]>
IRCT20131009014957N9 IRCT 2020-03-14 Tabriz University of Medical Sciences The Effect of rose damascene oil and sesame oil on the prevention of striae gravidarum The Effect of rose damascene oil, sesame oil and placebo on the prevention of striae gravidarum in nulliparous women: A randomized controlled clinical trial 2020-06-14 anticipated 150 Complete https://irct.ir/trial/45576 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using a computerized random number table, taking into account blocks of size 6 and 9, with a 1: 1: 1 allocation ratio, Blinding description: Since the drugs (medications) will be prepared in similar tubes; participant, researcher, clinical caregiver and intervention analyst will not be aware of the content of the tubes. 3 Pregnancy striae. Intervention 1: Intervention group 1: Rose damascene oil. The 10% rose damascene oil at the base of the cream will be produced by a pharmacognosist at the Biotechnology Research Center and it will be supplied in the numbered, identical size and color tubes . The drug will be applied topically twice daily to the abdomen without rubbing, from 16th to 20th week of gestation for 20 weeks. Intervention 2: Intervention group 2: Sesame Oil. The 10% sesame oil at the base of the cream will be produced by a pharmacognosist at the Biotechnology Research Center and it will be supplied in the numbered, identical size and color tubes . The drug will be applied topically twice daily to the abdomen without rubbing, from 16th to 20th week of gestation for 20 weeks. Intervention 3: Control group: placebo. Base cream (stearic acid) as placebo will be produced by a pharmacognosist at the Biotechnology Research Center and it will be supplied in the numbered, identical size and color tubes . The drug will be applied topically twice daily to the abdomen without rubbing, from 16th to 20th week of gestation for 20 weeks. Yes - There is a plan to make this available What will be shared: Part of the outcome data is published When: 6 months after printing the results To whom: Researchers at institutions have access to data Conditions: To help with scientific progress in the field of research Where to obtain: farshbafa@tbzmed.ac.ir How to obtain: Scientific approval of applicant by Tabriz University of Medical Sciences Comments:
public Azizeh Farshbaf-khalili
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2295 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Azizeh Farshbaf-khalili
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2295 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Gestational age of 16-20 weeks Having a single live fetus Nulliparity Being at the age of 18-35 years Body mass index of 18.5-25 kg /m2 Being literate (at least writing and reading skills) 18 years 35 years Female The use of other herbal or chemical drugs on the affected area Sensitivity to rose oil and sesame oil and not being able to use the drug twice daily Taking corticosteroids previous striae Surgical scar on the abdomen Having chronic diseases Having adrenal glands diseases Presence of skin disease L99 Other disorders of skin and subcutaneous tissue in diseases classified elsewhere Prevention Prevention Placebo Intervention group 1: Rose damascene oil. The 10% rose damascene oil at the base of the cream will be produced by a pharmacognosist at the Biotechnology Research Center and it will be supplied in the numbered, identical size and color tubes . The drug will be applied topically twice daily to the abdomen without rubbing, from 16th to 20th week of gestation for 20 weeks. Intervention group 2: Sesame Oil. The 10% sesame oil at the base of the cream will be produced by a pharmacognosist at the Biotechnology Research Center and it will be supplied in the numbered, identical size and color tubes . The drug will be applied topically twice daily to the abdomen without rubbing, from 16th to 20th week of gestation for 20 weeks. Control group: placebo. Base cream (stearic acid) as placebo will be produced by a pharmacognosist at the Biotechnology Research Center and it will be supplied in the numbered, identical size and color tubes . The drug will be applied topically twice daily to the abdomen without rubbing, from 16th to 20th week of gestation for 20 weeks. Incidence rate of gestational striae. Timepoint: Evaluation of incidence in 35-37 weeks of gestation. Method of measurement: Davey method. Incidence rate of itching. Timepoint: The incidence of pruritus in 35-37 weeks of gestation. Method of measurement: Kamini method. Severity of gestational striae. Timepoint: Evaluation of severity of striae in 35-37 weeks of gestation. Method of measurement: Davey method. Severity of itching. Timepoint: Evaluation of severity of pruritus in 35-37 weeks of gestation. Method of measurement: Kamini method. Satisfaction of medication use. Timepoint: 35-38 weeks of gestation. Method of measurement: Satisfaction Questionnaire. Side effects. Timepoint: 35-38 weeks of gestation. Method of measurement: Side effects Questionnaire. Tabriz University of Medical Sciences Approved 2020-02-03 Ethics committee of Tabriz University of Medical Sciences Nutrition Research Center, Tabriz University of Medical Sciences; Attar Neishabouri avenue, Golgasht Tabriz East Azarbaijan Iran (Islamic Republic of)