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Clinical Study on Prevention Colorectal Adenomatous Polyp Recurrence After Polypectomy Under Colonoscopy by Xiaoai Jiedu Decoction

Primary Purpose

Gastroenterology

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Xiaoai Jiedu Decoction

About this trial

This is an interventional prevention trial for Gastroenterology focused on measuring colorectal adenomatous polyps, Clinical curative effect

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

meet the colorectal adenomatous polyp diagnosis.
polypectomy under colonoscopy;Including snare polypectomy,endoscopic mucosal resection,endoscopic submucosal dissection.
aged 18-70.
sign informed consent.

Exclusion Criteria:

colonoscopy was reported, but no pathological findings were found.
patients with hereditary polyposis.
there is reliable evidence that the tumor has infiltrated into the intrinsic mucosal layer,or deep infiltration under the mucosa is suspected.
combined with colorectal malignancy or previous history of colorectal malignancy.
colonoscopy highly suggests inflammatory bowel disease.
pregnant and lactating women.
women who recently have a planning pregnant programme.
prone to bleeding and using anticoagulants.
patients with severe cardiovascular,pulmonary and cerebrovascular diseases and liver and kidney dysfunction (ALT and AST are two times higher than the upper limit of normal value in the laboratory of the center;Serum creatinine and urea nitrogen are 1.5 times higher than the upper limit of the normal value in the laboratory of the center.
unstable vital signs.
suspect or have a history of alcohol or drug abuse.
frequent changes in the working environment or other circumstances are likely to cause loss of interview.
drugs (aspirin, folic acid, vitamin D, calcium) with potential to treat colorectal adenomas have been used.
those who are participating in other clinical trials.

Sites / Locations

Affiliated Hospital of Nanjing University of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TCM-Xiaoai Jiedu Decoction

TCM-Xiaoai Jiedu Decoction Placebo

Arm Description

Xiaoai Jiedu Decoction：Oldenlandia 20g,kuh-seng 9g,Codonopsis pilosula 15g,bighead atractylodes rhizome 12g,smoked plum 9g,the rhizome of Chinese goldthread 3g,RHIZOMA ZINGIBERIS PREPARATA 6g,Semen Coicis 20g. Take one pack a day, divided into twice one day, 28 days for each course of treatment, 2 days rest, followed by the second course of treatment, 3 consecutive courses of treatment in every year， last two years.

The control group took placebo twice a day, 28 days for each course of treatment, 2 days rest, followed by the second course of treatment, 3 consecutive courses of treatment in every year，last two years.

Outcomes

Primary Outcome Measures

Colorectal Adenomatous Polyp Recurrence

Evaluate Colorectal Adenomatous Polyp Recurrence by Colonoscopy

Secondary Outcome Measures

Malignant Colorectal Adenomatous Polyp

Evaluate Malignant Colorectal Adenomatous Polyp by Colonoscopy

Full Information

NCT ID

NCT03616444

First Posted

July 26, 2018

Last Updated

July 27, 2018

Sponsor

Jiangsu Famous Medical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03616444

Brief Title

Clinical Study on Prevention Colorectal Adenomatous Polyp Recurrence After Polypectomy Under Colonoscopy by Xiaoai Jiedu Decoction

Official Title

Clinical Evidence-based Evaluation of the Efficacy of Xiaoai Jiedu Decoction in Preventing Colorectal Adenomatous Polyp Recurrence After Polypectomy Under Colonoscopy and Its Therapeutic Mechanism

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 19, 2018 (Anticipated)

Primary Completion Date

August 18, 2020 (Anticipated)

Study Completion Date

October 18, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Famous Medical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study evaluates the Xiaoai Jiedu Decoction in Prevention of Colorectal Adenomatous Polyp Recurrence After Colonoscopy.Half of participants will receive Xiaoai Jiedu Decoction,while the other half will receive a placebo.

Detailed Description

There is no internationally recognized standard treatment for the prevention of recurrence of colorectal adenomatous polyps. Based on TCM,previous studies have found that Xiaoai Jiedu Decoction can significantly reduce the recurrence and deterioration rate of colorectal adenomatous polyps,reduce the proliferation of tumor cells and promote apoptosis of tumor cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroenterology

Keywords

colorectal adenomatous polyps, Clinical curative effect

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

colorectal adenomatous polyp patients after colonoscopy under colonoscopy

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TCM-Xiaoai Jiedu Decoction

Arm Type

Experimental

Arm Description

Arm Title

TCM-Xiaoai Jiedu Decoction Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Xiaoai Jiedu Decoction

Other Intervention Name(s)

placebo

Intervention Description

The experimental group took Xiaoai Jiedu Decoction twice a day, 28 days for each course of treatment, 2 days rest, followed by the second course of treatment, 3 consecutive courses of treatment in every year， last two years. The control group took placebo twice a day, 28 days for each course of treatment, 2 days rest, followed by the second course of treatment, 3 consecutive courses of treatment in every year，last two years.

Primary Outcome Measure Information:

Title

Colorectal Adenomatous Polyp Recurrence

Description

Evaluate Colorectal Adenomatous Polyp Recurrence by Colonoscopy

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Malignant Colorectal Adenomatous Polyp

Description

Evaluate Malignant Colorectal Adenomatous Polyp by Colonoscopy

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: meet the colorectal adenomatous polyp diagnosis. polypectomy under colonoscopy;Including snare polypectomy,endoscopic mucosal resection,endoscopic submucosal dissection. aged 18-70. sign informed consent. Exclusion Criteria: colonoscopy was reported, but no pathological findings were found. patients with hereditary polyposis. there is reliable evidence that the tumor has infiltrated into the intrinsic mucosal layer,or deep infiltration under the mucosa is suspected. combined with colorectal malignancy or previous history of colorectal malignancy. colonoscopy highly suggests inflammatory bowel disease. pregnant and lactating women. women who recently have a planning pregnant programme. prone to bleeding and using anticoagulants. patients with severe cardiovascular,pulmonary and cerebrovascular diseases and liver and kidney dysfunction (ALT and AST are two times higher than the upper limit of normal value in the laboratory of the center;Serum creatinine and urea nitrogen are 1.5 times higher than the upper limit of the normal value in the laboratory of the center. unstable vital signs. suspect or have a history of alcohol or drug abuse. frequent changes in the working environment or other circumstances are likely to cause loss of interview. drugs (aspirin, folic acid, vitamin D, calcium) with potential to treat colorectal adenomas have been used. those who are participating in other clinical trials.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chen Haibo, PhD

Phone

86-025-85811005

hbcheng@njucm.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zhou Qing, PhD

Phone

86-13601401869

13601401869@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chen Yugen, PhD

Organizational Affiliation

Key members of the study

Official's Role

Study Chair

Facility Information:

Facility Name

Affiliated Hospital of Nanjing University of TCM

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

31374049

Citation

Zhou Q, Chen YG, Xiao J, Chen TT, Liu JR, Zhou W, Li WZ, Wang Y, Zhang BP, Lin J, Meng FD, Gong B, Zheng GY, Han ST, Cheng HB. Traditional Chinese medicine (Xiaoai Jiedu Decoction) as an adjuvant treatment for prevention new colorectal adenomatous polyp occurrence in post-polypectomy: Study protocol for a randomized controlled trial. Medicine (Baltimore). 2019 Aug;98(31):e16680. doi: 10.1097/MD.0000000000016680.

Results Reference

derived

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Clinical Study on Prevention Colorectal Adenomatous Polyp Recurrence After Polypectomy Under Colonoscopy by Xiaoai Jiedu Decoction

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