The aim of this study was to determine the effect of Green tea, Sesamum indicum L and Corylus avellans L on prevention striae gravidarum in nuliparus women. This study was a clinical trial, single center, double blinded, with random allocation. The population of the study was the eligible nuliparus women referred to reproductive health clinic of Hajar Hospital in Shahrekord who were excluded if they had hepatic diseases, allergy to herbal components, termination of pregnancy and use of glucocorticoid drugs during the study period. With a randomly allocation, 150 nuliparus women were allocated in five different groups (30 in each group). The women in intervention groups used cream or base of cream twice a day in different area of abdomen, buttocks, thigh and breast. The women in control group did not use any cream or other substances in order to striae prevention. The intervention was initiated in 20 weeks of gestation and continued until 32 weeks of gestation. The severity of striae gravidarum was evaluated at the beginning of the study, thirty-Sixth weeks of pregnancy and after delivery (until two weeks).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606192085N18
Registration date:2016-06-30, 1395/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-30, 1395/04/10
Registrant information
Name
Neda Parvin
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5652
Email address
nedali285@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2012-12-30, 1391/10/10
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Green tea, Sesamum indicum L and Corylus avellans L cream on prevention striae gravidarum in nuliparus women
Public title
Effect of Green tea, Sesamum indicum L and Corylus avellans L cream on prevention striae gravidarum in nuliparus women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age of 20 weeks, singleton, aged 18 to 35 years old
Exclusion criteria: Hepatic or systemic diseases, allergy to herbal components, termination of pregnancy, use of glucocorticoid drugs during the study period, lack of follow up
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was performed using a box containing five balls with different colors and bring out the random balls.Each color was assigned to a specific group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Approval date
2012-12-30, 1391/10/10
Ethics committee reference number
10-10-91
Health conditions studied
1
Description of health condition studied
Striae gravidarum
ICD-10 code
L90.6
ICD-10 code description
Striae atrophicae
Primary outcomes
1
Description
Severity of striae gravidarum
Timepoint
At the twentieth and thirty-Sixth weeks of pregnancy and after delivery (until two weeks)
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Sesamum indicum L cream group: In this group, the Sesamum indicum L cream 10% were used twice a day during the intervention period in different area of abdomen, buttocks, thigh and breast.
Category
Treatment - Drugs
2
Description
Corylus avellans L cream group: In this group, the Corylus avellans L cream 5% were used twice a day during the intervention period in different area of abdomen, buttocks, thigh and breast.
Category
Treatment - Drugs
3
Description
Green tea cream group: In this group, the green tea cream 3% were used twice a day during the intervention period in different area of abdomen, buttocks, thigh and breast.
Category
Treatment - Drugs
4
Description
Cream base group: In this group, the base of cream were used twice a day during the intervention period in different area of abdomen, buttocks, thigh and breast.
Category
Treatment - Drugs
5
Description
Control group: The patients in this group did not use any substance for prevention of striae.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Reproductive health clinic of Shahrekord Hajar Hospital
Full name of responsible person
Neda Parvin
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr.Sayed Kamal Solati
Street address
Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38333335652
Fax
Email
np285@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38333335652
Fax
Email
np285@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38333335652
Fax
Email
np285@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)