PsoriasisEarly Phase 1NCT06402760
Comprehensive Intervention of Diabetes and Psoriasis Comorbidity Prevention and Control
A Early Phase 1 study testing TCM comprehensive treatment and Western medicine in people with Psoriasis and Diabetes, run by Shanghai Yueyang Integrated Medicine Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- TCM comprehensive treatment and Western medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2025
- Phase
- Early Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the Western medicine diagnostic criteria for vulgaris psoriasis and the Traditional Chinese Medicine diagnostic criteria for blood stasis syndrome in psoriasis.
- Newly diagnosed or previously diagnosed with psoriasis; if previously diagnosed, prior treatment methods are not restricted.
- Identified as high risk for comorbid diabetes based on a risk model calculation.
- Age between 18 and 80 years old, any gender.
- Willing to participate in this study and provide informed consent.
Who cannot join
- Patients already diagnosed with diabetes.
- Presence of other active skin diseases that may affect the assessment of the condition.
- In severe, difficult-to-control acute or chronic infection locally or systemically.
- 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) < 1.510^9/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;
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- 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.
- History of malignant tumors and primary or secondary immunodeficiency or hypersensitivity.
- Underwent major surgery within 8 weeks or will require such surgery during the study period.
- Pregnant or lactating women.
- History of alcoholism, drug abuse, or substance abuse.
- History of severe mental illness or family history thereof.
- Family history of tumors.
- Other reasons deemed inappropriate for participation by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Being tested
- TCM comprehensive treatment, Western medicine
- Medical subject headings
- Psoriasis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM comprehensive treatmentOther
- 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.
- 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.
- 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.
Western medicineDrug
The treatment methods prescribed in the guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Western medicine group | Active comparator | 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. Receives: Drug: Western medicine |
| TCM comprehensive treatment group | Experimental | 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. Receives: Other: TCM comprehensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants assessed for diabetes prevention efficacy based on Glycated Hemoglobin (HbA1c)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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).
Improvement of PASI= PASI at week 0 - PASI at week 16 and week 40.
Measured: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
Secondary outcomes (20)
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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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).
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
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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)
Measured: 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.
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).
Measured: 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.
Traditional Chinese Medicine symptom score is used to assess changes in syndrome-related symptoms during treatment.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Hongkou District Center for Disease Control And Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402760
- Sponsor's protocol ID
- GWVI-11.1-24
- Status last verified
- May 2024
- First submitted
- 9 Apr 2024
- Last updated
- 7 May 2024
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06402760
- Acronym / sponsor ID
- GWVI-11.1-24
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Collaborators
- Shanghai Hongkou District Center for Disease Control And Prevention
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 May 2024 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Western medicine group | Active comparator | Drug: Western medicineTreatment 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. |
| TCM comprehensive treatment group | Experimental | Other: TCM comprehensive treatmentIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the Western medicine diagnostic criteria for vulgaris psoriasis and the Traditional Chinese Medicine diagnostic criteria for blood stasis syndrome in psoriasis.
- Newly diagnosed or previously diagnosed with psoriasis; if previously diagnosed, prior treatment methods are not restricted.
- Identified as high risk for comorbid diabetes based on a risk model calculation.
- Age between 18 and 80 years old, any gender.
- Willing to participate in this study and provide informed consent.
Key exclusion criteria (15 listed)
- Patients already diagnosed with diabetes.
- Presence of other active skin diseases that may affect the assessment of the condition.
- In severe, difficult-to-control acute or chronic infection locally or systemically.
- 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) < 1.510^9/L;
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 |
|---|---|---|
| TCM comprehensive treatment1. 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. | Other | TCM comprehensive treatment group |
| Western medicineThe treatment methods prescribed in the guidelines. | Drug | Western medicine group |
Primary outcome
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.
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.
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.
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.
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.
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.
20 secondary outcomes
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 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 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 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 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 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 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 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).
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).
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).
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).
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).
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).
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 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 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 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 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 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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TCM comprehensive treatment and Western medicine in people with Psoriasis and Diabetes, run by Shanghai Yueyang Integrated Medicine Hospital.
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 15 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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Li (13661956326, 13661956326@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 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 7 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.