A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease

Abstract Background Gastro-esophageal reflux disease (GERD) is a major cause of chronic cough. GERD-induced chronic cough is difficult to diagnose because some patients do not complain of any gastrointestinal (GI) reflux symptoms. Although chronic cough due to GERD is highly prevalent, no effective treatment is currently available, especially for GERD-related cough without GI symptoms. As the herbal medicines Ojeok-san and Saengmaek-san can effectively treat GERD and cough, we aim to evaluate the efficacy and safety of a combination of these components for relieving chronic cough due to GERD. Methods This is a study protocol of a randomized, double-blind, placebo-controlled, single-center pilot trial. After one-week run-in period, a total of 30 patients with GERD-induced chronic cough will be randomly allocated to an intervention group (n=15) or placebo group (n=15). Participants will receive 5.76 g of Ojeok-san plus Saengmaek-san or a placebo three times per day for 6 weeks. The primary outcome measures, the frequency and severity of cough, will be recorded using a cough diary. The secondary outcome measures will include a cough visual analog scale, the Leicester Cough Questionnaire (Korean version), Gastrointestinal Symptom Rating Scale, Hull Airway Reflux (hypersensitivity) Questionnaire, Pattern Identification for Chronic Cough Questionnaire, Pattern Identification for Gastroesophageal Reflux Disease, and safety testing. Adverse events will also be reported. Discussion This will be the first clinical trial to explore herbal medicines for the GERD-related chronic cough, including patients without GI reflux symptoms. This study will provide useful evidence regarding the efficacy and safety of Ojeok-san plus Saengmaek-san treatment. In addition, this trial will offer scientific basis for the combination of herbal medicines. This finding will also serve as an important data for conducting a larger-scale clinical trial on GERD-induced chronic cough. Trial registration This trial has been registered with Clinical Research Information Service (CRIS) of South Korea (http://cris.nih.go.kr; registration number: KCT0003115). Registered August 28, 2018.

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The efficacy and safety of Ojeok-san plus Saengmaek-san for gastro-esophageal reflux-induced chronic cough: a protocol for a pilot, randomized, double-blind, placebo-controlled trial

10.21203/rs.2.9926/v3 ◽

2019 ◽

Author(s):

Beom-Joon Lee ◽

Jun-Hwan Lee ◽

Yeon Hee Bhang ◽

Kwan-Il Kim ◽

Jaehyo Kim ◽

...

Keyword(s):

Clinical Trial ◽

Outcome Measures ◽

Reflux Disease ◽

Chronic Cough ◽

Herbal Medicines ◽

Pattern Identification ◽

Efficacy And Safety ◽

Esophageal Reflux ◽

Double Blind ◽

Double Blind Placebo

Abstract Background Gastro-esophageal reflux disease (GERD) is a major cause of chronic cough. GERD-induced chronic cough is difficult to diagnose because some patients do not complain of any gastrointestinal (GI) reflux symptoms. Although chronic cough due to GERD is highly prevalent, no effective treatment is currently available, especially for GERD-related cough without GI symptoms. As the herbal medicines Ojeok-san and Saengmaek-san can effectively treat GERD and cough, we aim to evaluate the efficacy and safety of a combination of these components for relieving chronic cough due to GERD. Methods This is a study protocol of a randomized, double-blind, placebo-controlled, single-center pilot trial. After one-week run-in period, a total of 30 patients with GERD-induced chronic cough will be randomly allocated to an intervention group (n=15) or placebo group (n=15). Participants will receive 5.76 g of Ojeok-san plus Saengmaek-san or a placebo three times per day for 6 weeks. The primary outcome measures, the frequency and severity of cough, will be recorded using a cough diary. The secondary outcome measures will include a cough visual analog scale, the Leicester Cough Questionnaire (Korean version), Gastrointestinal Symptom Rating Scale, Hull Airway Reflux (hypersensitivity) Questionnaire, Pattern Identification for Chronic Cough Questionnaire, Pattern Identification for Gastroesophageal Reflux Disease, and safety testing. Adverse events will also be reported. Discussion This will be the first clinical trial to explore herbal medicines for the GERD-related chronic cough, including patients without GI reflux symptoms. This study will provide useful evidence regarding the efficacy and safety of Ojeok-san plus Saengmaek-san treatment. In addition, this trial will offer scientific basis for the combination of herbal medicines. This finding will also serve as an important data for conducting a larger-scale clinical trial on GERD-induced chronic cough. Trial registration This trial has been registered with Clinical Research Information Service (CRIS) of South Korea (http://cris.nih.go.kr; registration number: KCT0003115). Registered August 28, 2018.

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The efficacy and safety of Ojeok-san plus Saengmaek-san for gastro-esophageal reflux-induced chronic cough: a protocol for a pilot, randomized, double-blind, placebo-controlled trial

10.21203/rs.2.9926/v2 ◽

2019 ◽

Author(s):

Beom-Joon Lee ◽

Jun-Hwan Lee ◽

Yeon Hee Bhang ◽

Kwan-Il Kim ◽

Jaehyo Kim ◽

...

Keyword(s):

Clinical Trial ◽

Outcome Measures ◽

Reflux Disease ◽

Chronic Cough ◽

Herbal Medicines ◽

Pattern Identification ◽

Efficacy And Safety ◽

Esophageal Reflux ◽

Double Blind ◽

Double Blind Placebo

Abstract Background Gastro-esophageal reflux disease (GERD) is a major cause of chronic cough. GERD-induced chronic cough is difficult to diagnose because some patients do not complain of any gastrointestinal (GI) reflux symptoms. Although chronic cough due to GERD is highly prevalent, no effective treatment is currently available, especially for GERD-related cough without GI symptoms. As the herbal medicines Ojeok-san and Saengmaek-san can effectively treat GERD and cough, we aim to evaluate the efficacy and safety of a combination of these components for relieving chronic cough due to GERD. Methods This is a study protocol of a randomized, double-blind, placebo-controlled, single-center pilot trial. After one-week run-in period, a total of 30 patients with GERD-induced chronic cough will be randomly allocated to an intervention group (n=15) or placebo group (n=15). Participants will receive 5.76 g of Ojeok-san plus Saengmaek-san or a placebo three times per day for 6 weeks. The primary outcome measures, the frequency and severity of cough, will be recorded using a cough diary. The secondary outcome measures will include a cough visual analog scale, the Leicester Cough Questionnaire (Korean version), Gastrointestinal Symptom Rating Scale, Hull Airway Reflux (hypersensitivity) Questionnaire, Pattern Identification for Chronic Cough Questionnaire, Pattern Identification for Gastroesophageal Reflux Disease, and safety testing. Adverse events will also be reported. Discussion This will be the first clinical trial to explore herbal medicines for the GERD-related chronic cough, including patients without GI reflux symptoms. This study will provide useful evidence regarding the efficacy and safety of Ojeok-san plus Saengmaek-san treatment. In addition, this trial will offer scientific basis for the combination of herbal medicines. This finding will also serve as an important data for conducting a larger-scale clinical trial on GERD-induced chronic cough. Trial registration This trial has been registered with Clinical Research Information Service (CRIS) of South Korea (http://cris.nih.go.kr; registration number: KCT0003115). Registered August 28, 2018.

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Rationale and Design of BeatNF2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Bevacizumab in Patients with Neurofibromatosis Type 2 Related Vestibular Schwannoma

Current Oncology ◽

10.3390/curroncol28010071 ◽

2021 ◽

Vol 28 (1) ◽

pp. 726-739

Author(s):

Masazumi Fujii ◽

Masao Kobayakawa ◽

Kiyoshi Saito ◽

Akihiro Inano ◽

Akio Morita ◽

...

Keyword(s):

Clinical Trial ◽

Neurofibromatosis Type ◽

Primary Objective ◽

Neurofibromatosis Type 2 ◽

Efficacy And Safety ◽

Multicenter Clinical Trial ◽

Double Blind ◽

Hearing Function ◽

Initial Intervention

Neurofibromatosis type 2 (NF2) causes bilateral vestibular schwannomas (VSs), leading to deafness. VS is treated by surgery or radiation, but neither treatments prevent hearing loss. Bevacizumab was found to be effective in suppressing the tumor’s growth and may help to improve hearing. We are conducting a randomized, double-blind, multicenter clinical trial to verify the efficacy and safety of bevacizumab in NF2-related VS. The primary objective is to evaluate the efficacy of bevacizumab in improving hearing in the affected ear. One of the secondary objectives is to evaluate bevacizumab’s efficacy in rechallenge treatment in relapsed cases. Sixty patients will randomly receive either bevacizumab or a placebo and will be clinically observed for 48 weeks in the initial intervention phase. In the first half (24 weeks), they will receive either 5 mg/kg of bevacizumab or a placebo drug. In the second half, all patients will receive 5 mg/kg of bevacizumab. If hearing function deteriorated in a patient who had shown improvement during the first phase, a rechallenge dose with bevacizumab would be offered.

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