Determination of the Effect of Consumption of Calendula, Chamomile, Geranium, Cocoa and Soybean bean on Streams of Pregnancy in Pregnant Women
Design
Randomized controlled trial phase 3, the Parallel-group with the triple blinded. 140 pregnant nulliparous women. Simple randomization.
Settings and conduct
The research site will be Mashhad health centers. The study is triple blind and parallel controlled clinical trials. In this study, the participants, the researchers and the person who performs the analysis of results will be blinded.
Participants/Inclusion and exclusion criteria
Pregnant nullipara women, Gestational Age range 14-16 week, Age range 20-35 year, BMI range 18.5-25 Kg/m2, No smoking, Not having any chronic diseases (Cardiovascular, Hypertension, diabetes, ...)
Intervention groups
Intervention group: use of topically-applied herbal cream twice a day in four regions of the abdomen
Control group: Use of placebo cream twice a day in four regions of the abdomen
Main outcome variables
The number, severity, and size of gravidarum steriae
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180926041143N1
Registration date:2019-01-02, 1397/10/12
Registration timing:registered_while_recruiting
Last update:2019-01-02, 1397/10/12
Update count:0
Registration date
2019-01-02, 1397/10/12
Registrant information
Name
Somayeh Alirezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3501 2276
Email address
alirezaeis961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-06, 1397/07/14
Expected recruitment end date
2019-04-03, 1398/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topically-applied combined herbal cream on prevention of Striae gravidarum in nulligravida women
Public title
The effect of topically-applied combined herbal cream on Striae gravidarum in nulligravida women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant nullipara women Gestational Age range 14-16 week Age range 20-35 year BMI range 18.5-25 Kg/m2 No smoking Not having any chronic diseases (Cardiovascular, Hypertension, diabetes, ...)
Exclusion criteria:
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be based on simple randomization. The method used to randomize will be a random number table. To hide random assignments, numbered drug containers with random number sequences will be used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
For the primary blindness of the study, since the possibility of sampling is different between the two groups, pregnant women have no knowledge of the contents of the cans in the other group. The second stage of blinding is that the researcher's assistance in the field of training and delivery of cans does not have the information on the type of the groups and the contents of the cans, and only records the cans in the sample form when the code is delivered. The next steps are to get the worm by the manufacturer to fit the group that belongs to him. The final stage of blindness is in relation to the individual who will analyze the results. She is also unaware of the groups and intervention. The research team leader will only decode the codes after analyzing the results.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Num 18, Daneshgah Ave, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
38412081
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.040
Health conditions studied
1
Description of health condition studied
Steriae Gravidarum
ICD-10 code
ICD-10 code description
ster
Primary outcomes
1
Description
The number, Severity and Size of Steriae Geravidarum based on Atwal Scoring
Timepoint
Evaluation of Steriae Gravidarum at 27-30 and 38-40 of Gestational Age
Method of measurement
The numerical scoring system of Atwal
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Herbal cream consisting of Calendula, Chamomile, Geranium, Cocoa and soybean seeds on pregnancy stretch from 14-16 weeks of gestation in primiparous women, twice daily by 0.3 grams or a half teaspoon in all four areas From the body, including 1. Separate the umbilicus to the symphysis pubis 2. Immediately above the umbilical in the transverse direction, 3. The right side in the longitudinal direction, 4. The left side, in the longitudinal direction, and massage gently, until the end of pregnancy. This herbal cream is made by Tus Amithis Ariaia company, under the supervision of the Center for the Growth of the Buali Institute in Mashhad.
Category
Prevention
2
Description
Control group: Placebo cream consisting of Calendula, Chamomile, Geranium, Cocoa and soybean seeds on pregnancy stretch from 14-16 weeks of gestation in primiparous women, twice daily by 0.3 grams or a half teaspoon in all four areas From the body, including 1. Separate the umbilicus to the symphysis pubis 2. Immediately above the umbilical in the transverse direction, 3. The right side in the longitudinal direction, 4. The left side, in the longitudinal direction, and massage gently, until the end of pregnancy. This herbal cream is made by Tus Amithis Ariaia company, under the supervision of the Center for the Growth of the Buali Institute in Mashhad.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center 1 mashhad
Full name of responsible person
Somayeh Alirezaei
Street address
Between 66th & 68th Vakil Abad, Vakil Abad Ave, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9179793945
Phone
+98 51 3501 8011
Email
hc1.pr@mums.ac.ir
2
Recruitment center
Name of recruitment center
Health center 3 Mashhad
Full name of responsible person
Somayeh Alirezaei
Street address
Payam St, Ershad 8 Ave, Khayam Bldv, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3763 4007
Email
ch3.pr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Num 18, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
38430249
Phone
+98 51 3841 2081
Fax
Email
vsresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Somayeh Alirezaei
Position
PhD Student of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery, School of Nursing & Midwifery, Mashhad University of Medical Sciences, Ebn Sine St, Daneshgah Ave, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
38528512
Phone
+98 51 3852 8512
Email
Alirezaeis961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Somayeh Alirezaei
Position
PhD Student of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ebn Sina St, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51338591511
Email
Alirezaeis961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Somayeh Alirezaei
Position
PhD Student of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ebn Sina St, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51338591511
Email
Alirezaeis961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
So far, there is no definite program and protocol in Mashhad University of medical sciences.