Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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.

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.

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.

Shenbai Granules

Chen Yugen, PhD

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.

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.

colorectal adenomatous polyp patients after colonoscopy under colonoscopy

A double-blind design is used in this study for the investigators and subjects. The blinding codes are separately sealed and stored by the independent third-party organization. Trial granules are randomly coded as subject unique identification codes, and used by each clinical site according to the assigned drug numbers and in the order of case enrollment. Clinical monitors and investigators must be blinded at all times.

A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma

Clinical Evidence-based Evaluation of the Efficacy of Shenbai Granules in Preventing Recurrent Colorectal Adenomas After Polypectomy and Its Therapeutic Mechanism

The data supporting the findings of this study are restricted in availability due to patient confidentiality reasons.

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.

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.

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.

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.

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

Jiangsu Famous Medical Technology Co., Ltd.

Nervous System Diseases

Substance Related Disorders

Rare Diseases

Neurotoxicity Syndromes

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

The dosage of granules: Sheng huangqi granule 5.5g/bag, Guizhi granule 0.9g/bag, Baishao granule 1.6g/bag, Ganjiang granule 1.7g/bag, Dazao granule 7g/bag. Take twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles)

The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles)

The experimental group took Huangqi Guizhi Wuwu decoction twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles).

The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles).

Huangqi Guizhi Wuwu decoction

Chen Haibo, PhD

Gu Yanhong, PhD

Shu Peng, PhD

Chen Xiaofeng, PhD

To evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity.

The purpose of this study is to evaluate whether the preventive effect of Huangqi Guizhi Wuwu decoction on oxaliplatin induced peripheral neurotoxicity is better than that of simulator, and to provide evidence-based medicine basis for the clinical promotion of single medicine granule. This trial purpose is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity. This trial design type is a randomized, controlled, double-blind, multicenter clinical study was conducted.

Patients with colorectal cancer diagnosed by histopathological examination; patients after radical resection of colorectal cancer confirmed by histopathological examination, staged as high-risk II stage

Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction

Study on Efficacy and Safety of Huangqi Guizhi Wuwu Decoction Treatment for Oxaliplatin Induced Peripheral Neurotoxicity: a Protocol for a Randomized, Controlled, Double-blind, Multi-center Trial

Differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment

Difference in the incidence of acute neurotoxicity

Time of occurrence of chronic toxicity to grade 2 and 3

Recovery time of grade 2 and 3 neurotoxicity

Cumulative dose of oxaliplatin and the proportion of patients who stop using oxaliplatin because of neurotoxicity

Incidence of nausea, vomiting, diarrhea, and hand-foot syndrome

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma	NCT03616444	Gastroenterolog...	Shenbai Granule...	18 Years - 70 Years	Jiangsu Famous Medical Technology Co., Ltd.
Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction	NCT04261920	Oncology	Huangqi Guizhi ...	18 Years - 75 Years	Jiangsu Famous Medical Technology Co., Ltd.
A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma	NCT03616444	Gastroenterolog...	Shenbai Granule...	18 Years - 70 Years	Jiangsu Famous Medical Technology Co., Ltd.
Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction	NCT04261920	Oncology	Huangqi Guizhi ...	18 Years - 75 Years	Jiangsu Famous Medical Technology Co., Ltd.

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