scholarly journals Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Kyou-Young Lee ◽  
In-Sik Han ◽  
Ho-Yeon Go ◽  
Dong-Nyung Lee ◽  
Jun-Sang Yu ◽  
...  
Keyword(s):  
Clinical Study ◽  
Korean Women ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Parallel Group ◽  
Cold Hypersensitivity ◽  
Multicenter Clinical Study

scholarly journals A Randomized, Double-Blind, Multicenter Clinical Study Comparing the Efficacy and Safety of a Drug Combination of Lopinavir/Ritonavir-Azithromycin, Lopinavir/Ritonavir-Doxycycline, and Azithromycin-Hydroxychloroquine for Patients Diagnosed with Mild to Moderate COVID-19 Infections

2021 ◽  
Vol 2021 ◽  
pp. 1-12
Author(s):  
Purwati ◽  
Budiono ◽  
Brian Eka Rachman ◽  
Yulistiani ◽  
Andang Miatmoko ◽  
...  
Keyword(s):  
Clinical Study ◽  
Drug Combination ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Treatment Groups ◽  
Tnf Α ◽  
Testing Stage ◽  
Multicenter Clinical Study ◽  
All Treatment

Background. At the present time, COVID-19 vaccines are at the testing stage, and an effective treatment for COVID-19 incorporating appropriate safety measures remains the most significant obstacle to be overcome. A strategic countermeasure is, therefore, urgently required. Aim. This study aims to evaluate the efficacy and safety of a combination of lopinavir/ritonavir-azithromycin, lopinavir/ritonavir-doxycycline, and azithromycin-hydroxychloroquine used to treat patients with mild to moderate COVID-19 infections. Setting and Design. This study was conducted at four different clinical study sites in Indonesia. The subjects gave informed consent for their participation and were confirmed as being COVID-19-positive by means of an RT-PCR test. The present study constituted a randomized, double-blind, and multicenter clinical study of patients diagnosed with mild to moderate COVID-19 infection. Materials and Methods. Six treatment groups participated in this study: a Control group administered with a 500 mg dose of azithromycin; Group A which received a 200/50 mg dose of lopinavir/ritonavir and 500 mg of azithromycin; Group B treated with a 200/50 mg dose of lopinavir/ritonavir and 200 mg of doxycycline; Group C administered with 200 mg of hydroxychloroquine and 500 mg of azithromycin; Group D which received a 400/100 mg dose of lopinavir/ritonavir and 500 mg of azithromycin; and Group E treated with a 400/100 mg dose of lopinavir/ritonavir and 200 mg of doxycycline. Results. 754 subjects participated in this study: 694 patients (92.4%) who presented mild symptoms and 57 patients (7.6%) classified as suffering from a moderate case of COVID-19. On the third day after treatment, 91.7%–99.2% of the subjects in Groups A–E were confirmed negative by a PCR swab test compared to 26.9% in the Control group. Observation of all groups which experienced a significant decrease in virus load between day 1 and day 7 was undertaken. Other markers, such as CRP and IL-6, were significantly lower in all treatment groups ( p < 0.05 and p < 0.0001 ) than in the Control group. Furthermore, IL-10 and TNF-α levels were significantly elevated in all treatment groups ( p < 0.0001 ). The administration of azithromycin to the Control group increased CRP and IL-6 levels, while reduced IL-10 and TNF-α on day 7 ( p < 0.0001 ) compared with day 1. Decreases in ALT and AST levels were observed in all groups ( p < 0.0001 ). There was an increase in creatinine in the serum level of the Control, C, D, and E groups ( p < 0.05 ), whereas the BUN level was elevated in all groups ( p < 0.0001 ). Conclusions. The study findings suggest that the administration of lopinavir/ritonavir-doxycycline, lopinavir/ritonavir-azithromycin, and azithromycin-hydroxychloroquine as a dual drug combination produced a significantly rapid PCR conversion rate to negative in three-day treatment of mild to moderate COVID-19 cases. Further studies should involve observation of older patients with severe clinical symptoms in order to collate significant amounts of demographic data.

scholarly journals The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: A protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial

2019 ◽  
Author(s):  
Youme Ko ◽  
Seung-Ho Sun ◽  
In-Sik Han ◽  
Ho-Yeon Go ◽  
Tae-Hun Kim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Herbal Medicine ◽  
Randomized Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Parallel Group ◽  
Hands And Feet ◽  
Cold Hypersensitivity

Abstract Background: Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as menstrual pain, infertility, leucorrhea, and irregular bleeding may be related to CHHF. Sipjeondaebo-tang(SDT) is widely used in the treatment of various diseases including CHHF by balancing Yin and Yang, restoring the deterioration of physiological function, and improving immunity. However, the efficacy of SDT in the treatment of CHHF has not been assessed in clinical trials. Therefore, we aimed to investigate the feasibility of a full randomized clinical trial of SDT for the treatment of CHHF in Korean women through this trial. Methods: This study will be a pilot, randomized, double-blind, two-arm, placebo-controlled, parallel-group, multicenter clinical trial. Women aged 19-59 years who present with CHHF will be recruited from five university hospitals. A total of 60 subjects will be randomly assigned to a treatment group (SDT) or a placebo group at a 1:1 ratio. The subjects will receive 3 g of either SDT or placebo three times daily for 8 weeks. The primary outcome measures will be the Visual Analogue Scale scores of CHHF. The secondary outcome measures will be changes in body temperature in both the hands and the feet as measured by using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. Discussion: This will be the first trial to investigate the efficacy and safety of SDT in the treatment of CHHF. This study will provide basic clinical information regarding Korean herbal medicine treatment of CHHF and a clinical basis for designing a full randomized clinical trial. Trial registration: This study is registered at ClinicalTrials.gov, ID: NCT03374345. Registered on (15 February 2018). Keywords: Herbal medicine, Cold Hypersensitivity, Sipjeondaebo-tang, Cold intolerance.

scholarly journals The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: A protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial

2019 ◽  
Author(s):  
Youme Ko ◽  
Seung-Ho Sun ◽  
In-Sik Han ◽  
Ho-Yeon Go ◽  
Tae-Hun Kim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Outcome Measures ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Parallel Group ◽  
Hands And Feet ◽  
Cold Hypersensitivity

Abstract Background Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as menstrual pain, infertility, leucorrhea, and irregular bleeding may be related to CHHF. Sipjeondaebo-tang(SDT) is widely used in the treatment of various diseases including CHHF by balancing Yin and Yang, restoring the deterioration of physiological function, and improving immunity. However, the efficacy of SDT in the treatment of CHHF has not been assessed in clinical trials. Therefore, we aimed to investigate the feasibility of a full randomized clinical trial of SDT for the treatment of CHHF in Korean women through this trial. Methods This study will be a pilot, randomized, double-blind, two-arm, placebo-controlled, parallel-group, multicenter clinical trial. Women aged 19-59 years who present with CHHF will be recruited from five university hospitals. A total of 60 subjects will be randomly assigned to a treatment group (SDT) or a placebo group at a 1:1 ratio. The subjects will receive 3 g of either SDT or placebo three times daily for 8 weeks. The primary outcome measures will be the Visual Analogue Scale scores of CHHF. The secondary outcome measures will be changes in body temperature in both the hands and the feet as measured by using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. Discussion This will be the first trial to investigate the efficacy and safety of SDT in the treatment of CHHF. This study will provide basic clinical information regarding Korean herbal medicine treatment of CHHF and a clinical basis for designing a full randomized clinical trial.

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