StressNCT06714942
Efficacy and Safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women With High Stress and Anxiety: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
A study testing Proprietary Blend of Ashwagandha and KSM-66 Ashwagandha root extract in people with Stress and Anxiety, run by SF Research Institute, Inc. at 1 site in United States.
Trial summary
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women with High Stress and Anxiety. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Proprietary Blend of Ashwagandha and KSM-66 Ashwagandha root extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2024to 21 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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 between 14 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.
- Medication-free (any medications are known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pills 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 a total score of 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 a depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia, and mania.
- Patients with known post-traumatic stress disorder (PTSD) and Generalized Anxiety Disorder (GAD).
- Patients who have an established practice of meditation and relaxation techniques for three or more months.
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- Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
- Patients with a history of alcohol, tobacco dependence, or 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 the previous 3 months.
- Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco Research Institute
San Francisco, California, 94127
John Ademola
About this study
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women with High Stress and Anxiety. All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. Subjects will be informed about the purpose of the study and signed informed consent will be taken. Subjects will be randomized to either one of the three treatment arms. Subjects will then be asked to either take one capsule containing the proprietary blend of Ashwagandha root extract or Ashwagandha root extract or Placebo orally twice daily with a glass of water for 8 weeks. The primary objective is to compare the efficacy of a proprietary blend of Ashwagandha root extract in adults experiencing stress and anxiety. The secondary objective is to compare the safety of a proprietary blend versus KSM-66 versus Placebo in adults experiencing stress and anxiety.
Read the detailed description
To qualify for the study, participants must be aged between 18 to 55 years experiencing signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
In this study, a maximum of 51 patients will be enrolled and the goal is to complete the study with at least 45 patients.
After signing this consent form, participants 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.
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.e 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.
All eligible participants, will be given the required quantity of the study medication for self-administration, sufficient till the Visit 3- End of study visit, 8 weeks ± 4 Days. Participants will be randomized to either one of the three treatment arms.
Participants will be instructed to take one capsule of study medication to which they are randomized twice daily, with ambient temperature water for 8 weeks at home. Participants will be asked to visit the site for Visit 2 (4 weeks ± 4 Days), Visit 3 (8 weeks ± 4 Days). Adverse events and concomitant medication will be recorded throughout the study. Participants will be asked to get used and unused study medications and their subject diaries in this visit. All the participants will be asked to continue their routine diet and physical activities during the whole study period.
The primary end point is mean change in serum cortisol level from baseline. The secondary end points are Perceived Stress Scale (PSS) questionnaire, Hamilton Anxiety Rating Scale (HAM-A) questionnaire, Profile of Mood States (POMS, abbreviated version) questionnaire, Oxford Happiness Questionnaire from baseline. The safety end points are the Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks and the Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks.
- Being tested
- Proprietary Blend of Ashwagandha, KSM-66 Ashwagandha root extract, Placebo
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprietary Blend of AshwagandhaDietary supplement
One capsule (300mg) is taken twice daily with water
KSM-66 Ashwagandha root extractDietary supplement
One capsule (300mg) is taken twice daily with water
PlaceboDietary supplement
One capsule (300mg) is taken twice daily with water
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | One capsule of Proprietary Blend of Ashwagandha 300 mg twice a day, orally with water. Receives: Dietary Supplement: Proprietary Blend of Ashwagandha |
| Comparator Group | Experimental | One capsule of KSM-66 Ashwagandha 300mg two times a day, orally with water Receives: Dietary Supplement: KSM-66 Ashwagandha root extract |
| Control Group | Placebo comparator | One capsule of Placebo two times a day, orally with water Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cortisol level
Measured: Blood samples for serum cortisol will be collected at Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) and Visit 3- (Week 8)]
Secondary outcomes (4)
Perceived Stress Scale Score (PSS)
The Perceived Stress Scale (PSS-10) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. The questions in the PSS ask about feelings and thoughts during the last month.
Measured: PSS assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Hamilton Anxiety Rating Scale (HAM-A)
The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms and is still widely used today in both clinical and research settings. The HAM-A 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). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: HAM-A assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Profile of Mood States (POMS, abbreviated version)
The POMS is a 40-item questionnaire rated on a 5-point Likert Scale, asking respondents how they feel right now. Scores are calculated for Tension, Anger, Fatigue, Depression, Esteem-related affect, Vigor, Confusion, and Total Mood Disturbance.
Measured: POMS assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Oxford Happiness Questionnaire
The Oxford Happiness Scale (OHS) is a psychological assessment tool designed to measure an individual's subjective level of happiness. It was developed by researchers Michael Argyle and Peter Hills at the University of Oxford. The scale is widely used in positive psychology and well-being research to evaluate happiness as a multidimensional concept, encompassing emotional, cognitive, and social aspects.
Measured: Oxford Happiness Questionnaire assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start25 Oct 2024
- Primary completion27 Dec 2024 (estimated)
- Study completion21 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Collaborators
- Agaja Pharma Pvt. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714942
- Sponsor's protocol ID
- AGJ-1051-2023-01
- Status last verified
- Nov 2024
- First submitted
- 1 Dec 2024
- Last updated
- 4 Dec 2024
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women With High Stress and Anxiety: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06714942
- Acronym / sponsor ID
- AGJ-1051-2023-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Collaborators
- Agaja Pharma Pvt. Ltd.
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 27 Dec 2024 (estimated)
- Study completion
- 21 Jan 2025 (estimated)
- First posted
- 4 Dec 2024 (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 is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women with High Stress and Anxiety. All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. Subjects will be informed about the purpose of the study and signed informed consent will be taken. Subjects will be randomized to either one of the three treatment arms. Subjects will then be asked to either take one capsule containing the proprietary blend of Ashwagandha root extract or Ashwagandha root extract or Placebo orally twice daily with a glass of water for 8 weeks. The primary objective is to compare the efficacy of a proprietary blend of Ashwagandha root extract in adults experiencing stress and anxiety. The secondary objective is to compare the safety of a proprietary blend versus KSM-66 versus Placebo in adults experiencing stress and anxiety.
Detailed description
To qualify for the study, participants must be aged between 18 to 55 years experiencing signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
In this study, a maximum of 51 patients will be enrolled and the goal is to complete the study with at least 45 patients.
After signing this consent form, participants 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.
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.e 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.
All eligible participants, will be given the required quantity of the study medication for self-administration, sufficient till the Visit 3- End of study visit, 8 weeks ± 4 Days. Participants will be randomized to either one of the three treatment arms.
Participants will be instructed to take one capsule of study medication to which they are randomized twice daily, with ambient temperature water for 8 weeks at home. Participants will be asked to visit the site for Visit 2 (4 weeks ± 4 Days), Visit 3 (8 weeks ± 4 Days). Adverse events and concomitant medication will be recorded throughout the study. Participants will be asked to get used and unused study medications and their subject diaries in this visit. All the participants will be asked to continue their routine diet and physical activities during the whole study period.
The primary end point is mean change in serum cortisol level from baseline. The secondary end points are Perceived Stress Scale (PSS) questionnaire, Hamilton Anxiety Rating Scale (HAM-A) questionnaire, Profile of Mood States (POMS, abbreviated version) questionnaire, Oxford Happiness Questionnaire from baseline. The safety end points are the Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks and the Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: Proprietary Blend of AshwagandhaOne capsule of Proprietary Blend of Ashwagandha 300 mg twice a day, orally with water. |
| Comparator Group | Experimental | Dietary Supplement: KSM-66 Ashwagandha root extractOne capsule of KSM-66 Ashwagandha 300mg two times a day, orally with water |
| Control Group | Placebo comparator | Dietary Supplement: PlaceboOne 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 (8 listed)
- Adults (male and female) aged between 18 and 65 years.
- Experiencing signs and symptoms suggestive of 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 between 14 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 (12 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 a total score of 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 a depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia, and mania.
- Patients with known post-traumatic stress disorder (PTSD) and Generalized Anxiety Disorder (GAD).
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 |
|---|---|---|
| Proprietary Blend of AshwagandhaOne capsule (300mg) is taken twice daily with water | Dietary supplement | Treatment Group |
| KSM-66 Ashwagandha root extractOne capsule (300mg) is taken twice daily with water | Dietary supplement | Comparator Group |
| PlaceboOne capsule (300mg) is taken twice daily with water | Dietary supplement | Control Group |
Primary outcome
Serum cortisol level
Time frame: Blood samples for serum cortisol will be collected at Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) and Visit 3- (Week 8)]
4 secondary outcomes
Perceived Stress Scale Score (PSS)
Time frame: PSS assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: HAM-A assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Profile of Mood States (POMS, abbreviated version)
Time frame: POMS assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Oxford Happiness Questionnaire
Time frame: Oxford Happiness Questionnaire assessment will be done at Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4), and Visit 3 (Week 8).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprietary Blend of Ashwagandha and KSM-66 Ashwagandha root extract in people with Stress and Anxiety, 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Ademola (+1 (415) 845-4638, jademola@sfinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cortisol level (time frame: Blood samples for serum cortisol will be collected at Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) and Visit 3- (Week 8)]). 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 4 Dec 2024.