Randomized Trial Reports Symptom Improvements With Standardized Shatavari Extract in Perimenopausal Women

A randomized, double-blind, placebo-controlled trial published in the International Journal of Women's Health has reported statistically significant improvements in perimenopausal symptoms among women supplementing with a standardized Shatavari (Asparagus racemosus) root extract, branded SRI-81 and manufactured by Ixoreal Biomed Inc.¹

How Was the Trial Designed?

The eight-week trial screened 120 women aged 40 to 55 and randomized 80 eligible participants in a 1:1 ratio to receive either 300 mg per day of the Shatavari root extract or a matching placebo. Seventy-three participants completed the study according to protocol. Outcomes were tracked using four validated instruments: the Menopause Rating Scale (MRS), the Menopause-Specific Quality of Life questionnaire (MENQOL), the Perceived Stress Scale (PSS-10), and the Profile of Mood States (POMS), alongside blood work to monitor hormone levels and hepatic, renal, and thyroid safety markers. The extract used in the study is produced at a 13:1 herb-to-extract ratio through a solvent-free extraction process and standardized to a minimum of 10% total shatavarins by HPLC.

What Did the Trial Find?

At week eight, the Shatavari group showed significantly greater improvement than placebo across all three MRS subdomains — somato-vegetative, psychological, and urogenital — as well as in total MRS score. Hot flash frequency also declined significantly more in the treatment group than in the placebo group.

Secondary measures showed reductions in perceived stress at both week four and week eight, along with improvements in fatigue and vigor on the POMS. MENQOL total scores differed significantly between groups by the study's end. Estradiol, FSH, and T3 levels were higher in the treatment group at week eight, though changes from baseline were not statistically significant between arms.

No adverse events were reported, including no adverse changes in liver and kidney function. The study authors note that the single-site design and eight-week duration limit conclusions about longer-term outcomes such as urogenital atrophy and bone health, and they call for larger, longer trials to confirm the findings.

"Perimenopause affects women across multiple domains simultaneously, including vasomotor symptoms, stress, mood, and quality of life,” stated Kartikeya Baldwa, CEO of Ixoreal Biomed Inc., in a news release from the company.² “In this trial, SRI-81 produced significant improvements in several of these areas at a dose of 300 mg once daily. This provides clinical support for standardized, root-only Shatavari in women's health formulations.”

What Has Happened With SRI-81 Since the Trial Was Published?

Separately, Ixoreal's Canadian distribution partner, CK Nutraceuticals, announced in July 2026 that SRI-81 Shatavari had received a Natural Product Number (NPN 80149608) from Health Canada.³ The license permits formulators marketing products in Canada to use five approved health claims tied to the ingredient, covering general menopausal symptom management, relief of vasomotor symptoms such as hot flashes and night sweats, reduction of symptoms including mild anxiety, irritability, and fatigue, support for quality of life during menopause, and support for healthy sexual arousal and satisfaction in women.

Colleen Madden, vice president of innovation at CK Nutraceuticals, commented on the pathway the health claims provide. “The Health Canada approval represents an important milestone for SRI-81 Shatavari and provides Canadian supplement brands with a compliant pathway to formulate innovative women’s health products backed by both clinical research and regulatory approval.

Ixoreal is also the manufacturer of KSM-66 Ashwagandha, and the company describes SRI-81 as holding more than 27 quality certifications. The company's pipeline also includes trials in postpartum lactation support and polyendocrine metabolic ovarian syndrome (PMOS).

References

1. Mahajan S, Avad P, Langade J. Efficacy and safety of Shatavari (Asparagus racemosus) root extract for perimenopause: randomized, double-blind, placebo-controlled study. Int J Womens Health. 2025;17:4057-4073. doi:10.2147/IJWH.S544267
2. Ixoreal Biomed Inc. Randomized, Placebo-Controlled Trial Reports Improvements in Perimenopausal Symptoms with SRI-81® Shatavari. August 24, 2026. Accessed August 24, 2026.
3. SRI-81 Shatavari secures Health Canada NPN, along with five approved health claims. Nutritional Outlook. July 10, 2026. Accessed August 24, 2026. https://www.nutritionaloutlook.com/view/sri-81-shatavari-secures-health-canada-npn-along-with-five-approved-health-claims