Comparing the effect of Crocus sativus with placebo in treatment of female sexual dysfunction
Design
Randomized placebo-controlled clinical trial
Settings and conduct
This randomized clinical trial will be conducted among women with sexual dysfunction attending Arash Hospital, Tehran, Iran and Imam Khomeini Hospital, Tehran, Iran in 2018-2019. The participants, physicians and evaluators will not know the grouping
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with sexual dysfunction; married with stable marriage; age between 18 to 45 years; ability to read and write; score 16 or less on FSFI Exclusion criteria: pregnancy; breastfeeding;menopause;any life threatening medical disease; depression; receiving medications affecting sexual desire and function including antidepressants, ASA and anticoagulants.
Intervention groups
Capsule Crocus sativus 15 mg BID for 6 weeks as intervention group
Main outcome variables
Severity of sexual dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N110
Registration date:2018-07-25, 1397/05/03
Registration timing:registered_while_recruiting
Last update:2018-07-25, 1397/05/03
Update count:0
Registration date
2018-07-25, 1397/05/03
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-22, 1397/04/31
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Crocus sativus on sexual dysfunction in female referred to Rouzbeh and Imam Khomeini Hospital
Public title
The effect of Crocus sativus on sexual dysfunction in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-40
Married woman with stable marriage
Having score 16 and less in Female Sexual Function Index
The ability of Reading and writing
Exclusion criteria:
Pregnancy or breastfeeding
Menopause
Any life threatening medical disease
Depression
Receiving medications affecting sexual desire and function( including antidepressants, aspirin, anticoagulants)
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
By computerized randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Similarity of placebo and medication. Participants, care provider and investigator are blinded in this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-07-14, 1397/04/23
Ethics committee reference number
IR.TUMS.VCR.REC.1397.223
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Severity of sexual dysfunction
Timepoint
Baseline and weeks 3 and 6
Method of measurement
By Female sexual Function Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Crocus sativus 15 mg BID for 6 weeks