Determining the effect of saffron herbal tea on the happiness of postmenopausal women
Design
Clinical trial with control group, with parallel groups, one-sided, randomized, phase 3 on 72 postmenopausal women. The randomized blocks method will be used for randomization.
Settings and conduct
Study place: Health centers will be under the supervision of Larestan University of Medical Sciences. The research assistant will select eligible postmenopausal women by referring to the selected health center through available sampling. In the random allocation phase, the researcher will not know about the assignment of individuals to groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Samples are willing to participate in research voluntarily.
2. Volunteers do not suffer from acute psychosis, chronic and debilitating diseases and cognitive diseases such as dementia and They have also not been treated similarly recently.
3. Candidates should be familiar with Persian language.
4. Candidates should not participate in other treatment programs that interfere with the present study.
5. Candidates should be able to swallow and have no oral or digestive problems that interfere with drinking.
Exclusion criteria:
1. Occurrence of any social, family crisis during the study
2. Hospitalization or acute and chronic illness that interferes with research.
3. History of allergy to herbal medicines
4. Addiction to drugs and alcohol and painkillers
5. Taking psychiatric drugs
Intervention groups
The intervention group includes postmenopausal women who receive 30 mg of saffron herbal tea with candy in 300 ml of boiling water daily.
The control group includes postmenopausal women who receive 300 ml of warm water with candy daily.
Main outcome variables
happiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210403050818N1
Registration date:2021-04-09, 1400/01/20
Registration timing:prospective
Last update:2021-04-09, 1400/01/20
Update count:0
Registration date
2021-04-09, 1400/01/20
Registrant information
Name
Hamed Delam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5224 7110
Email address
h.delam@larums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-07-01, 1400/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Crocus sativus (saffron) herbal tea on happiness in postmenopausal women: A randomized clinical trial
Public title
The effect of Crocus sativus (saffron) herbal tea on happiness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Samples are willing to participate in research voluntarily.
Volunteers do not suffer from acute psychosis, chronic and debilitating diseases and cognitive diseases such as dementia and They have also not been treated similarly recently.
Candidates should be familiar with Persian language.
Candidates should not participate in other treatment programs that interfere with the present study.
Candidates should be able to swallow and have no oral or digestive problems that interfere with drinking.
Exclusion criteria:
Occurrence of any social, family crisis during the study
Hospitalization or acute and chronic illness that interferes with research.
History of allergy to herbal medicines
Reluctance of the samples to continue participating in the research
Addiction to drugs and alcohol and painkillers
Taking psychiatric drugs
Age
From 47 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block methods are used to randomly assign participants to intervention and control groups. The selected samples are placed in each of the intervention groups or the control group according to the randomized blocks according to the inclusion in the study. Thus, according to the sample size of this study, which is estimated at 72 people, 9 blocks of 8 are used. Each block consists of cells A and B. According to the previous agreement, cell A will belong to the intervention group and cell B will belong to the control group. At this stage, the researcher who assigns individuals to the intervention and control group will not know the type of allocation. This means that in each block, 4 people are in the intervention group and 4 people are in the control group. Sampling continues until 9 blocks are completed. Finally, 36 people in each group are selected in randomized blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Larestan University of Medical Sciences
Street address
North Ghadir Boulevard, Karmandan Street, behind Larestan Grand Bazaar
City
Larestan
Province
Fars
Postal code
7431889629
Approval date
2021-03-01, 1399/12/11
Ethics committee reference number
IR.LARUMS.REC.1399.017
Health conditions studied
1
Description of health condition studied
Happiness score in postmenopausal women
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes
Primary outcomes
1
Description
Happiness
Timepoint
Measurement of happiness score before intervention and 2 weeks after intervention
Method of measurement
Oxford Happiness Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention will involve the use of 30 mg of dried stigmas of the saffron plant, which are boiled once in the morning (in 300 ml of boiling water for 10-15 minutes).And with candy, it will be consumed daily in the form of 1 cup of saffron herbal tea. Patients will be instructed to use the drug completely and at the same time avoid using other herbs. According to previous research, the duration of this intervention will be 2 weeks. According to the results of previous studies, the maximum safe daily dose of saffron is 1.5 grams, so it is expected that the dose in the present study does not cause side effects. The subjects of the intervention group will receive the number of their drinks (30 mg teabags) for the whole study period (2 weeks) as soon as they enter the study, to monitor the consumption of saffron in the intervention group, according to the previous agreement and maintaining the confidentiality of information. The group will be contacted daily (up to two weeks) and the process of saffron consumption will be evaluated.
Category
Treatment - Drugs
2
Description
Control group: A glass of hot water and candy is provided daily for the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Larestan University of Medical Sciences
Full name of responsible person
Hamed Delam
Street address
North Ghadir Boulevard, Karmandan Street, behind Larestan Grand Bazaar
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
h.delam@larums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Meghdad Abdollahpour AliTappeh
Street address
North Ghadir Boulevard, Karmandan Street, behind Larestan Grand Bazaar
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
h.delam@larums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
Hamed Delam
Position
عضو هیئت علمی
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
North Ghadir Boulevard, Karmandan Street, behind Larestan Grand Bazaar
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
h.delam@larums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Hamed Delam
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahr-e Jadid - North Ghadir Boulevard, Karmandan Street - behind Larestan Grand Bazaar, Fars, Larestan, Iran
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5224 7110
Fax
+98 71 5224 7111
Email
h.delam@larums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Hamed Delam
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahr-e Jadid - North Ghadir Boulevard, Karmandan Street - behind Larestan Grand Bazaar, Fars, Larestan, Iran
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5224 7110
Fax
+98 71 5224 7111
Email
h.delam@larums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available