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

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Youme Ko ◽  
Seung-Ho Sun ◽  
In-Sik Han ◽  
Ho-Yeon Go ◽  
Tae-Hun Kim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Korean Patients ◽  
Parallel Group ◽  
Hands And Feet ◽  
Cold Hypersensitivity

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.

scholarly journals Zhizhu Kuanzhong Capsule in Treating Patients With Functional Dyspepsia Postprandial Distress Syndrome: Study Protocol For a Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Clinical Trial

2021 ◽  
Author(s):  
Mengli Xiao ◽  
Linda LD Zhong ◽  
Wai Ching Lam ◽  
Yingpan Zhao ◽  
Kok-Ann Gwee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Functional Dyspepsia ◽  
Distress Syndrome ◽  
Functional Gastrointestinal Disorders ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Postprandial Distress Syndrome ◽  
Parallel Group

Abstract Background: Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders. Based on the various symptoms present in patients with functional dyspepsia-postprandial distress syndrome (FD-PDS), routine agents such as acid suppressants, prokinetic drugs, and centrally acting drugs, offer limited treatment choice with potential side effects. As preliminary clinical trial showed that the marketed product Zhizhu Kuanzhong Capsule (ZZKZ) can improve symptoms in FD-PDS patients, our study aims to provide further evidence on the clinical efficacy and safety of ZZKZ in the treatment of patients with FD-PDS. Methods: In this multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial, we recruit patients with FD-PDS from 18 hospitals in China and Australia. The trial enrolls patients with FD-PDS based on the Rome IV diagnostic criteria. A total of 480 eligible patients are randomized 1:1 into either ZZKZ or placebo group with 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint is measured by self-rated Visual Analogue Score (VAS) for the degree of discomfort with both symptoms of postprandial fullness and early satiation, recorded once a day and 7 days a week. The primary analysis aims to compare the response rate for FD-PDS VAS score between the groups before and after 8 weeks of treatment with an alpha level of 0.05 (2-sided).Discussion: This trial aims to strengthen the evidence for the efficacy and safety of ZZKZ, a marketed product, in treating FD-PDS. Compared to previous clinical trial targeted FD-PDS, this trial has 8-week double-blind treatment period to investigate the effect of long-term mediation through comparison with the placebo group.Trial registration: This study is registered with ClinicalTrials.gov on 28 January 2019, number NCT03825692.

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