Clinical studies

Preclinical Studies

Study 1 was conducted in a murine menopausal model finding beneficial effect for Warmi compared to placebo in preventing body and uterine weight gain, and decreasing triglyceride and total cholesterol levels.

Clinical studies 

Study 2 was a phase 1, double-blinded, placebo-controlled, randomized clinical trial ( RCT)

Number of candidates 60 women, duration 3 months.

that found that the daily consumption of Warmi was safe and tolerable in healthy adult women. Moreover, there was no effect on menstrual cycles, serum hormonal profile (Estradiol, LH, FSH and progesterone), body mass, index and blood pressure values.

Study 3 was a phase 2 single blinded, three-armed controlled , randomized clinical trial including hormone therapy (HT). This study found that the decrease of baseline menopausal symptoms (MENQOL) after three months of treatment was significant in all three groups (two doses of Warmi and HT) without difference between the groups.

Number of candidates 60 women, duration 3 months.

Study 4 was a double-blinded randomized clinical trial, compared Warmi against HT and placebo

Number of candidates 60 women, duration 3 months.

Study 5 was a double-blinded randomized clinical trial, compared Warmi against HT and Isoflavones

Number of candidates 60 women, duration 3 months.

.

Both consistently found that oral administration of Warmi for six months significantly improved levels of total blood cholesterol ( decrease), LDL ( decrease), HDL (increase), estradiol, and IL-6. In addition, the RCT which compared warmi against Tibolone and Placebo found significant improvements in the LDL/HDL ratio and levels of osteocalcin and IL-8, as well as the alleviation of all common menopausal (Green Climacteric Scale) and sexuality symptoms ( McCoy Scale).

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