A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder (PLG001)

Naval Military Medical University (Second Military Medical University)

Status and phase

Not yet enrolling

Phase 4

Conditions

Polyps Gallbladder

Treatments

Drug: Danning Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT05668871

CCPE202201

Details and patient eligibility

About

The primary goal of this clinical trial is to evaluate the effect of Danning Tablet on shrinkage of gallbladder polyps compared to lifestyle intervention in 336 patients with gallbladder polyps. The main questions it aims to answer are:

Medicine may be effective on shrinkage of gallbladder polyps and alleviation of clinical symptoms of gallbladder polyps.
Chinese patent medicine (herbal medicine) may be safety in treatment of gallbladder polyps.

Full description

Study design:

In this study, 336 participants will be randomly allocated to the test group or the controlled group in ratio of 1:1 and receive lifestyle intervention from baseline to weeks 24±1. However, in experimental group, participants will take Danning Tablet from baseline to weeks 12±1 (3 times each day, 5 tablets each time). In controlled group, only lifestyle intervention will be adopted. The length of follow-up cycle is 24 weeks.

Evaluation indicators:

Primary indicator: Changes in maximum diameter of gallbladder polyps, use gallbladder ultrasonography to evaluate this indicator on weeks 12±1 and weeks 24±1.

Secondly Indicators:

Changes in thickness of gallbladder wall, use gallbladder ultrasonography to evaluate this indicator on weeks 12±1 and weeks 24±1.
Changes in clinical symptoms of gallbladder polyps, use Visual Analogue Scale (VAS) to evaluate this indicator on weeks 12±1 and weeks 24±1.
Clinical safety indexes, use laboratory examination such as blood biochemical examination, routine blood test for safety observation on weeks 12±1 and weeks 24±1. Besides, observe and record the occurrence of adverse events (AE) of subjects from baseline to follow-up cycle finished.

Enrollment

336 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants suitable for enrollment in this study must meet all of the following criteria:

Be between 18 and 75 years of age, male or female.
More than or equal to 2 gallbladder polyps were detected by B-ultrasound within 2 weeks before enrollment, and the maximum diameter of gallbladder polyps is between 3-7 mm.
No symptoms, or only some non-specific symptoms, such as ventosity, nausea, anorexia, right upper abdominal pain and right shoulder pain, etc.
Provide written informed consent.

Exclusion criteria

Participants who meet any of the following criteria will not be eligible for inclusion in this study:

Thickness of gallbladder wall is larger than 6 mm.
Clinically diagnosed as gallbladder cancer.
Clinically diagnosed as gallbladder and/or bile duct stones, and/or acute cholecystitis.
Previously performed gallbladder/biliary tract related operations, such as gallbladder-protected lithotomy, ERCP lithotomy, PTCS lithotomy and PTGBD.
Have severe infectious or severe primary diseases such as diseases in cardiovascular, cerebrovascular, pulmonary, renal or endocrine or hematopoietic system, or with mental diseases and/or behavioral abnormalities, which cannot be enrolled in the study determined by investigator.
Have irregular stool, and/or daily stool frequency more than or equal to 5 times in recent 2 weeks.
Regularly taken any Chinese patent medicine (including traditional Chinese medicine injection) with "soothing liver, cholagogic, clearing heat, dredging intestines" clearly written in the instructions, or regularly taken the traditional Chinese medicine decoction with the effect of soothing liver and cholagogic in recent 4 weeks.
Regularly taken proton pump inhibitors or H2 receptor antagonists or cholinergic receptor antagonists or gastrin receptor antagonists in recent 4 weeks.
Allergic to Danning Tablet and its components, has history of allergy, or has allergic constitution, or in allergic state.
Are pregnant, planning to be pregnant or breastfeeding.
Poor compliance, unable to cooperate with the investigator;
Have previously been involved in another clinical trial in the past three month;
Other situations not suitable for inclusion.