Sexual HealthNCT06972706
Efficacy and Safety of Shatavari in Women Sexual Wellness: A Prospective, Randomized, Double-Blind, Three-arm, Parallel, Placebo-Controlled Study
A study testing Shatavari and Shatavari + Ashwagandha extract in people with Sexual Health, run by SF Research Institute, Inc. at 1 site in United States.
Trial summary
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari in Women Sexual Wellness. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Health
- What is being tested?
- Shatavari and Shatavari + Ashwagandha extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 18 to 55 years of age.
- Women willing to have 4 or more attempts of sexual intercourse each month.
- Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
- 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.
- Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
- Able to read and write in English or any other vernacular language.
- No plan to commence new treatments over the study period.
- Must have the ability and willingness to sign an informed consent and to comply with all study procedures
Who cannot join
- Participants taking any form of herbal extract in the last 3 months before study entry.
- Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- Participants with any active medical, surgical, or gynaecological problems.
- Participants with a history of alcohol, tobacco dependence, or any other substance abuse
- Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult.
- Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Show all 11Show fewer
- Participants with evidence of uncooperative attitude, including poor compliance.
- Participants with inability to attend follow-up visits.
- Patients with known hypersensitivity to Shatavari, Ashwagandha or any of the ingredients of study medication.
- Patients who had participated in other clinical trials during the previous 3 months.
- Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Research Institute
San Francisco, California, 94127
About this study
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari in Women Sexual Wellness. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to assess the efficacy of Shatavari capsules for improvement in Women Sexual Wellness. The secondary objective is to assess the safety of Shatavari capsules in healthy women.
Read the detailed description
To qualify for the study, participants must be Women between 18 to 55 years of age. Women must be willing to have 4 or more attempts of sexual intercourse each month. Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.) are enrolled.
In this study, a maximum of 51 patients will be enrolled and the goal is to complete the study with at least 45 patients.
After signing this consent form, participants will answer questions regarding their medical history, including any medications they are taking. Physical exams with vital signs (pulse, temperature, sitting blood pressure and respiratory rate) will be performed at both visits by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist, or Medical Doctor.
A blood sample will be required from subjects. Subject's right or left arm will be used as the blood draw site, requiring a 5mL sample. The blood will be analyzing Sr. Estradiol, FSH, LH, Testosterone levels. These blood draws will be administered by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist or Medical Doctor.
All eligible participants, will be given the required quantity of the study medication for self-administration, sufficient till the Visit 3- End of study visit, 8 weeks ± 4 Days. Participants will be randomized to either one of the three treatment arms.
Participants will be instructed to take one capsule of study medication to which they are randomized after breakfast, with ambient temperature water for 8 weeks at home. Participants will be asked to visit the site for Visit 2 (4 weeks ± 4 Days), Visit 3 (8 weeks ± 4 Days). Adverse events and concomitant medication will be recorded throughout the study. Participants will be asked to get used and unused study medications and their subject diaries in this visit. All the participants will be asked to continue their routine diet and physical activities during the whole study period.
The primary end point is the mean change in scores for Female Sexual Function Index (FSFI) from baseline. And the secondary end points are mean changes scores for Satisfying Sexual Events (SSEs), Female Sexual Distress Scale (FSDS), Profile of Mood States, Oxford Happiness Questionnaire (OHQ), Pittsburgh Sleep Quality Index (PSQI) Questionnaire and mean changes in Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) levels from baseline.
- Conditions
- Sexual Health
- Being tested
- Shatavari, Shatavari + Ashwagandha extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShatavariDietary supplement
Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.
Shatavari + Ashwagandha extractDietary supplement
Shatavari is scientifically known as Asparagus racemosus along with Ashwagandha root extract scientifically known as Withania somnifera. One capsule containing Shatavari 300mg + Ashwagandha root extract 250mg should be taken once daily.
PlaceboDietary supplement
Placebo (starch)
| Study group | Role | What they receive |
|---|---|---|
| Shatavari | Experimental | One capsule of Shatavari 300 mg (contains Shatavari extract) once a day, orally with water. Receives: Dietary Supplement: Shatavari |
| Shatavari + Ashwagandha | Experimental | One capsule of Shatavari (300mg) + Ashwagandha (250mg) (contains Shatavari + Ashwagandha root extract) once a day, orally with water. Receives: Dietary Supplement: Shatavari + Ashwagandha extract |
| Placebo | Placebo comparator | One capsule of Placebo 300 mg (contains starch extract) once a day, orally with water. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index (FSFI)
FSFI questions are coded from 0.0 to 5.0. Based on clinical considerations, the scale is considered to have six sexual domains: desire, arousal, lubrication, orgasm, satisfaction, pain. Each domain is contributing to the overarching construct of female sexual function. The maximum score for each domain is 6.0, obtained by summing item responses and multiplying by a correction factor. The total composite sexual function score is a sum of domain scores and ranges from 2.0 (not sexually active and no desire) to 36.0.
Measured: FSFI assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).
Secondary outcomes (6)
Satisfying Sexual Events (SSEs)
SSE included subject's inputs for number of intercourse and non-intercourse sexual events, number of orgasms, level of sexual desire, and satisfying sexual activity experienced. The subjects will be asked to mark a score for their sexual desire. They will be asked, "Indicate your most intense level of sexual desire in the last 24 hours/since your last visit." Potential responses included "no," "low," "moderate," or "strong", scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire)
Measured: SSEs assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).
Female Sexual Distress Scale (FSDS)
The Female Sexual Distress Scale (FSDS), a 12-item patient-reported outcome (PRO) instrument, was developed to measure sexually related personal distress in women. Both the original 12-item version and the 13-item FSDS-Revised (FSDS-R) version have been shown to have a high degree of internal consistency, test-retest reliability, and discriminative validity to distinguish between sexual function and dysfunction among women.
The FSDS-R psychometric instrument with a 7-day recall demonstrated good discriminant validity, high test-retest reliability, and a high degree of internal consistency in measuring sexually related personal distress in women
Measured: FSDS assessments will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).
Profile of Mood States (POMS, abbreviated version)
The POMS is a 40-item questionnaire rated on a 5-point Likert Scale, asking respondents how they feel right now. Scores are calculated for Tension, Anger, Fatigue, Depression, Esteem- related affect, Vigor, Confusion, and Total Mood Disturbance.
Measured: POMS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).
Oxford Happiness Questionnaire (OHQ)
Measured: OHQ assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep-in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.
Measured: PSQI assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3 (Week 8)
Serum Hormones
Measured: Time Frame: Blood samples for Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) will be collected at Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) and Visit 3- (Week 8)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start26 Oct 2024
- Primary completion15 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Collaborators
- Ixoreal Biomed Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972706
- Sponsor's protocol ID
- SHT-1077-2024-02
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Shatavari in Women Sexual Wellness: A Prospective, Randomized, Double-Blind, Three-arm, Parallel, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06972706
- Acronym / sponsor ID
- SHT-1077-2024-02
- Conditions
- Sexual Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Collaborators
- Ixoreal Biomed Inc.
- Study start
- 26 Oct 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari in Women Sexual Wellness. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to assess the efficacy of Shatavari capsules for improvement in Women Sexual Wellness. The secondary objective is to assess the safety of Shatavari capsules in healthy women.
Detailed description
To qualify for the study, participants must be Women between 18 to 55 years of age. Women must be willing to have 4 or more attempts of sexual intercourse each month. Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.) are enrolled.
In this study, a maximum of 51 patients will be enrolled and the goal is to complete the study with at least 45 patients.
After signing this consent form, participants will answer questions regarding their medical history, including any medications they are taking. Physical exams with vital signs (pulse, temperature, sitting blood pressure and respiratory rate) will be performed at both visits by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist, or Medical Doctor.
A blood sample will be required from subjects. Subject's right or left arm will be used as the blood draw site, requiring a 5mL sample. The blood will be analyzing Sr. Estradiol, FSH, LH, Testosterone levels. These blood draws will be administered by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist or Medical Doctor.
All eligible participants, will be given the required quantity of the study medication for self-administration, sufficient till the Visit 3- End of study visit, 8 weeks ± 4 Days. Participants will be randomized to either one of the three treatment arms.
Participants will be instructed to take one capsule of study medication to which they are randomized after breakfast, with ambient temperature water for 8 weeks at home. Participants will be asked to visit the site for Visit 2 (4 weeks ± 4 Days), Visit 3 (8 weeks ± 4 Days). Adverse events and concomitant medication will be recorded throughout the study. Participants will be asked to get used and unused study medications and their subject diaries in this visit. All the participants will be asked to continue their routine diet and physical activities during the whole study period.
The primary end point is the mean change in scores for Female Sexual Function Index (FSFI) from baseline. And the secondary end points are mean changes scores for Satisfying Sexual Events (SSEs), Female Sexual Distress Scale (FSDS), Profile of Mood States, Oxford Happiness Questionnaire (OHQ), Pittsburgh Sleep Quality Index (PSQI) Questionnaire and mean changes in Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) levels from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shatavari | Experimental | Dietary Supplement: ShatavariOne capsule of Shatavari 300 mg (contains Shatavari extract) once a day, orally with water. |
| Shatavari + Ashwagandha | Experimental | Dietary Supplement: Shatavari + Ashwagandha extractOne capsule of Shatavari (300mg) + Ashwagandha (250mg) (contains Shatavari + Ashwagandha root extract) once a day, orally with water. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne capsule of Placebo 300 mg (contains starch extract) once a day, orally with water. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women between 18 to 55 years of age.
- Women willing to have 4 or more attempts of sexual intercourse each month.
- Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
- 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.
- Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
Key exclusion criteria (11 listed)
- Participants taking any form of herbal extract in the last 3 months before study entry.
- Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- Participants with any active medical, surgical, or gynaecological problems.
- Participants with a history of alcohol, tobacco dependence, or any other substance abuse
- Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShatavariShatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily. | Dietary supplement | Shatavari |
| Shatavari + Ashwagandha extractShatavari is scientifically known as Asparagus racemosus along with Ashwagandha root extract scientifically known as Withania somnifera. One capsule containing Shatavari 300mg + Ashwagandha root extract 250mg should be taken once daily. | Dietary supplement | Shatavari + Ashwagandha |
| PlaceboPlacebo (starch) | Dietary supplement | Placebo |
Primary outcome
Female Sexual Function Index (FSFI)
Time frame: FSFI assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).
FSFI questions are coded from 0.0 to 5.0. Based on clinical considerations, the scale is considered to have six sexual domains: desire, arousal, lubrication, orgasm, satisfaction, pain. Each domain is contributing to the overarching construct of female sexual function. The maximum score for each domain is 6.0, obtained by summing item responses and multiplying by a correction factor. The total composite sexual function score is a sum of domain scores and ranges from 2.0 (not sexually active and no desire) to 36.0.
6 secondary outcomes
Satisfying Sexual Events (SSEs)
Time frame: SSEs assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).
Female Sexual Distress Scale (FSDS)
Time frame: FSDS assessments will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).
Profile of Mood States (POMS, abbreviated version)
Time frame: POMS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).
Oxford Happiness Questionnaire (OHQ)
Time frame: OHQ assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Pittsburgh Sleep Quality Index (PSQI)
Time frame: PSQI assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3 (Week 8)
Serum Hormones
Time frame: Time Frame: Blood samples for Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) will be collected at Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) and Visit 3- (Week 8)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shatavari and Shatavari + Ashwagandha extract in people with Sexual Health, run by SF Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) (time frame: FSFI assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.