Safety of Ashwagandha (Withania Somnifera) Root Extract

NCT06261476 | Recruiting

• 1 other identifier: DYP-Pharm-RP-23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (20)

• Hemoglobin Test

  Evaluate the mean change in hemoglobin from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Total Erythrocyte Count

  Evaluate the mean change in total erythrocytes from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Total Leukocyte Count

  Evaluate the mean change in total leukocytes from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Platelet Count

  Evaluate the mean change in platelets from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Hematocrit Test

  Evaluate the mean change in hematocrit from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Total Cholesterol Test

  Evaluate the mean change in total cholesterol from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• LDL Test

  Evaluate the mean change in LDL from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• HDL Test

  Evaluate the mean change in HDL from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Triglycerides Test

  Evaluate the mean change in triglycerides from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Serum Alkaline Transaminase Test

  Evaluate the mean change in serum alkaline transaminase from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Aspartate Transaminase Test

  Evaluate the mean change in aspartate transaminase from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Alkaline Phosphatase Test

  Evaluate the mean change in Alkaline Phosphatase from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Bilirubin Test

  Evaluate the mean change in bilirubin from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Serum Creatinine Test

  Evaluate the mean change in serum creatinine from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Blood Urea Nitrogen Test

  Evaluate the mean change in blood urea nitrogen from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• T4

  Evaluate the mean change in thyroid profile serum thyroxin (T4) from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• T3

  Evaluate the mean change in serum triiodothyronine (T3) from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Serum TSH

  Evaluate the mean change in serum TSH from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• Fasting Blood Sugar

  Evaluate the mean change in fasting blood sugar from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

• HbA1c

  Evaluate the mean change in HbA1c from Visit 1 (Screening/Enrollment/Baseline Visit), Visit 2 (Week 4), Visit 3 (Week 8), and Visit 4 (Week 12), end of study in healthy subjects.

  12 weeks

Secondary Outcomes (2)

• Adverse Events

  12 weeks

• Quality of Life (SF-36 QoL)

  12 weeks

Study Arms (1)

Ashwagandha (Withania somnifera) Root Extract

EXPERIMENTAL

Participants will take two Ashwagandha capsules containing 500 mg standardized root extract twice daily after breakfast and dinner, for a duration of 12 weeks.

Dietary Supplement: Ashwagandha (Withnia somnifera)

Interventions

Ashwagandha (Withnia somnifera) DIETARY_SUPPLEMENT

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.

Ashwagandha (Withania somnifera) Root Extract

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SF Research Institute, Inc.: lead

Study Sites (1)

SF Research Institute

San Francisco, California, 94127, United States

RECRUITING

MeSH Terms

Interventions

Ashwagandha

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 15, 2024
• Study Start: February 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

US (1)