GastroenterologyPhase 2/3NCT03616444
A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma
A Phase 2/3 study testing Shenbai Granules in people with Gastroenterology, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.
Trial summary
This study evaluates Shenbai Granules in Prevention of Colorectal Adenomatous Polyp Recurrence After Colonoscopy.Half of participants will receive Shenbai Granules,while the other half will receive a placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroenterology
- What is being tested?
- Shenbai Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2018to 28 Jun 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet the colorectal adenomatous polyp diagnosis.
- polypectomy under colonoscopy;Including snare polypectomy,endoscopic mucosal resection,endoscopic submucosal dissection.
- aged 18-70.
- sign informed consent.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Nanjing University of TCM
Nanjing, Jiangsu, 210029
About this study
Official title: Clinical Evidence-based Evaluation of the Efficacy of Shenbai Granules in Preventing Recurrent Colorectal Adenomas After Polypectomy and Its Therapeutic Mechanism
This study evaluates Shenbai Granules in Prevention of Colorectal Adenomatous Polyp Recurrence After Colonoscopy.Half of participants will receive Shenbai Granules,while the other half will receive a placebo.
Read the 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 Shenbai Granules can significantly reduce the recurrence and deterioration rate of colorectal adenomatous polyps,reduce the proliferation of tumor cells and promote apoptosis of tumor cells.
- Conditions
- Gastroenterology
- Being tested
- Shenbai Granules
- Keywords
- colorectal adenoma, Clinical curative effect, Complementary and alternative medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenbai GranulesDrug
Also called placebo
In the first year, the trial granules will be started after enrollment for 3 months; In the second year, the trial granules will be started in the first 3 months; Each participant should have completed 6 months of trial granules.
| Study group | Role | What they receive |
|---|---|---|
| TCM-Shenbai Granules | Experimental | Shenbai Granules: Hedyotis diffusa 10g, Sophorae flavescentis radix 4.5g, Codonopsis radix 7.5g, Atractylodis macrocephalae rhizoma 6g, Mume fructus 4.5g, Coptidis rhizoma 1.5g, Zingiberis rhizome praeparatum 3g, Coicis semen 10g.
Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day. Receives: Drug: Shenbai Granules |
| TCM-Placebo | Placebo comparator | It contains 5% SBG content, and the remaining ingredients are flavoring agents, starch and coloring agents. It is the same with SBG in appearance, smell and dosage form.
Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day. Receives: Drug: Shenbai Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
The ratio of the number of patients with new adenoma detected by colonoscopy to the total number of cases in this group during follow-up.
Measured: 2 years
Secondary outcomes (3)
The detection rate of any polypoid lesions
The ratio of the number of patients with any polypoid lesions detected by colonoscopy to the total number of cases in this group during follow-up.
Measured: 2 years
The detection rate of high-risk adenomas
The ratio of the number of patients with high-risk adenomas detected by colonoscopy to the total number of cases in this group during follow-up.
Measured: 2 years
The detection rate of sessile serrated lesions
The ratio of the number of patients with sessile serrated lesions detected by colonoscopy to the total number of cases in this group during follow-up.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start3 Dec 2018
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroenterologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- colorectal adenomatous polyp patients after colonoscopy under colonoscopy
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Affiliated Hospital of Nanjing University of Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, ShuGuang Hospital, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Changhai Hospital, Beijing Friendship Hospital, The First Affiliated Hospital with Nanjing Medical University, West China Hospital
- Responsible party
- Sponsor
- Investigators
- Chen Yugen, PhD, Study chair, Key members of the study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616444
- Sponsor's protocol ID
- 2017YFC1700602
- Status last verified
- Nov 2023
- First submitted
- 26 Jul 2018
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data supporting the findings of this study are restricted in availability due to patient confidentiality reasons.
Publications
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.
PubMed 31374049
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evidence-based Evaluation of the Efficacy of Shenbai Granules in Preventing Recurrent Colorectal Adenomas After Polypectomy and Its Therapeutic Mechanism
- ClinicalTrials.gov ID
- NCT03616444
- Acronym / sponsor ID
- 2017YFC1700602
- Conditions
- Gastroenterology
- Keywords
- colorectal adenoma, Clinical curative effect, Complementary and alternative medicine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Affiliated Hospital of Nanjing University of Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, ShuGuang Hospital, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Changhai Hospital, Beijing Friendship Hospital, The First Affiliated Hospital with Nanjing Medical University, West China Hospital
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates Shenbai Granules in Prevention of Colorectal Adenomatous Polyp Recurrence After Colonoscopy.Half of participants will receive Shenbai Granules,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 Shenbai Granules 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- colorectal adenomatous polyp patients after colonoscopy under colonoscopy
| Arm | Type | Receives |
|---|---|---|
| TCM-Shenbai Granules | Experimental | Drug: Shenbai GranulesShenbai Granules: Hedyotis diffusa 10g, Sophorae flavescentis radix 4.5g, Codonopsis radix 7.5g, Atractylodis macrocephalae rhizoma 6g, Mume fructus 4.5g, Coptidis rhizoma 1.5g, Zingiberis rhizome praeparatum 3g, Coicis semen 10g. Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day. |
| TCM-Placebo | Placebo comparator | Drug: Shenbai GranulesIt contains 5% SBG content, and the remaining ingredients are flavoring agents, starch and coloring agents. It is the same with SBG in appearance, smell and dosage form. Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- meet the colorectal adenomatous polyp diagnosis.
- polypectomy under colonoscopy;Including snare polypectomy,endoscopic mucosal resection,endoscopic submucosal dissection.
- aged 18-70.
- sign informed consent.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shenbai GranulesAlso: placeboIn the first year, the trial granules will be started after enrollment for 3 months; In the second year, the trial granules will be started in the first 3 months; Each participant should have completed 6 months of trial granules. | Drug | TCM-Placebo, TCM-Shenbai Granules |
Primary outcome
Adenoma detection rate
Time frame: 2 years
The ratio of the number of patients with new adenoma detected by colonoscopy to the total number of cases in this group during follow-up.
3 secondary outcomes
The detection rate of any polypoid lesions
Time frame: 2 years
The detection rate of high-risk adenomas
Time frame: 2 years
The detection rate of sessile serrated lesions
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 31374049Zhou 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.
- Individual participant dataSharing planned: No. The data supporting the findings of this study are restricted in availability due to patient confidentiality reasons.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Yugen, PhD study chair
Key members of the study
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Shenbai Granules in people with Gastroenterology, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03616444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.