CTRI Number	CTRI/2015/07/006045 [Registered on: 23/07/2015] Trial Registered Retrospectively
Last Modified On:	08/01/2014
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Ayurveda
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study	Study Of Ashwagandha (Withania somnifera)in Female Sexual Dysfunction
Scientific Title of Study	Efficacy Of KSM66 Ashwagandha (Withania Somnifera) In Improving the Female Sexual Function Index (FSFI) In Healthy Women with Female Sexual Dysfunction (FSD): A Prospective, Randomized, Placebo-controlled Study
Secondary IDs if Any Modification(s)	Secondary ID  Registry  KSM/FSD/Fem/04/2013 Version 1.0 dt. 03rd Aug. 2013   Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Swati Dongre  Address  Cosmos Paradise,Devdaya Nagar Pokharan Rd 2, 1and2 Link Road Cosmos Paradise,Devdaya Nagar Pokharan Rd 2, 1 and 2 Link Road Thane MAHARASHTRA 400606 India  Phone  02225856666   Fax  02225856567   Email  drswati@santatifertility.com
Details Contact Person Scientific Query	Name  Dr Swati Dongre  Address  Cosmos Paradise,Devdaya Nagar Pokharan Rd 2, 1and2 Link Road Cosmos Paradise,Devdaya Nagar Pokharan Rd 2, 1 and 2 Link Road Thane MAHARASHTRA 400606 India  Phone  02225856666   Fax  02225856567   Email  drswati@santatifertility.com
Details Contact Person Public Query	Name  Dr Swati Dongre  Address  Cosmos Paradise,Devdaya Nagar Pokharan Rd 2, 1and2 Link Road Cosmos Paradise,Devdaya Nagar Pokharan Rd 2, 1 and 2 Link Road Thane MAHARASHTRA 400606 India  Phone  02225856666   Fax  02225856567   Email  drswati@santatifertility.com
Source of Monetary or Material Support	Shri Kartikeya Pharma
Primary Sponsor	Name  Shri Kartikeya Pharma  Address  5-9-225, Sanali Estate, Abids, Hyderabad - 500001 Ph: (0091) 40-23204385 / 86 / 87  Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Swati Dongre  Trupti Hospital and Santati Fertility Center  Cosmos Paradise Devdaya Nagar Pokharan Rd 2 1 and 2 Link Road Thane   02225856666 drswati@santatifertility.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  InstitutionalEthicsCommitteeBharatiVidyapeethDeemedUniversityDentalCollege  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Female Sexual Dysfunction
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  KSM66(Ashwagandha)  One capsule(300 mg) twice daily orally for 8 weeks  Comparator Agent  Placebo  Placebo capsule identical to KSM 66 (Withania somnifera)(300 mg) but without active ingredients.One capsule twice daily orally for 8 weeks
Inclusion Criteria	Age From  21.00 Year(s) Age To  50.00 Year(s) Gender  Female  Details  1.Females between 21 to 50 years of age 2.Have been previously “functional” 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 <26 on the Female Sexual Function Index (FSFI) 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
ExclusionCriteria	Details  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 investigator’s opinion) interfere with the subject’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 Investigator’s opinion, would interfere with the subject’s ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Pre-numbered or coded identical Containers
Blinding/Masking	Double Blind Double Dummy
Primary Outcome	Outcome  TimePoints  Improvement from baseline in the total score and domain scores for Female Sexual Function Index (FSFI)   8 weeks
Secondary Outcome	Outcome  TimePoints  Improvement in the Female Sexual Distress Scale (FSDS)  8 weeks  Improvement in the sexual activity from baseline   8 weeks  Incidence of adverse events, either spontaneously reported by the patient, or noticed by the physician will be recorded during the trial   Day 1, week 4, week 8  Patients Global Assessment of Response to Therapy (PGART) on a 5-point scale of “Excellent response, Good response, Moderate response, Poor response& Worst response” will be assessed by the patients at the end of therapy  8 weeks  Patients Global Assessment of Tolerability to Therapy (PGATT) on a 5-point scale of “Excellent tolerability, Good tolerability, Moderate tolerability, Poor tolerability & Worst tolerability” will be assessed by the patients at the end of therapy  8 weeks
Target Sample Size	Total Sample Size="50" Sample Size from India="50"
Phase of Trial	Post Marketing Surveillance
Date of First Enrollment (India)	12/11/2013
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Open to Recruitment
Publication Details
Brief Summary	Experiencing problems with the sexual activities is being reported as the strongest and most consistent risk factor for women’s sexual distress in a number of studies. This study is planned to assess the efficacy of KSM66 Ashwagandha (Withania somnifera) in improving the female sexual function index (FSFI) in healthy women with female sexual dysfunction (FSD): A Prospective, Randomized, Placebo-controlled Study. In this study female patients between 21 to 50 years of age with Female Sexual Dysfunction (FSD) with baseline total score of <26 on the Female Sexual Function Index (FSFI),and baseline total score of >11 on the Female Sexual Distress Scale (FSDS) were enrolled. Study duration will be 8 weeks for each subject with baseline, week 4 & week 8 visits. Subjects were asked to take 2 capsules two times daily (total 4 capsules per day) with water daily for 8 weeks. At the end of study primary outcome will be assessed as improvement from baseline in the total score and domain scores for FSFI & secondary as improvement from baseline in the total score of sexual activity record (SAR) and FSDS. Global assessment by patient will be done at the end of study.