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Can an herbal tablet shrink gallbladder polyps without surgery?

NCT ID NCT05668871

Disease control Sponsor: Eastern Hepatobiliary Surgery Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether Danning tablets, an herbal medicine, can reduce the size or clear multiple gallbladder polyps when combined with lifestyle changes like a low-fat diet and avoiding alcohol. Adults aged 18-75 with polyps between 3-7 mm are enrolled. The main goal is to see if the treatment improves symptoms and shrinks polyps after 24 weeks, compared to lifestyle changes alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Danning Tablet (Biliflow), an herbal medicine taken orally, combined with lifestyle management (diet and habits)
What this could lead to
If effective, Danning tablets could offer a non-surgical way to shrink or clear gallbladder polyps, potentially reducing the need for surgery.
What could go wrong
This is a phase 4 trial, but results are not yet known. The effect may be modest, and some people may not respond. Side effects are possible, though the medicine is already in use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

326 people

The number who actually took part.

Started

Dec 2022

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants suitable for enrollment in this study must meet all of the following criteria: 1. Adults aged 18-75 years, both male and female. 2. Diagnosed with multiple gallbladder polyps (≥2 polyps) based on ultrasound examinations within 2 weeks before enrolment, with largest polyps measuring between 3 mm and 7 mm in diameter. 3. Participants with non-specific or without symptoms related to gallpladder polyps, such as ventosity, nausea, anorexia, right upper abdominal pain, and right shoulder radiating pain, etc. 4. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: Participants who meet any of the following criteria will not be eligible for inclusion in this study: 1. Clinical diagnosis of gallbladder cancer, and/or gallbladder/bile duct stones, and/or acute cholecystitis. 2. Previous gallbladder/biliary tract surgery, such as gallbladder-preserving cholecystolithotomy, lithotomy by endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC), etc. 3. Thickness of gallbladder wall \>6 mm based on ultrasound examinations. 4. Severe comorbid conditions, including active severe infectious or severe primary cardiovascular, cerebrovascular, pulmonary, renal, endocrine, or hematopoietic disease, or with mental disorders and/or behavioural abnormalities. 5. Irregular stool and/or stool evacuation frequency ≥5 times/day within 2 weeks before enrolment. 6. Regularly taking any Chinese patent medicine (including TCM injection) with "soothing liver, cholagogic, clearing heat, dredging intestines" clearly written in the instructions, or regularly taking the TCM decoction with the effect of soothing liver and cholagogic within 4 weeks before enrolment. 7. Currently receiving other pharmacological treatments for MGPs. 8. Regularly taking proton pump inhibitors or H2-receptor antagonists, cholinergic receptor antagonists or gastrin receptor antagonists within 4 weeks before enrolment. 9. Pregnancy or lactation: Women who are pregnant, planning to become pregnant, or breastfeeding. 10. Allergies: Participants with known hypersensitivity to any components of Danning Tablets. 11. Poor patient compliance or being unable to cooperate with the investigator. 12. Participation in another trial within 3 months before enrolment. 13. Any other situations not suitable for inclusion.

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Conditions

The condition(s) this trial relates to.

polyp polyposis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple gallbladder polyps

Contacts and locations

Locations

  • Affiliated Hospital of Shaoxing University

    Shaoxing, Zhejiang, 0086575, China

  • Anning First People's Hospital

    Anning, Yunan, 0086871, China

  • Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)

    Jinan, Shandong, 0086531, China

  • Chongqing General Hospital

    Chongqing, China

  • Eastern Hepatobiliary Surgery Hospital, Naval Medical University,

    Shanghai, Shanghai Municipality, 0086021, China

  • Ezhou Central Hospital

    Ezhou, Hubei, China

  • Hebei general hospital

    Shijiazhuang, Hebei, China

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 0086579, China

  • Loudi Central Hospital

    Loudi, Hunan, 0086738, China

  • Ningbo Municipal Hospital of Traditional Chinese Medicine

    Ningbo, Zhejiang, 0086574, China

  • People's Hospital of Yiyang

    Yiyang, Hunan, 0086737, China

  • Shangrao People's Hospital

    Shangrao, Jiangxi, 0086793, China

  • Shanxi Traditional Chinese Medicine Hospital

    Taiyuan, Shanxi, China

  • Tangshan Central Hospital

    Tangshan, Hebei, China

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan, 0086734, China

  • The Sixth People's Hospital of Chengdu

    Chengdu, Sichuan, 0086028, China

  • Xiangya Changde Hospital

    Changde, Hunan, 0086736, China

  • Xiantao First People's Hospital

    Xiantao, Hubei, China

  • Yiwu Central Hospital

    Yiwu, Zhejiang, China