Clinical Study on Prevention Colorectal Adenomatous Polyp Recurrence After Polypectomy Under Colonoscopy by Xiaoai Jiedu Decoction
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Colorectal Adenomatous Polyp Recurrence [2 years]
Evaluate Colorectal Adenomatous Polyp Recurrence by Colonoscopy
Secondary Outcome Measures
- Malignant Colorectal Adenomatous Polyp [2 years]
Evaluate Malignant Colorectal Adenomatous Polyp by Colonoscopy
Eligibility Criteria
Criteria
Inclusion Criteria:
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meet the colorectal adenomatous polyp diagnosis.
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polypectomy under colonoscopy;Including snare polypectomy,endoscopic mucosal resection,endoscopic submucosal dissection.
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aged 18-70.
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sign informed consent.
Exclusion Criteria:
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colonoscopy was reported, but no pathological findings were found.
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patients with hereditary polyposis.
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there is reliable evidence that the tumor has infiltrated into the intrinsic mucosal layer,or deep infiltration under the mucosa is suspected.
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combined with colorectal malignancy or previous history of colorectal malignancy.
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colonoscopy highly suggests inflammatory bowel disease.
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pregnant and lactating women.
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women who recently have a planning pregnant programme.
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prone to bleeding and using anticoagulants.
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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.
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unstable vital signs.
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suspect or have a history of alcohol or drug abuse.
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frequent changes in the working environment or other circumstances are likely to cause loss of interview.
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drugs (aspirin, folic acid, vitamin D, calcium) with potential to treat colorectal adenomas have been used.
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those who are participating in other clinical trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Affiliated Hospital of Nanjing University of TCM | Nanjing | Jiangsu | China | 210029 |
Sponsors and Collaborators
- Jiangsu Famous Medical Technology Co., Ltd.
Investigators
- Study Chair: Chen Yugen, PhD, Key members of the study
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017YFC1700602