Health Condition 1: null- Female Sexual Dysfunction
Conditions
Interventions
Intervention1: KSM66(Ashwagandha): One capsule(300 mg) twice daily orally for 8 weeks
Control Intervention1: Placebo: Placebo capsule identical to KSM 66 (Withania somnifera)(300 mg) but without activ
Sponsors
Shri Kartikeya Pharma
Eligibility
Inclusion criteria
Inclusion criteria: 1.Females between 21 to 50 years of age 2.Have been previously â??functionalâ?? or experienced sexual desire/arousal/orgasm for several years in the past 3.Have a stable heterosexual relationship with a male partner for at least 1 year 4.Have a male partner with a score of "not impotent" or "minimally impotent" on the Single-Question, Self-report of Erectile Dysfunction (Massachusetts Male Aging Study) 5.Meet the diagnostic criteria for Female Sexual Dysfunction (FSD) for any one or more of the following disorder: a.Hypoactive sexual desire disorder (HSDD) b.Female sexual arousal disorder (FSAD) c.Female orgasmic disorder (FOD) d.Combined genital and subjective arousal disorder e.Genital sexual arousal disorder 6.Have a baseline total score of 7.Have a baseline total score of >11 on the Female Sexual Distress Scale (FSDS) 8.Willing to engage in sexual activities with intent to attain orgasm at least 2 times per week 9.Provide written informed consent 10.Willing and able to understand and comply with all study requirements
Exclusion criteria
Exclusion criteria: 1.Evidence of unresolved sexual trauma or abuse 2.Primary anorgasmia, vaginismus, sexual pain disorder (dyspareunia), sexual aversion disorder, or persistent sexual arousal disorder 3.Chronic dyspareunia not attributable to vaginal dryness within previous 12 months 4.Female sexual dysfunction (FSD) caused by untreated endocrine disease, e.g.hypopituitarism, hypothyroidism, diabetes mellitus 5.Pregnant or lactating 6.Hypersensitivity to Ashwagandha 7.Chronic or complicated urinary tract or vaginal infections within previous 12 months 8.Pelvic inflammatory disease within previous 12 months 9.Currently active sexually transmitted disease 10.Currently active moderate to severe vaginitis 11.Cervical dysplasia within previous 12 months 12.Significant cervicitis as manifested by mucopurulent discharge from the cervix 13.Significant gynecologic conditions such as uterine fibroids, vulvar vestibulitis, or vaginismus that may (in the investigatorâ??s opinion) interfere with the subjectâ??s ability to comply with study procedures 14.Psychoses and bipolar disorder 15.Use of neuroleptics or lithium within previous 3 months 16.Unwillingness to forego any medications, herbal treatments, or dietary supplements intended to enhance sexual function during the course of the study 17.History of myocardial infarction within previous 6 months 18.History or evidence of significant renal or hepatic disease within previous 6 months 19.Significant central nervous system diseases within the last 6 months, i.e., stroke, spinal cord injury, multiple sclerosis, etc. 20.Unwillingness to omit cunnilingus (use by a sex partner of the mouth, lips, and tongue to stimulate the females clitoris or other parts of the vulva or vagina) from sexual activities during the study 21.Unwillingness to avoid post-coital fellatio (act of oral stimulation of the penis by a sexual partner) 22.Any condition which, in the Investigatorâ??s opinion, would interfere with the subjectâ??s ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement from baseline in the total score and domain scores for Female Sexual Function Index (FSFI) Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the Female Sexual Distress Scale (FSDS)Timepoint: 8 weeks;Improvement in the sexual activity from baseline Timepoint: 8 weeks;Incidence of adverse events, either spontaneously reported by the patient, or noticed by the physician will be recorded during the trialTimepoint: Day 1, week 4, week 8;Patients Global Assessment of Response to Therapy (PGART) on a 5-point scale of â??Excellent response, Good response, Moderate response, Poor response& Worst responseâ?? will be assessed by the patients at the end of therapyTimepoint: 8 weeks;Patients Global Assessment of Tolerability to Therapy (PGATT) on a 5-point scale of â??Excellent tolerability, Good tolerability, Moderate tolerability, Poor tolerability & Worst tolerabilityâ?? will be assessed by the patients at the end of therapyTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Swati Dongre
Trupti Hospital and Santati Fertility Center
Outcome results
None listed