scholarly journals Study Protocol Daiobotanpito combined with antibiotic therapy for treatment of acute diverticulitis: a study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Keiko Ogawa-Ochiai ◽  
Keinichi Yoshimura ◽  
Akiko Shirai ◽  
Seisho Sakai ◽  
Hideki Moriyama ◽  
...  
Keyword(s):  
Recurrence Rate ◽  
Study Protocol ◽  
Conventional Therapy ◽  
Controlled Trial ◽  
Acute Diverticulitis ◽  
Treatment Success ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Intravenous Antibiotics

Abstract Background: Colonic diverticular disease has been increasing in prevalence due to the rapidly aging global population, but standard treatment has not changed dramatically in recent years. Daiobotanpito (DBT; Da Huang Mu Dan Tang in Chinese) has been used in medical treatment of acute abdominal abscesses, such as appendicitis or diverticulitis in traditional Japanese (Kampo) medicine for many years, based on more than 3000 years of experience. Prior to this study, a retrospective open-label trial was conducted to compare patients with acute diverticulitis who received oral DBT combined with intravenous antibiotics with those who received intravenous antibiotic alone; it showed a positive effect of DBT on acute diverticulitis. We aim to investigate whether moderate to severe acute diverticulitis shows greater improvement with intravenous antibiotics plus orally administered DBT compared with intravenous antibiotics with placebo. Methods: This is a two-group, randomized, double-blind, placebo-controlled, multi-center trial, which is designed to evaluate the efficacy and safety of DBT for moderate to severe diverticulitis patients treated with intravenous antibiotics. Eligible participants will be randomized to either a treatment group receiving a 10-day oral DBT regimen plus conventional therapy or a control group receiving a 10-day placebo regimen plus conventional therapy. The primary outcome will be the treatment success rate of diverticulitis defined as fever relief to <37.5 ℃ within 3 days or/and elimination of abdominal pain within 4 days. Secondary endpoints will include hospitalization days, changes in inflammatory response (CRP, WBC, neutrophil count), thermal type, number of days before beginning food intake, recurrence rate (observation for 1 year after registration), and adverse event expression rate. Assessments will be performed at baseline and on the day of discharge. The recurrence rate will be recorded at 1 year after registration. Discussion: This study is expected to provide evidence to support the clinical benefits of DBT in the treatment of acute diverticulitis. It may also provide evidence regarding the efficacy and safety of DBT in the recurrence of acute diverticulitis. Trial registration: UMIN000027381, registered on April 27th, 2017 https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000031377, and changed to jRCTs041180063, registered on July 30th, 2019; https://jrct.niph.go.jp/en-latest-detail/jRCTs041180063 as a result of the revision of the domestic law in 2018 in Japan.

scholarly journals Daiobotanpito combined with antibiotic therapy for treatment of acute diverticulitis: a study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Keiko Ogawa-Ochiai ◽  
Kenichi Yoshimura ◽  
Akiko Shirai ◽  
Seisho Sakai ◽  
Hideki Moriyama ◽  
...  
Keyword(s):  
Recurrence Rate ◽  
Conventional Therapy ◽  
Controlled Trial ◽  
Acute Diverticulitis ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Abdominal Abscesses ◽  
Intravenous Antibiotics

Abstract Background: Colonic diverticular disease has been increasing in prevalence due to the rapidly aging global population, but standard treatment has not changed dramatically in recent years. Daiobotanpito (DBT; Da Huang Mu Dan Tang in Chinese) has been used in medical treatment of acute abdominal abscesses, such as appendicitis or diverticulitis in traditional Japanese (Kampo) medicine for many years, based on more than 3000 years of experience. Prior to this study, a retrospective open-label trial was conducted to compare patients with acute diverticulitis who received oral DBT combined with intravenous antibiotics with those who received intravenous antibiotic alone; it showed a positive effect of DBT on acute diverticulitis. We aim to investigate whether moderate to severe acute diverticulitis shows greater improvement with intravenous antibiotics plus orally administered DBT compared with intravenous antibiotics with placebo. Methods: This is a two-group, randomized, double-blind, placebo-controlled, multi-center trial, which is designed to evaluate the efficacy and safety of DBT for moderate to severe diverticulitis patients treated with intravenous antibiotics. Eligible participants will be randomized to either a treatment group receiving a 10-day oral DBT regimen plus conventional therapy or a control group receiving a 10-day placebo regimen plus conventional therapy. The primary outcome will be the rate of fever reduction within 3 days or/and abdominal pain relief within 4 days. Secondary endpoints will include hospitalization days, changes in inflammatory response (CRP, WBC, neutrophil count), thermal type, number of days before beginning food intake, recurrence rate (observation for 1 year after registration), and adverse event expression rate. Assessments will be performed at baseline and on the day of discharge. The recurrence rate will be recorded at 1 year after registration. Discussion: This study is expected to provide evidence to support the clinical benefits of DBT in the treatment of acute diverticulitis. It may also provide evidence regarding the efficacy and safety of DBT in the recurrence of acute diverticulitis. Trial registration: UMIN000027381, registered on April 27th, 2017; https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000031377.

scholarly journals Daiobotanpito combined with antibiotic therapy for treatment of acute diverticulitis: a study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Keiko Ogawa-Ochiai ◽  
Keinichi Yoshimura ◽  
Akiko Shirai ◽  
Seisho Sakai ◽  
Hideki Moriyama ◽  
...  
Keyword(s):  
Recurrence Rate ◽  
Conventional Therapy ◽  
Controlled Trial ◽  
Acute Diverticulitis ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Abdominal Abscesses ◽  
Intravenous Antibiotics

Abstract Background: Colonic diverticular disease has been increasing in prevalence due to the rapidly aging global population, but standard treatment has not changed dramatically in recent years. Daiobotanpito (DBT; Da Huang Mu Dan Tang in Chinese) has been used in medical treatment of acute abdominal abscesses, such as appendicitis or diverticulitis in traditional Japanese (Kampo) medicine for many years, based on more than 3000 years of experience. Prior to this study, a retrospective open-label trial was conducted to compare patients with acute diverticulitis who received oral DBT combined with intravenous antibiotics with those who received intravenous antibiotic alone; it showed a positive effect of DBT on acute diverticulitis. We aim to investigate whether moderate to severe acute diverticulitis shows greater improvement with intravenous antibiotics plus orally administered DBT compared with intravenous antibiotics with placebo. Methods: This is a two-group, randomized, double-blind, placebo-controlled, multi-center trial, which is designed to evaluate the efficacy and safety of DBT for moderate to severe diverticulitis patients treated with intravenous antibiotics. Eligible participants will be randomized to either a treatment group receiving a 10-day oral DBT regimen plus conventional therapy or a control group receiving a 10-day placebo regimen plus conventional therapy. The primary outcome will be the rate of fever reduction within 3 days or/and abdominal pain relief within 4 days. Secondary endpoints will include hospitalization days, changes in inflammatory response (CRP, WBC, neutrophil count), thermal type, number of days before beginning food intake, recurrence rate (observation for 1 year after registration), and adverse event expression rate. Assessments will be performed at baseline and on the day of discharge. The recurrence rate will be recorded at 1 year after registration. Discussion: This study is expected to provide evidence to support the clinical benefits of DBT in the treatment of acute diverticulitis. It may also provide evidence regarding the efficacy and safety of DBT in the recurrence of acute diverticulitis. Trial registration: UMIN000027381, registered on April 27th, 2017 https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000031377, and changed to jRCTs041180063, registered on July 30th, 2019; https://jrct.niph.go.jp/en-latest-detail/jRCTs041180063

scholarly journals Study Protocol Daiobotanpito combined with antibiotic therapy for treatment of acute diverticulitis: a study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Keiko Ogawa-Ochiai ◽  
Keinichi Yoshimura ◽  
Akiko Shirai ◽  
Seisho Sakai ◽  
Hideki Moriyama ◽  
...  
Keyword(s):  
Abdominal Pain ◽  
Success Rate ◽  
Recurrence Rate ◽  
Study Protocol ◽  
Conventional Therapy ◽  
Primary Outcome ◽  
Acute Diverticulitis ◽  
Treatment Success ◽  
Efficacy And Safety ◽  
Intravenous Antibiotics

Abstract Background: Colonic diverticular disease has been increasing in prevalence due to the rapidly aging global population, but standard treatment has not changed dramatically in recent years. Daiobotanpito (DBT; Da Huang Mu Dan Tang in Chinese) has been used in medical treatment of acute abdominal abscesses, such as appendicitis or diverticulitis in traditional Japanese (Kampo) medicine for many years, based on more than 3000 years of experience. Prior to this study, a retrospective open-label trial was conducted to compare patients with acute diverticulitis who received oral DBT combined with intravenous antibiotics with those who received intravenous antibiotic alone; it showed a positive effect of DBT on acute diverticulitis. We aim to investigate whether moderate to severe acute diverticulitis shows greater improvement with intravenous antibiotics plus orally administered DBT compared with intravenous antibiotics with placebo. Methods: This is a two-group, randomized, double-blind, placebo-controlled, multi-center trial, which is designed to evaluate the efficacy and safety of DBT for moderate to severe diverticulitis patients treated with intravenous antibiotics. Eligible participants will be randomized to either a treatment group receiving a 10-day oral DBT regimen plus conventional therapy or a control group receiving a 10-day placebo regimen plus conventional therapy. The primary outcome will be the treatment success rate of diverticulitis defined as fever relief to <37.5 ℃ within 3 days or/and elimination of abdominal pain within 4 days. In other words, the primary outcome will be the treatment success rate of diverticulitis defined as elimination of abdominal pain within 4 days for all patients, and if they have fever ≧37.5℃ on inclusion to this study, fever relief to <37.5℃ within 3 days. Secondary endpoints will include hospitalization days, changes in inflammatory response (CRP, WBC, neutrophil count), thermal type, number of days before beginning food intake, recurrence rate (observation for 1 year after registration), and adverse event expression rate. Assessments will be performed at baseline and on the day of discharge. The recurrence rate will be recorded at 1 year after registration. Discussion: This study is expected to provide evidence to support the clinical benefits of DBT in the treatment of acute diverticulitis. It may also provide evidence regarding the efficacy and safety of DBT in the recurrence of acute diverticulitis. Trial registration: UMIN000027381, registered on April 27th, 2017 https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000031377, and changed to jRCTs041180063, registered on July 30th, 2019; https://jrct.niph.go.jp/en-latest-detail/jRCTs041180063 as a result of the revision of the domestic law in 2018 in Japan.

scholarly journals Study Protocol Daiobotanpito combined with antibiotic therapy for treatment of acute diverticulitis: a study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Keiko Ogawa-Ochiai ◽  
Keinichi Yoshimura ◽  
Akiko Shirai ◽  
Seisho Sakai ◽  
Hideki Moriyama ◽  
...  
Keyword(s):  
Abdominal Pain ◽  
Success Rate ◽  
Recurrence Rate ◽  
Study Protocol ◽  
Conventional Therapy ◽  
Primary Outcome ◽  
Acute Diverticulitis ◽  
Treatment Success ◽  
Efficacy And Safety ◽  
Intravenous Antibiotics

Abstract Background: Colonic diverticular disease has been increasing in prevalence due to the rapidly aging global population, but standard treatment has not changed dramatically in recent years. Daiobotanpito (DBT; Da Huang Mu Dan Tang in Chinese) has been used in medical treatment of acute abdominal abscesses, such as appendicitis or diverticulitis in traditional Japanese (Kampo) medicine for many years, based on more than 3000 years of experience. Prior to this study, a retrospective open-label trial was conducted to compare patients with acute diverticulitis who received oral DBT combined with intravenous antibiotics with those who received intravenous antibiotic alone; it showed a positive effect of DBT on acute diverticulitis. We aim to investigate whether moderate to severe acute diverticulitis shows greater improvement with intravenous antibiotics plus orally administered DBT compared with intravenous antibiotics with placebo. Methods: This is a two-group, randomized, double-blind, placebo-controlled, multi-center trial, which is designed to evaluate the efficacy and safety of DBT for moderate to severe diverticulitis patients treated with intravenous antibiotics. Eligible participants will be randomized to either a treatment group receiving a 10-day oral DBT regimen plus conventional therapy or a control group receiving a 10-day placebo regimen plus conventional therapy. The primary outcome will be the treatment success rate of diverticulitis defined as fever relief to <37.5℃ within 3 days or/and elimination of abdominal pain within 4 days. In other words, the primary outcome will be the treatment success rate of diverticulitis defined as elimination of abdominal pain within 4 days for all patients, and if they have fever ≧37.5℃ on inclusion to this study, fever relief to <37.5℃ within 3 days. Secondary endpoints will include hospitalization days, changes in inflammatory response (CRP, WBC, neutrophil count), thermal type, number of days before beginning food intake, recurrence rate (observation for 1 year after registration), and adverse event expression rate. Assessments will be performed at baseline and on the day of discharge. The recurrence rate will be recorded at 1 year after registration. Discussion: This study is expected to provide evidence to support the clinical benefits of DBT in the treatment of acute diverticulitis. It may also provide evidence regarding the efficacy and safety of DBT in the recurrence of acute diverticulitis. Trial registration: UMIN000027381, registered on April 27th, 2017 https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000031377, and changed to jRCTs041180063, registered on July 30th, 2019; https://jrct.niph.go.jp/en-latest-detail/jRCTs041180063 as a result of the revision of the domestic law in 2018 in Japan.

Efficacy and safety of Qu Xie capsule in metastatic colorectal cancer: A double-blind, randomized, placebo-controlled trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15069-e15069
Author(s):  
Tong Zhang ◽  
Yufei Yang
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Treatment Group ◽  
Metastatic Colorectal Cancer ◽  
Ming Dynasty ◽  
Conventional Therapy ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind

e15069 Background:Qu Xie capsule was discovered by Li Zhongzi, a traditional Chinese Medicine doctor in the Ming Dynasty. Doctor Yang Yufei improved Qu Xie capsule and used it clinically for more than 10 years. In a previous study, we found that Qu Xie capsule reduces the risk of stage II–III colorectal cancer postoperative recurrence and metastasis and prolongs the survival of patients with metastatic colorectal cancer (mCRC). The present clinical trial was designed to verify the efficacy and safety of Qu Xie capsule in patients with mCRC. Methods: The present study was a randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into two groups at a 1:1 ratio. The treatment group received conventional therapy combined with Qu Xie capsule. The control group was treated with conventional therapy combined with placebo. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Results: A total of 121 patients were enrolled and 60 patients were eligible; 54 patients were analyzed. The median OS was 23 months in the treatment group [95% confidence interval (CI) 15–not calculated] vs. 14 months in the control group (95% CI 11–22) (Kaplan–Meier, Log-rank p = 0.060). The OS of the treatment group tended to be longer than that of the control group, although the difference was not significant. This may have been related to the small sample size. In the subgroups of patients < 65 years old, left-sided colon, and ≥second-line therapy, the treatment group showed a significant survival benefit compared with the control group ( p = 0.006, 0.038, 0.013). There were no significant differences between the two groups in PFS. Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group. In the treatment group, one patient had 'abdominal pain' once, which may have been related to the Qu Xie capsule. No other related adverse events were reported. Conclusions:Qu Xie capsule showed good safety and efficacy, and can prolong the OS of patients with mCRC. Clinical trial information: ChiCTR-IOR-16009733.

scholarly journals Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Jun Ni ◽  
Huisheng Chen ◽  
Guofang Chen ◽  
Yong Ji ◽  
Fei Yi ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Thrombolytic Therapy ◽  
Acute Ischemic Stroke ◽  
Barthel Index ◽  
Controlled Trial ◽  
Survival Rates ◽  
Control Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Double Blind

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

scholarly journals Efficacy and safety of Jie-du-qing-nao granules for first-episode schizophrenics: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Ziyan Li ◽  
Yanzhe Ning ◽  
Pei Chen ◽  
Yi Zhang ◽  
Dongqing Yin ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Complete Blood Count ◽  
Controlled Trial ◽  
First Episode ◽  
Control Group ◽  
Study Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Symptom Scale ◽  
Double Blind

Abstract BackgroundAt present, the focus and difficulty of schizophrenia (SCZ) treatment is to improve cognitive function and negative symptoms. Jie-du-qing-nao granules(JQG) , a traditional Chinese medicine(TCM) prescription , has a good clinical effectiveness in enhancing the cognition and negative symptoms of patients with SCZ. However, its clear effectiveness and safety have not been adequately supported by clinical studies. The main objective of this study is to explore the efficacy and safety of JQG for first-episode schizophrenics.Methods/designThis trial is a prospective, randomized, single-centered, parallel-controlled clinical study with double-blind design. A total of 96 eligible participants will be randomly assigned to either the study group or the control group in a ratio of 1:1. Participants allocated to the study group will receive JQG and aripiprazole, control group will receive placebo and aripiprazole. The treatment course will last 12 weeks, with follow-up every 4 weeks. Outcome measurements include Positive and Negative Syndrome Scale (PANSS), self face test , MATRICS Consensus Cognitive Battery (MCCB), TNFα, IL-6, IL-1β, BDNF, vital signs, complete blood count, liver and kidney function tests, urinalysis, and electrocardiograph. Adverse reactions will be evaluated using the Treatment Emergent Symptom Scale (TESS).DiscussionThis study will provide evidence for the efficacy and safety of JQG as a complementary approach, which can be initiated following with antipsychotics therapy. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR1900028250 . Registered on December 16, 2019, http://www.chictr.org.cn/edit.aspx?pid=41880&htm=4 .

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