NCT06972706

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: SF Research Institute, Inc. · Network
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Shatavari	Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.
DIETARY_SUPPLEMENT	Shatavari + Ashwagandha extract	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.
DIETARY_SUPPLEMENT	Placebo	Placebo (starch)

Timeline

• Start date: 2024-10-26
• Primary completion: 2025-02-15
• Completion: 2025-02-28
• First posted: 2025-05-15
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States