The Effect Of Consumption Of grape syrup,saffron and omani lemon(debs) on postpartum fatigue in hospitals of Shiraz University of Medical Sciences in 2022.
Assessing the effect of consumption Of grape syrup,saffron and omani lemon(debs) on postpartum fatigue
Design
Clinical trials with control group and with parallel groups, triple blind randomized, phase 2-3 on 100 people will be done using excel software for randomization
Settings and conduct
Sampling will be done in hospitals of Shiraz University of Medical Sciences.The study is triple blind.
Participants/Inclusion and exclusion criteria
1-Mothers aged 18-40 who are capable of participating in the study with their own satisfaction. 2- Mother and infant have no underlying diseases. 3- Mother should be primigravida and have basic literacy. 4-The infant should be full-term and singleton. 5- Infant should be between 2500-4000 gr. 6- Mother should not have abnormal bleeding after labor. 7- Mother should pass a low-risk pregnancy. 8- Mother’s BMI should be ≤30 (not be obese). 9- Delivery should not be difficult using vacuum or forceps. ; Exclusion criteria: 1- Mother’s severe postpartum bleeding.2-Possible sensitivity to syrup.3-not willing participants to continue the study.
Intervention groups
Intervention group: Active drug (grape, saffron, and Omani lemon syrup), control group: Placebo
Main outcome variables
postpartum fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200815048407N2
Registration date:2022-02-07, 1400/11/18
Registration timing:prospective
Last update:2022-02-07, 1400/11/18
Update count:0
Registration date
2022-02-07, 1400/11/18
Registrant information
Name
Mahboobe Mojtahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4223 6150
Email address
mojtahedi.mahboobe@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Consumption Of grape syrup,saffron and omani lemon(debs) on postpartum fatigue in hospitals of Shiraz University of Medical Sciences in 2022.
Public title
The Effect Of Consumption Of grape syrup,saffron and omani lemon(debs) on postpartum fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers are between 18-40 years old.
Mother and infant have no underlying diseases.
The infant should be full-term and singleton.
Infant should be between 2500-4000 gr.
Mother should not have abnormal bleeding after labor.
Mother’s BMI should be ≤30 (not be obese).
Mother should pass a low-risk pregnancy.
Delivery should not be difficult using vacuum or forceps.
Mother should be primigravida and have basic literacy.
Exclusion criteria:
Women with heavy postpartum bleeding.
Possible sensitivity to syrup
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize and allocate individuals to groups, random number function will be used. Randomization is as follow using excel software: first, groups will be entered in one column as A,B together; as the number of samples in each group has been defined as 50 (including sample drop), thus, B, A, should be entered in order and beneath. In the other column , using the command RAND , the random numbers are generated . In the next step, using the command sort, the generated random numbers will be organized ranging from lowest numbers to highest ones or vice versa, this will result a change in groups order as A, B. using the new order, individuals will be allocated to different groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is triple blind. This means that the researcher, participants, and statistic consultant will have no information about the drugs used by each group or each A or B syrup filled with which type of drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of assistance of research and technology of Shahid Beheshti University of Medical S
Street address
Niyayesh Intersection, Valiasre Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-09-11, 1400/06/20
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.496
Health conditions studied
1
Description of health condition studied
postpartum fatigue
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
postpartum fatigue
Timepoint
1,3,10,30,42 days after deliver
Method of measurement
Multidimensional Fatigue Assessment Questionnaire and Krap et al.'s Fatigue Intensity Scale Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: syrup contains grape juice,saffron and dried lime / each12 hours 10cc for 6 weeks / the syrups will be provided at School of Traditional Iranian Medicine of Shahid Beheshti University of Medical Sciences
Category
Treatment - Drugs
2
Description
Control group: placebo syrup /each 12 hours 10cc for 6 weeks/ the syrups will be provided at School of Traditional Iranian Medicine of Shahid Beheshti University of Medical Sciences
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospita
Full name of responsible person
Babak Hoseini
Street address
Abiverdi, Chamran Ave
City
Shiraz
Province
Fars
Postal code
71946-34786
Phone
+98 71 3647 9531
Email
Hafez@sums.ac.ir
2
Recruitment center
Name of recruitment center
Shoushtari hospital
Full name of responsible person
Mohammad Afarid
Street address
Enghelab (Nader) Ave.
City
Shiraz
Province
Fars
Postal code
7173775617
Phone
+98 71 3232 4806
Email
shoushtari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Homa Hajimahdipoor
Street address
Vali asr Ave
City
Tehran
Province
Tehran
Postal code
.
Phone
+98 21 8877 3521
Email
sitm@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobe Mojtahedi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
22Bahman Ave
City
Kazeroon
Province
Fars
Postal code
7317814494
Phone
+98 71 4223 6150
Email
mahboobemojtahedi72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Vali asr Ave
City
Tehran
Province
Tehran
Postal code
.
Phone
.
Email
tansaz_mojgon@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboobe Mojtahedi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
22 Bahman Ave
City
Kazeroon
Province
Fars
Postal code
7317814494
Phone
+98 71 4223 6150
Email
Mojtahedi.mahboobe@sbmu.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
.
When the data will become available and for how long
.
To whom data/document is available
.
Under which criteria data/document could be used
.
From where data/document is obtainable
.
What processes are involved for a request to access data/document