Safety of Ashwagandha (Withania Somnifera) Root Extract

Description

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

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Study Overview

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Study Details

Study overview

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.

Safety of Ashwagandha (Withania Somnifera) Root Extract: An Open-Label, Non-Comparative, Prospective Study in Healthy Subjects

Safety of Ashwagandha (Withania Somnifera) Root Extract

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

San Francisco

SF Research Institute, San Francisco, California, United States, 94127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Both adults (male and female) aged between 18 and 65 years.
  • * Participant should be healthy and free from any chronic illness, such as diabetic, cardiovascular or any other condition that could affect the safety of the study.
  • * No plan to commence any other alternative treatment modality for their conditions.
  • * Willingness to sign an informed consent document and to comply with all study related procedures.
  • * History of Alcohol or smoking abuse.
  • * History of hypersensitivity to Ashwagandha.
  • * Taking nutritional or energy supplements, medication, or steroids.
  • * Any history of drug abuse.
  • * Having any clinical abnormalities.
  • * Simultaneously participating in any other clinical trial or participated in the past three months.
  • * Participants who use medication for blood pressure, use betablockers, inhaled any beta-agonists, use any hormonal contraceptives, having a history of corticosteroid use within three months, participants under psychotropic medication within last 8 weeks, and
  • * Participants diagnosed with any heart disease, diabetes, stroke, neurological disorders or depression.
  • * Have clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
  • * Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder, alcohol dependency; schizophrenia and mania.
  • * Patients with post traumatic disorder.
  • * Have an established practice of meditation for three or more months.
  • * Pregnant and lactating women.
  • * Participation in other clinical trials during previous 3 months.
  • * Any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

SF Research Institute, Inc.,

Study Record Dates

2024-05