Ashwagandha RCT with eSense SR and Pulse (Mahadevan 2025)

What was investigated?

Researchers at multiple Indian research institutions investigated in a randomized, double-blind, placebo-controlled study whether a newly developed Ashwagandha formulation (Zenroot™, standardized to 1.5% total withanolides) can alleviate stress and anxiety symptoms in healthy adults with mild to moderate, non-chronic stress. In addition to subjective self-assessments, objective physiological stress markers were explicitly recorded — including through mobile biofeedback sensors by Mindfield Biosystems.

Methods

90 healthy adults (45 in the treatment group, 45 in the placebo group; mean age approximately 35 years; balanced gender distribution) participated over 84 days. The treatment group received 125 mg Zenroot™ powder daily; the control group received a visually identical placebo. Measurements were taken at five time points (baseline and days 14, 28, 56, and 84). The primary endpoint was the Perceived Stress Scale (PSS). Secondary endpoints included physiological parameters (EDA, HRV), Beck Anxiety Inventory (BAI), mood profile (POMS), sleep quality (PSQI), and biochemical markers (serum cortisol, salivary alpha-amylase).

Results

The researchers reported the following findings for the Zenroot™ group compared to placebo:

Perceived stress (PSS): Significant improvements from day 28, sustained through day 84. 100% of treatment participants reached clinically relevant improvement thresholds, compared to 13.3% in the placebo group.

Anxiety (BAI): Significant reductions in anxiety scores (p < 0.05) on days 28, 56, and 84 compared to placebo.

Sleep quality (PSQI): Significant improvements from day 28. 91.1% of treatment participants met clinical improvement criteria.

Mood (POMS): Significant reduction in total mood disturbance on days 56 and 84. 84.4% of treatment participants achieved clinically relevant improvements.

Objective physiological parameters: EDA measurements with the eSense Skin Response showed significant changes on days 14, 28, and 84; HRV measurements with the eSense Pulse showed significant changes (RMSSD and SDNN) on day 14. Serum cortisol and salivary alpha-amylase showed no significant group differences, which the researchers attributed to the normal cortisol baseline levels of the healthy study population.

Significance

As a randomized, double-blind, placebo-controlled study (RCT), this investigation represents the highest methodological level of evidence in clinical research. The simultaneous use of eSense Skin Response and eSense Pulse as primary objective measurement instruments in a published RCT is a rare and strong demonstration of the scientific applicability of both sensors.

The combination of subjective scales and objective physiological measurements with two Mindfield sensors substantially strengthens the study’s validity. The study was published in 2025 in Advances in Therapy (Springer) — an internationally recognized journal for therapeutic research.