Evaluating the Efficacy of Cinnamunum Tamala on decreased libido , in SSRI induced sexual dysfunction(libido) in patients with neurologic and psychotic disorders
Evaluating the Efficacy of Cinnamunum Tamala on decreased libido , in SSRI induced sexual dysfunction(libido) in patients with neurologic and psychotic disorders
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site. on 64 patients
Settings and conduct
in two intervention and control groups , we enter them, we ask about the level of sexual desire According to the Arizona Standard Questionnaire, (questionnaires are numbered for randomization and are given by the doctor to people so that the interventionist is blind ) and we give people A a continuation of the SSRI and a capsule containing Cinnamomum Tamala, and we give a continuation of the SSRI and a capsule apparently similar to the previous group, which is a placebo, to people B. During 8 weeks, we will follow them and after that we will again ask about the level of their sexual desire according to the questionnaire and then we will check the effectiveness of the medicine.
Participants/Inclusion and exclusion criteria
include criteria: history of taking SSRI drugs and consuming now and complaining of decreased libido after starting to taking SSRIs.
women in in childbearing ages (adults , non-menopaused , female)
being married ( having regular intercourse )
completing consent forms.
exclude criteria:
pregnancy and breast feeding
allergy to cinnamon contents
chronic metabolic disorders and taking cardiac drugs and anti diabetic agents and anti-hypertension drugs and anti-coagulants and etc.
addiction and smoking and alcohol abusers.
Intervention groups
intervention group receiving Cinnamomum Tamala capsules
control group receiving placebo ( null flour)
Main outcome variables
libido
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240813062746N1
Registration date:2024-08-21, 1403/05/31
Registration timing:prospective
Last update:2024-08-21, 1403/05/31
Update count:0
Registration date
2024-08-21, 1403/05/31
Registrant information
Name
Marziye Bayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 297 5817
Email address
parisa.bayat9372@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Efficacy of Cinnamunum Tamala on decreased libido , in SSRI induced sexual dysfunction(libido) in patients with neurologic and psychotic disorders
Public title
Evaluating the Efficacy of Cinnamunum Tamala on decreased libido , in SSRI induced sexual dysfunction(libido) in patients with neurologic and psychotic disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Taking one of SSRI drugs at least for one month ,
decreased libido after taking SSRI drugs ,
being married ,
consent
Exclusion criteria:
metabolic disorders ,
taking drugs such as anti-hypertension, anti-coagulant , anti-diabetic and cardiac
pregnancy
breastfeeding mothers
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
By online block randomization software Block and cluster randomization will be done. Using the software, codes A and B will be generated, where code A means applying the Cinnamomum Tamala group and code B means applying the control group (placebo) for each block of 2 to 3. Finally, the codes will be placed in a sealed envelope and the number of each questionnaire will be written on the envelope (1 to 46). After the arrival of each patient, the doctor will open the envelope and apply the desired treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
drug cans containing original drugs and placebo are same in shape and color and every details. the person who allocates every questionnaire to each drug or placebo can is different from the person who gives the drug can to patients. drugs are given to patients by phycologist . the researcher does not interfere this process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran university of medical sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-08-13, 1403/05/23
Ethics committee reference number
IR.IUMS.REC.1403.399
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
2
Description of health condition studied
adverse effect of SSRIs
ICD-10 code
Y49.2
ICD-10 code description
Y49.2Other and unspecified antidepressants
3
Description of health condition studied
sexual dysfunction due to taking SSRI drugs
ICD-10 code
F13
ICD-10 code description
Sedative, hypnotic, or anxiolytic related disorders
Primary outcomes
1
Description
libido
Timepoint
at begin and after 8 weeks
Method of measurement
Arizona questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: taking 500 mg of dried leaves of Cinnamomum Tamala in powdered form ( 30 capsules in every can ) , provided from herbal plants market and total microbial count tested in food and drug laboratory . it is prescribed twice daily after breakfast and lunch for 8 weeks. with standard treatment ( SSRI)
Category
Treatment - Drugs
2
Description
Control group: placebo ( null flour)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Marziye Bayat
Street address
Imam Khomeini hospital . Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1625
Email
parisa.bayat9372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research group of school of traditional medicine of Iran university of medical sciences