Efficacy and Safety of Shatavari in Women Sexual Wellness: A Prospective, Randomized, Double-Blind, Three-arm, Parallel, Placebo-Controlled Study

NCT06972706 | Completed

• 1 other identifier: SHT-1077-2024-02
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sexual Health

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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)

  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)

  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)

  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)

Study Arms (3)

Shatavari

EXPERIMENTAL

One capsule of Shatavari 300 mg (contains Shatavari extract) once a day, orally with water.

Dietary Supplement: Shatavari

Shatavari + Ashwagandha

EXPERIMENTAL

One capsule of Shatavari (300mg) + Ashwagandha (250mg) (contains Shatavari + Ashwagandha root extract) once a day, orally with water.

Dietary Supplement: Shatavari + Ashwagandha extract

Placebo

PLACEBO COMPARATOR

One capsule of Placebo 300 mg (contains starch extract) once a day, orally with water.

Dietary Supplement: Placebo

Interventions

Shatavari DIETARY_SUPPLEMENT

Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.

Shatavari

Shatavari + Ashwagandha extract DIETARY_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.

Shatavari + Ashwagandha

Placebo DIETARY_SUPPLEMENT

Placebo (starch)

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SF Research Institute, Inc.: lead
• Ixoreal Biomed Inc.: collaborator

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94127, United States

Location

MeSH Terms

Interventions

Ashwagandha

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: May 15, 2025
• Study Start: October 26, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 28, 2025
• Last Updated: May 15, 2025

Record last verified: 2024-11

Locations

US (1)