A Study of Danning Tablet in Patients With Polypoid Lesions of Gallbladder

Polyps Gallbladder Clinical Trial

— PLG001  

Official title:

Effects of Danning Tablet Under Lifestyle Intervention in Patients With Polypoid Lesions of Gallbladder: A Randomized, Open-labelled, Multicenter, Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05668871
• Other study ID #: CCPE202201
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2022
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Tian Yang
• Phone: +8613636330827
• Email: yangtian6666[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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:

1. Changes in thickness of gallbladder wall, use gallbladder ultrasonography to evaluate this indicator on weeks 12±1 and weeks 24±1.

2. Changes in clinical symptoms of gallbladder polyps, use Visual Analogue Scale (VAS) to evaluate this indicator on weeks 12±1 and weeks 24±1.

3. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 336
• Est. completion date: November 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

1. Be between 18 and 75 years of age, male or female.

2. 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.

3. No symptoms, or only some non-specific symptoms, such as ventosity, nausea, anorexia, right upper abdominal pain and right shoulder pain, etc.

4. Provide written informed consent.

Exclusion Criteria:

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

1. Thickness of gallbladder wall is larger than 6 mm.

2. Clinically diagnosed as gallbladder cancer.

3. Clinically diagnosed as gallbladder and/or bile duct stones, and/or acute cholecystitis.

4. Previously performed gallbladder/biliary tract related operations, such as gallbladder-protected lithotomy, ERCP lithotomy, PTCS lithotomy and PTGBD.

5. 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.

6. Have irregular stool, and/or daily stool frequency more than or equal to 5 times in recent 2 weeks.

7. 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.

8. Regularly taken proton pump inhibitors or H2 receptor antagonists or cholinergic receptor antagonists or gastrin receptor antagonists in recent 4 weeks.

9. Allergic to Danning Tablet and its components, has history of allergy, or has allergic constitution, or in allergic state.

10. Are pregnant, planning to be pregnant or breastfeeding.

11. Poor compliance, unable to cooperate with the investigator;

12. Have previously been involved in another clinical trial in the past three month;

13. Other situations not suitable for inclusion.

Related Conditions & MeSH terms

• Polyps
• Polyps Gallbladder

Intervention

Drug:
• Danning Tablet
3 times each day, 5 tablets each time, take orally after meals.

Locations

Country	Name	City	State
China	Anning First People's Hospital	Anning	Yunan
China	Xiangya Changde Hospital	Changde	Hunan
China	The Sixth People's Hospital of Chengdu	Chengdu	Sichuan
China	First Affiliated Hospital of Gannan Medical University	Ganzhou	Jiangxi
China	The First Affiliated Hospital of University of South China	Hengyang	Hunan
China	Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)	Jinan	Shandong
China	Shandong Provincial Third Hospital	Jinan	Shandong
China	Jinhua Municipal Central Hospital	Jinhua	Zhejiang
China	Loudi Central Hospital	Loudi	Hunan
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Ningbo Municipal Hospital of Traditional Chinese Medicine	Ningbo	Zhejiang
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Eastern Hepatobiliary Surgery Hospital, Naval Medical University,	Shanghai	Shanghai
China	Shangrao People's Hospital	Shangrao	Jiangxi
China	Affiliated Hospital of Shaoxing University	Shaoxing	Zhejiang
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Yiyang Central Hospital	Yiyang	Hunan
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum diameter of gallbladder polyps on weeks 12±1	Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps.	weeks 12±1
Primary	Maximum diameter of gallbladder polyps on weeks 24±1	Use gallbladder ultrasonography to evaluate the maximum diameter of gallbladder polyps.	weeks 24±1
Secondary	Thickness of gallbladder wall on weeks 12±1	Use gallbladder ultrasonography to evaluate thickness of gallbladder wall.	weeks 12±1
Secondary	Thickness of gallbladder wall on weeks 24±1	Use gallbladder ultrasonography to evaluate thickness of gallbladder wall.	weeks 24±1
Secondary	Level of abdominal pain on weeks 4±1	Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.	weeks 4±1
Secondary	Level of abdominal pain on weeks 8±1	Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.	weeks 8±1
Secondary	Level of abdominal pain on weeks 12±1	Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.	weeks 12±1
Secondary	Level of abdominal pain on weeks 24±1	Use Visual Analogue Scale (VAS) to evaluate the level of abdominal pain caused by gallbladder polyps.	weeks 24±1
Secondary	Clinical safety indexes	Observe and record the occurrence of adverse events (AE) of subjects from baseline to follow-up cycle finished.	up to weeks 24±1