Comprehensive Intervention of Diabetes and Psoriasis Comorbidity Prevention and Control

May 2, 2024 updated by: Shanghai Yueyang Integrated Medicine Hospital

A Cohort Study on Comprehensive Intervention of Diabetes and Psoriasis Comorbidity Prevention and Control Using Traditional Chinese Medicine of Blood-activating and Stasis-dissolving Method

We will recruit 300 patients with psoriasis from Yueyang Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, who will not be currently diagnosed with diabetes but will have been identified as high-risk individuals based on the developed risk assessment model. Based on doctor's treatment opinions and patient preferences, participants will be divided into two groups in a 1:1 ratio: a Western medicine group and a TCM comprehensive treatment group.

Patients in the Western medicine group will receive treatment according to guidelines. Patients in the TCM comprehensive treatment group will be treated according to the guidelines and will additionally receive Taodan granules (to be taken daily during the treatment period after brewing the granules with lukewarm water in the morning and evening) and fish oil (1g, taken orally twice daily).

Patients in the TCM comprehensive treatment group will be required to complete at least 150 minutes of moderate-intensity aerobic exercise per week under the supervision of a physician. The patients will be treated for 16 weeks and followed up for 24 weeks to see if the treatment prevents the development of diabetes or insulin resistance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Meet the Western medicine diagnostic criteria for vulgaris psoriasis and the Traditional Chinese Medicine diagnostic criteria for blood stasis syndrome in psoriasis.
  2. Newly diagnosed or previously diagnosed with psoriasis; if previously diagnosed, prior treatment methods are not restricted.
  3. Identified as high risk for comorbid diabetes based on a risk model calculation.
  4. Age between 18 and 80 years old, any gender.
  5. Willing to participate in this study and provide informed consent.

Exclusion Criteria:

  1. Patients already diagnosed with diabetes.
  2. Presence of other active skin diseases that may affect the assessment of the condition.
  3. In severe, difficult-to-control acute or chronic infection locally or systemically.

  4. Severe systemic diseases; or patients with clinical laboratory indicators falling into any of the following conditions:

    ① Hematology: Hemoglobin (HGB) < 90g/L; Platelet count (PLT) < 10010^9/L; White blood cell count (WBC) < 310^9/L; Absolute neutrophil count (NEUT) < 1.5*10^9/L;

    ② Liver function: Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal;

    ③ Renal function: Serum creatinine greater than 1.5 times the upper limit of normal;

    ④ Other abnormal laboratory test results judged by the investigator to potentially affect the patient's completion of the trial or interfere with the trial results.

  5. History of malignant tumors and primary or secondary immunodeficiency or hypersensitivity.
  6. Underwent major surgery within 8 weeks or will require such surgery during the study period.
  7. Pregnant or lactating women.
  8. History of alcoholism, drug abuse, or substance abuse.
  9. History of severe mental illness or family history thereof.
  10. Family history of tumors.
  11. Other reasons deemed inappropriate for participation by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Western medicine group
Treatment will be stratified according to the severity of psoriasis in patients, with therapeutic methods limited to the traditional treatment approaches outlined in the Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2023 Simplified Version). The treatment duration will be 16 weeks, followed by a 24-week follow-up period during which patients will not be restricted in their treatment modalities.
Drug: Western medicine
The treatment methods prescribed in the guidelines.
Experimental: TCM comprehensive treatment group
In addition to the Western medicine treatment prescribed in the guidelines, patients are required to take fish oil orally and Taodan Granules, and engage in moderate to high-intensity aerobic exercise weekly.
Other: TCM comprehensive treatment
  1. Taodan Granules (TCM formulation for promoting blood circulation and removing blood stasis): The granules consist of the following herbal components: milkvetch, licorice, angelica, rhizoma chuanxiong, peach seed, Salvia miltiorrhiza, Curcuma zedoaria, Achyranthes bidentata, and sarsaparilla. Patients will take it orally in two divided doses after breakfast and dinner.
  2. Fish Oil: Patients will take 1g of fish oil orally twice daily. Patients will be instructed to purchase fish oil under the guidance of the researchers.
  3. Exercise Plan: Researchers will design an exercise plan for patients, who will be required to engage in at least 150 minutes of moderate-intensity aerobic exercise per week.

Patients will undergo a 16-week treatment period followed by a 24-week follow-up period. During the follow-up, patients will continue taking fish oil and adhering to the exercise regimen, while other treatment modalities will be unrestricted.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The number of participants assessed for diabetes prevention efficacy based on Glycated Hemoglobin (HbA1c)
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
The members of the two groups will measure glycosylated hemoglobin (HbA1c) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine at the 16th week of treatment and the follow-up period (40th week) to judge whether diabetes or insulin resistance occurs.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
The number of participants assessed for diabetes prevention efficacy based on Fasting Plasma Glucose (FPG)
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
The members of the two groups will measure Fasting Plasma Glucose (FPG) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine at the 16th week of treatment and the follow-up period (40th week) to judge whether diabetes or insulin resistance occurs.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
The number of participants assessed for diabetes prevention efficacy based on Postprandial 2-hour Plasma Glucose (PPG)
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
The members of the two groups will measure Plasma Glucose (PPG) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine at the 16th week of treatment and the follow-up period (40th week) to judge whether diabetes or insulin resistance occurs.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
The number of participants assessed for diabetes prevention efficacy based on Fasting Insulin (FINS)
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
The members of the two groups will measure Fasting Insulin (FINS) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine at the 16th week of treatment and the follow-up period (40th week) to judge whether diabetes or insulin resistance occurs.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
The number of participants assessed for diabetes prevention efficacy based on C-peptide
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
The members of the two groups will measure C-peptide in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine at the 16th week of treatment and the follow-up period (40th week) to judge whether diabetes or insulin resistance occurs.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of PASI (Psoriasis Area and Severity Index).
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
Improvement of PASI= PASI at week 0 - PASI at week 16 and week 40.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on serum triglyceride (TG) evaluation.
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of the two groups will test the serum triglyceride (TG) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine to determine whether the metabolic situation related to psoriasis and diabetes is improving.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum Total Cholesterol (TC) evaluation.
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of the two groups will test the Serum Total Cholesterol (TC) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine to determine whether the metabolic situation related to psoriasis and diabetes is improving.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on erum High-Density Lipoprotein Cholesterol (HDL) evaluation.
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of the two groups will test the Serum High-Density Lipoprotein Cholesterol (HDL) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine to determine whether the metabolic situation related to psoriasis and diabetes is improving.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum Low-Density Lipoprotein Cholesterol (LDL) evaluation.
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of the two groups will test the Serum Low-Density Lipoprotein Cholesterol (LDL) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine to determine whether the metabolic situation related to psoriasis and diabetes is improving.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum Apolipoprotein AI (ApoAI) evaluation.
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of the two groups will test Serum Apolipoprotein AI (ApoAI) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine to determine whether the metabolic situation related to psoriasis and diabetes is improving.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum Apolipoprotein B (ApoB) evaluation.
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of the two groups will test Serum Apolipoprotein B (ApoB) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine to determine whether the metabolic situation related to psoriasis and diabetes is improving.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum Lipoprotein α evaluation.
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of the two groups will test Serum Lipoprotein α in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine to determine whether the metabolic situation related to psoriasis and diabetes is improving.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum small dense low-density lipoprotein (sdLDL) evaluation.
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of the two groups will testSerum small dense low-density lipoprotein (sdLDL) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine to determine whether the metabolic situation related to psoriasis and diabetes is improving.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using HsCRP
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of both groups will undergo HsCRP testing at the Yueyang Integrative Medicine Hospital affiliated with Shanghai University of Traditional Chinese Medicine to assess whether there is a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using IL-1β
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of both groups will undergo IL-1β testing at the Yueyang Integrative Medicine Hospital affiliated with Shanghai University of Traditional Chinese Medicine to assess whether there is a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using IL-6
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of both groups will undergo IL-6 testing at the Yueyang Integrative Medicine Hospital affiliated with Shanghai University of Traditional Chinese Medicine to assess whether there is a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using TNFα
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of both groups will undergo TNFα testing at the Yueyang Integrative Medicine Hospital affiliated with Shanghai University of Traditional Chinese Medicine to assess whether there is a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using IL-17A
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of both groups will undergo IL-17A testing at the Yueyang Integrative Medicine Hospital affiliated with Shanghai University of Traditional Chinese Medicine to assess whether there is a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using FGL1
Time Frame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The members of both groups will undergo FGL1 testing at the Yueyang Integrative Medicine Hospital affiliated with Shanghai University of Traditional Chinese Medicine to assess whether there is a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes.
Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of Body Surface Area (BSA).
Time Frame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
The percentage of BSA involved in psoriasis is estimated by the handprint method, in which the patient's entire palm (that is, the patient's fully outstretched palm, fingers, and thumb) represents about 1% of the total BSA
Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of Physician's Global Assessment (PGA).
Time Frame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
The PGA is a 5-point scale that is used to reflect the overall assessment of erythema (E), infiltration (I), and desquamation (D) in psoriatic lesions.
Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of Dermatology Life Quality Index (DLQI).
Time Frame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).

The DLQI is a 10item questionnaire assessing the impact of skin disease on health-related quality of life (HRQOL). The total score ranges from 0 to 30; higher scores indicate a lower quality of life . Foreign clinical studies have reported that its 4 Evidence-Based Complementary and Alternative Medicin

minimal clinically important difference (MCID) is 5 points [30]. +at is, after treatment, DLQI is decreased by 5 points, which can be considered an improvement in quality of life and treatment efficacy.
Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of Psoriasis-related Quality of Life (PRQoL).
Time Frame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
The questionnaire consists of 15 questions, including five parts: daily activities, at work, personal relationships, leisure activities, and treatment. +e answer to each question gives a score from 0 to 3. +e choice of each question is "very many" (3 points), "a lot" (2 points), "a little" (1 point), and "no answer at all" (0 points)
Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of self-assessment of itching symptoms (VAS) score.
Time Frame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
VAS is an often-used tool to measure subjective phenomena, which has shown good reliability and validity in terms of assessment of pain. In the clinical study of psoriasis, it can be used as a tool to measure the degree of pruritus from 0 to 100 mm (with 0 being no pruritis and 100 being maximum pruritis).
Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of Traditional Chinese Medicine symptom score.
Time Frame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
Traditional Chinese Medicine symptom score is used to assess changes in syndrome-related symptoms during treatment.
Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Yueyang Integrated Medicine Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Hongkou District Center for Disease Control And Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GWVI-11.1-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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