Determination of the effect of rosa damasena flower capsule on the severity of depression and anxiety in menopausal women
Design
Clinical trial with blind, double blind, parallel, randomized, control group with a sample size of 110 patients who participated in intervention for 40 days.
Settings and conduct
Health centers affiliated to Shahid Beheshti University of Medical Sciences were randomly selected and then two centers were randomly selected. 110 people (55 in the intervention group and 55 in the control group) will be selected. For sealing the medicine, the capsule of rose in the envelope will be placed next to the placebo. For example, the envelope A contains 500 mg capsules of rose and B envelopes containing placebo capsules. The researcher and the units of the research are not codifying and that each envelope contains what drug. The simple random sampling method by coin tossing assigns the envelope A to the intervention centers and envelope B to the control centers.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range 60-45 yr. Having normal blood pressure, no history or history of breast, uterine, aneurysm and methotrexing, abnormal vaginal bleeding, liver disease, hyperthyroidism, lack of history of hysterectomy or ovariectomy, no physical or mental illness Known.
Non-compliance criteria:
Sensitization to herbal medicines, smoking and alcohol.
Intervention groups
The participants are 110 people. The intervention group is 55. The study examines the effect of rose capsule on depression and anxiety in these patients. The control group is 55 who are studying the effect of placebo on depression and anxiety.
Main outcome variables
Anxiety, Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190305042936N1
Registration date:2019-07-28, 1398/05/06
Registration timing:prospective
Last update:2019-07-28, 1398/05/06
Update count:0
Registration date
2019-07-28, 1398/05/06
Registrant information
Name
Qamar Riazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4447 8576
Email address
riazi.qamar2430@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rose (Rosa damascena) Capsule on the Severity of Depression and Anxiety in Menopausal Women
Public title
The effect of Rose (Rosa damascena) Capsule on the Severity of Depression and Anxiety in Menopausal Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal women aged 45-60 years
Having normal blood pressure
Not having a historyof BreastCancer, uterine, endometrial hyperplasia, abnormal vaginal bleeding, liver disease, hyperthyroidism
Not having a history of hysterectomy or ovariectomy
Not having physical (Diabet) or psychiatric illnesses
Do not use rose or dried rose extract
Exclusion criteria:
Sensitization to herbal medicines
Smoking and Alcohol
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Among the health centers affiliated to Shahid Beheshti University of Medical Sciences who are most referred to, two centers will be randomly selected. 110 people (55 in the intervention group and 55 in the control group) will be selected. In order to blow up the medicine, the rose capsule in the envelope will be placed adjacent to the placebo to relieve the scent of the roses to the placebo capsule. The investigator and the research units are not aware of the coding and the fact that each envelope contains any drug. Using a simple random sampling method by throwing a coin, a sealed envelope containing the drug will be assigned to one of the centers and another sealed envelope containing the placebo to the next center. Postmenopausal women, as a research sample, will be in one of the relevant groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blow up the medicine, the capsule of rose in the envelope will be placed in the immediate vicinity of the placebo to transfer some of the rosy smell to the placebo capsule. The drugs are encoded in the pharmacy department of Shahid Beheshti University of Medical Sciences. The researcher and the research units are not aware of the coding and the fact that each envelope contains the drug, and only the pharmacist advised of the encoding of the envelopes and the type of medication.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Valiasr Street
City
Tehran
Province
Tehran
Postal code
: 1985717443
Approval date
2019-04-15, 1398/01/26
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.033
Health conditions studied
1
Description of health condition studied
ِDepression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode , unspecifide
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Depression Score in Beck Questionnaire
Timepoint
Before the start of the study, 20 days later, 40 days later
Method of measurement
Beck questionnaire
2
Description
Anxiety Scale in the Spielberg Burner Questionnaire
Timepoint
Before the start of the study, 20 days later, 40 days later
Method of measurement
Spielberger questionnaire
Secondary outcomes
1
Description
Quality score
Timepoint
At the beginning of the study, 20 days later, 40 days after starting the dose.
Method of measurement
Quality of Life questionnaire
Intervention groups
1
Description
"Intervention group:" Menopausal women aged between 45-60 years old referred to Shahid Beheshti University of Medical Sciences, who received 1000 mg (two 500 mg capsules of rose, containing 500 mg of powdered dried rice with active ingredient (citronella) Vengerinol) take daily, twice, every 12 hours, in the morning and night after a meal for 40 days. "Control group: Menopausal women aged between 45-60 years old referring to Shahid Beheshti University of Medical Sciences 1000 mg (Two 500 mg starch capsules) every 12 hours, twice daily, morning and evening, after eating for 40 days. Capsules at the School of Pharmacy, University of Medical Sciences When is the martyr Beheshti prepared.
Category
Treatment - Drugs
2
Description
Control group: Menopausal women aged between 45-60 years old referring to Shahid Beheshti University of Medical Sciences 1000 mg (Two 500 mg starch capsules) every 12 hours, twice daily, morning and evening, after eating for 40 days. Capsules at the School of Pharmacy, University of Medical Sciences When is the martyr Beheshti prepared.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shobeir health center
Full name of responsible person
Qamar Riazi
Street address
Shobeir health center,Ghanbari St,Khorasan Square,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
riazi.qamar2430@gmail.com
2
Recruitment center
Name of recruitment center
Seraj health center
Full name of responsible person
Qamar Riazi
Street address
Seraj health center, Street Najafi Isfahani, Ordibehesht Blvd, Street Farjam,Tehranpars, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
riazi.qamar2430@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Faculty of Nursing and Midwifery, Shahid Behesti,Valiasr Street shti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
sbnmf@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
Qamar Riazi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti University of Medical Science-Valiasr St
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
riazi.qamar2430@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Simbar
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti University of Medical Science-Valiasr St
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
msimbar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Qamar Riazi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti University of Medical Science-Valiasr St
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
riazi.qamar2430@gmail.com
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