ClinicalTrials.gg
Not yet recruitingNCT07759323Updated Aug 12, 2026

Polygonatum Sibiricum Reduces Visceral Fat in Obese Adults

An interventional study of Polygonatum sibiricum and Lifestyle Intervention in Visceral Obesity and Metabolic Syndrome, sponsored by Zhejiang Provincial Tongde Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Zhejiang Provincial Tongde Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study is being done to find out if a traditional Chinese herb called Polygonatum sibiricum (Huangjing) can help reduce belly fat and improve metabolic health in adults with visceral obesity.

Visceral obesity means having too much fat stored deep inside the belly, around the organs. This type of fat is linked to a higher risk of diabetes, fatty liver, and heart disease.

The study will include 66 adults with visceral obesity. Participants will be randomly assigned to one of two groups:

One group will receive a Polygonatum sibiricum decoction (15 grams daily) plus standard lifestyle advice on diet and exercise.

The other group will receive the same lifestyle advice only.

The study will last for 12 weeks. Researchers will measure changes in visceral fat area, body weight, waist size, blood sugar, blood lipids, and liver fat. They will also look at gut bacteria and related markers to better understand how Polygonatum sibiricum might work.

Participation involves 4 visits to the study site over the 12-week period. All participants will receive free health assessments and dietitian guidance. The study is not a treatment but a research study to test whether this herb has potential benefits for visceral obesity.

02

Conditions studied

  • Visceral Obesity
  • Metabolic Syndrome

Keywords

  • Polygonatum sibiricum
  • Visceral Fat Area
03

In context

Obesity, Abdominal

294 studies on the registry are indexed under Obesity, Abdominal; 45 are open to participants now.

This study's planned enrollment of 66 is above the median of 58 across 234 interventional studies indexed under Obesity, Abdominal.

Browse Obesity, Abdominal studies →

Lead sponsor

Zhejiang Provincial Tongde Hospital is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 to 65 years, male or female;
  • (BMI) ≥ 24 kg/m², or body fat percentage ≥ 25% for males or ≥ 30% for females, and visceral fat area ≥ 100 cm²;
  • Body weight stable within the past 3 months, with fluctuation not exceeding 5%;
  • Able to understand the study content, voluntarily sign the form, and willing to complete follow-up visits and required examinations as scheduled.

Exclusion criteria

Exclusion Criteria:

  • Secondary obesity (e.g., caused by endocrine disorders such as hypothyroidism, Cushing's syndrome, or polycystic ovary syndrome);
  • Previous metabolic surgery or current use of weight-loss medications;
  • Concomitant severe hyperglycemia or lipid metabolism disorders requiring immediate intensive treatment;
  • Concomitant severe cardiovascular or cerebrovascular disease, or unstable medical condition;
  • Significant hepatic or renal dysfunction (e.g., or AST > 2-3 times the , or \< 60 ml/min/1.73 m²);
  • Malignant tumors, active infections, or diseases;
  • Use of antibiotics, probiotics, or other agents that may affect gut microbiota within the past month;
  • Pregnancy, lactation, or plans for pregnancy;
  • Allergy to or intolerance of any component of the product;
  • Any other conditions deemed unsuitable for participation in this study by the investigator.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Polygonatum sibiricum Intervention Group

    Polygonatum sibiricum and lifestyle intervention

    Dietary Supplement: Polygonatum sibiricum · Behavioral: Lifestyle Intervention

  • Active comparator
    Control Group

    Lifestyle intervention

    Behavioral: Lifestyle Intervention

Interventions

  • Dietary supplementPolygonatum sibiricum

    Polygonatum sibiricum decoction, 15 g daily, taken orally in 1-2 divided doses after meals, for 12 consecutive weeks. The herbal decoction is prepared by the Pharmaceutical Department of Zhejiang Provincial Tongde Hospital from authenticated Polygonatum sibiricum raw material. Batch number management, dispensing logs, and residual drug recovery are implemented to ensure traceability. All participants in this arm also receive standardized lifestyle intervention (individualized calorie-restricted diet, moderate-intensity aerobic combined with resistance exercise for at least 150 minutes per week, and Traditional Chinese Medicine behavioral guidance). The study is a randomized, open-label, parallel-controlled trial designed to evaluate the effects of Polygonatum sibiricum on visceral fat area and related metabolic parameters.

    Also known as: Huangjing

  • BehavioralLifestyle Intervention

    Standardized lifestyle intervention consisting of three components: (1) individualized calorie-restricted diet prescribed by a dietitian based on each participant's basal metabolic rate and physical activity level, following the principles of total energy control, reduced sugar and fat intake, and regular meals; (2) moderate-intensity aerobic exercise combined with resistance training, with a target of at least 150 minutes per week; and (3) Traditional Chinese Medicine "preventive treatment" behavioral guidance, including sleep management, stress management, and daily living and dietary education. This intervention is provided to all participants in both groups throughout the 12-week study period.

    Also known as: Standardized Lifestyle Intervention

06

What researchers measure

Primary outcomes

  1. Change in visceral fat area

    Using bioelectrical impedance analysis (BIA), the change in visceral fat area after 12 weeks of intervention compared to the baseline was measured to evaluate the intervention effect of rehmannia on visceral fat accumulation.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Body weight

    Time frame: Baseline and Week 12

  2. waist circumference

    Time frame: Baseline and Week 12

  3. body fat rate

    Time frame: Baseline and Week 12

  4. Blood lipids

    Time frame: Baseline and Week 12

  5. fasting blood glucose

    Time frame: Baseline and Week 12

  6. fasting insulin

    Time frame: Baseline and Week 12

  7. HOMA-IR

    Time frame: Baseline and Week 12

  8. degree of hepatic steatosis

    Time frame: Baseline and Week 12

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Jul 2027, 11 months later.

Of 106 non-industry interventional studies with no phase under Obesity, Abdominal, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 11 months is below that.

Counting every sponsor, half of 116 studies reached it within 16 months; a quarter within 7 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Aug 12, 2026
StartEst.
Aug 15, 2026
Primary completionEst.
Jul 30, 2027
CompletionEst.
Jul 30, 2027
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07759323
Lead sponsor
Zhejiang Provincial Tongde Hospital
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Jul 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Aug 12, 2026

Study contacts

Xiaoli Wang, Ph.D.
Contact
wxldoctor@126.com
+86 15168448356

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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