18-40 years; Primi Para; No history of psychological illness; non-use of psychological drugs. exclusion criteria: Unwillingness to continue cooperation; Allergy to drug useage.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
40 years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hyperemesis gravidarum, mild or unspecified, starting before the end of the 22nd week of gestation
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Nausea and Vomiting during pregnancy.
Hyperemesis gravidarum, mild or unspecified, starting before the end of the 22nd week of gestation
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Intervention(s)
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Intervention group: The participants will randomly select to one of four oral treatments groups for one week : Ondansetron (4 mg/twice a day), and Rhizome (250 mg/twice a day) or Vitamin B6 (40 mg/twice a day)
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Control group: Prescription Placebo twice a day for one week.
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Treatment - Drugs
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Intervention 1: Intervention group: The participants will randomly select to one of four oral treatments groups for one week : Ondansetron (4 mg/twice a day), and Rhizome (250 mg/twice a day) or Vitamin B6 (40 mg/twice a day). Intervention 2: Control group: Prescription Placebo twice a day for one week.
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Placebo
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Primary Outcome(s)
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Nausea and vomiting. Timepoint: Before the intervention and one week after the intervention. Method of measurement: PUQE-24 questionnaire.
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Secondary Outcome(s)
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Severity of nausea and vomiting. Timepoint: Before the intervention, and one week after the intervention. Method of measurement: PUQE-24 questionnaire.
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Source(s) of Monetary Support
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Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of Hamadan University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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