“Cydonia Oblonga” fruit or “Quince” is used for treatment of nausea and vomiting of pregnancy in Iranian Traditional Medicine. This clinical trial has been designed to assess this effect and compare “Cydonia Oblonga” with Vit-B6 in treatment of mild to moderate nausea and vomiting during pregnancy. The study population are 90 pregnant women aging 18- 40 years at 6-14 weeks of pregnancy, with pregnancy induced nausea and vomiting without any secondary causes. They will be assigned to two groups with Simple random sampling. Group I receives a product from “Quince” in the form of syrup consuming 1 table spoon three times a day before meals for one week and Group II receives 20mg Vitamin B6 pills, three times a day before meals for one week. General information and current and previous pregnancies information, their history of nausea, vomiting and retching in pregnancy, the severity of their nausea, vomiting and retching, and a history of other diseases will be collected. PUQE (The Pregnancy-Unique Quantification of Emesis scale) is used to assess the symptoms before and one week and two weeks after interventions. A Visual Analogue Scale is used to assess the severity of symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012081110559N1
Registration date:2013-03-03, 1391/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-03, 1391/12/13
Registrant information
Name
Efat Jafari Dehkordi
Name of organization / entity
Faculty of Traditional Medicine, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5515 2192
Email address
e-jafarid@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medical Sciences 2- Research Institute for Islamic and Complementary Medicine, Tehran University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-08-19, 1392/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of "Cydonia Oblonga" fruit product with B6 on nausea and vomiting in pregnancy
Public title
Effect of "Cydonia Oblonga" fruit on nausea and vomiting in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-40 years, gestational age 6-14 weeks, singleton pregnancy with live fetus based on ultrasound, mild to moderate nausea and vomiting of pregnancy (13 > score of PUQE 24 Questionnaire ≥ 6)
Exclusion criteria: severe nausea and vomiting during pregnancy that may require fluid therapy and hospitalization, nausea and vomiting of pregnancy by secondary causes: peptic ulcer, hepatitis, pyelonephritis, pancreatitis, cholecystitis, appendicitis, gastroenteritis, UTI, CNS disorders, gasteroesophageal reflux disease, hyperthyroidism, multiple pregnancy, ectopic pregnancy, mole, presence of pregnancy complications such as bleeding, threatened abortion, history of chronic disease, history of drug addiction, alcoholism and smoking, history of drug allergy, and at least 48 hours before presentation anti- nausea medication (B6, Metoclopramide, etc.) are not used
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will conducted by the table of random number
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Research Institute for Islamic and Complementary Medicine, (Tehran Universit
Street address
No: 9, Pirnia Alley, Lalehzar St., Jomhury Ave., Tehran, Iran Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
Approval date
2012-10-09, 1391/07/18
Ethics committee reference number
733/ط م/ 26 پ
Health conditions studied
1
Description of health condition studied
Nausea and vomiting induced by pregnancy
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
Nausea
Timepoint
Before, one week and two weeks after intervention
Method of measurement
PUQE 24 hours Questionnaire and VAS (Visual Analogue Scale)
2
Description
Vomiting
Timepoint
Before, one week and two weeks after intervention
Method of measurement
PUQE 24 hours Questionnaire and VAS (Visual Analogue Scale)
3
Description
Retching
Timepoint
Before, one week and two weeks after intervention
Method of measurement
PUQE 24 hours questionnaire and VAS (Visual Analogue Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: syrup of Quince fruit, 1 table spoon three times a day before meals for one week
Control: Vitamin B-6 20 mg tablet three times daily before meals for one week
Category
Treatment - Drugs
2
Description
control: Vitamin B-6 20 mg tablet three times daily before meals for one week