InsomniaPhase 2NCT07504536
Ning Shen Dan Xiang Gao Fang for Heart-Kidney Disharmony Insomnia
A Phase 2 study testing Ningshen Danxiang Donkey-hide Gelatin Medicated Paste and Ningshen Danxiang Agar Medicated Paste (agar as excipient) in people with Insomnia, run by Shanghai 7th People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Ning Shen Dan Xiang paste combined with Ejiao (donkey-hide gelatin) works better than Ning Shen Dan Xiang paste combined with agar (placebo substitute) to treat chronic insomnia of the heart-kidney disharmony type in adults. It will also assess safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Ningshen Danxiang Donkey-hide Gelatin Medicated Paste and Ningshen Danxiang Agar Medicated Paste (agar as excipient)
- 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 siteChina
- Study dates
- 15 Mar 2026to 31 Dec 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the diagnostic criteria for chronic insomnia and simultaneously meets the diagnostic criteria for heart-kidney disharmony syndrome.
- Pittsburgh Sleep Quality Index (PSQI) total score > 7 points.
- No insomnia treatment medication received within 2 weeks prior to the trial.
- Age > 18 years, gender unrestricted.
- Voluntarily participates in this study, signs the informed consent form, and is willing to take medication on time and undergo follow-up visits.
Who cannot join
- Pregnant or lactating women.
- Patients with an allergic constitution or hypersensitivity to multiple drugs.
- Patients with primary diseases of the heart, liver, kidney, respiratory system, nervous system, hematopoietic system, or other systems, who are assessed by the investigator as unsuitable for participation in this study.
- Patients with schizophrenia, bipolar affective disorder, major depressive disorder (Hamilton Depression Rating Scale HAMD17 > 24 points), anxiety disorder (Hamilton Anxiety Rating Scale score ≥ 21 points), or other psychiatric disorders, as well as patients with senile dementia.
- Patients with insomnia induced by drugs, strong coffee/tea, or other substances, or those who have taken Chinese or Western medicines for the treatment of insomnia within 2 weeks prior to enrollment.
- History of alcohol or drug abuse.
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- Laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of the normal range, or creatinine (Cr) > the upper limit of the normal range.
- Patients who have participated in any other clinical trial within the past 3 months.
- Patients whom the investigator considers unsuitable for participation in this clinical trial.
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
Shanghai Seventh People's Hospital
Shanghai, Pudong New Area
Yunduan Song, Ph.D, 021-58670561 ext. 6730, qiyuankyc@163.com
About this study
Official title: A Randomized, Double-Blind, Dual-Control (Internal and External) Clinical Study of Ning Shen Dan Xiang Gao Fang in the Treatment of Insomnia (Heart-Kidney Disharmony Type)
The goal of this clinical trial is to learn if Ning Shen Dan Xiang paste combined with Ejiao (donkey-hide gelatin) works better than Ning Shen Dan Xiang paste combined with agar (placebo substitute) to treat chronic insomnia of the heart-kidney disharmony type in adults. It will also assess safety. The main question is:
- Does Ning Shen Dan Xiang + Ejiao improve sleep quality more than the placebo version, as shown by the change in Pittsburgh Sleep Quality Index (PSQI) score after 8 weeks?
Read more
Researchers will compare the two pastes (identical in appearance and taste except for Ejiao) and use published literature data as an additional external control.
Participants will:
Take 20 g of the assigned paste twice daily (morning and evening) for 8 weeks. Attend clinic visits at baseline, week 4, week 8, and 1 week after stopping (week 9 follow-up).
Complete PSQI and ISI questionnaires, keep a daily electronic sleep diary, provide blood/stool samples, and undergo safety monitoring (blood/urine tests, ECG, vital signs, and side effect checks).
Read the detailed description
This is a randomized, double-blind, parallel-group clinical trial with internal and external controls to evaluate the efficacy and safety of Ningshen Danxiang Gelatin Formula (Ningshen Danxiang combined with donkey-hide gelatin) compared to Ningshen Danxiang Agar Formula (Ningshen Danxiang combined with agar placebo) in treating insomnia of the heart-kidney disharmony type according to Traditional Chinese Medicine (TCM). The study aims to assess changes in Pittsburgh Sleep Quality Index (PSQI) scores from baseline after 8 weeks of treatment. Sixty adult participants (>18 years) with chronic insomnia, PSQI >7, and meeting TCM criteria for heart-kidney disharmony will be randomized 1:1 to receive either the experimental formula (20g twice daily) or control (20g twice daily) for 8 weeks. External controls will be synthesized from literature data on placebo and standard treatments for insomnia. Key secondary outcomes include Insomnia Severity Index (ISI), TCM syndrome scores, sleep logs via electronic patient-reported outcomes (ePRO)and rebound rates. Safety will be monitored through adverse events, laboratory tests, and vital signs.
- Conditions
- Insomnia
- Being tested
- Ningshen Danxiang Donkey-hide Gelatin Medicated Paste, Ningshen Danxiang Agar Medicated Paste (agar as excipient)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ningshen Danxiang Donkey-hide Gelatin Medicated PasteDrug
Take 1 bag each time (each bag contains 20 g of crude herbal drug). Dissolve in warm boiled water and take orally, once in the morning and once in the evening. It is optimal to take on an empty stomach. Continue for 8 consecutive weeks. If gastrointestinal discomfort occurs when taken on an empty stomach, it may also be taken after meals.
Ningshen Danxiang Agar Medicated Paste (agar as excipient)Drug
Take 1 bag each time (each bag contains 20 g of crude herbal drug). Dissolve in warm boiled water and take orally, once in the morning and once in the evening. It is optimal to take on an empty stomach. Continue for 8 consecutive weeks. If gastrointestinal discomfort occurs when taken on an empty stomach, it may also be taken after meals.
| Study group | Role | What they receive |
|---|---|---|
| Ningshen Danxiang Donkey-hide Gelatin Medicated Paste | Experimental | Formula Composition: Mori Fructus (Sang Shen / Mulberry fruit) 300 g Ligustri Lucidi Fructus (Nü Zhen Zi / Glossy privet fruit) 300 g Polygoni Multiflori Caulis (Shou Wu Teng / Fleeceflower stem) 300 g Sedum aizoon Herba (Jing Tian San Qi / Aizoon stonecrop) 300 g Salviae Miltiorrhizae Radix et Rhizoma (Dan Shen / Red sage root) 300 g Citri Medica Fructus (Xiang Yuan / Fragrant citron fruit) 100 g Cyperi Rhizoma (Xiang Fu / Nutgrass rhizome) 100 g Asini Corii Colla (E Jiao / Donkey-hide gelatin) 500 g Receives: Drug: Ningshen Danxiang Donkey-hide Gelatin Medicated Paste |
| Ningshen Danxiang Agar Medicated Paste (agar as excipient) | Placebo comparator | Formula Composition: Mori Fructus (Sang Shen / Mulberry fruit) 300 g Ligustri Lucidi Fructus (Nü Zhen Zi / Glossy privet fruit) 300 g Polygoni Multiflori Caulis (Shou Wu Teng / Fleeceflower stem) 300 g Sedum aizoon Herba (Jing Tian San Qi / Aizoon stonecrop) 300 g Salviae Miltiorrhizae Radix et Rhizoma (Dan Shen / Red sage root) 300 g Citri Medica Fructus (Xiang Yuan / Fragrant citron fruit) 100 g Cyperi Rhizoma (Xiang Fu / Nutgrass rhizome) 100 g Agar 500 g Receives: Drug: Ningshen Danxiang Agar Medicated Paste (agar as excipient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
Use the PSQI scale to assess the subjects' sleep quality . The PSQI consists of 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each dimension is scored from 0 to 3 points, with higher scores indicating greater severity of sleep disturbance.
The total PSQI score ranges from 0 to 21. A PSQI score >7 indicates poor sleep quality, while a PSQI score ≤7 indicates good sleep quality.
Measured: Baseline, Week 4, Week 8, Follow-up (Week 9)
Secondary outcomes (7)
Insomnia Severity Index (ISI)
Use the ISI scale to assess the severity of insomnia in the subjects. This scale consists of 7 questions, each scored from 0 to 4 points (5 grading levels in total). No clinically significant insomnia (i.e., cured): 0 ≤ ISI ≤ 7; mild insomnia: 8 ≤ ISI ≤ 14; moderate insomnia: 15 ≤ ISI ≤ 21; severe insomnia: 22 ≤ ISI ≤ 28.
Measured: Baseline, Week 4, Week 8
Change in Daily Total Sleep Time(TST)
Assessed via an Electronic Patient-Reported Outcome (ePRO) daily sleep diary. This measure reports the change in the patient's daily total sleep time.
Unit of Measure: Minutes ( or Hours)
Measured: Baseline, Week 4, Week 8
Change in Sleep Onset Latency (SOL)
SOL is defined as the time interval from the point the patient attempts to fall asleep until the onset of sleep. Data is recorded daily by patients via an electronic Patient-Reported Outcome (ePRO) sleep diary. Unit of Measure: Minutes
Measured: Baseline, Week 4, Week 8
Change in Wake After Sleep Onset (WASO)
Assessed via an electronic Patient-Reported Outcome(ePRO) daily sleep diary. WASO refers to the total amount of time the patient spent awake after initially falling asleep and before fully waking up for the day.Unit of Measure: Minutes
Measured: Baseline, Week 4, Week 8
Change in Number of Awakenings
Assessed via an Assessed via an electronic Patient-Reported Outcome(ePRO) daily sleep diary. This measure records the total frequency of nighttime awakenings experienced by the patient after initial sleep onset.
Unit of Measure: Count (or Number of awakenings)
Measured: Baseline, Week 4, Week 8
Traditional Chinese Medicine(TCM) Syndrome Score - Efficacy Evaluation
The TCM symptom grading and quantification criteria include three main symptoms-difficulty falling asleep, vexation and insomnia, and excessive dreaming-which are scored on a 0, 2, 4, or 6 scale according to severity and frequency; the nine secondary symptoms-palpitations, tinnitus, soreness and weakness of the waist and knees, tidal fever with night sweats, vexing heat in the five centers, dry throat, dry mouth, seminal emission in men, and irregular menstruation in women-are scored on a 0-3 scale according to severity and frequency. Tongue and pulse: red tongue tip with scant coating and a thready rapid pulse.The Nimodipine method is used to assess the therapeutic efficacy of TCM syndromes. The syndrome score calculation formula is:
((pre-treatment score - post-treatment score)/pre-treatment score)*100% Effective: All symptoms and signs show improvement; syndrome score reduction ≥50%; Ineffective: Symptoms and signs show no obvious improvement; syndrome score reduction <50%.
Measured: Baseline, Week 4, Week 8, Follow-up (Week 9)
Rebound Insomnia Rate
Rebound insomnia is defined as Pittsburgh Sleep Quality Index (PSQI) total score > baseline score at 1 week following drug discontinuation
Measured: 1 week after treatment discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start15 Mar 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2028 (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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 7th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine, DongE E Jiao Coporation Limited
- Responsible party
- Principal investigator, Xiaodan Zhang, Shanghai 7th People's Hospital
- Investigators
- Xiaodan Zhang, Ph.D, Principal investigator, Shanghai 7th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504536
- Sponsor's protocol ID
- QY-NSDXGF-001
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 1 Apr 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Dual-Control (Internal and External) Clinical Study of Ning Shen Dan Xiang Gao Fang in the Treatment of Insomnia (Heart-Kidney Disharmony Type)
- ClinicalTrials.gov ID
- NCT07504536
- Acronym / sponsor ID
- QY-NSDXGF-001
- Conditions
- Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai 7th People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine, DongE E Jiao Coporation Limited
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Apr 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.
The goal of this clinical trial is to learn if Ning Shen Dan Xiang paste combined with Ejiao (donkey-hide gelatin) works better than Ning Shen Dan Xiang paste combined with agar (placebo substitute) to treat chronic insomnia of the heart-kidney disharmony type in adults. It will also assess safety. The main question is:
- Does Ning Shen Dan Xiang + Ejiao improve sleep quality more than the placebo version, as shown by the change in Pittsburgh Sleep Quality Index (PSQI) score after 8 weeks?
Researchers will compare the two pastes (identical in appearance and taste except for Ejiao) and use published literature data as an additional external control.
Participants will:
Take 20 g of the assigned paste twice daily (morning and evening) for 8 weeks. Attend clinic visits at baseline, week 4, week 8, and 1 week after stopping (week 9 follow-up).
Complete PSQI and ISI questionnaires, keep a daily electronic sleep diary, provide blood/stool samples, and undergo safety monitoring (blood/urine tests, ECG, vital signs, and side effect checks).
Detailed description
This is a randomized, double-blind, parallel-group clinical trial with internal and external controls to evaluate the efficacy and safety of Ningshen Danxiang Gelatin Formula (Ningshen Danxiang combined with donkey-hide gelatin) compared to Ningshen Danxiang Agar Formula (Ningshen Danxiang combined with agar placebo) in treating insomnia of the heart-kidney disharmony type according to Traditional Chinese Medicine (TCM). The study aims to assess changes in Pittsburgh Sleep Quality Index (PSQI) scores from baseline after 8 weeks of treatment. Sixty adult participants (>18 years) with chronic insomnia, PSQI >7, and meeting TCM criteria for heart-kidney disharmony will be randomized 1:1 to receive either the experimental formula (20g twice daily) or control (20g twice daily) for 8 weeks. External controls will be synthesized from literature data on placebo and standard treatments for insomnia. Key secondary outcomes include Insomnia Severity Index (ISI), TCM syndrome scores, sleep logs via electronic patient-reported outcomes (ePRO)and rebound rates. Safety will be monitored through adverse events, laboratory tests, and vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ningshen Danxiang Donkey-hide Gelatin Medicated Paste | Experimental | Drug: Ningshen Danxiang Donkey-hide Gelatin Medicated PasteFormula Composition: Mori Fructus (Sang Shen / Mulberry fruit) 300 g Ligustri Lucidi Fructus (Nü Zhen Zi / Glossy privet fruit) 300 g Polygoni Multiflori Caulis (Shou Wu Teng / Fleeceflower stem) 300 g Sedum aizoon Herba (Jing Tian San Qi / Aizoon stonecrop) 300 g Salviae Miltiorrhizae Radix et Rhizoma (Dan Shen / Red sage root) 300 g Citri Medica Fructus (Xiang Yuan / Fragrant citron fruit) 100 g Cyperi Rhizoma (Xiang Fu / Nutgrass rhizome) 100 g Asini Corii Colla (E Jiao / Donkey-hide gelatin) 500 g |
| Ningshen Danxiang Agar Medicated Paste (agar as excipient) | Placebo comparator | Drug: Ningshen Danxiang Agar Medicated Paste (agar as excipient)Formula Composition: Mori Fructus (Sang Shen / Mulberry fruit) 300 g Ligustri Lucidi Fructus (Nü Zhen Zi / Glossy privet fruit) 300 g Polygoni Multiflori Caulis (Shou Wu Teng / Fleeceflower stem) 300 g Sedum aizoon Herba (Jing Tian San Qi / Aizoon stonecrop) 300 g Salviae Miltiorrhizae Radix et Rhizoma (Dan Shen / Red sage root) 300 g Citri Medica Fructus (Xiang Yuan / Fragrant citron fruit) 100 g Cyperi Rhizoma (Xiang Fu / Nutgrass rhizome) 100 g Agar 500 g |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets the diagnostic criteria for chronic insomnia and simultaneously meets the diagnostic criteria for heart-kidney disharmony syndrome.
- Pittsburgh Sleep Quality Index (PSQI) total score > 7 points.
- No insomnia treatment medication received within 2 weeks prior to the trial.
- Age > 18 years, gender unrestricted.
- Voluntarily participates in this study, signs the informed consent form, and is willing to take medication on time and undergo follow-up visits.
Key exclusion criteria (9 listed)
- Pregnant or lactating women.
- Patients with an allergic constitution or hypersensitivity to multiple drugs.
- Patients with primary diseases of the heart, liver, kidney, respiratory system, nervous system, hematopoietic system, or other systems, who are assessed by the investigator as unsuitable for participation in this study.
- Patients with schizophrenia, bipolar affective disorder, major depressive disorder (Hamilton Depression Rating Scale HAMD17 > 24 points), anxiety disorder (Hamilton Anxiety Rating Scale score ≥ 21 points), or other psychiatric disorders, as well as patients with senile dementia.
- Patients with insomnia induced by drugs, strong coffee/tea, or other substances, or those who have taken Chinese or Western medicines for the treatment of insomnia within 2 weeks prior to enrollment.
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 |
|---|---|---|
| Ningshen Danxiang Donkey-hide Gelatin Medicated PasteTake 1 bag each time (each bag contains 20 g of crude herbal drug). Dissolve in warm boiled water and take orally, once in the morning and once in the evening. It is optimal to take on an empty stomach. Continue for 8 consecutive weeks. If gastrointestinal discomfort occurs when taken on an empty stomach, it may also be taken after meals. | Drug | Ningshen Danxiang Donkey-hide Gelatin Medicated Paste |
| Ningshen Danxiang Agar Medicated Paste (agar as excipient)Take 1 bag each time (each bag contains 20 g of crude herbal drug). Dissolve in warm boiled water and take orally, once in the morning and once in the evening. It is optimal to take on an empty stomach. Continue for 8 consecutive weeks. If gastrointestinal discomfort occurs when taken on an empty stomach, it may also be taken after meals. | Drug | Ningshen Danxiang Agar Medicated Paste (agar as excipient) |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Week 4, Week 8, Follow-up (Week 9)
Use the PSQI scale to assess the subjects' sleep quality . The PSQI consists of 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each dimension is scored from 0 to 3 points, with higher scores indicating greater severity of sleep disturbance. The total PSQI score ranges from 0 to 21. A PSQI score >7 indicates poor sleep quality, while a PSQI score ≤7 indicates good sleep quality.
7 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: Baseline, Week 4, Week 8
Change in Daily Total Sleep Time(TST)
Time frame: Baseline, Week 4, Week 8
Change in Sleep Onset Latency (SOL)
Time frame: Baseline, Week 4, Week 8
Change in Wake After Sleep Onset (WASO)
Time frame: Baseline, Week 4, Week 8
Change in Number of Awakenings
Time frame: Baseline, Week 4, Week 8
Traditional Chinese Medicine(TCM) Syndrome Score - Efficacy Evaluation
Time frame: Baseline, Week 4, Week 8, Follow-up (Week 9)
Rebound Insomnia Rate
Time frame: 1 week after treatment discontinuation
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 1 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Xiaodan Zhang, Ph.D principal investigator
Shanghai 7th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ningshen Danxiang Donkey-hide Gelatin Medicated Paste and Ningshen Danxiang Agar Medicated Paste (agar as excipient) in people with Insomnia, run by Shanghai 7th People's Hospital 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 9 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 1 Apr 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Chunyan Zhang, M.D. (021-58670561 ext. 6659, zhcy205@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline, Week 4, Week 8, Follow-up (Week 9)). 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 1 Apr 2026.