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Safety of Ashwagandha (Withania Somnifera) Root Extract

NCT06261476 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-15

No results posted yet for this study

Summary

The primary objective is to evaluate the laboratory safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy based on Complete Blood Count, Renal Function Test, Liver Function Test, Lipid Profile and Thyroid Function Test, Fasting blood sugar and HbA1c Test. The secondary objectives are to evaluate the clinical safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy and to evaluate the effect of the Ashwagandha standardized root extract 500 mg on Quality of Life (QoL) using the SF-36 tool.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Ashwagandha (Withnia somnifera)

Ashwagandha is the active ingredient in Withania somnifera (a medicinal plant in Indian medicine). Ashwagandha is known as an adaptogen, an herb in capsule form that protects the body from stress.

Sponsors & Collaborators

  • SF Research Institute, Inc.

    lead NETWORK

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06261476 on ClinicalTrials.gov