Los Angeles, CA—Ixoreal Biomed Inc. is highlighting findings from a new randomized, double-blind, placebo-controlled study published in the International Journal of Women’s Health examining the effects of SRI-81 Shatavari on women’s sexual wellness.
The eight-week study involved 135 women ages 18 to 55 at two research sites in India and the United States. Participants were randomly assigned to receive a daily regimen of either 300 mg of SRI-81 Shatavari, a combination of 300 mg of SRI-81 Shatavari and 250 mg of KSM-66 Ashwagandha, or a placebo. Researchers evaluated changes in sexual function, satisfaction, sexual distress, and other measures of well-being.
Improvements in Sexual Function and Satisfaction
Of the 135 women enrolled, 127 were included in the per-protocol analysis, with 41 receiving SRI-81 Shatavari, 44 receiving the combination treatment, and 42 receiving a placebo.
Among participants receiving SRI-81 Shatavari alone, researchers reported the following findings:
- After eight weeks, total FSFI scores increased by 34.1% in the SRI-81 group, compared with 19.6% increase in the placebo group (p=0.025).
- Improvements were observed in the FSFI satisfaction domain, with scores increasing 63.9% in the SRI-81 group versus 19.0% in the placebo group (p<0.0001).
- Sexual distress declined by 28.7% among participants receiving SRI-81, compared with an 8.8% reduction in the placebo group (p=0.008).
- Researchers also reported statistically significant improvements in Oxford Happiness Questionnaire scores among participants receiving SRI-81 compared with placebo (p=0.001).
Participants receiving the combination of SRI-81 Shatavari and KSM-66 Ashwagandha also experienced significant improvements in several measures of sexual wellness. Findings included:
- 37.5% increase in total FSFI scores from baseline (p=0.005).
- 78.0% increase in sexual intercourse frequency, compared with 20.3% in the placebo group (p=0.001).
- 43.6% reduction in sexual distress (p<0.0001).
- Significant improvements in the FSFI arousal, lubrication, and orgasm domains, as well as Oxford Happiness Questionnaire scores (p<0.0001).
Improvements in total FSFI scores were comparable between the combination treatment and SRI-81 Shatavari alone.
Both active treatments were well tolerated throughout the study. Reported adverse events were mild, occurred across all three groups, including placebo, and resolved without intervention. No serious or product-related adverse events were reported, and liver, kidney, and thyroid safety parameters remained within normal ranges.
“Sexual wellness is one of the most overlooked areas in women’s health, and it is rarely discussed as openly as sleep or stress,” shared Kartikeya Baldwa, Chief Executive Officer, Ixoreal Biomed Inc. “This study adds placebo-controlled data to an area where good evidence has been limited, and the results show meaningful improvements in sexual function, satisfaction and sexual distress over eight weeks. The additional findings from the combination arm also broaden our understanding of how Shatavari and Ashwagandha may be studied together as part of women’s wellness formulations.”
The full study can be found here.
