Metabolic SyndromePhase 4NCT04812236
Clinical Study on Wuling Powder in Treating Metabolic Syndrome of Spleen Deficiency and Dampness
A Phase 4 study testing Wulingsan single decoction granules, Wulingsan co-decoction granules and Wuling Powder in people with Metabolic Syndrome, run by Jiangsu Famous Medical Technology Co., Ltd..
Trial summary
In this study, a randomized, partially double-blind, controlled, multi-center clinical research method was used. A total of 4 groups were designed, namely, single decoction group, co-decoction group, powder group and simulation group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Wulingsan single decoction granules, Wulingsan co-decoction granules and Wuling Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 May 2023
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the diagnostic criteria of metabolic syndrome;
- TCM syndrome differentiation of spleen deficiency and dampness patients;
- Patients with phlegm-dampness constitution score>30;
- Patients aged 18 to 70 years;
- Patients who have signed informed consent and are highly compliant.
Who cannot join
- Patients with hypertension, hyperglycemia, and hyperlipidemia caused by secondary metabolic syndrome (disease, drugs, surgery, etc.);
- Patients with severe primary diseases such as heart, liver, kidney, lung, brain, endocrine, hematopoietic system in the past or at the time of enrollment;
- Those who are confirmed to have acute coronary syndrome, malignant arrhythmia, and other serious heart diseases;
- Patients with co-infection, malignant tumors or mental illness;
- Patients with Cushing syndrome;
- Patients with allergies or allergies to this drug;
- Pregnant or breastfeeding women;
- Those who have adjusted hypoglycemic, lipid-lowering, antihypertensive drugs or taking weight-loss drugs within 1 month before enrollment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Partially Double-blind, Controlled, Multi-center Clinical Study of Wulingsan Single Decoction Granules Combined With Conventional Therapy in the Treatment of Metabolic Syndrome of Spleen Deficiency, Dampness and Sleepiness
In this study, a randomized, partially double-blind, controlled, multi-center clinical research method was used. A total of 4 groups were designed, namely, single decoction group, co-decoction group, powder group and simulation group. The four groups of patients all received basic health education, diet control and increased exercise guidance. All the patients in the group have taken western medicine according to their own conditions and followed the doctor's instructions for hypoglycemic, blood pressure, and lipid-lowering treatments. After joining the group, they continue to take the medicine at the original dose, and the patients are advised not to change the medicine during the observation period. Take 12 weeks as a course of treatment, and set the observation period to 12 weeks. Follow up every 4 weeks.
Read the detailed description
The research purpose of this project is to observe the effectiveness and safety of Wulingsan single decoction granules compared with traditional powder, co-decoction granules and analogues in the treatment of metabolic syndrome in combination with conventional therapies. ; Compared with Wulingsan traditional powder and co-decoction granule group, observe the effectiveness and safety of traditional powder combined with conventional therapy in the treatment of metabolic syndrome. The trial adopts a randomized, partially double-blind, controlled, multi-center clinical research method. A total of 320 cases were included in 4 groups, namely, single decoction group, co-decoction group, powder group, and simulated agent group. The four groups of patients all received basic health education, diet control and increased exercise guidance. All the patients in the group have taken western medicine according to their own conditions and followed the doctor's instructions for hypoglycemic, blood pressure, and lipid-lowering treatments. After joining the group, they continue to take the medicine at the original dose, and the patients are advised not to change the medicine during the observation period. Take 12 weeks as a course of treatment, and the observation period is set to 12 weeks. Follow up every 4 weeks.
- Conditions
- Metabolic Syndrome
- Being tested
- Wulingsan single decoction granules, Wulingsan co-decoction granules, Wuling Powder, Wulingsan granule simulant
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wulingsan single decoction granulesDrug
Wulingsan single decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water
Wulingsan co-decoction granulesDrug
Wulingsan co-decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water
Wuling PowderDrug
Wuling powder is composed of Alisma, Polyporus, Atractylodes, Poria, Guizhi. 2 times a day, 5g each time, take it with warm water
Wulingsan granule simulantDrug
Wulingsan granule simulant, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water
| Study group | Role | What they receive |
|---|---|---|
| Single decoction group: Wulingsan single decoction granules | Experimental | Wulingsan single decoction granules, Alisma orientalis (15g), Polyporus (10g), Baizhu (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day.Take 12 weeks as a course of treatment. Receives: Drug: Wulingsan single decoction granules |
| Co-decocting group: Wulingsan co-decocting granules | Other | Wulingsan co-decoction granules, Alisma orientalis (15g), Polyporus (10g), Atractylodes (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day.Take 12 weeks as a course of treatment. Receives: Drug: Wulingsan co-decoction granules |
| Powder group: Wuling powder powder | Other | Wuling powder is composed of Alisma, Polyporus, Atractylodes, Poria, Guizhi. Take 5g each time with warm water twice a day.Take 12 weeks as a course of treatment. Receives: Drug: Wuling Powder |
| Simulant group: Simulant of granular dosage form | Placebo comparator | Granule simulant, the composition is Alisma orientalis (15g), Polyporus (10g), Atractylodes (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day. Take 12 weeks as a course of treatment. Receives: Drug: Wulingsan granule simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of changes in waist-to-hip ratio at 12 weeks
Measure and record the waist-to-hip ratio of the patient before and after treatment
Measured: 12 weeks
Analysis of body mass index changes in 12 weeks
Measure and record the patient's BMI before and after treatment
Measured: 12 weeks
Secondary outcomes (7)
Improvement of the conversion score of phlegm-damp constitution judgment
To study the improvement of the conversion score of phlegm-damp constitution before and after treatment
Measured: 12 weeks
Lipid Index
Investigate the changes in triglycerides, high-density lipoprotein cholesterol, cholesterol and low-density lipoprotein cholesterol during treatment
Measured: 4 weeks，8 weeks，12 weeks
Fasting blood glucose index
Investigate changes in fasting blood glucose during treatment
Measured: 4 weeks，8 weeks，12 weeks
2h blood glucose after meal
Investigate changes in 2h blood glucose after meal during treatment
Measured: 4 weeks，8 weeks，12 weeks
HOMAA insulin resistance index
To investigate the changes of HOMAA insulin resistance index during treatment
Measured: 12 weeks
Blood pressure index
Observe the changes in systolic and diastolic blood pressure during treatment
Measured: 4 weeks，8 weeks，12 weeks
Inflammatory factors
Investigate the changes of hypersensitivity C-reactive protein and endotoxin during treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812236
- Sponsor's protocol ID
- FM-P8-2018052801
- Status last verified
- Jan 2021
- First submitted
- 22 Feb 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Partially Double-blind, Controlled, Multi-center Clinical Study of Wulingsan Single Decoction Granules Combined With Conventional Therapy in the Treatment of Metabolic Syndrome of Spleen Deficiency, Dampness and Sleepiness
- ClinicalTrials.gov ID
- NCT04812236
- Acronym / sponsor ID
- FM-P8-2018052801
- Conditions
- Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 23 Mar 2021 (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.
In this study, a randomized, partially double-blind, controlled, multi-center clinical research method was used. A total of 4 groups were designed, namely, single decoction group, co-decoction group, powder group and simulation group. The four groups of patients all received basic health education, diet control and increased exercise guidance. All the patients in the group have taken western medicine according to their own conditions and followed the doctor's instructions for hypoglycemic, blood pressure, and lipid-lowering treatments. After joining the group, they continue to take the medicine at the original dose, and the patients are advised not to change the medicine during the observation period. Take 12 weeks as a course of treatment, and set the observation period to 12 weeks. Follow up every 4 weeks.
Detailed description
The research purpose of this project is to observe the effectiveness and safety of Wulingsan single decoction granules compared with traditional powder, co-decoction granules and analogues in the treatment of metabolic syndrome in combination with conventional therapies. ; Compared with Wulingsan traditional powder and co-decoction granule group, observe the effectiveness and safety of traditional powder combined with conventional therapy in the treatment of metabolic syndrome. The trial adopts a randomized, partially double-blind, controlled, multi-center clinical research method. A total of 320 cases were included in 4 groups, namely, single decoction group, co-decoction group, powder group, and simulated agent group. The four groups of patients all received basic health education, diet control and increased exercise guidance. All the patients in the group have taken western medicine according to their own conditions and followed the doctor's instructions for hypoglycemic, blood pressure, and lipid-lowering treatments. After joining the group, they continue to take the medicine at the original dose, and the patients are advised not to change the medicine during the observation period. Take 12 weeks as a course of treatment, and the observation period is set to 12 weeks. Follow up every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single decoction group: Wulingsan single decoction granules | Experimental | Drug: Wulingsan single decoction granulesWulingsan single decoction granules, Alisma orientalis (15g), Polyporus (10g), Baizhu (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day.Take 12 weeks as a course of treatment. |
| Co-decocting group: Wulingsan co-decocting granules | Other | Drug: Wulingsan co-decoction granulesWulingsan co-decoction granules, Alisma orientalis (15g), Polyporus (10g), Atractylodes (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day.Take 12 weeks as a course of treatment. |
| Powder group: Wuling powder powder | Other | Drug: Wuling PowderWuling powder is composed of Alisma, Polyporus, Atractylodes, Poria, Guizhi. Take 5g each time with warm water twice a day.Take 12 weeks as a course of treatment. |
| Simulant group: Simulant of granular dosage form | Placebo comparator | Drug: Wulingsan granule simulantGranule simulant, the composition is Alisma orientalis (15g), Polyporus (10g), Atractylodes (10g), Poria (10g), Guizhi (6g). Take 1 bag each time with warm water twice a day. Take 12 weeks as a course of treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who meet the diagnostic criteria of metabolic syndrome;
- TCM syndrome differentiation of spleen deficiency and dampness patients;
- Patients with phlegm-dampness constitution score>30;
- Patients aged 18 to 70 years;
- Patients who have signed informed consent and are highly compliant.
Key exclusion criteria (8 listed)
- Patients with hypertension, hyperglycemia, and hyperlipidemia caused by secondary metabolic syndrome (disease, drugs, surgery, etc.);
- Patients with severe primary diseases such as heart, liver, kidney, lung, brain, endocrine, hematopoietic system in the past or at the time of enrollment;
- Those who are confirmed to have acute coronary syndrome, malignant arrhythmia, and other serious heart diseases;
- Patients with co-infection, malignant tumors or mental illness;
- Patients with Cushing syndrome;
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 |
|---|---|---|
| Wulingsan single decoction granulesWulingsan single decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water | Drug | Single decoction group: Wulingsan single decoction granules |
| Wulingsan co-decoction granulesWulingsan co-decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water | Drug | Co-decocting group: Wulingsan co-decocting granules |
| Wuling PowderWuling powder is composed of Alisma, Polyporus, Atractylodes, Poria, Guizhi. 2 times a day, 5g each time, take it with warm water | Drug | Powder group: Wuling powder powder |
| Wulingsan granule simulantWulingsan granule simulant, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water | Drug | Simulant group: Simulant of granular dosage form |
Primary outcome
Analysis of changes in waist-to-hip ratio at 12 weeks
Time frame: 12 weeks
Measure and record the waist-to-hip ratio of the patient before and after treatment
Analysis of body mass index changes in 12 weeks
Time frame: 12 weeks
Measure and record the patient's BMI before and after treatment
7 secondary outcomes
Improvement of the conversion score of phlegm-damp constitution judgment
Time frame: 12 weeks
Lipid Index
Time frame: 4 weeks，8 weeks，12 weeks
Fasting blood glucose index
Time frame: 4 weeks，8 weeks，12 weeks
2h blood glucose after meal
Time frame: 4 weeks，8 weeks，12 weeks
HOMAA insulin resistance index
Time frame: 12 weeks
Blood pressure index
Time frame: 4 weeks，8 weeks，12 weeks
Inflammatory factors
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing Wulingsan single decoction granules, Wulingsan co-decoction granules and Wuling Powder in people with Metabolic Syndrome, run by Jiangsu Famous Medical Technology Co., Ltd..
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 8 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 23 Mar 2021. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Lu Shu, PhD (86-13961701999, Lushu@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of changes in waist-to-hip ratio at 12 weeks (time frame: 12 weeks). The study lists 2 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 23 Mar 2021.