Effect of standardised aqueous root extract-Physta on testosterone levels and quality of life in ageing male subjects: a randomised, double-blind, placebo-controlled multicentre study.

Background: Low testosterone levels cause physiological changes that compromise the quality of life in ageing men. A standardised water extract from the root of (EL), known as Physta, is known to increase testosterone levels.

Objective: To evaluate the safety and efficacy of Physta in improving the testosterone levels and quality of life in ageing male subjects.

Design: This randomised, double-blind, placebo-controlled study enrolled 105 male subjects aged 50-70 years with a testosterone level <300 ng/dL, BMI ≥ 18 and ≤30.0 kg/m. The subjects were given either Physta 100 mg, 200 mg or placebo daily for 12 weeks. The primary endpoints were changes in serum total and free testosterone levels. The secondary endpoints included changes in the level of sex hormone-binding globulin (SHBG), dihydroepiandrosterone (DHEA), glycated haemoglobin (HbA1c), insulin-like growth factor-1 (IGF-1), thyroid function tests (T3, T4, TSH and Free T3) and cortisol. Changes in Ageing Male Symptoms (AMS) score, Fatigue Severity Scale (FSS) score and muscle strength are other secondary endpoints. The safety of the intervention products was measured by complete blood count, lipid profile, liver and renal function tests.

Results: There was a significant increase in the total testosterone levels at week 12 ( < 0.05) in the Physta 100 mg group and at weeks 4 ( < 0.05), 8 ( < 0.01) and 12 ( < 0.001) in the Physta 200 mg group compared to placebo. No significant between-group differences in free testosterone levels were observed but a significant within-group increase occurred at weeks 4 ( < 0.01), 8 ( < 0.001) and 12 ( < 0.001) in the Physta100 mg group and at weeks 2 ( < 0.01), 4 ( < 0.01), 8 ( < 0.001) and 12 ( < 0.001) in the Physta 200 mg group. The AMS and FSS showed significant reduction ( < 0.001) in total scores at all time-points within- and between-group in both Physta groups. DHEA levels significantly increased ( < 0.05) within-group in both Physta groups from week 2 onwards. Cortisol levels significantly ( < 0.01) decreased in the Physta 200 mg group, while muscle strength significantly ( < 0.001) increased in both Physta groups at week 12 in the within-group comparison. There were no significant changes in SHBG. No safety related clinically relevant changes were observed.

Conclusion: Supplementation of Physta at 200 mg was able to increase the serum total testosterone, reduce fatigue and improve the quality of life in ageing men within 2 weeks' time.

Trial Registration: This clinical study has been registered in ctri.nic.in (CTRI/2019/03/017959).