InsomniaEarly Phase 1NCT07754383
Qing-Xin-Jiao-Tai Decoction for Insomnia Comorbid With Obesity Presenting With Heart-Kidney Non-interaction Syndrome
A Early Phase 1 study testing Qingxin Jiaotai Decoction in people with Insomnia and Obesity, run by Fohow Pharmaceutical Group at 1 site in China.
Trial summary
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of Qing-Xin-Jiao-Tai Decoction (QXJTD), a Traditional Chinese Medicine formula, in treating adults (aged 18-65) suffering from both insomnia and obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Qingxin Jiaotai Decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 1 Oct 2030
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who meet both diagnostic criteria for sleep disorders and obesity, and have a Pittsburgh Sleep Quality Index (PSQI) score exceeding 7
- Meet the TCM syndrome differentiation criteria for either the heart-kidney disharmony syndrome or the liver-fire disturbing the heart syndrome
- Aged 18-65, male or female
- Those who can actively cooperate with oral Chinese medicine treatment
- Voluntarily accept this study and sign the informed consent form
Who cannot join
- Patients with severe cardiovascular and cerebrovascular diseases, hematological system diseases, severe liver and kidney dysfunction, tumors, and other severe organic diseases
- Individuals with a history of allergy to the study drug or with an allergic constitution
- Women planning to become pregnant, pregnant, or breastfeeding
- Currently taking or having taken sedative traditional Chinese patent medicines and simple preparations within 4 weeks prior to enrollment, or having used semaglutide and other GLP-1 receptor agonists or weight-reducing preparations with long-term weight-loss effects within 12 weeks prior to enrollment
- Those with severe cognitive dysfunction or unable to take care of themselves and therefore unable to cooperate with the clinical trial protocol
- Patients with severe anxiety, depression [Self-rating Anxiety Scale (SAS) score ≥70, Self-rating Depression Scale (SDS) score ≥73], mania, schizophrenia, and suicidal tendencies.
- Individuals who are severely allergic to PSG electrode patches, or who cannot cooperate with polysomnography (PSG) and heart rate variability (HRV) testing due to work/lifestyle habits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Haidian
Zijing Wu, +8618905993524, wzjjjing@163.com
About this study
Official title: Intelligent Diagnosis and Effective Prescription Verification of Sleep Disorders Complicated With Obesity Based on Disease-syndrome Combination
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of Qing-Xin-Jiao-Tai Decoction (QXJTD), a Traditional Chinese Medicine formula, in treating adults (aged 18-65) suffering from both insomnia and obesity. Specifically, the study targets patients diagnosed with Heart-Kidney Non-interaction syndrome. In this study, 72 eligible participants will be randomly assigned to receive either QXJTD granules or a matching placebo twice daily for 8 weeks. Both groups will concurrently receive a personalized lifestyle intervention program that includes structured dietary and exercise guidance. The primary purpose of this research is to determine if QXJTD combined with lifestyle modifications can significantly improve sleep quality and promote weight loss compared to the placebo. The primary endpoints evaluated will be objective sleep parameters measured via overnight polysomnography, the percentage of body weight lost, and subjective sleep improvements assessed by the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI). By evaluating these outcomes, the researchers hope to provide a safe and effective integrative treatment strategy for patients struggling with this complex comorbidity.
- Being tested
- Qingxin Jiaotai Decoction, Placebo
- Keywords
- Insomnia, Obesity, Medicine, Chinese Traditional, Autonomic Nervous System, Randomized Controlled Trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qingxin Jiaotai DecoctionDrug
Also called Qingxin Jiaotai Decoction Combined with Personalized Lifestyle Intervention Plan
Participants in the experimental group will receive Qing-Xin-Jiao-Tai Decoction (QXJTD) granules, custom-prepared by the Preparation Room of Xiyuan Hospital. It is administered orally twice daily, 1 sachet per dose dissolved in 250 mL of warm water, taken 30 minutes before lunch and dinner for 12 weeks. QXJTD comprises 11 Traditional Chinese Medicine herbs, including Fructus Tritici Levis, Herba Lophatheri, Herba Menthae, Semen Nelumbinis, Bulbus Lilii, Concha Ostreae, Colla Corii Asini, Fructus Amomi, Poria cum Pini Radice, Cortex Cinnamomi, and Semen Ziziphi Spinosae. Concurrently, participants will adhere to a standardized, personalized lifestyle intervention (PLSI) program managed via a dedicated WeChat mini-program, which incorporates tailored dietary calorie/macro calculations (carbohydrates 50%-65%, proteins 10%-15%, fats 20%-30%), weekly structured aerobic/resistance exercise prescriptions (at least 150 minutes/week), and behavioral monitoring by a multidisciplinary team.
PlaceboDrug
Also called Placebo Combined with Personalized Lifestyle Intervention Program
Participants in the control group will receive a matched placebo decoction in granule form, manufactured to be identical to QXJTD in appearance, color, odor, and taste. To ensure blinding efficacy and baseline contrast, the active ingredient content of the prepared placebo is strictly controlled to less than 10% of the active ingredients in QXJTD. The administration method is identical to the experimental group: orally twice daily, 1 sachet per dose dissolved in 250 mL of warm water 30 minutes before lunch and dinner for 12 weeks. Participants will simultaneously receive the exact same personalized lifestyle intervention (PLSI) plan (encompassing dietary management, exercise prescriptions, and WeChat mini-program digital monitoring) as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Qingxin Jiaotai Decoction + Personalized Lifestyle Intervention Plan Receives: Drug: Qingxin Jiaotai Decoction |
| Control Group | Placebo comparator | Placebo control + personalized lifestyle intervention program Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body weight will be measured in kilograms using a calibrated digital scale.
Measured: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Body Fat Percentage Assessed by Bioelectrical Impedance Analysis (BIA)
Body fat percentage will be measured using the InBody 770 Body Composition Analyzer.
Measured: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA)
Skeletal muscle mass (in kilograms) will be measured using the InBody 770 Body Composition Analyzer.
Measured: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Waist-to-Hip Ratio (WHR)
WHR is calculated by dividing waist circumference (in centimeters) by hip circumference (in centimeters).
Measured: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Pittsburgh Sleep Quality Index (PSQI) Score
The PSQI is a self-report questionnaire that assesses sleep quality. The total global score ranges from 0 to 21. Higher scores indicate worse sleep quality (a worse outcome).
Measured: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Insomnia Severity Index (ISI) Score
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The total score ranges from 0 to 28. Higher scores indicate greater insomnia severity (a worse outcome).
Measured: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Total Sleep Time (TST) Assessed by Polysomnography (PSG)
TST is defined as the total amount of sleep time scored during the total overnight recording time, measured in minutes.
Measured: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Sleep Efficiency (SE) Assessed by Polysomnography (PSG)
Sleep efficiency is calculated as the ratio of Total Sleep Time to Time in Bed, expressed as a percentage (%).
Measured: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Secondary outcomes (9)
Number of Participants With Clinically Significant Abnormalities in Blood Routine Test
Safety will be assessed by counting the number of participants who experience treatment-emergent, clinically significant abnormal values in blood routine tests.
Measured: Baseline (Week 0), Endpoint (Week 8)
Number of Participants With Clinically Significant Abnormalities in Liver and Kidney Function Tests
Safety will be assessed by counting the number of participants who experience treatment-emergent, clinically significant abnormal values in liver and kidney function tests.
Measured: Baseline (Week 0), Endpoint (Week 8)
Number of Participants With Clinically Significant Abnormalities in Urinalysis
Safety will be assessed by counting the number of participants who experience treatment-emergent, clinically significant abnormal values in routine urinalysis.
Measured: Baseline (Week 0), Endpoint (Week 8)
Number of Participants With Clinically Significant Abnormalities on Electrocardiogram (ECG)
Safety will be assessed by counting the number of participants who present with treatment-emergent, clinically significant abnormal findings on a standard 12-lead ECG.
Measured: Baseline (Week 0), Endpoint (Week 8)
Sleep and Quality of Life Assessment Scale
Measured: Baseline (Week 0), Endpoint (Week 8)
The frequency, dosage, and date of taking sedative, anti-anxiety, and anti-depression western medications
Measured: Baseline (Week 0), Endpoint (Week 8)
Serum Interleukin-6 (IL-6) Concentration
IL-6 concentration will be measured from fasting venous blood samples to evaluate systemic inflammation.
Measured: Baseline (Week 0), Endpoint (Week 8)
Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration
TNF-α concentration will be measured from fasting venous blood samples to evaluate systemic inflammation.
Measured: Baseline (Week 0), Endpoint (Week 8)
Serum High-sensitivity C-reactive Protein (hs-CRP) Concentration
hs-CRP concentration will be measured from fasting venous blood samples to evaluate systemic inflammation.
Measured: Baseline (Week 0), Endpoint (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fohow Pharmaceutical Group
- Sponsor type
- University, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754383
- Sponsor's protocol ID
- 2025XLA162-2
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant privacy and maintain strict confidentiality in accordance with local institutional review board (IRB) policies and national data protection regulations. De-identified aggregate data and secondary study results will be made available through peer-reviewed publications upon study completion.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Diagnosis and Effective Prescription Verification of Sleep Disorders Complicated With Obesity Based on Disease-syndrome Combination
- ClinicalTrials.gov ID
- NCT07754383
- Acronym / sponsor ID
- 2025XLA162-2
- Keywords
- Insomnia, Obesity, Medicine, Chinese Traditional, Autonomic Nervous System, Randomized Controlled Trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Fohow Pharmaceutical GroupUniversity, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 10 Aug 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.
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of Qing-Xin-Jiao-Tai Decoction (QXJTD), a Traditional Chinese Medicine formula, in treating adults (aged 18-65) suffering from both insomnia and obesity. Specifically, the study targets patients diagnosed with Heart-Kidney Non-interaction syndrome. In this study, 72 eligible participants will be randomly assigned to receive either QXJTD granules or a matching placebo twice daily for 8 weeks. Both groups will concurrently receive a personalized lifestyle intervention program that includes structured dietary and exercise guidance. The primary purpose of this research is to determine if QXJTD combined with lifestyle modifications can significantly improve sleep quality and promote weight loss compared to the placebo. The primary endpoints evaluated will be objective sleep parameters measured via overnight polysomnography, the percentage of body weight lost, and subjective sleep improvements assessed by the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI). By evaluating these outcomes, the researchers hope to provide a safe and effective integrative treatment strategy for patients struggling with this complex comorbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Qingxin Jiaotai DecoctionQingxin Jiaotai Decoction + Personalized Lifestyle Intervention Plan |
| Control Group | Placebo comparator | Drug: PlaceboPlacebo control + personalized lifestyle intervention program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals who meet both diagnostic criteria for sleep disorders and obesity, and have a Pittsburgh Sleep Quality Index (PSQI) score exceeding 7
- Meet the TCM syndrome differentiation criteria for either the heart-kidney disharmony syndrome or the liver-fire disturbing the heart syndrome
- Aged 18-65, male or female
- Those who can actively cooperate with oral Chinese medicine treatment
- Voluntarily accept this study and sign the informed consent form
Key exclusion criteria (7 listed)
- Patients with severe cardiovascular and cerebrovascular diseases, hematological system diseases, severe liver and kidney dysfunction, tumors, and other severe organic diseases
- Individuals with a history of allergy to the study drug or with an allergic constitution
- Women planning to become pregnant, pregnant, or breastfeeding
- Currently taking or having taken sedative traditional Chinese patent medicines and simple preparations within 4 weeks prior to enrollment, or having used semaglutide and other GLP-1 receptor agonists or weight-reducing preparations with long-term weight-loss effects within 12 weeks prior to enrollment
- Those with severe cognitive dysfunction or unable to take care of themselves and therefore unable to cooperate with the 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 |
|---|---|---|
| Qingxin Jiaotai DecoctionAlso: Qingxin Jiaotai Decoction Combined with Personalized Lifestyle Intervention PlanParticipants in the experimental group will receive Qing-Xin-Jiao-Tai Decoction (QXJTD) granules, custom-prepared by the Preparation Room of Xiyuan Hospital. It is administered orally twice daily, 1 sachet per dose dissolved in 250 mL of warm water, taken 30 minutes before lunch and dinner for 12 weeks. QXJTD comprises 11 Traditional Chinese Medicine herbs, including Fructus Tritici Levis, Herba Lophatheri, Herba Menthae, Semen Nelumbinis, Bulbus Lilii, Concha Ostreae, Colla Corii Asini, Fructus Amomi, Poria cum Pini Radice, Cortex Cinnamomi, and Semen Ziziphi Spinosae. Concurrently, participants will adhere to a standardized, personalized lifestyle intervention (PLSI) program managed via a dedicated WeChat mini-program, which incorporates tailored dietary calorie/macro calculations (carbohydrates 50%-65%, proteins 10%-15%, fats 20%-30%), weekly structured aerobic/resistance exercise prescriptions (at least 150 minutes/week), and behavioral monitoring by a multidisciplinary team. | Drug | Experimental Group |
| PlaceboAlso: Placebo Combined with Personalized Lifestyle Intervention ProgramParticipants in the control group will receive a matched placebo decoction in granule form, manufactured to be identical to QXJTD in appearance, color, odor, and taste. To ensure blinding efficacy and baseline contrast, the active ingredient content of the prepared placebo is strictly controlled to less than 10% of the active ingredients in QXJTD. The administration method is identical to the experimental group: orally twice daily, 1 sachet per dose dissolved in 250 mL of warm water 30 minutes before lunch and dinner for 12 weeks. Participants will simultaneously receive the exact same personalized lifestyle intervention (PLSI) plan (encompassing dietary management, exercise prescriptions, and WeChat mini-program digital monitoring) as the experimental group. | Drug | Control Group |
Primary outcome
Body Weight
Time frame: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Body weight will be measured in kilograms using a calibrated digital scale.
Body Fat Percentage Assessed by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Body fat percentage will be measured using the InBody 770 Body Composition Analyzer.
Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Skeletal muscle mass (in kilograms) will be measured using the InBody 770 Body Composition Analyzer.
Waist-to-Hip Ratio (WHR)
Time frame: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
WHR is calculated by dividing waist circumference (in centimeters) by hip circumference (in centimeters).
Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
The PSQI is a self-report questionnaire that assesses sleep quality. The total global score ranges from 0 to 21. Higher scores indicate worse sleep quality (a worse outcome).
Insomnia Severity Index (ISI) Score
Time frame: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The total score ranges from 0 to 28. Higher scores indicate greater insomnia severity (a worse outcome).
Total Sleep Time (TST) Assessed by Polysomnography (PSG)
Time frame: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
TST is defined as the total amount of sleep time scored during the total overnight recording time, measured in minutes.
Sleep Efficiency (SE) Assessed by Polysomnography (PSG)
Time frame: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)
Sleep efficiency is calculated as the ratio of Total Sleep Time to Time in Bed, expressed as a percentage (%).
9 secondary outcomes
Number of Participants With Clinically Significant Abnormalities in Blood Routine Test
Time frame: Baseline (Week 0), Endpoint (Week 8)
Number of Participants With Clinically Significant Abnormalities in Liver and Kidney Function Tests
Time frame: Baseline (Week 0), Endpoint (Week 8)
Number of Participants With Clinically Significant Abnormalities in Urinalysis
Time frame: Baseline (Week 0), Endpoint (Week 8)
Number of Participants With Clinically Significant Abnormalities on Electrocardiogram (ECG)
Time frame: Baseline (Week 0), Endpoint (Week 8)
Sleep and Quality of Life Assessment Scale
Time frame: Baseline (Week 0), Endpoint (Week 8)
The frequency, dosage, and date of taking sedative, anti-anxiety, and anti-depression western medications
Time frame: Baseline (Week 0), Endpoint (Week 8)
Serum Interleukin-6 (IL-6) Concentration
Time frame: Baseline (Week 0), Endpoint (Week 8)
Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration
Time frame: Baseline (Week 0), Endpoint (Week 8)
Serum High-sensitivity C-reactive Protein (hs-CRP) Concentration
Time frame: Baseline (Week 0), Endpoint (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 10 Aug 2026.
- Individual participant dataSharing planned: No. To protect participant privacy and maintain strict confidentiality in accordance with local institutional review board (IRB) policies and national data protection regulations. De-identified aggregate data and secondary study results will be made available through peer-reviewed publications upon study completion.
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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 Early Phase 1 study testing Qingxin Jiaotai Decoction in people with Insomnia and Obesity, run by Fohow Pharmaceutical Group at 1 site in China.
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 7 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 10 Aug 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 China. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jin Zhang (+86 10 62835180, xyyyzwb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Baseline (Week 0), Mid-term (Week 4), Endpoint (Week 8), Follow-up (Week 12)). The study lists 8 primary outcomes in all. 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 10 Aug 2026.