RCTJadad 5/5RandomizedDouble-BlindPlacebo-Controlled

Ashwagandha for Stress and Weight Loss: What a 24-Week Trial Actually Found

Journal of Medicine and LifeDecember 1, 2025Vol. 18 (12)

Summary

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What This Means For You

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Important Considerations

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Terms Explained

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Technical Study Details

Study Design

Duration24 weeks

Total Score

JADAD Quality Assessment

/ 5

評価詳細

Randomization

2 / 2

Is the study described as randomized?

Yes+1

Rationale: The article explicitly and repeatedly describes itself as "randomized" in the abstract, methods (study design and randomization/blinding sections), and discussion, including detail on the randomization sequence generation method (Rando version 1.2 software).

Is the method of randomization described and appropriate?

Yes+1

Rationale: The article explicitly describes the randomization method: a computer-generated randomization sequence produced using PC-based Rando version 1.2 software. Computer-generated randomization is an appropriate method per Jadad scale criteria, so this criterion is satisfied.

Blinding

2 / 2

Is the study described as double-blind?

Yes+1

Rationale: The article explicitly and repeatedly describes the study as "double-blind" in the abstract, methods (study design), and discussion sections.

Is the method of blinding described and appropriate?

Yes+1

Rationale: The article explicitly describes the blinding method: the ARE capsules and placebo capsules were identical in appearance, packaging, and labeling (placebo being inert starch), which is an appropriate double-blinding technique consistent with Jadad scale criteria for describing and validating an appropriate blinding method.

Dropouts/Withdrawals

1 / 1

Is there a description of dropouts and withdrawals?

Yes+1

Rationale: The article specifies the number of withdrawals/dropouts for each treatment group separately (5 from ARE, 4 from PL) along with a stated reason (lost to follow-up), and reconciles these with the final analyzed sample sizes per group (45 ARE, 46 PL out of 50 each), satisfying the Jadad Q5 criterion for describing withdrawals and dropouts by group.</rationale> </invoke>

Study Population

Sample Size100

Age Range19-65 years

ConditionOverweight/obesity (BMI 25.0-39.9 kg/m2) with associated stress

Inclusion Criteria

Adults aged 19 to 65 years
BMI between 25.0 and 39.9 kg/m2
Willing to sign written informed consent before trial commencement
Agreed to take the investigational product for the full 24-week study duration

Interventions

Ashwagandha Root Extract (KSM-66 Ashwagandha®)

Treatment

Dose300 mg per capsule (600 mg/day total)

FrequencyTwice daily (after breakfast and after dinner)

Duration24 weeks

RouteOral

Placebo

Control

Dose300 mg per capsule

FrequencyTwice daily (after breakfast and after dinner)

Duration24 weeks

RouteOral

Outcomes

Outcome	Type	Effect	p-value
Body weight	Primary	-	P < 0.0001Significant
Body mass index (BMI)	Primary	-1.92	P < 0.0001Significant
Perceived Stress Scale	Secondary	-	P < 0.05Significant
Health-related quality of life	Secondary	-	P < 0.05Significant
Subjective satisfaction	Secondary	-	P < 0.05Significant
Food cravings	Secondary	-	P < 0.05Significant
Serum cortisol	Secondary	-2.32	p=0.006Significant
Glycated hemoglobin (HbA1c)	Secondary	-	p=0.028Significant
Serum total cholesterol	Secondary	-	p=0.028Significant

Safety

Adverse Events13

Serious AEs0

Dropout Rate9.0%

Seven participants in the ARE group and six in the placebo group reported mild adverse events (nausea, abdominal pain, drowsiness), which resolved without any intervention. No serious adverse events were reported. No clinically significant changes in laboratory parameters (CBC, renal function, liver function, lipid profile, thyroid function, glycemic parameters) were observed after 24 weeks, except for lower HbA1c and total cholesterol with ARE at week 12 (P = 0.028 for both).

Conclusion

Ashwagandha root extract (300 mg twice daily for 24 weeks) significantly reduced stress levels, body weight, and food cravings compared with placebo, with accompanying improvements in quality of life and subjective satisfaction. ARE was well tolerated, with only mild, self-resolving adverse events (nausea, abdominal pain, drowsiness), no serious adverse events, and no clinically meaningful changes in laboratory safety parameters over 24 weeks, supporting its long-term use as a safe and promising intervention for stress reduction and weight management in overweight adults.

Limitations

Single-center study design, which may limit generalizability of the results
Limited sample size
Limited demographic diversity of the study population
Potential confounding factors such as diet, sleep quality, and physical activity levels were not monitored or controlled, which could have influenced outcomes related to stress, body weight, and overall well-being