CTRI/2025/01/078901尚未招募不适用
Efficacy and Safety of Single Dose (600 mg) Ashwagandha Root Extract on Sexual Health in Healthy Women: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean change in FSFI scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 2), Visit 3 (Week 4) to Visit 4- End of study (Week 8) in healthy women
研究概览
简要总结
â— All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.
â— Subjects will be informed about the purpose of the study and signed informed consent will be taken.
◠Blood sampling for serum E2, FSH, LH, Prolactin, Testosterone and Progesterone hormone levels will be done at Screening/Baseline Visit and End of Study Visit (Week 8 ± 3).
â— Efficacy assessments mentioned above will be done appropriately during the study.
All Subjects will be followed-up during the study period (Screening /Baseline- Day 1, Week 2 ± 3 days, Week 4 ± 3 days, and Week 8 ± 3 days till the complete course of treatment)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female participants between 18 to 55 years of age.
- •2.Participants with a baseline total score of 1 to 26 on the FSFI.
- •3.Participants with a baseline total score of 1 to 26 on FSDS.
- •4.The participants should inform their partner about the study.
- •5.Her partner should be willing to let her participate in the study.
- •6.Participants are willing to try to have sexual intercourse regularly.
- •7.Participants in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 6 months prior to the Screening Visit.
- •8.Participant’s partner is expected to be physically present at least 50% of each month.
- •9.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.
- •10.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.
- •11.Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
- •12.Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
- •13.Participants who are willing to have 4 or more attempts of sexual intercourse each month.
排除标准
- •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 exist 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 indicate that their sexual partner has inadequately treated sexual problems that could interfere with the Subjects response to treatment.
- •8.Participants who have entered the menopausal transition or menopause or have had a hysterectomy.
- •9.Participants with findings of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female genital organs, at the Screening Visit.
- •10.Participants who are breastfeeding or have breastfed within the last 6 months prior to the Baseline Visit.
- •12.Participants having primary hypoactive sexual desire.
- •13.Participants with a history of malignancy.
- •14.Participants themselves are not planning to get pregnant for next six months.
- •15.Participants who cannot cooperate to complete the subject records during the study.
结局指标
主要结局
Mean change in FSFI scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 2), Visit 3 (Week 4) to Visit 4- End of study (Week 8) in healthy women
时间窗: Baseline, Week 2, Week 4, Week 8
次要结局
- Mean change in SSEs from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 2), Visit 3 (Week 4) to Visit 4- End of study (Week 8) in healthy women(Baseline, Week 2, Week 4, Week 8)
- Mean change in FSDS scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 2), Visit 3 (Week 4) to Visit 4- End of study (Week 8) in healthy women(Baseline, Week 2, Week 4, Week 8)
- Mean change in serum hormones (Estrogen-E2, Progesterone, FSH, LH, Prolactin, and Testosterone) from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1) to Visit 4- End of study (Week 8) in healthy women(Baseline, Week 2, Week 4, Week 8)
- Mean change in PSS-10 scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 2), Visit 3 (Week 4) to Visit 4- End of study (Week 8) in healthy women(Baseline, Week 2, Week 4, Week 8)
- Mean change in SF-12 scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 2), Visit 3 (Week 4) to Visit 4- End of study (Week 8) in healthy women(Baseline, Week 2, Week 4, Week 8)
- Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) over 8 weeks treatment period(Baseline, Week 2, Week 4, Week 8)
研究者
Dr Ujwala Bardapurkar
Yash Narsing home
研究点 (1)
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