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Effect of Ginger and pyridoxin(vitB6) and placebo in the treatment of pica

Phase 2
Conditions
nausea and vomiting induced by pregnancy.
Vomiting of pregnancy, unspecified
Registration Number
IRCT2015020320923N1
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
90
Inclusion Criteria

Gestational age 6-16 weeks from LMP OR ultrasound ; Mild to moderate nausea and vomiting induced by pregnancy according to Rhodes index ; Single pregnancy with an alive and healthy fetus ; Without any GI diseases or other organs diseases ; Ability to read and write ; Age 20-35 years ; Not to have any allergy to herbal drugs.
Exclusion criteria: Severe nausea and vomiting that needs to be hospitalized; Not to have any tendency to continue use of herbal medicines; Other signs like diarrhea that show nausea and vomiting are pathological; Each disease which makes or increases nausea and vomiting; Allergy to Ginger or pyridoxin.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Duration of nausea. Timepoint: before intervention & 4days after started. Method of measurement: rhodes index (hour).;Frequency of nausea. Timepoint: before intervention & 4days after started. Method of measurement: Rhodes index(number).;Distress from retching. Timepoint: before intervention & 4days after started. Method of measurement: Rhodes index(score).;Frequency of retching. Timepoint: before intervention & 4days after started. Method of measurement: Rhodes index(number).;Vomiting distress. Timepoint: before intervention & 4days after started. Method of measurement: Rhodes index(score).;Amount of vomiting. Timepoint: before intervention & 4days after started. Method of measurement: Rhodes index ( CC).;Distress from nausea. Timepoint: before intervention & 4days after started. Method of measurement: Rhodes index(score).;Frequency of vomiting. Timepoint: before intervention & 4days after started. Method of measurement: Rhodes index (number).
Secondary Outcome Measures
NameTimeMethod
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