scholarly journals A Randomized, Double-Blind, Placebo-Controlled Parallel Study on the Efficacy and Safety of Centella asiatica L. Extract for Reducing Alanine Transaminase (ALT) Level in Subjects with Elevated ALT

2021 ◽  
Vol 11 (23) ◽  
pp. 11498
Author(s):  
Yong Joon Jeong ◽  
Hyelin Jeon ◽  
Se Chan Kang
Keyword(s):  
Herbal Medicines ◽  
Centella Asiatica ◽  
Current Data ◽  
Alanine Transaminase ◽  
Efficacy And Safety ◽  
Parallel Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Synthetic Drugs ◽  
Clinically Significant

The liver is an important organ that detoxifies various metabolites, synthesizes proteins, and produces biochemicals necessary for life. There are many medications on the market to treat liver diseases, but these can be a strain on the liver due to the need for a detoxification process in the organ. Herbal medicines are replacing synthetic drugs. In the present study, we aimed to evaluate the efficacy and safety of Centella aisatica L. extract for reducing alanine transaminase (ALT) levels using a randomized, double-blind, placebo-controlled parallel study. Investigators performed a clinical trial in which an herbal treatment was administered every morning for 12 weeks to 80 patients in two groups. The study protocol number was SYN/RM/CA-008. The results demonstrated improved ALT levels with a positive change in the investigational product (IP) group (−19.9) compared to the placebo group (1.8) (p < 0.0001). In addition, IP treatment was safe and non-toxic. The current data indicate that CA-HE50 exhibits clinically significant changes for all hepatoprotective efficacy parameters, suggesting potential for development and applicability as a hepatoprotective substance.

scholarly journals 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

2019 ◽  
Author(s):  
Yeon Hee Bhang ◽  
Kwan-Il Kim ◽  
Jaehyo Kim ◽  
Junmo Ahn ◽  
Hwan-Su Jung ◽  
...  
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.

FC03-04 - Lamotrigine treatment of acute alcohol hallucinosis comorbid depersonalizations disorders: A randomimized double-blind, placebo-controlled study

2011 ◽  
Vol 26 (S2) ◽  
pp. 1825-1825 ◽  
Author(s):  
N. Aliyev ◽  
A.A. Aliyev ◽  
Z.N. Aliyev ◽  
A. Aliyev
Keyword(s):  
Controlled Study ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Parallel Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Primary Efficacy Measure ◽  
Efficacy Measure ◽  
Alcohol Hallucinosis ◽  
Icd 10

AimsWe compared the efficacy and safety of lamotrigine versus placebo for the treatment of acute alcohol hallucinosis comorbid depersonalization disorders.Methods10 days, randomized, double-blind, parallel study. A total of 40 patients with an ICD-10 diagnosis of acute alcohol hallucinosis comorbid depersonalization disorders were randomized to lamotrigine 300 mg/d (n = 40), or placebo (n = 40). The primary efficacy measure was the PANSS subscale for hallucinosis and Cambridge Depersonalization Scale (CDS).ResultsIamotrigine treated patients demonstrated a statistically significant greater improvement in PANSS subscale for hallucinosis and CDS than placebo-treated patients.ConclusionLamotrigine demonstrated greater efficacy than placebo in treatment of acute hallucinosis comorbid depersonalization disorders and was generally well tolerated.

scholarly journals 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

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.

scholarly journals 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

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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