AnxietyNCT05684991
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
A study testing KMS-66 Ashwagandha 300mg in people with Anxiety and Stress, run by SF Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- KMS-66 Ashwagandha 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SF Research Institute, Inc.
San Francisco, California, 94127
About this study
Official title: Prospective, Randomized, Multi-centric, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) in Adults Experiencing High Stress and/or Anxiety
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.
Read the detailed description
To qualify for this study, subjects must report experiencing high stress or anxiety in the past few months. Subjects must be between 18 to 65 years of age. Subjects must be non-smoking. Subjects must be in generally healthy condition with no serious illnesses, which might interfere with study participation. Subjects are required to maintain usual dietary habits for the duration of the study.
Up to 50 participants will be enrolled in this study at the SF Research Institute (SFRI) site. Approximately half of the subjects will be randomized to receive test treatment supplements, KSM-66, designed to improve anxiety and stress. And the other half of subjects will be randomized to receive placebo (a pill in appearance of test treatment supplement, but is harmless, ingredient of starch powder). This study will require subjects to return questionnaires and remaining test products (via USPS mail or drop off in person if you are able) to the testing facility (Address: 2345 Ocean Ave, San Francisco, CA 94127) by the end of eight weeks testing.
After signing this consent form, subjects will answer questions regarding their medical history, including any medications they are taking. Physical exams with vital signs (pulse, temperature, sitting blood pressure and respiratory rate) will be performed at both visits by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist, or Medical Doctor. In order to be qualified to participate this study at initial Visit (Baseline), BMI score range between 20-35 are required.
A blood sample will be required from subjects. Subject's right or left arm will be used as the blood draw site, requiring a 5mL sample. The blood will be analyzing Cortisol level. These blood draws will be administered by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist or Medical Doctor.
A two-page Hamilton Anxiety Rating Scale (HAM-A) Test and Perceived Stress Scale (PSS) will be given and administered as self-assessment.
After these tests are completed, subjects will be given the study oral supplement. Approximately 50% of the subjects that are enrolled will receive the study supplement. The remaining subjects will receive a placebo. The subject will be required to record use of the assigned product on a Daily Diary.
Subjects will be interviewed by phone at week 4 (Visit 2, remotely) and week 12 (Visit 4, remote follow-up). These calls will take approximately 15 minutes each. Both remote visits will be conducted by a trained clinician and will be assessed with a short questionnaire (PSS). The whole study is 12 weeks in length, clinical trial of test product is only going to be used for first 8 weeks and Visit 4 (remote follow-up) will be conducted remotely by phone call 4 weeks after finish using the testing product.
- Being tested
- KMS-66 Ashwagandha 300mg, placebo capsule
- Keywords
- Ashwagandha
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KMS-66 Ashwagandha 300mgDietary supplement
One capsule is taken by mouth twice daily with water
placebo capsuleDietary supplement
One capsule is taken by mouth twice daily with water
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | One capsule of KSM-66 300 mg (contains Ashwagandha extract) two times a day, orally with water Receives: Dietary Supplement: KMS-66 Ashwagandha 300mg |
| Control Group | Placebo comparator | One capsule of Placebo two times a day, orally with water Receives: Dietary Supplement: placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks
Secondary outcomes (3)
Perceived Stress Scale (PSS)
The 10-item Perceived Stress Scale will be used to evaluate perception of stressful events over the past month by using a 5- point Likert scale (0 = never to 4 = very often)
Measured: 8 weeks
Clinical Global Impression-Improvement scale
The CGI-I scale measures the change in the patient's clinical status from a specific point in time using a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change.
Measured: 8 weeks
serum cortisol
a stress hormone in the blood circulation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start19 Sep 2022
- Primary completion10 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Collaborators
- Ixoreal Biomed Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684991
- Sponsor's protocol ID
- KSM-66/PMS/2018/09
- Status last verified
- Jan 2023
- First submitted
- 30 Sep 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-centric, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) in Adults Experiencing High Stress and/or Anxiety
- ClinicalTrials.gov ID
- NCT05684991
- Acronym / sponsor ID
- KSM-66/PMS/2018/09
- Keywords
- Ashwagandha
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Collaborators
- Ixoreal Biomed Inc.
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 10 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To qualify for this study, subjects must report experiencing high stress or anxiety in the past few months. Subjects must be between 18 to 65 years of age. Subjects must be non-smoking. Subjects must be in generally healthy condition with no serious illnesses, which might interfere with study participation. Subjects are required to maintain usual dietary habits for the duration of the study.
Up to 50 participants will be enrolled in this study at the SF Research Institute (SFRI) site. Approximately half of the subjects will be randomized to receive test treatment supplements, KSM-66, designed to improve anxiety and stress. And the other half of subjects will be randomized to receive placebo (a pill in appearance of test treatment supplement, but is harmless, ingredient of starch powder). This study will require subjects to return questionnaires and remaining test products (via USPS mail or drop off in person if you are able) to the testing facility (Address: 2345 Ocean Ave, San Francisco, CA 94127) by the end of eight weeks testing.
After signing this consent form, subjects will answer questions regarding their medical history, including any medications they are taking. Physical exams with vital signs (pulse, temperature, sitting blood pressure and respiratory rate) will be performed at both visits by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist, or Medical Doctor. In order to be qualified to participate this study at initial Visit (Baseline), BMI score range between 20-35 are required.
A blood sample will be required from subjects. Subject's right or left arm will be used as the blood draw site, requiring a 5mL sample. The blood will be analyzing Cortisol level. These blood draws will be administered by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist or Medical Doctor.
A two-page Hamilton Anxiety Rating Scale (HAM-A) Test and Perceived Stress Scale (PSS) will be given and administered as self-assessment.
After these tests are completed, subjects will be given the study oral supplement. Approximately 50% of the subjects that are enrolled will receive the study supplement. The remaining subjects will receive a placebo. The subject will be required to record use of the assigned product on a Daily Diary.
Subjects will be interviewed by phone at week 4 (Visit 2, remotely) and week 12 (Visit 4, remote follow-up). These calls will take approximately 15 minutes each. Both remote visits will be conducted by a trained clinician and will be assessed with a short questionnaire (PSS). The whole study is 12 weeks in length, clinical trial of test product is only going to be used for first 8 weeks and Visit 4 (remote follow-up) will be conducted remotely by phone call 4 weeks after finish using the testing product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: KMS-66 Ashwagandha 300mgOne capsule of KSM-66 300 mg (contains Ashwagandha extract) two times a day, orally with water |
| Control Group | Placebo comparator | Dietary Supplement: placebo capsuleOne capsule of Placebo two times a day, orally with water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KMS-66 Ashwagandha 300mgOne capsule is taken by mouth twice daily with water | Dietary supplement | Treatment Group |
| placebo capsuleOne capsule is taken by mouth twice daily with water | Dietary supplement | Control Group |
Primary outcome
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 8 weeks
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)
3 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: 8 weeks
Clinical Global Impression-Improvement scale
Time frame: 8 weeks
serum cortisol
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Anxiety
Recruiting
Internet-Based EMDR Flash Intervention for Test Anxiety in University Students
Test Anxiety
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Recruiting
High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
Recurrent Pregnancy Loss(RPL), Anxiety
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder: A Randomized Controlled Trial
Obsessive - Compulsive Disorder, Family Accommodation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KMS-66 Ashwagandha 300mg in people with Anxiety and Stress, run by SF Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HAM-A) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.