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

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ClinicalTrials.gov Identifier: NCT03616444
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu Famous Medical Technology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Gastroenterology Drug: Xiaoai Jiedu Decoction Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: colorectal adenomatous polyp patients after colonoscopy under colonoscopy
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : August 19, 2018
Estimated Primary Completion Date : August 18, 2020
Estimated Study Completion Date : October 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: TCM—Xiaoai Jiedu Decoction
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.
Drug: Xiaoai Jiedu Decoction

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.

Other Name: placebo

Placebo Comparator: TCM—Xiaoai Jiedu Decoction Placebo
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.
Drug: Xiaoai Jiedu Decoction

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.

Other Name: placebo




Primary Outcome Measures :
  1. Colorectal Adenomatous Polyp Recurrence [ Time Frame: 2 years ]
    Evaluate Colorectal Adenomatous Polyp Recurrence by Colonoscopy


Secondary Outcome Measures :
  1. Malignant Colorectal Adenomatous Polyp [ Time Frame: 2 years ]
    Evaluate Malignant Colorectal Adenomatous Polyp by Colonoscopy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. colonoscopy was reported, but no pathological findings were found.
  2. patients with hereditary polyposis.
  3. there is reliable evidence that the tumor has infiltrated into the intrinsic mucosal layer,or deep infiltration under the mucosa is suspected.
  4. combined with colorectal malignancy or previous history of colorectal malignancy.
  5. colonoscopy highly suggests inflammatory bowel disease.
  6. pregnant and lactating women.
  7. women who recently have a planning pregnant programme.
  8. prone to bleeding and using anticoagulants.
  9. 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.
  10. unstable vital signs.
  11. suspect or have a history of alcohol or drug abuse.
  12. frequent changes in the working environment or other circumstances are likely to cause loss of interview.
  13. drugs (aspirin, folic acid, vitamin D, calcium) with potential to treat colorectal adenomas have been used.
  14. those who are participating in other clinical trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616444


Contacts
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Contact: Chen Haibo, PhD 86-025-85811005 hbcheng@njucm.edu.cn
Contact: Zhou Qing, PhD 86-13601401869 13601401869@163.com

Locations
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China, Jiangsu
Affiliated Hospital of Nanjing University of TCM
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
Jiangsu Famous Medical Technology Co., Ltd.
Investigators
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Study Chair: Chen Yugen, PhD Key members of the study

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jiangsu Famous Medical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03616444     History of Changes
Other Study ID Numbers: 2017YFC1700602
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Famous Medical Technology Co., Ltd.:
colorectal adenomatous polyps
Clinical curative effect
Additional relevant MeSH terms:
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Adenomatous Polyps
Recurrence
Disease Attributes
Pathologic Processes
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms