AllNCT06244147
Long Term Safety and Efficacy of KSM-66 Ashwagandha in Adults
An observational study of All, run by SF Research Institute, Inc. at 1 site in United States.
Trial summary
The primary objective is to evaluate the clinical safety of KSM-66 Ashwagandha (Withania Somnifera) on long-term administration over 12 months. The secondary objectives are to evaluate the laboratory safety of KSM-66 Ashwagandha (Withania Somnifera) on long-term administration over 12 months and to evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- All
- What is being tested?
- KSM-66 Ashwagandha Root Extract
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 15 Oct 2025
- Phase
- Observational
- 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
Study population: A total of 200 subjects who are prescribed KSM-66 Ashwagandha by their clinicians for long-term period for their respective health conditions will be included for this observational study.
Who may be able to join
- Adults (male and female) aged between 18 and 65 years.
- Prescribed KSM-66 Ashwagandha by their clinicians for long-term period.
- 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.
- Participants with Body mass index between 25 and 39.9 kg/m2.
Who cannot join
- Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to 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).
- Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
- 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
San Francisco, California, 94127
About this study
Official title: Long Term Safety and Efficacy of KSM-66 Ashwagandha (Standardized Root Extract of Withania Somnifera) in Adults: A Prospective, Observational Study
The primary objective is to evaluate the clinical safety of KSM-66 Ashwagandha (Withania Somnifera) on long-term administration over 12 months. The secondary objectives are to evaluate the laboratory safety of KSM-66 Ashwagandha (Withania Somnifera) on long-term administration over 12 months and to evaluate the efficacy of KSM-66 Ashwagandha (Withania Somnifera) on long-term administration over 12 months.
Read the detailed description
To qualify for this study, participant must be male or female between 18 and 65 years old and prescribed KSM-66 Ashwagandha by their clinicians for a long-term period. Participants must have no plan to commence any other alternative treatment modality for their conditions. Participants must be willing to sign an informed consent document and to comply with all study related procedures. Participants must have a body mass index between 25 and 39.9 kg/m2.
In this study, a total of 200 subjects will be included across 4-5 study sites, for a total duration of 12 months. At the initial visit, prospective patients will be screened for enrollment based on the requirements of the study, medical history, and clinical examination. Before starting any study related procedures, participants will be explained about the study in detail and a written informed consent will be obtained from participants prior to participation in this study. This document is a part of the written informed consent procedure. A detailed medical history including the associated conditions will be recorded. A general and physical examination will be performed to detect any abnormal parameters. If participants meet the eligibility criteria, they will be enrolled in the study.
After enrollment in the study, participants will be asked to consume Ashwagandha 300 mg root extract capsule orally twice daily, morning and evening after breakfast and dinner with a glass of water. At Visit 1 (Screening/Enrollment/Baseline Visit - Day -3 to Day 0), demography and medical history will be taken, physical examination and vital signs will be performed, blood will be collected, study medication will be dispensed, and Clinical Global Impression - Improvement (CGI-I) scale and Quality of Life using the SF-12 QoL scale will be assessed.
At Visits 2 to 6 (Months 1, 2, 3, 4, 5), participants will follow up remotely via a phone call. Compliance and concomitant medication will be noted.
At Visit 7 (Month 7), participants will follow up on site, where a physical examination and vital signs will be performed, blood will be collected, study medication will be dispensed, Clinical Global Impression - Improvement (CGI-I) scale and Quality of Life using the SF-12 QoL scale will be assessed, and compliance will be assessed.
At Visits 8 to 12 (Months 7, 8, 9, 10, 11), participants will follow up remotely via a phone call. Compliance and concomitant medication will be noted.
At Visit 13 (Final Visit - Month 12), participants will follow up on site, where a physical examination and vital signs will be performed, blood will be collected, Clinical Global Impression - Improvement (CGI-I) scale and Quality of Life using the SF-12 QoL scale will be assessed, and compliance will be assessed. Participants will be monitored throughout the study, including any adverse events.
- Conditions
- All
- Being tested
- KSM-66 Ashwagandha Root Extract
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSM-66 Ashwagandha Root ExtractDietary supplement
Participants will take KSM-66 Ashwagandha root extract 300mg twice a day for the duration of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) due to KSM-66 Ashwagandha (Withania Somnifera) over 12 months period
Measured: 12 months
Secondary outcomes (12)
Liver Parameters
Changes in laboratory values for serum alanine transaminase 6 months and 12 months after start of KSM-66 Ashwagandha
Measured: 6 and 12 months
Liver Parameters
Changes in laboratory values for aspartate transaminase 6 months and 12 months after start of KSM-66 Ashwagandha
Measured: 6 and 12 months
Liver Parameters
Changes in laboratory values for alkaline phosphatase 6 months and 12 months after start of KSM-66 Ashwagandha
Measured: 6 and 12 months
Liver Parameters
Changes in laboratory values for bilirubin 6 months and 12 months after start of KSM-66 Ashwagandha
Measured: 6 and 12 months
Renal Parameters
Changes in laboratory values for renal parameters (serum creatinine, blood urea nitrogen) 6 months and 12 months after start of KSM-66 Ashwagandha
Measured: 6 and 12 months
Muscle Parameters
Changes in laboratory values for serum creatine phosphokinase-MB 6 months and 12 months after start of KSM-66 Ashwagandha
Measured: 6 and 12 months
Sex Hormones
Changes in laboratory values for serum testosterone 6 months and 12 months after start of KSM-66 Ashwagandha
Measured: 6 and 12 months
Muscle Parameters
Changes in laboratory values for muscle parameters (serum creatine phosphokinase-MB), thyroid parameters (serum TSH, T3 and T4), and sex hormones (serum testosterone) 6 months and 12 months after start of KSM-66 Ashwagandha
Measured: 6 and 12 months
Thyroid Parameters
Changes in laboratory values for thyroid parameters (serum TSH, T3 and T4) 6 months and 12 months after start of KSM-66 Ashwagandha
Measured: 6 and 12 months
Serum Cortisol and Testosterone
Changes in laboratory values for serum cortisol and serum testosterone 6 months and 12 months after start of KSM-66 Ashwagandha
Measured: 6 and 12 months
Clinical Global Impression
Clinical Global Impression - Improvement scale (CGI-I) score 6 months and 12 months after start of KSM-66 Ashwagandha [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: 6 and 12 months
Quality of Life Score
Changes from baseline in the Quality of Life (SF-12 QoL) scores 6 months and 12 months after start of KSM-66 Ashwagandha
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start15 Feb 2024
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244147
- Sponsor's protocol ID
- Ixoreal-Safety-CT-06-22
- Status last verified
- Nov 2025
- First submitted
- 24 Jan 2024
- Last updated
- 6 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salve J, Kale S, Prajapati BL, Sparavigna A, Savant M, Ademola J, Langade D. Safety of 12-Months Administration of Ashwagandha ( Withania somnifera ) Standardized Root Extract in Healthy Adults: A Prospective, Observational Study. Phytother Res. 2026 Aug;40(8):4802-4812. doi: 10.1002/ptr.70096. Epub 2025 Oct 8.
PubMed 41063394
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Safety and Efficacy of KSM-66 Ashwagandha (Standardized Root Extract of Withania Somnifera) in Adults: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06244147
- Acronym / sponsor ID
- Ixoreal-Safety-CT-06-22
- Conditions
- All
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 6 Feb 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.
The primary objective is to evaluate the clinical safety of KSM-66 Ashwagandha (Withania Somnifera) on long-term administration over 12 months. The secondary objectives are to evaluate the laboratory safety of KSM-66 Ashwagandha (Withania Somnifera) on long-term administration over 12 months and to evaluate the efficacy of KSM-66 Ashwagandha (Withania Somnifera) on long-term administration over 12 months.
Detailed description
To qualify for this study, participant must be male or female between 18 and 65 years old and prescribed KSM-66 Ashwagandha by their clinicians for a long-term period. Participants must have no plan to commence any other alternative treatment modality for their conditions. Participants must be willing to sign an informed consent document and to comply with all study related procedures. Participants must have a body mass index between 25 and 39.9 kg/m2.
In this study, a total of 200 subjects will be included across 4-5 study sites, for a total duration of 12 months. At the initial visit, prospective patients will be screened for enrollment based on the requirements of the study, medical history, and clinical examination. Before starting any study related procedures, participants will be explained about the study in detail and a written informed consent will be obtained from participants prior to participation in this study. This document is a part of the written informed consent procedure. A detailed medical history including the associated conditions will be recorded. A general and physical examination will be performed to detect any abnormal parameters. If participants meet the eligibility criteria, they will be enrolled in the study.
After enrollment in the study, participants will be asked to consume Ashwagandha 300 mg root extract capsule orally twice daily, morning and evening after breakfast and dinner with a glass of water. At Visit 1 (Screening/Enrollment/Baseline Visit - Day -3 to Day 0), demography and medical history will be taken, physical examination and vital signs will be performed, blood will be collected, study medication will be dispensed, and Clinical Global Impression - Improvement (CGI-I) scale and Quality of Life using the SF-12 QoL scale will be assessed.
At Visits 2 to 6 (Months 1, 2, 3, 4, 5), participants will follow up remotely via a phone call. Compliance and concomitant medication will be noted.
At Visit 7 (Month 7), participants will follow up on site, where a physical examination and vital signs will be performed, blood will be collected, study medication will be dispensed, Clinical Global Impression - Improvement (CGI-I) scale and Quality of Life using the SF-12 QoL scale will be assessed, and compliance will be assessed.
At Visits 8 to 12 (Months 7, 8, 9, 10, 11), participants will follow up remotely via a phone call. Compliance and concomitant medication will be noted.
At Visit 13 (Final Visit - Month 12), participants will follow up on site, where a physical examination and vital signs will be performed, blood will be collected, Clinical Global Impression - Improvement (CGI-I) scale and Quality of Life using the SF-12 QoL scale will be assessed, and compliance will be assessed. Participants will be monitored throughout the study, including any adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 200 subjects who are prescribed KSM-66 Ashwagandha by their clinicians for long-term period for their respective health conditions will be included for this observational study.
Key inclusion criteria (5 listed)
- Adults (male and female) aged between 18 and 65 years.
- Prescribed KSM-66 Ashwagandha by their clinicians for long-term period.
- 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.
- Participants with Body mass index between 25 and 39.9 kg/m2.
Key exclusion criteria (8 listed)
- Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to 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).
- Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
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 |
|---|---|---|
| KSM-66 Ashwagandha Root ExtractParticipants will take KSM-66 Ashwagandha root extract 300mg twice a day for the duration of the study. | Dietary supplement | – |
Primary outcome
Adverse Events
Time frame: 12 months
Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) due to KSM-66 Ashwagandha (Withania Somnifera) over 12 months period
12 secondary outcomes
Liver Parameters
Time frame: 6 and 12 months
Liver Parameters
Time frame: 6 and 12 months
Liver Parameters
Time frame: 6 and 12 months
Liver Parameters
Time frame: 6 and 12 months
Renal Parameters
Time frame: 6 and 12 months
Muscle Parameters
Time frame: 6 and 12 months
Sex Hormones
Time frame: 6 and 12 months
Muscle Parameters
Time frame: 6 and 12 months
Thyroid Parameters
Time frame: 6 and 12 months
Serum Cortisol and Testosterone
Time frame: 6 and 12 months
Clinical Global Impression
Time frame: 6 and 12 months
Quality of Life Score
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Derived from this study: PubMed 41063394Salve J, Kale S, Prajapati BL, Sparavigna A, Savant M, Ademola J, Langade D. Safety of 12-Months Administration of Ashwagandha ( Withania somnifera ) Standardized Root Extract in Healthy Adults: A Prospective, Observational Study. Phytother Res. 2026 Aug;40(8):4802-4812. doi: 10.1002/ptr.70096. Epub 2025 Oct 8.
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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. 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?
An observational study of All, 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 6 Nov 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06244147, which also lists 1 linked publication.
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 6 Nov 2025.