IRCT20221017056213N1RecruitingPhase 3
Evaluation of the effect of oral traditional Persian medicine product of silk (Bombyx mori L. Cocoon), on sexual dysfunction and Quality of Life in women of reproductive age, compare with placebo. a triple-blind randomized clinical trial
Ghoum University of Medical Sciences0 sites74 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 74
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 50 years (—)
- Sex
- Female
Inclusion Criteria
- •Women aged 18-50 years
- •The woman being married and her husband being monogamous
- •FSFI women's sexual function index score<28 in the initial evaluation
- •Ability to read, understand and complete the questionnaire
- •People with BMI less than 30
- •Having informed consent to enter the study
Exclusion Criteria
- •pregnancy and breastfeeding
- •delaying menstruation for 2 months or more
- •significant clinical findings in physical examination, screening tests or other findings that prevent safe participation in the study, including the presence of any organic, anatomical disease (such as malformation of the anatomy of the external genitalia, spinal cord injuries or related surgery), hormonal in the study group such as diabetes, cerebrovascular disease, liver and kidney function damage, heart disease, hypothyroidism, cancers in history and medical history of psychiatric diseases that are under drug treatment.
- •receiving psychotherapy or other treatments for sexual dysfunction
- •using tobacco, alcohol, drug abuse
- •using any chemical and herbal medicine known to affect libido
- •being participate in another clinical trial study
- •major changes in recent relationships, ongoing or unforeseeable disorder or disturbance that is not related to his sexual dysfunction.
Investigators
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