Randomized controlled trial2018

Efficacy and Safety of Ashwagandha Root Extract in Subclinical Hypothyroid Patients: A Double-Blind, Randomized Placebo-Controlled Trial

Sharma AK, Basu I, Singh S

Journal of alternative and complementary medicine (New York, N.Y.) · 66 citations

Review labels

Funding not disclosed

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Funding not disclosed

Publication

Published
2017-08-22 · J Altern Complement Med · vol. 24 · issue 3 · pp. 243–248
Publisher
Mary Ann Liebert, Inc.
Cited
115 citations · more than 92% of similar papers · 2.9× the field average
Impact
Top 10% most cited in its field
References
18 works
Access
Paywalled
Research areas
Thyroid Disorders and Treatments · Phytochemicals and Medicinal Plants
Keywords
Medicine, Subclinical infection, Placebo, Withania somnifera, Internal medicine, Triiodothyronine, Thyroid, Population, Randomized controlled trial, Alternative medicine
MeSH
humans, withania, hypothyroidism, thyroid hormones, plant extracts, prospective studies, pilot projects, double-blind method, adult, female, male

3 authors

  • Ashok Kumar Sharma
  • Indraneel Basu
  • Siddarth Singh

Abstract

Background

Subclinical hypothyroidism, a thyroid disorder without obvious symptoms of thyroid deficiency, occurs in 3%-8% of the global population. Ashwagandha [Withania somnifera (L.) Dunal], a traditional medicine in Ayurveda, is often prescribed for thyroid dysfunctions.

Objective

This pilot study was designed to evaluate the efficacy and safety of ashwagandha root extract in subclinical hypothyroid patients.

Design, setting, and participants

A prospective, randomized, double-blind, single-center placebo-controlled study was performed at Sudbhawana Hospital, Varanasi, India between May 2016 and September 2016. Fifty subjects with elevated serum thyroid stimulating hormone (TSH) levels (4.5-10 μIU/L) aged between 18 and 50 were randomized in either treatment (n = 25) or placebo (n = 25) groups for an 8-week treatment period.

Interventions

Ashwagandha root extract (600 mg daily) or starch as placebo. Efficacy Variables: Serum TSH, serum triiodothyronine (T3), and thyroxine (T4) levels.

Results

A total of four subjects (two from each group) withdrew their consent before the second visit. Eight weeks of treatment with ashwagandha improved serum TSH (p < 0.001), T3 (p = 0.0031), and T4 (p = 0.0096) levels significantly compared to placebo. Ashwagandha treatment effectively normalized the serum thyroid indices during the 8-week treatment period in a significant manner (time-effects: TSH [p < 0.001], T3 [p < 0.001], and T4 [p < 0.001]). Four subjects (8%) (ashwagandha: 1[4%]; Placebo: 3[12%]) out of 50 reported few mild and temporary adverse effects during this study.

Conclusion

Treatment with ashwagandha may be beneficial for normalizing thyroid indices in subclinical hypothyroid patients.

Abstract via Europe PMC. Copyright remains with the authors or publisher.

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