Prospective, Multi Centric, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) in Adults Experiencing High Stress and/or Anxiety

NCT05684991 | Unknown

• 1 other identifier: KSM-66/PMS/2018/09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-centre, multi-national, prospective, randomized, double-blind placebo-controlled study. The study lasts 12 weeks which includes 2 on-site visits and 2 remote visits. Primary objective is to compare the efficacy of KSM-66 Ashwagandha (Withania somnifera) versus placebo in adults experiencing high stress and/or anxiety. Secondary objectives to compare the safety of KSM-66 Ashwagandha (Withania somnifera) versus placebo in adults experiencing high stress and/or anxiety.

Conditions

Anxiety; Stress

Keywords

Ashwagandha

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Rating Scale (HAM-A)

  The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety)

  8 weeks

Secondary Outcomes (3)

• Perceived Stress Scale (PSS)

  8 weeks

• Clinical Global Impression-Improvement scale

  8 weeks

• serum cortisol

  8 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

One capsule of KSM-66 300 mg (contains Ashwagandha extract) two times a day, orally with water

Dietary Supplement: KMS-66 Ashwagandha 300mg

Control Group

PLACEBO COMPARATOR

One capsule of Placebo two times a day, orally with water

Dietary Supplement: placebo capsule

Interventions

KMS-66 Ashwagandha 300mg DIETARY_SUPPLEMENT

One capsule is taken by mouth twice daily with water

Treatment Group

placebo capsule DIETARY_SUPPLEMENT

One capsule is taken by mouth twice daily with water

Control Group

Eligibility Criteria

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

You may qualify if:

• Adults (male and female) aged between 18 and 65 years
• Experiencing signs and symptoms suggestive of high stress (e.g., difficulty concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion etc.)
• Hamilton Anxiety Rating Scale (HAM-A) total score between14 and 30 at the screening/randomization visit
• Perceived Stress Scale (PSS) score ≥13 at the screening/randomization visit
• BMI between 20 and 35
• No plan to commence new treatments over the study period
• Non-smoker
• Medication-free (any medications known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pill are permissible.
• Must have the ability and willingness to sign an informed consent and to comply with all study procedures.

You may not qualify if:

• Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, antipsychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening.
• Patients having total score less than 14 on HAM-A at screening.
• Patients currently (or within the past 4 weeks prior to screening) taking any over the counter use of herbal extracts such as Ginkgo Biloba, St. John's Wort, Omega-3 etc.
• Patients with depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania
• Patients with known post-traumatic stress disorder (PTSD) 6. Patients who have an established practice of meditation and relaxation techniques for three or more months
• Patients with known clinically significant acute unstable hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
• Patients with history of alcohol, tobacco dependence or with any substance abuse
• Pregnant and lactating women or suspected to be pregnant
• Patients with known hypersensitivity to Ashwagandha
• Patients who had participated in other clinical trials during previous 3 months
• Patients who have any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol

Sponsors & Collaborators

• SF Research Institute, Inc.: lead
• Ixoreal Biomed Inc.: collaborator

Study Sites (1)

SF Research Institute, Inc.

San Francisco, California, 94127, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: January 13, 2023
• Study Start: September 19, 2022
• Primary Completion: January 10, 2023
• Study Completion: January 31, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

US (1)