An interventional study of KMS-66 Ashwagandha 300mg and placebo capsule in Anxiety and Stress, sponsored by SF Research Institute, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-13.
Sponsored by SF Research Institute, Inc. · Not applicable, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →SF Research Institute, Inc. is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One capsule of KSM-66 300 mg (contains Ashwagandha extract) two times a day, orally with water
Dietary Supplement: KMS-66 Ashwagandha 300mg
One capsule of Placebo two times a day, orally with water
Dietary Supplement: placebo capsule
One capsule is taken by mouth twice daily with water
One capsule is taken by mouth twice daily with water
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)
Time frame: 8 weeks
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)
Time frame: 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.
Time frame: 8 weeks
serum cortisol
a stress hormone in the blood circulation
Time frame: 8 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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SF Research Institute, Inc.