To Study the Effects of Ashwagandha Capsule on Sexual Health in Healthy Wome
- Registration Number
- CTRI/2022/09/045890
- Lead Sponsor
- Ixoreal Biomed Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
1.Female participants between 18 to 55 years of age.
2.Female participants having regular menstrual periods who have Hypoactive Sexual Desire Disorder (HSDD) through Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV Sexual Desire Screening Questionnaire).
HSDD is defined as Persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activity ? along with marked distress or interpersonal difficulty ?
3.Participants with a baseline total score of 11 to 26 on the FSFI.
4.Participants with a baseline total score of 11 to 26on FSDS
5.Participants willing to try to have sexual intercourse regularly.
6.Participants in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 6 months prior to the Screening Visit.
7.Participant’s partner is expected to be physically present at least 50% of each month.
8.Participants who have used a medically acceptable method of contraception for at least 3 months before the baseline Visit (Visit 1) and continue to use that medically acceptable method of contraception during the trial.
9.Participants who are reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them as per investigator’s opinion.
10.Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
11.Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
12.Participants who are willing to have 4 or more attempts of sexual intercourse each month.
1.Participants who are not willing to take an investigational product.
2.Any acute illness which may hamper the study participation as per principal investigator discretion at the time of enrolment.
3.Participants having any clinically significant medical history, medical finding or an on-going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
4.Individuals participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements (for improving the sexual function during the 3 months prior to study commencement).
5.Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses).
6.Participants with current alcohol or drug addiction or with a history of drug dependence or abuse within the past one year.
7.Participants who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in Hypoactive Sexual Desire Disorder (HSDD) (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
8.Participants who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the Subjects response to treatment.
9.Participants who have entered the menopausal transition or menopause or have had a hysterectomy.
10.Participants with findings of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female genital organs, at the Screening Visit.
11.Participants who are breastfeeding or have breastfed within the last 6 months prior to the Baseline Visit.
12.Participants who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
13.Participants having primary hypoactive sexual desire.
14.Participants with a history of malignancy.
15.Participants who cannot cooperate to complete the subject records during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Female Sexual Function Index (FSFI)Timepoint: Baseline, 2 weeks, 4 weeks, 8 weeks
- Secondary Outcome Measures
Name Time Method Female Sexual Distress Scale (FSDS)Timepoint: Baseline, 2 weeks, 4 weeks, 8 weeks;Perceived Stress Scale (PSS-10)Timepoint: Baseline, 2 weeks, 4 weeks, 8 weeks;Quality of Life (SF-12 QoL)Timepoint: Baseline, 2 weeks, 4 weeks, 8 weeks;Satisfying Sexual Events (SSEs)Timepoint: Baseline, 2 weeks, 4 weeks, 8 weeks;Serum hormones (Estrogen-E2, Progesterone, FSH, LH, Prolactin, and Testosterone)Timepoint: Baseline, 8 weeks