Premenstrual SyndromeNCT07441096
Efficacy and Safety of Shatavari Root Extract for Premenstrual Syndrome in Women
A study testing Shatavari Root Extract in people with Premenstrual Syndrome and Women Health, run by SF Research Institute, Inc. at 1 site in United States.
Trial summary
Premenstrual syndrome (PMS) is a common condition that affects women of reproductive age and is associated with emotional, physical, and behavioral symptoms such as mood swings, irritability, stress, sleep problems, fatigue, and abdominal discomfort. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Women Health
- What is being tested?
- Shatavari Root Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2026to 8 Jul 2026
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women aged 18-40 years with intact uterus and ovaries.
- Females with complaints of experiencing mild to moderate PMS confirmed by one baseline cycle using the DRSP.
- PSST sores consistent with PMS and not meeting criteria for severe PMS or PMDD.
- Body mass index 18-35 kg/m2.
- Subject who has given written informed consent to participate in the study and understand the nature of the study.
- Able to read and write in English or any other vernacular language.
- No plan to commence new treatments over the study period.
- Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
Who cannot join
- 1. Participants taking any form of herbal extract in the last 3 months before study entry. 2. Participants who are on hormone replacement therapy (HRT) for more than 3 months. 3. Participants who are pregnant. 4. Participants with irregular menstrual cycles in the past 12 months (cycle length variability >7 days), ≥2 missed cycles in the past 12 months, or amenorrhea ≥60 days. 5. Participants with Present active medical, surgical, and gynaecological problems. 6. Participants with a history of alcohol, tobacco dependence, or any substance abuse. 7. Participants who had undergone bilateral ovariectomy 8. Participants with history of breast or cervical carcinoma 9. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate. 10. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study results difficult. 11. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 12. Participants with demonstrated inability to comply with study procedures or follow-up visits. 13. Participants with inability to attend follow-up visit 14. Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective. 15. Patients who had participated in other clinical trials during the previous 3 months. 16. 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
San Francisco Research Institute
San Francisco, California, 94132
Komal Makwana, 267-466-9000, komalk.sfinstitute@gmail.com
About this study
Official title: Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for the Treatment of Premenstrual Syndrome Symptoms in Women: A Randomized, Double-Blind, Two-Arm, Parallel, Placebo-Controlled Study
Premenstrual syndrome (PMS) is a common condition that affects women of reproductive age and is associated with emotional, physical, and behavioral symptoms such as mood swings, irritability, stress, sleep problems, fatigue, and abdominal discomfort. These symptoms typically occur during the days leading up to menstruation and may interfere with daily activities and overall quality of life.
This study is designed to evaluate the efficacy and safety of Shatavari (Asparagus racemosus) root extract compared with placebo in women with mild to moderate PMS. Eligible participants will be randomly assigned to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. The study will assess changes in PMS symptoms, stress levels, sleep quality, and quality of life using validated questionnaires, along with measurements of salivary cortisol. Safety will be evaluated through clinical laboratory tests and monitoring of adverse events throughout the study.
Read the detailed description
Premenstrual syndrome (PMS) is characterized by recurrent emotional, physical, and behavioral symptoms that occur during the luteal phase of the menstrual cycle and resolve shortly after the onset of menstruation. A significant proportion of women experience PMS, and in many cases the symptoms are severe enough to impair daily functioning, work productivity, and interpersonal relationships. Hormonal fluctuations, stress sensitivity, and neuroendocrine dysregulation are considered key contributors to the condition.
Shatavari (Asparagus racemosus) is a traditional Ayurvedic herb widely used to support women's reproductive health. It is regarded as an adaptogenic and hormonal-modulating botanical, containing bioactive constituents such as steroidal saponins (shatavarins) that may help regulate hormonal balance and stress response. Traditional use and emerging scientific evidence suggest that Shatavari may be beneficial in alleviating mood disturbances, fatigue, sleep problems, and stress-related symptoms commonly associated with PMS.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of a standardized Shatavari root extract in women with mild to moderate PMS. Approximately 160 premenopausal women aged 18 to 40 years will be enrolled across study sites in India and the United States. Eligibility will be confirmed using clinical history and prospective symptom assessment with the Daily Record of Severity of Problems (DRSP) during a baseline cycle.
Participants will be randomized in a 1:1 ratio to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. Study visits will occur at baseline and at Weeks 4, 8, and 12. Efficacy will be evaluated using validated patient-reported outcome measures including the DRSP, Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI), and Women's Quality of Life Questionnaire (WOMQOL). Neuroendocrine stress response will be assessed through salivary cortisol measurements, including cortisol awakening response and bedtime cortisol levels, collected at baseline and at the end of the study.
Safety will be monitored throughout the study through physical examinations, vital signs, laboratory assessments of liver, renal, and thyroid function, and systematic recording of treatment-emergent adverse events and serious adverse events.
The findings of this study are expected to provide clinical evidence regarding the efficacy, safety, and tolerability of Shatavari root extract for the management of premenstrual syndrome symptoms and to support future confirmatory clinical research.
- Conditions
- Premenstrual Syndrome, Women Health
- Being tested
- Shatavari Root Extract, Placebo Capsule
- Keywords
- PMS, Shatavari, Asparagus racemosus
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shatavari Root ExtractDietary supplement
Shatavari (Asparagus racemosus) root extract is a standardized herbal dietary supplement formulated as an oral capsule. Each capsule contains 300 mg of Shatavari root extract standardized to total shatavarins. Participants will take one capsule orally once daily in the morning with water for a duration of 12 weeks.
Placebo CapsuleOther
The placebo is an oral capsule identical in appearance to the active intervention and contains 300 mg of starch. Participants will take one capsule orally once daily in the morning with water for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Shatavari Root Extract | Experimental | Participants assigned to this arm will receive Shatavari (Asparagus racemosus) root extract capsules at a dose of 300 mg taken orally once daily for 12 weeks. Receives: Dietary Supplement: Shatavari Root Extract |
| Placebo (Inactive capsule) | Placebo comparator | Participants assigned to this arm will receive an identical placebo capsule containing starch, taken orally once daily for 12 weeks. Receives: Other: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Daily Record of Severity of Problems (DRSP) Total Score
The Daily Record of Severity of Problems (DRSP) is a validated patient-reported questionnaire used to assess emotional, physical, and functional symptoms associated with premenstrual syndrome (PMS). The DRSP consists of 21 items scored daily from 1 (not at all) to 6 (extreme). The total score ranges from 21 to 126, with higher scores indicating greater symptom severity (worse outcome).
DRSP scores will be recorded daily and averaged/summarized for each assessment visit. This outcome measures the mean change from baseline in DRSP total score, where a reduction in score indicates improvement in premenstrual symptom severity.
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (10)
Change in Perceived Stress Scale (PSS) Score
The Perceived Stress Scale (PSS-10) is a validated 10-item questionnaire assessing the degree to which situations in life are appraised as stressful. Each item is scored from 0 (never) to 4 (very often). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress (worse outcome).
This outcome measures the mean change from baseline in PSS-10 total score, where a reduction in score indicates improvement in perceived stress.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire evaluating sleep quality and disturbances over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome).
This outcome measures the mean change from baseline in PSQI global score, where a reduction in score indicates improvement in sleep quality.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Women's Quality of Life Questionnaire (WOMQOL) Score
The Women's Quality of Life Questionnaire (WOMQOL) evaluates quality of life across physical, psychological, social, and spiritual domains. The total score ranges from 0 to 100, with higher scores indicating better quality of life (better outcome).
This outcome measures the mean change from baseline in WOMQOL total score, where an increase in score indicates improvement in overall quality of life.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Bedtime Salivary Cortisol Level
This outcome evaluates changes in bedtime salivary cortisol levels as a biomarker of stress response. Saliva samples will be collected at bedtime and analyzed using standardized immunoassay methods.
Measured: Baseline and Week 12
Change in Cortisol Awakening Response (CAR)
This outcome measures changes in the cortisol awakening response (CAR), assessed by salivary cortisol collected immediately upon awakening and 30 minutes post-awakening, reflecting hypothalamic-pituitary-adrenal axis activity.
Measured: Baseline and Week 12
Change in Liver Function Parameters
This outcome assesses the mean change in liver function parameters including serum alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), and bilirubin to evaluate hepatic safety of the intervention.
Measured: Baseline and Week 12
Change in Renal Function Parameters
This outcome evaluates the mean change in renal function parameters including serum creatinine and blood urea nitrogen to assess renal safety during the study period.
Measured: Baseline and Week 12
Change in Thyroid Function Parameters
This outcome assesses the mean change in thyroid function parameters including triiodothyronine (T3), thyroxine (T4), and thyroid stimulating hormone (TSH) to monitor thyroid safety.
Measured: Baseline and Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
This outcome measures the number and proportion of participants experiencing treatment-emergent adverse events during the study period, regardless of relationship to the study intervention.
Measured: Baseline, Week 4, Week 8, and Week 12
Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)
This outcome measures the number and proportion of participants experiencing treatment-emergent serious adverse events during the study period.
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start20 Mar 2026 (estimated)
- Primary completion22 Jun 2026 (estimated)
- Study completion8 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Collaborators
- Ixoreal Biomed Private Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441096
- Sponsor's protocol ID
- Ixo/2025/1315/SHT/PMS/GB/02
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for the Treatment of Premenstrual Syndrome Symptoms in Women: A Randomized, Double-Blind, Two-Arm, Parallel, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07441096
- Acronym / sponsor ID
- Ixo/2025/1315/SHT/PMS/GB/02
- Conditions
- Premenstrual Syndrome, Women Health
- Keywords
- PMS, Shatavari, Asparagus racemosus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Collaborators
- Ixoreal Biomed Private Limited
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 22 Jun 2026 (estimated)
- Study completion
- 8 Jul 2026 (estimated)
- First posted
- 27 Feb 2026 (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.
Premenstrual syndrome (PMS) is a common condition that affects women of reproductive age and is associated with emotional, physical, and behavioral symptoms such as mood swings, irritability, stress, sleep problems, fatigue, and abdominal discomfort. These symptoms typically occur during the days leading up to menstruation and may interfere with daily activities and overall quality of life.
This study is designed to evaluate the efficacy and safety of Shatavari (Asparagus racemosus) root extract compared with placebo in women with mild to moderate PMS. Eligible participants will be randomly assigned to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. The study will assess changes in PMS symptoms, stress levels, sleep quality, and quality of life using validated questionnaires, along with measurements of salivary cortisol. Safety will be evaluated through clinical laboratory tests and monitoring of adverse events throughout the study.
Detailed description
Premenstrual syndrome (PMS) is characterized by recurrent emotional, physical, and behavioral symptoms that occur during the luteal phase of the menstrual cycle and resolve shortly after the onset of menstruation. A significant proportion of women experience PMS, and in many cases the symptoms are severe enough to impair daily functioning, work productivity, and interpersonal relationships. Hormonal fluctuations, stress sensitivity, and neuroendocrine dysregulation are considered key contributors to the condition.
Shatavari (Asparagus racemosus) is a traditional Ayurvedic herb widely used to support women's reproductive health. It is regarded as an adaptogenic and hormonal-modulating botanical, containing bioactive constituents such as steroidal saponins (shatavarins) that may help regulate hormonal balance and stress response. Traditional use and emerging scientific evidence suggest that Shatavari may be beneficial in alleviating mood disturbances, fatigue, sleep problems, and stress-related symptoms commonly associated with PMS.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of a standardized Shatavari root extract in women with mild to moderate PMS. Approximately 160 premenopausal women aged 18 to 40 years will be enrolled across study sites in India and the United States. Eligibility will be confirmed using clinical history and prospective symptom assessment with the Daily Record of Severity of Problems (DRSP) during a baseline cycle.
Participants will be randomized in a 1:1 ratio to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. Study visits will occur at baseline and at Weeks 4, 8, and 12. Efficacy will be evaluated using validated patient-reported outcome measures including the DRSP, Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI), and Women's Quality of Life Questionnaire (WOMQOL). Neuroendocrine stress response will be assessed through salivary cortisol measurements, including cortisol awakening response and bedtime cortisol levels, collected at baseline and at the end of the study.
Safety will be monitored throughout the study through physical examinations, vital signs, laboratory assessments of liver, renal, and thyroid function, and systematic recording of treatment-emergent adverse events and serious adverse events.
The findings of this study are expected to provide clinical evidence regarding the efficacy, safety, and tolerability of Shatavari root extract for the management of premenstrual syndrome symptoms and to support future confirmatory clinical research.
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 |
|---|---|---|
| Shatavari Root Extract | Experimental | Dietary Supplement: Shatavari Root ExtractParticipants assigned to this arm will receive Shatavari (Asparagus racemosus) root extract capsules at a dose of 300 mg taken orally once daily for 12 weeks. |
| Placebo (Inactive capsule) | Placebo comparator | Other: Placebo CapsuleParticipants assigned to this arm will receive an identical placebo capsule containing starch, taken orally once daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy women aged 18-40 years with intact uterus and ovaries.
- Females with complaints of experiencing mild to moderate PMS confirmed by one baseline cycle using the DRSP.
- PSST sores consistent with PMS and not meeting criteria for severe PMS or PMDD.
- Body mass index 18-35 kg/m2.
- Subject who has given written informed consent to participate in the study and understand the nature of the study.
Key exclusion criteria (1 listed)
- 1. Participants taking any form of herbal extract in the last 3 months before study entry. 2. Participants who are on hormone replacement therapy (HRT) for more than 3 months. 3. Participants who are pregnant. 4. Participants with irregular menstrual cycles in the past 12 months (cycle length variability >7 days), ≥2 missed cycles in the past 12 months, or amenorrhea ≥60 days. 5. Participants with Present active medical, surgical, and gynaecological problems. 6. Participants with a history of alcohol, tobacco dependence, or any substance abuse. 7. Participants who had undergone bilateral ovariectomy 8. Participants with history of breast or cervical carcinoma 9. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate. 10. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study results difficult. 11. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 12. Participants with demonstrated inability to comply with study procedures or follow-up visits. 13. Participants with inability to attend follow-up visit 14. Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective. 15. Patients who had participated in other clinical trials during the previous 3 months. 16. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
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 |
|---|---|---|
| Shatavari Root ExtractShatavari (Asparagus racemosus) root extract is a standardized herbal dietary supplement formulated as an oral capsule. Each capsule contains 300 mg of Shatavari root extract standardized to total shatavarins. Participants will take one capsule orally once daily in the morning with water for a duration of 12 weeks. | Dietary supplement | Shatavari Root Extract |
| Placebo CapsuleThe placebo is an oral capsule identical in appearance to the active intervention and contains 300 mg of starch. Participants will take one capsule orally once daily in the morning with water for 12 weeks. | Other | Placebo (Inactive capsule) |
Primary outcome
Change in Daily Record of Severity of Problems (DRSP) Total Score
Time frame: Baseline, Week 4, Week 8, and Week 12
The Daily Record of Severity of Problems (DRSP) is a validated patient-reported questionnaire used to assess emotional, physical, and functional symptoms associated with premenstrual syndrome (PMS). The DRSP consists of 21 items scored daily from 1 (not at all) to 6 (extreme). The total score ranges from 21 to 126, with higher scores indicating greater symptom severity (worse outcome). DRSP scores will be recorded daily and averaged/summarized for each assessment visit. This outcome measures the mean change from baseline in DRSP total score, where a reduction in score indicates improvement in premenstrual symptom severity.
10 secondary outcomes
Change in Perceived Stress Scale (PSS) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Women's Quality of Life Questionnaire (WOMQOL) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Bedtime Salivary Cortisol Level
Time frame: Baseline and Week 12
Change in Cortisol Awakening Response (CAR)
Time frame: Baseline and Week 12
Change in Liver Function Parameters
Time frame: Baseline and Week 12
Change in Renal Function Parameters
Time frame: Baseline and Week 12
Change in Thyroid Function Parameters
Time frame: Baseline and Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline, Week 4, Week 8, and Week 12
Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Baseline, Week 4, Week 8, and Week 12
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 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Premenstrual Syndrome
Not yet recruitingPhase 1
MLS101 Study in PMDD
Premenstrual Dysphoric Disorder ( PMDD), PMDD
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
Premenstrual Syndrome, Menstrual Discomfort
RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
Premenstrual Dysphoric Disorder (PMDD)
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 Shatavari Root Extract in people with Premenstrual Syndrome and Women Health, 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 1 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: opening soon, as of the sponsor's last update on 3 Mar 2026. 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 Dr. John Ademola (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?
Change in Daily Record of Severity of Problems (DRSP) Total Score (time frame: Baseline, Week 4, Week 8, and Week 12). 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 3 Mar 2026.