CompletedNCT06575478Updated Oct 5, 2026Results posted

Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients

A Phase 2 interventional study of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Diabetes Mellitus, Type 2, Diabetes and Type2diabetes, sponsored by Beijing Supreme Life Pharmaceutical Technology Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Beijing Supreme Life Pharmaceutical Technology Co., Ltd. · Phase 2, Interventional, and Treatment

Updated Oct 5, 2026Newly registeredGo to Updates ↓

Phase: Phase 2
Study type: Interventional
Enrollment: 95
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

The goal of this investigator-initiated clinical trial is to investigate the efficacy and safety of sequential therapy of Fuling Yunhua Granules (prescription A) and Dihuang Baoyuan Granule (prescription B) in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study, including a up to 2-week screening period, a 1-week baseline period, a 12-week treatment period and a 1-week follow-up period.

72 participants who meet the enrollment requirements will enter the baseline period, during which 7 days of CGM data will be collected. After entering the treatment period, participants will be randomly assigned to prescription ABA group, prescription ABA-matched placebo group, prescription BAB group and prescription BAB-matched placebo group in a ratio of 2:1:2:1 and receive corresponding treatment.

It is expected that an interim analysis will be conducted after 30 participants have completed 4 weeks of treatment and 4 weeks of their data is obtained. Based on the CGM data of the participants in the 4th week of treatment, the change of TIR in the 4th week compared with the baseline will be analyzed, and the IDMC will make a decision based on the results of this analysis.

Conditions studied

Diabetes Mellitus, Type 2
Diabetes
Type2diabetes

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In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 95 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

This is the only study on the registry with Beijing Supreme Life Pharmaceutical Technology Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age 18-75 years (inclusive), male or female;
Patients diagnosed with T2DM ≥ 8 weeks according to the 2020 WHO diagnostic criteria and classification;
Have controlled blood sugar through diet and exercise for 3 months before screening and did not receive any hypoglycemic drugs, or used hypoglycemic drugs for no more than 2 weeks within 3 months before screening and did not use hypoglycemic drugs within 1 month before screening;
Body mass index (BMI) ≥ 19 kg/m2;
Glycated hemoglobin (HbA1c) ≥ 7.0% and \< 10.5% at screening;
Fasting plasma glucose (FPG) \< 13.9 mmol/L at screening;
Able to understand the procedures and methods of this study, willing to strictly abide by the clinical research protocol to complete this study, and voluntarily sign the ICF

Exclusion criteria

Exclusion Criteria:

Non-type 2 diabetes: type 1 diabetes, gestational diabetes, special types of diabetes;
History of acute complications of diabetes within 6 months before screening (diabetic ketoacidosis, diabetic hyperglycemic hyperosmolar syndrome or lactic acidosis, etc.);
History of chronic complications of diabetes with unstable condition or requiring treatment within 6 months before screening (proliferative retinal disease, severe diabetic neuropathy or intermittent claudication, etc.);
Experienced more than 3 episodes of grade 3 hypoglycemia within 6 months before screening;
Have used systemic (intravenous, oral or intra-articular) glucocorticoids continuously or cumulatively for ≥ 7 days within 3 months before screening;
Severe infection within 3 months before screening;
Diagnosed with malignant tumors within 5 years before screening (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
Severe cardiovascular disease, such as heart failure (New York Heart Association [NYHA] grade III-IV), myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention, occurred within 6 months before screening, Sustained and clinically significant arrhythmia (such as second- or third-degree atrioventricular block or QTc interval prolongation ≥470 ms in men and ≥480 ms in women), acute coronary syndrome or transient ischemic attack or stroke wait;
Suffering from diseases that may significantly affect drug absorption, distribution, metabolism and excretion within 6 months before screening: inflammatory bowel disease, peptic ulcer, history of gastrointestinal or rectal bleeding, history of important gastrointestinal surgery (such as : Gastrectomy, gastrointestinal anastomosis, or intestinal resection), etc.;
Accompanied by thyroid dysfunction that cannot be controlled with stable drug dosage during screening;
History of hypertension and take antihypertensive treatment regularly for more than 4 weeks but still have poor blood pressure control, with systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg;
History of organ transplantation or severe autoimmune diseases in the past or present;
History of clinically significant drug allergy or atopic allergic disease (asthma, urticaria, eczematous dermatitis);
History of major surgery (intrathoracic, intracranial, abdominal, etc.) within 6 months before screening, or those who plan to undergo surgery during the study that may affect study completion or compliance;
Any laboratory test meets any of the following criteria during screening:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN) × 2.5 times Glomerular filtration rate (eGFR) calculated using the CKD-EPI formula \< 60 mL/min /1.73m2 Total bilirubin (TBIL)>ULN×1.5 times Fasting triglyceride (TG)>5.7 mmol/L Fasting C-peptide \<0.8 ng/ml (or 0.26 nmol/L)
Those who are positive for hepatitis B surface antigen during screening (except those whose quantitative test results of hepatitis B virus deoxyribonucleic acid [HBV-DNA] are lower than the lower limit of the detection reference range and who are not using anti-hepatitis B virus drugs during screening), or who are receiving anti-hepatitis B virus drug treatment , or those who are hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, or Treponema pallidum antibody positive;
Blood donation or massive blood loss (>400 mL) within 3 months before screening;
Pregnant or lactating women, or men or women of childbearing potential who plan to become pregnant during the study or are unwilling to take medically recognized contraceptive measures;
History of alcohol, tobacco addiction or drug abuse is known or suspected at the time of screening;
Participated in any interventional drug clinical research within 3 months before screening;
Allergic to study drugs and their ingredients;
Participants who the researcher believes have any other factors that are inappropriate for participating in this study.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 95 participants (actual)

Study arms

Experimental
prescription ABA
Fuling Yunhua Granules and Dihuang Baoyuan Granules
Drug: Fuling Yunhua Granules
Experimental
prescription BAB
Fuling Yunhua Granules and Dihuang Baoyuan Granules
Drug: Dihuang Baoyuan Granules
Placebo comparator
prescription ABA-matched placebo/ BAB-matched placebo
Fuling Yunhua Granules placebo and Dihuang Baoyuan Granules placebo
Drug: Fuling Yunhua Granules matched placebo/Dihuang Baoyuan Granules matched placebo

Interventions

DrugFuling Yunhua Granules
Fuling Yunhua Granules
Also known as: prescription A
DrugDihuang Baoyuan Granules
Dihuang Baoyuan Granules
Also known as: prescription B
DrugFuling Yunhua Granules matched placebo/Dihuang Baoyuan Granules matched placebo
Fuling Yunhua Granules placebo/Dihuang Baoyuan Granules placebo
Also known as: prescription A matched placebo/B matched placebo

What researchers measure

Primary outcomes

Change in HbA1c Concentrations (%) From Baseline
Change in HbA1c concentrations (%) from baseline is the numerical difference between a participant's hemoglobin A1c (HbA1c) level at a specified follow-up time point(s) and their baseline level (initial assessment before intervention). HbA1c, a glycated hemoglobin biomarker, reflects average blood glucose over 8-12 weeks. Venous blood is collected via standard phlebotomy, and HbA1c is quantified using a laboratory-certified method (e.g., high-performance liquid chromatography \[HPLC\] or immunoassay) for accuracy. Calculated as: Follow-up HbA1c (%) - Baseline HbA1c (%), positive values mean increased average blood glucose, negative values mean decreased. This metric evaluates intervention efficacy (e.g., medications, lifestyle modifications) for glycemic control in diabetes or prediabetes populations.
Time frame: 12 weeks

Secondary outcomes

Change in FPG (mmol/L) From Baseline
Change in Fasting Plasma Glucose (FPG) (mmol/L) from baseline is the numerical difference between a participant's FPG level at follow-up and their baseline FPG. FPG measures plasma glucose concentration after an 8-12 hour fast, reflecting overnight glycemic control. Venous blood samples are collected via standard phlebotomy, with glucose quantified using laboratory methods (e.g., hexokinase assay). Calculated as: Follow-up FPG (mmol/L) - Baseline FPG (mmol/L), positive values indicate increased fasting glucose, negative values a decrease. This metric assesses intervention efficacy in regulating fasting glycemia, critical for diabetes management.
Time frame: 12 weeks
The Proportion of Participants Who Achieved HbA1c Target
The proportion of participants who achieved HbA1c target (HbA1c\<7.0% and \<6.5% Patient percentage)
Time frame: 12 weeks
Changes in TIR From Baseline
Changes in Time in Range (TIR) from baseline refers to the difference between a participant's TIR at follow-up and their baseline TIR. TIR is the percentage of time blood glucose levels stay within a target range (typically 3.9-10.0 mmol/L \[70-180 mg/dL\] for most people with diabetes) over a specified period, measured via continuous glucose monitoring (CGM) devices. Calculated as: Follow-up TIR (%) - Baseline TIR (%), positive values indicate increased time in target range, negative values a decrease. This metric assesses glycemic stability and intervention effectiveness (e.g., medication adjustments, lifestyle changes) in managing blood glucose control.
Time frame: 12 weeks
Changes in TBR From Baseline
Changes in Time Below Range (TBR) from baseline is the difference between a participant's TBR at follow-up and their baseline TBR. TBR is the percentage of time blood glucose levels fall below a target range (e.g., \<3.9 mmol/L \[70 mg/dL\] for adults) over a specified period, measured via continuous glucose monitoring (CGM). Calculated as: Follow-up TBR (%) - Baseline TBR (%), positive values indicate increased time below range, negative values a decrease. This metric evaluates risks of hypoglycemia and intervention impact on maintaining glucose above target levels.
Time frame: 12 weeks
Changes in TAR From Baseline
Changes in Time Above Range (TAR) from baseline refers to the difference between a participant's TAR at follow-up and their baseline TAR. TAR is the percentage of time blood glucose levels exceed a target range (e.g., \>10.0 mmol/L \[180 mg/dL\] for most adults with diabetes) over a specified period, measured via continuous glucose monitoring (CGM). Calculated as: Follow-up TAR (%) - Baseline TAR (%), positive values indicate increased time above range, negative values a decrease. This metric assesses risks of hyperglycemia and intervention effectiveness in keeping glucose within target levels.
Time frame: 12 weeks
Changes in MAGE From Baseline
Changes in Mean Amplitude of Glycemic Excursions (MAGE) from baseline is the difference between a participant's MAGE at follow-up and their baseline MAGE. MAGE quantifies the average magnitude of significant blood glucose fluctuations (exceeding a threshold, typically 1.4 mmol/L \[25 mg/dL\]) over a specified period, derived from continuous glucose monitoring (CGM) data. Calculated as: Follow-up MAGE - Baseline MAGE, higher values indicate greater glycemic variability, lower values more stable glucose. This metric evaluates intervention impact on reducing glucose swings, relevant for assessing glycemic stability in diabetes management.
Time frame: 12 weeks
Change From Baseline in Total Cholesterol (TC) at Week 12
TTotal cholesterol (TC) was measured in venous blood samples and reported in mmol/L. Change from baseline was calculated as the TC value at Week 12 minus the baseline TC value. Negative values indicate a reduction in total cholesterol.
Time frame: 12 weeks
Change From Baseline in Body Weight at Week 12
Body weight was measured in kilograms. Change from baseline was calculated as body weight at Week 12 minus baseline body weight. Negative values indicate weight loss, and positive values indicate weight gain.
Time frame: 12 weeks

Results

Posted Oct 5, 2026

Participant flow

Participant flow — Overall Study
Milestone	Prescription ABA	Prescription BAB	Prescription Fuling Yunhua Granules Placebo/BAB-matched Placebo
Started	32	32	31
Completed	26	32	30
Not completed	6	0	1

Outcome measures

PrimaryChange in HbA1c Concentrations (%) From Baseline

Change in HbA1c concentrations (%) from baseline is the numerical difference between a participant's hemoglobin A1c (HbA1c) level at a specified follow-up time point(s) and their baseline level (initial assessment before intervention). HbA1c, a glycated hemoglobin biomarker, reflects average blood glucose over 8-12 weeks. Venous blood is collected via standard phlebotomy, and HbA1c is quantified using a laboratory-certified method (e.g., high-performance liquid chromatography \[HPLC\] or immunoassay) for accuracy. Calculated as: Follow-up HbA1c (%) - Baseline HbA1c (%), positive values mean increased average blood glucose, negative values mean decreased. This metric evaluates intervention efficacy (e.g., medications, lifestyle modifications) for glycemic control in diabetes or prediabetes populations.

Time frame:: 12 weeks
Reported as:: Mean · percentage of HbA1c

Change in HbA1c Concentrations (%) From Baseline
percentage of HbA1c	Prescription ABA	Prescription BAB	Prescription ABA/BAB-matched Placebo
Baseline HbA1c	8.17 ± 0.767	8.31 ± 1.031	8.25 ± 0.819
HbA1c at Week 12	7.20 ± 0.971	7.27 ± 0.963	7.93 ± 1.004

SecondaryChange in FPG (mmol/L) From Baseline

Change in Fasting Plasma Glucose (FPG) (mmol/L) from baseline is the numerical difference between a participant's FPG level at follow-up and their baseline FPG. FPG measures plasma glucose concentration after an 8-12 hour fast, reflecting overnight glycemic control. Venous blood samples are collected via standard phlebotomy, with glucose quantified using laboratory methods (e.g., hexokinase assay). Calculated as: Follow-up FPG (mmol/L) - Baseline FPG (mmol/L), positive values indicate increased fasting glucose, negative values a decrease. This metric assesses intervention efficacy in regulating fasting glycemia, critical for diabetes management.

Time frame:: 12 weeks
Reported as:: Mean · mmol/L

Change in FPG (mmol/L) From Baseline
mmol/L	Prescription ABA	Prescription BAB	Prescription ABA/BAB-matched Placebo
Baseline FPG	9.048 ± 1.628	9.583 ± 1.5431	9.149 ± 1.8092
FPG (mmol/L) after 12 weeks of treatment	7.672 ± 1.3091	7.993 ± 1.6283	9.170 ± 2.0752
Relative change in FPG from baseline after 12 weeks of treatment (mmol/L)	-1.463 ± 1.2551	-1.590 ± 1.6809	0.027 ± 2.1562

SecondaryThe Proportion of Participants Who Achieved HbA1c Target

The proportion of participants who achieved HbA1c target (HbA1c\<7.0% and \<6.5% Patient percentage)

Time frame:: 12 weeks
Reported as:: Count of participants · Participants

The Proportion of Participants Who Achieved HbA1c Target
Participants	Prescription ABA	Prescription BAB	Prescription ABA-matched Placebo/ BAB-matched Placebo
HbA1c<7%at Week 12	14	13	3
HbA1c<6.5%at Week 12	8	7	1

SecondaryChanges in TIR From Baseline

Changes in Time in Range (TIR) from baseline refers to the difference between a participant's TIR at follow-up and their baseline TIR. TIR is the percentage of time blood glucose levels stay within a target range (typically 3.9-10.0 mmol/L \[70-180 mg/dL\] for most people with diabetes) over a specified period, measured via continuous glucose monitoring (CGM) devices. Calculated as: Follow-up TIR (%) - Baseline TIR (%), positive values indicate increased time in target range, negative values a decrease. This metric assesses glycemic stability and intervention effectiveness (e.g., medication adjustments, lifestyle changes) in managing blood glucose control.

Time frame:: 12 weeks
Reported as:: Mean · percentage of TIR

Changes in TIR From Baseline
percentage of TIR	Prescription ABA	Prescription BAB	Prescription Fuling Yunhua Granules Placebo/BAB-matched Placebo
Time in Range (TIR) Baseline	52.59 ± 25.287	46.26 ± 23.821	56.13 ± 21.859
Time in Range (TIR)After 12 Weeks	74.55 ± 23.379	77.25 ± 25.24	57.11 ± 63.99
Changes in TIR from baseline	20.29 ± 29.827	30.81 ± 26.159	-0.42 ± 19.604

SecondaryChanges in TBR From Baseline

Changes in Time Below Range (TBR) from baseline is the difference between a participant's TBR at follow-up and their baseline TBR. TBR is the percentage of time blood glucose levels fall below a target range (e.g., \<3.9 mmol/L \[70 mg/dL\] for adults) over a specified period, measured via continuous glucose monitoring (CGM). Calculated as: Follow-up TBR (%) - Baseline TBR (%), positive values indicate increased time below range, negative values a decrease. This metric evaluates risks of hypoglycemia and intervention impact on maintaining glucose above target levels.

Time frame:: 12 weeks
Reported as:: Mean · percentage of TBR

Changes in TBR From Baseline
percentage of TBR	Prescription ABA	Prescription BAB	Prescription ABA/BAB-matched Placebo
Time Below Range (TBR) Baseline	0.37 ± 1.145	0.13 ± 0.479	0.13 ± 0.624
Time Below Range After 12 Weeks(TBR)	0.35 ± 1.221	0.46 ± 1.261	0.38 ± 1.372
Changes in TBR from baseline	0.08 ± 1.569	0.32 ± 1.402	0.36 ± 1.342

SecondaryChanges in TAR From Baseline

Changes in Time Above Range (TAR) from baseline refers to the difference between a participant's TAR at follow-up and their baseline TAR. TAR is the percentage of time blood glucose levels exceed a target range (e.g., \>10.0 mmol/L \[180 mg/dL\] for most adults with diabetes) over a specified period, measured via continuous glucose monitoring (CGM). Calculated as: Follow-up TAR (%) - Baseline TAR (%), positive values indicate increased time above range, negative values a decrease. This metric assesses risks of hyperglycemia and intervention effectiveness in keeping glucose within target levels.

Time frame:: 12 weeks
Reported as:: Mean · percentage of TAR

Changes in TAR From Baseline
percentage of TAR	Prescription ABA	Prescription BAB	Prescription ABA/BAB-matched Placebo
TAR Baseline	47.04 ± 25.460	53.61 ± 24.073	43.74 ± 21.880
TAR After 12 Weeks	25.09 ± 23.695	22.29 ± 25.427	42.51 ± 29.108
Changes in TAR from baseline	-20.37 ± 30.113	-31.12 ± 26.531	0.05 ± 19.846

SecondaryChanges in MAGE From Baseline

Changes in Mean Amplitude of Glycemic Excursions (MAGE) from baseline is the difference between a participant's MAGE at follow-up and their baseline MAGE. MAGE quantifies the average magnitude of significant blood glucose fluctuations (exceeding a threshold, typically 1.4 mmol/L \[25 mg/dL\]) over a specified period, derived from continuous glucose monitoring (CGM) data. Calculated as: Follow-up MAGE - Baseline MAGE, higher values indicate greater glycemic variability, lower values more stable glucose. This metric evaluates intervention impact on reducing glucose swings, relevant for assessing glycemic stability in diabetes management.

Time frame:: 12 weeks
Reported as:: Mean · mmol/l

Changes in MAGE From Baseline
mmol/l	Prescription ABA	Prescription BAB	Prescription ABA/BAB-matched Placebo
Baseline	6.80 ± 2.141	7 ± 1.646	6.95 ± 1.816
After 12 Weeks	5.3 ± 2.016	4.95 ± 1.78	6.35 ± 1.414
Changes in MAGE from baseline	-1.27 ± 1.896	-2.01 ± 1.766	-0.54 ± 1.645

SecondaryChange From Baseline in Total Cholesterol (TC) at Week 12

TTotal cholesterol (TC) was measured in venous blood samples and reported in mmol/L. Change from baseline was calculated as the TC value at Week 12 minus the baseline TC value. Negative values indicate a reduction in total cholesterol.

Time frame:: 12 weeks
Reported as:: Mean · mmol/L

Change From Baseline in Total Cholesterol (TC) at Week 12
mmol/L	Prescription ABA	Prescription BAB	Prescription ABA/BAB-matched Placebo
Total Cholesterol at Baseline	5.253 ± 1.0526	4.978 ± 0.9903	5.171 ± 0.9263
Total Cholesterol at Week 12	4.854 ± 1.0387	4.793 ± 0.8504	5.101 ± 1.1281
Change From Baseline at Week 12 from baseline	-0.468 ± 0.6479	-0.186 ± 0.7691	-0.033 ± 0.8066

SecondaryChange From Baseline in Body Weight at Week 12

Body weight was measured in kilograms. Change from baseline was calculated as body weight at Week 12 minus baseline body weight. Negative values indicate weight loss, and positive values indicate weight gain.

Time frame:: 12 weeks
Reported as:: Mean · kg

Change From Baseline in Body Weight at Week 12
kg	Prescription ABA	Prescription BAB	Prescription ABA-matched Placebo/ BAB-matched Placebo
Body Weight at Baseline	69.20 ± 9.347	73.53 ± 13.634	69.39 ± 13.921
Body Weight at Week 12	68.71 ± 9.676	73.66 ± 13.927	68.78 ± 13.858
Change From Baseline in Body Weight at Week 12	-0.41 ± 2.070	0.13 ± 1.678	-0.54 ± 1.768

Adverse events

Collected over 12 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Prescription ABA	0/32 (0%)	1/32 (3.1%)	24/32 (75%)
Prescription BAB	0/32 (0%)	0/32 (0%)	19/32 (59.4%)
Prescription ABA-matched Placebo/ BAB-matched Placebo	0/31 (0%)	0/31 (0%)	12/31 (38.7%)

Most frequent serious events

Most frequent serious events
Event	Prescription ABA	Prescription BAB	Prescription ABA-matched Placebo/ BAB-matched Placebo
Microvascular Coronary Artery DiseaseCardiac disorders	1/32	0/32	0/31

Most frequent other events

Most frequent other events
Event	Prescription ABA	Prescription BAB	Prescription ABA-matched Placebo/ BAB-matched Placebo
diarrheaGastrointestinal disorders	11/32	9/32	3/31
Abnormal liver functionHepatobiliary disorders	6/32	2/32	1/31
Gastrointestinal distensionGastrointestinal disorders	2/32	4/32	4/31
Urinary tract infectionsInfections and infestations	4/32	0/32	3/31
NauseaGastrointestinal disorders	3/32	3/32	0/31
Upper respiratory tract infectionsInfections and infestations	3/32	1/32	1/31

Baseline characteristics

95 participants were randomly assigned to the 12-week treatment period (BAB regimen group, n=32; ABA regimen group, n=32; Placebo group, n=31)

Age, Continuous
Age, Continuous(years)	Prescription ABA	Prescription BAB	Prescription ABA/BAB-matched Placebo	Total
Mean	56.7 ± 11.51	52.8 ± 9.62	57.2 ± 8.79	55.5 ± 10.14

Sex: Female, Male
Sex: Female, Male(Participants)	Prescription ABA	Prescription BAB	Prescription ABA/BAB-matched Placebo	Total
Female	17	15	14	46
Male	15	17	17	49

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Prescription ABA	Prescription BAB	Prescription ABA/BAB-matched Placebo	Total
Asian	32	32	31	95

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)	Prescription ABA	Prescription BAB	Prescription ABA/BAB-matched Placebo	Total
Mean	25.03 ± 2.459	26.58 ± 3.911	25.20 ± 3.202	25.61 ± 3.286

Study locations

1 site

Peking University People's Hospital
Beijing, China

References and documents

Study documents

Study protocol · Feb 18, 2025
Statistical analysis plan · Feb 18, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.

Updates

1 registry update since Sep 25, 2026

Registered

First appeared on the registry. No changes since

Oct 5, 2026

Show all 1 update

Oct 5, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06575478
Lead sponsor: Beijing Supreme Life Pharmaceutical Technology Co., Ltd.
Collaborators: Peking University People's Hospital
Responsible party: Sponsor
First posted: Aug 28, 2024
Start date: Jul 31, 2024
Primary completion: Jan 27, 2025
Completion: Jan 27, 2025
Results posted: Oct 5, 2026
Last update: Oct 5, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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