The Effect of Oral Capsule of hydro-alcoholic Extract of Red Onion (Allium cepa) on Blood Glucose in Women with Gestational diabetes mellitus under Diet Therapy
The Effect of Oral Capsule of hydro-alcoholic Extract of Red Onion (Allium cepa) on Blood Glucose in women with Gestational diabetes mellitus under Diet Therapy
Design
Phase 3 clinical trial with placebo group, A randomized, three -blind, parallel group of 82 pregnant women with gestational diabetes mellitus was selected as available.
Settings and conduct
Research units for women with gestational diabetes will be eligible to be referred to health centers in Mashhad. At the beginning of the study, and at the end of the second and fourth weeks, fasting blood glucose testing and two hours after a meal will be performed.
Participants/Inclusion and exclusion criteria
Conditions of entry: Persian and resident of Mashhad, maternal age between 35-18 years, single pregnancy, gestational age 30-24 weeks, gestational diabetes confirmed by tests and physicians, fasting blood sugar following 93 mg/dl and blood sugar two hours after meals below 120 mg/dl, serum glucose level fasting below 92 mg/dl L in the first pregnancy visit.
Non-entry conditions: lack of medical condition and midwifery problems, under the view of psychiatrists in the last 6 months and non-use of mental drugs, lack of sensitivity to onion or lyliase family, abnormal results of screening of abnormalities and sonography of fetal anomaly.
Intervention groups
The intervention group received oral capsules containing 500 mg of red onion extract and the placebo group received capsules containing 500 mg avicel twice daily for 4 weeks.
Main outcome variables
Fasting blood glucose and two hours after meals
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200224046607N1
Registration date:2020-03-29, 1399/01/10
Registration timing:prospective
Last update:2020-03-29, 1399/01/10
Update count:0
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Farzaneh Salajegheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
salajeghehtf971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Oral Capsule of hydro-alcoholic Extract of Red Onion (Allium cepa) on Blood Glucose in Women with Gestational diabetes mellitus under Diet Therapy
Public title
"Red Onion in Gestational diabetes mellitus"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality and resident in Mashhad
Has minimum literacy skills
Written consent to participate in the study
Phone number for urgent contact with yourself or family members
Pregnant mother age between 18-35 years
Single pregnancy
Gestational age 30-24 weeks
Gestational diabetes is confirmed by tests and a doctor
Fasting blood glucose test and two hours postprandial (to confirm treatment of gestational diabetes with post-OGTT impairment) fasting blood glucose below 93 mg / dl and two hours postprandial blood glucose below 120 mg / dl and confirmation of gestational diabetes control With a diet by a gynecologist
Fasting serum glucose levels below 92mg / dl at first pregnancy visit
Normal outcome of fetal malformation screening tests and fetal anomaly ultrasound
Exclusion criteria:
Addiction to psychotropic substances, stimulants, alcohol, tobacco and opioids
Having a medical condition
Having midwifery problems
Being a psychiatrist in the last 6 months and taking psychotropic drugs
Allergy to onions or Lilias family members
Preventive Speech and Behavioral Disorders Communication with Researcher
Age
From 18 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:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done using available sampling and random allocation through binary blocks created by random Allocation Software, using random number table www.randomization.com in two groups (intervention and control).In fact, randomization is performed using binary blocks AB(1) and BA(2), so that A is the intervention group and B is the placebo group. The method of concealment would be to provide sealed envelopes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the capsule of red onion extract and placebo, the researcher is provided with similar shapes and cans. Each box contains a code that the pharmacy consulting professor is aware of. Individuals with inclusion criteria are grouped according to the codes using a random number table. Therefore, by the end of the study, the researcher and the statistical analyst will not be aware of the codes for the red onion and placebo extract capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences-School of Nursing and Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street, mashhad university of medical sciences, iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2020-02-18, 1398/11/29
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.104
Health conditions studied
1
Description of health condition studied
Gestational Diabetes Mellitus
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
At baseline, 2 weeks and 4 weeks after intervention
Method of measurement
Intravenous Blood Test
2
Description
Blood glucose two hours after meals
Timepoint
At baseline, 2 weeks and 4 weeks after intervention
Method of measurement
Intravenous Blood Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Take the red onion extract capsule twice daily and in a 500 mg capsule half an hour after breakfast and lunch, with a 6 to 7 hour interval between meals and routine care including routine gestational diabetes training For 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: Take Avesil containing placebo (microcrystalline cellulose) capsules two times a day, and a 500-mg capsule half an hour after breakfast and lunch, with a 6 to 7-hour interval between meals and routine care including diet training The usual diet will get gestational diabetes for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 2 (Mofateh, Vahdat, Imam Hassan, Amir al-Momenin centers)
Full name of responsible person
Ali Asghar Mahmoudi
Street address
next to Vahdat park, Vahdat street, Five ways Down the street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١۵٣٩١٣١۵٣
Phone
+98 51 3368 3000
Email
M2HCenter@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
School of Nursing and Midwifery, Ibn Sina Street, mashhad university of medical sciences, iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
tafaghodim@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
100
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
Farzaneh salajegheh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street, mashhad university of medical sciences, iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
salajeghehtf971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Babazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street, mashhad university of medical sciences, iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
BabazadehR@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Salajegheh tezerji
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street, mashhad university of medical sciences, iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
salajeghehtf971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Documents are shared after they are unrecognizable.
When the data will become available and for how long
8 months after recording the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
All mothers with gestational diabetes and midwifery staff
From where data/document is obtainable
Email to address salajeghehtf971@mums.ac.ir
What processes are involved for a request to access data/document
Initially, an e-mail will be sent to the library of Mashhad School of Nursing and Midwifery, if not answered for up to one week.