Stroke, IschemicPhase 2BOSSNCT04408261

BuqitongluO Granule for Qi Deficiency and Blood Stasis Syndrome

A Phase 2 study testing Buqitongluo Granule in people with Stroke, Ischemic and Coronary Artery Disease, run by Dongzhimen Hospital, Beijing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The main purpose of this trial is to evaluate the efficacy and safety of Buqitongluo Granule in treating qi deficiency and blood stasis syndrome, and explore the effect of the improvement of qi deficiency and blood stasis syndrome on the prognosis of diseases. Read more about this study

Who is it for?: Ages 35 to 80 years
Conditions the study is for: Stroke, Ischemic, Coronary Artery Disease, Angina Pectoris, Stable
What is being tested?: Buqitongluo Granule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 432 participants
Where: 1 siteChina
Study dates: 22 Jul 2020to Dec 2022
Phase: Phase 2
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 35 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of qi deficiency and blood stasis syndrome
Diagnosis of ischemic stroke
Age ≥ 35 and ≤ 80 years
The interval from the onset to recruitment was 14-30 days
NIHSS score ≥ 4 and ≤ 22
Patient or legally authorized representative has signed informed consent.

Show all 15Show fewer

Diagnosis of qi deficiency and blood stasis syndrome
Diagnosis of stable angina pectoris of coronary artery disease
Age ≥ 35 and ≤ 80 years
Canadian Cardiovascular Society (CCS) Classification of Angina Pectoris classⅠ-Ⅲ
Patient or legally authorized representative has signed informed consent.
Diagnosis of qi deficiency and blood stasis syndrome
Diagnosis of diabetic peripheral neuropathies
Age ≥ 35 and ≤ 80 years
Patient or legally authorized representative has signed informed consent.

Who cannot join

Confirmed secondary stroke caused by tumor, brain trauma, or hematological diseases by clinical examination;
Other conditions that lead to motor dysfunction (e.g. lameness, osteoarthrosis, rheumatoid arthritis, gouty arthritis), which render the neurological function examination unlikely to be assessed;
Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), or renal or hepatic insufficiency (hepatic insufficiency is defined as an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is 1.5 times the upper limit of normal, renal insufficiency is defined as a serum creatinine concentration value that is over the upper limit of normal);
Other conditions or mental disorders which according to the judgement of researchers that restrict evaluation of mental function or render outcomes or follow-up unlikely to be assessed;
Woman with pregnancy, lactation, or woman who wants to be pregnant in recent;
Patient who is allergic to the study drug or has severe allergic constitution;

Show all 30Show fewer

Patient with yellow thick slimy tongue coating;
Patient who has been participated in other drug or device clinical trials in recent 3 months.
Stable angina pectoris of coronary artery disease
Acute coronary syndrome or unstable angina pectoris in the prior 3 months, or other heart diseases (e.g. cardiomyopathy, pericardial disease);
Severe cardiopulmonary insufficiency (congestive heart failure NYHA class IV, severe abnormal pulmonary function), or severe arrhythmias (e.g. rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia);
Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), or renal or hepatic insufficiency (hepatic insufficiency is defined as an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is 1.5 times the upper limit of normal, renal insufficiency is defined as a serum creatinine concentration value that is over the upper limit of normal);
Other conditions or mental disorders which according to the judgement of researchers that restrict evaluation of mental function or render outcomes or follow-up unlikely to be assessed;
Woman with pregnancy, lactation, or woman who wants to be pregnant in recent;
Patient who is allergic to the study drug or has severe allergic constitution;
Patient with yellow thick slimy tongue coating;
Patient who has been participated in other drug or device clinical trials in recent 3 months.
Diabetic peripheral neuropathy
HbA1c >10% in the screening period;
Acute critical disease of diabetes mellitus in the prior 3 months (e.g. hyperglycemia and hypertonic syndrome, diabetic lactic acidosis, diabetic ketoacidosis);
Severe heart disease, brain disease, or kidney disease;
Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), or renal or hepatic insufficiency (hepatic insufficiency is defined as an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is 1.5 times the upper limit of normal, renal insufficiency is defined as a serum creatinine concentration value that is over the upper limit of normal);
Patient with spinal cord injury, cervical or lumbar vertebra disease (nerve root compression, spinal stenosis, cervical or lumbar vertebra degenerative disease), or sequelae of cerebrovascular disease, neuromuscular junction or muscular disease;
Neuropathies caused by other diseases (e.g. Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), VitB deficiency, hypothyroidism, alcoholism, severe arteriovenous vasculopathy such as venous embolism, lymphangitis);
Other conditions or mental disorders which according to the judgement of researchers that restrict evaluation of mental function or render outcomes or follow-up unlikely to be assessed;
Woman with pregnancy, lactation, or woman who wants to be pregnant in recent;
Patient who is allergic to the study drug or has severe allergic constitution;
Patient with yellow thick slimy tongue coating;
Patient with red tongue and scanty tongue coating;
Patient who has been participated in other drug or device clinical trials in recent 3 months.

Trial locations and contacts

1 site in 1 country.

Ying Gao, MD contact

Weidi Liu contact

China1 site, 1 recruiting

Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Ying Gao, MD, 0086-010-84013209, gaoying973@126.com
Weidi Liu, 0086-15301025939, L305613099@163.com
Recruiting

Other trials in China

About this study

Official title: Buqitongluo Granule for Qi Deficiency and Blood Stasis Syndrome: A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial

Read the detailed description

The BOSS study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary hypothesis of this trial is that Buqitongluo Granule will improve the syndrome score of Qi Deficiency and Blood Stasis in convalescence of ischemic stroke, stable angina pectoris of coronary artery disease and diabetic peripheral neuropathy with qi deficiency and blood stasis syndrome. Buqitongluo Granule will be compared to placebo, combined with guidelines-based standard care in patients. During the trial, it is forbidden to use acupuncture, Traditional Chinese Medicine decoction (compound granule), Traditional Chinese Medicine injection, Chinese patent medicine (including external use), external washing of Traditional Chinese Medicine and health product (composition or efficacy similar to the study drug).

Conditions: Stroke, Ischemic, Coronary Artery Disease, Angina Pectoris, Stable, Diabetic Peripheral Neuropathy
Being tested: Buqitongluo Granule, Buqitongluo Granule Placebo, Standard care
Keywords: Qi Deficiency and Blood Stasis Syndrome, Buqitongluo Granule, Traditional Chinese Medicine, Double-Blind, Randomized Controlled Trial
Medical subject headings: Ischemic Stroke, Coronary Artery Disease, Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Buqitongluo GranuleDrug
Buqitongluo Granules were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.
Buqitongluo Granule PlaceboDrug
Buqitongluo Granule placeboes were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.
Standard careOther
Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.

Study groups in NCT04408261
Study group	Role	What they receive
Buqitongluo Granule	Experimental	Subjects will receive orally administered Buqitongluo Granules, combined with guidelines-based standard care. Receives: Drug: Buqitongluo Granule; Other: Standard care
Placebo	Placebo comparator	Subjects will receive orally administered Buqitongluo Granule placeboes, combined with guidelines-based standard care. Receives: Drug: Buqitongluo Granule Placebo; Other: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the syndrome score of Qi Deficiency and Blood Stasis
The dynamic evaluation will be defined by Evaluation Scale of Qi Deficiency and Blood Stasis Syndrome. The Evaluation Scale of Qi Deficiency and Blood Stasis Syndrome score ranges from 0 (best score) to 51 (worst score).
Measured: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment

Secondary outcomes (10)

Neurological impairment will be evaluated by National Institute of Health Stroke Scale (NIHSS) for convalescence of ischemic stroke
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Measured: Baseline, at day 14, day 28, day 42 during treatment
Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for convalescence of ischemic stroke
Including limb numbness, swelling of hands or feet, spontaneous sweating (hemilateral sweating). Participants rated their symptoms on the 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm (no symptom) to 100 mm (worst symptom).
Measured: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
Continuous changes of Modified Rankin Scale for convalescence of ischemic stroke
The Modified Rankin Scale score ranges from 0 (best score) to 6 (worst score).
Measured: Baseline, at day 42 during treatment, and at 90 days after onset
Activities of daily living will be measured by Barthel Index (BI) score for convalescence of ischemic stroke
The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Measured: Baseline, at day 42 during treatment, and at 90 days after onset
Quality of life will be measured by Short Form 36 (SF-36) Quality of Life Scale for convalescence of ischemic stroke
The SF-36 quality of life scale is used to monitor change in subject reported functionality, well-being, and overall health status. The score of each part ranges from 0 (worst score) to 100 (best score).
Measured: Baseline, at day 42 during treatment, and at 90 days after onset
Change of the Seattle Angina Questionnaire (SAQ) Score for stable angina pectoris of coronary artery disease
The maximum score is 100, and the higher the score, the better the quality of life and the state of body function of patient.
Measured: Baseline, at day 28 during treatment, at day 14 after treatment, and at 90 days after recruitment
Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for stable angina pectoris of coronary artery disease
Including chest tightness, chest pain, palpitation, fatigue, spontaneous sweating. Participants rated their symptoms on the 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm (no symptom) to 100 mm (worst symptom).
Measured: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
Change of the Clinical Scoring System of Toronto (TCSS) for diabetic peripheral neuropathy
TCSS includes a score of neural symptoms, nerve reflex scores and sensory examination. The TCSS score ranges from 0 (best score) to 19 (worst score).
Measured: Baseline, at day 14, day 28, day 42 during treatment, at day 14 after treatment, and at 90 days after recruitment
Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for diabetic peripheral neuropathy
Including local pain, limb numbness, paresthesia (e.g. burning sensation, formication, electrical sensation). Participants rated their symptoms on the 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm (no symptom) to 100 mm (worst symptom).
Measured: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
Quality of life will be measured by Short Form 36 (SF-36) Quality of Life Scale for stable angina pectoris of coronary artery disease and diabetic peripheral neuropathy
The SF-36 quality of life scale is used to monitor change in subject reported functionality, well-being, and overall health status. The score of each part ranges from 0 (worst score) to 100 (best score).
Measured: Baseline, at day 42 during treatment, and at 90 days after recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 2020Dec 2022

First posted29 May 2020
Study start22 Jul 2020
Primary completionDec 2022 (estimated)
Study completionDec 2022 (estimated)

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 Stroke, IschemicStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 432 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04408261
Sponsor's protocol ID: 2017L04609
Acronym: BOSS
Status last verified: May 2020
First submitted: 26 May 2020
Last updated: 1 Apr 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Liu W, Zhou L, Feng L, Zhang D, Zhang C, Gao Y; behalf of the BOSS Group. BuqiTongluo Granule for Ischemic Stroke, Stable Angina Pectoris, Diabetic Peripheral Neuropathy with Qi Deficiency and Blood Stasis Syndrome: Rationale and Novel Basket Design. Front Pharmacol. 2021 Oct 18;12:764669. doi: 10.3389/fphar.2021.764669. eCollection 2021.
PubMed 34733163

Want to know more?

Ying Gao, MD

0086-010-84013209

gaoying973@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Buqitongluo Granule for Qi Deficiency and Blood Stasis Syndrome: A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial
ClinicalTrials.gov ID: NCT04408261
Acronym / sponsor ID: BOSS / 2017L04609
Conditions: Stroke, Ischemic, Coronary Artery Disease, Angina Pectoris, Stable, Diabetic Peripheral Neuropathy
Keywords: Qi Deficiency and Blood Stasis Syndrome, Buqitongluo Granule, Traditional Chinese Medicine, Double-Blind, Randomized Controlled Trial
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 432 participants (estimated)
Lead sponsor: Dongzhimen Hospital, BeijingUniversity, hospital or other
Collaborators: Affiliated Hospital of Changchun University of Chinese Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine, The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, First Affiliated Hospital of Heilongjiang Chinese Medicine University, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Hunan Academy of Traditional Chinese Medicine Affiliated Hospital, The First Clinical Hospital of Jilin Academy of Traditional Chinese Medicine, Shaanxi Buchang Pharmaceutical Co., Ltd, Beijing Chuanglikechuang Medical Technology Development Co., Ltd., Shanghai Youningwei Biotechnology Co., Ltd., Wuhan Zhizhi Medical Technology Co., Ltd., Wuhan Third Hospital, Rizhao Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Guangxi Medical University, People's Hospital of Guangxi Zhuang Autonomous Region
Study start: 22 Jul 2020 (actual)
Primary completion: Dec 2022 (estimated)
Study completion: Dec 2022 (estimated)
First posted: 29 May 2020 (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.

Detailed description

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
Buqitongluo Granule	Experimental	Drug: Buqitongluo Granule, Other: Standard careSubjects will receive orally administered Buqitongluo Granules, combined with guidelines-based standard care.
Placebo	Placebo comparator	Drug: Buqitongluo Granule Placebo, Other: Standard careSubjects will receive orally administered Buqitongluo Granule placeboes, combined with guidelines-based standard care.

Who may qualify

Ages: 35 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Diagnosis of qi deficiency and blood stasis syndrome
Diagnosis of ischemic stroke
Age ≥ 35 and ≤ 80 years
The interval from the onset to recruitment was 14-30 days
NIHSS score ≥ 4 and ≤ 22

Key exclusion criteria (30 listed)

Confirmed secondary stroke caused by tumor, brain trauma, or hematological diseases by clinical examination;
Other conditions that lead to motor dysfunction (e.g. lameness, osteoarthrosis, rheumatoid arthritis, gouty arthritis), which render the neurological function examination unlikely to be assessed;
Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), or renal or hepatic insufficiency (hepatic insufficiency is defined as an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value that is 1.5 times the upper limit of normal, renal insufficiency is defined as a serum creatinine concentration value that is over the upper limit of normal);
Other conditions or mental disorders which according to the judgement of researchers that restrict evaluation of mental function or render outcomes or follow-up unlikely to be assessed;
Woman with pregnancy, lactation, or woman who wants to be pregnant in recent;

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
Buqitongluo GranuleBuqitongluo Granules were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.	Drug	Buqitongluo Granule
Buqitongluo Granule PlaceboBuqitongluo Granule placeboes were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.	Drug	Placebo
Standard careGuidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.	Other	Buqitongluo Granule, Placebo

Primary outcome

Change in the syndrome score of Qi Deficiency and Blood Stasis
Time frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
The dynamic evaluation will be defined by Evaluation Scale of Qi Deficiency and Blood Stasis Syndrome. The Evaluation Scale of Qi Deficiency and Blood Stasis Syndrome score ranges from 0 (best score) to 51 (worst score).

10 secondary outcomes

Neurological impairment will be evaluated by National Institute of Health Stroke Scale (NIHSS) for convalescence of ischemic stroke
Time frame: Baseline, at day 14, day 28, day 42 during treatment
Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for convalescence of ischemic stroke
Time frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
Continuous changes of Modified Rankin Scale for convalescence of ischemic stroke
Time frame: Baseline, at day 42 during treatment, and at 90 days after onset
Activities of daily living will be measured by Barthel Index (BI) score for convalescence of ischemic stroke
Time frame: Baseline, at day 42 during treatment, and at 90 days after onset
Quality of life will be measured by Short Form 36 (SF-36) Quality of Life Scale for convalescence of ischemic stroke
Time frame: Baseline, at day 42 during treatment, and at 90 days after onset
Change of the Seattle Angina Questionnaire (SAQ) Score for stable angina pectoris of coronary artery disease
Time frame: Baseline, at day 28 during treatment, at day 14 after treatment, and at 90 days after recruitment
Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for stable angina pectoris of coronary artery disease
Time frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
Change of the Clinical Scoring System of Toronto (TCSS) for diabetic peripheral neuropathy
Time frame: Baseline, at day 14, day 28, day 42 during treatment, at day 14 after treatment, and at 90 days after recruitment
Self-rating symptoms will be evaluated by Visual Analog Scale (VAS) for diabetic peripheral neuropathy
Time frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment
Quality of life will be measured by Short Form 36 (SF-36) Quality of Life Scale for stable angina pectoris of coronary artery disease and diabetic peripheral neuropathy
Time frame: Baseline, at day 42 during treatment, and at 90 days after recruitment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
Derived from this study: PubMed 34733163Liu W, Zhou L, Feng L, Zhang D, Zhang C, Gao Y; behalf of the BOSS Group. BuqiTongluo Granule for Ischemic Stroke, Stable Angina Pectoris, Diabetic Peripheral Neuropathy with Qi Deficiency and Blood Stasis Syndrome: Rationale and Novel Basket Design. Front Pharmacol. 2021 Oct 18;12:764669. doi: 10.3389/fphar.2021.764669. eCollection 2021.

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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.

Ying Gao, MD contact

Weidi Liu contact

Ying Gao, MD principal investigator

Dongzhimen 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 Buqitongluo Granule in people with Stroke, Ischemic and Coronary Artery Disease, run by Dongzhimen Hospital, Beijing 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 15 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 1 Apr 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ying Gao, MD (0086-010-84013209, gaoying973@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the syndrome score of Qi Deficiency and Blood Stasis (time frame: Baseline, at day 14, day 28, day 42 during treatment, and at day 14 after treatment). 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 NCT04408261, 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 1 Apr 2021.