Dataset Information

Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study.

ABSTRACT:

Background

This study aims to evaluate the safety, efficacy, and feasibility of a full randomized clinical trial of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet.

Methods

This study is a multicenter, double-blinded, randomized, placebo-controlled, two-arm, parallel-group pilot clinical trial. A total of 60 participants will be enrolled and randomly assigned to the Ojeok-san treatment group or the placebo control group, in a 1:1 ratio using an Internet-based randomization system. Each group will be administered Ojeok-san or placebo three times per day for 8 weeks. The primary outcome will be the mean change in the Visual Analog Scale scores of cold hypersensitivity in the hands from baseline to week 8. Secondary outcomes will include the mean changes in the skin temperature of the extremities, recovery rate of the skin temperature of hands after cold stress test, and the score of Korean version of the WHO Quality of Life Scale abbreviated version.

Discussion

The findings of this study should provide meaningful information for a further large-scale, randomized controlled trial to confirm the safety and efficacy of Ojeok-san on cold hypersensitivity in the hands and feet in female patients.

Trial registration

ClinicalTrials.gov, ID: NCT03083522 . Registered on 20 March 2017.

SUBMITTER: Ko Y

PROVIDER: S-EPMC6267068 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study.

Ko Youme Y Go Ho-Yeon HY Han In-Sik IS Lee Kyou-Young KY Kim Tae-Hoon TH Lee Jin-Moo JM Jang Jun-Bok JB Song Yun-Kyung YK Sun Seung-Ho SH Jeon Chan-Yong CY Ko Seong-Gyu SG

Trials 20181129 1

<h4>Background</h4>This study aims to evaluate the safety, efficacy, and feasibility of a full randomized clinical trial of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet.<h4>Methods</h4>This study is a multicenter, double-blinded, randomized, placebo-controlled, two-arm, parallel-group pilot clinical trial. A total of 60 participants will be enrolled and randomly assigned to the Ojeok-san treatment group or the placebo control group, in a 1:1 ratio using an ...[more]

PMID: 30497488

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Project description:ObjectiveCold hypersensitivity in the hands and feet(CHHF) is a common condition that reduces the quality of life and causes daily discomfort. The current treatments are primarily pharmacological. This study aimed to expand treatment options by comparing the efficacy of electroacupuncture (EA) and acupuncture (AC) with that of no treatment (control).MethodsA three-group randomized controlled trial was conducted with 72 women diagnosed with cold hypersensitivity in the hands and feet, as confirmed by subjective symptoms and objective temperature differences. Participants were randomly assigned to the EA, AC, or control groups. Outcome measures included hand and feet visual analog scale (VAS) scores, temperature changes measured using a non-contact thermometer, and World Health Organization Quality of Life-BREF (WHOQOL-BREF) scores assessed at pretreatment (T0), posttreatment (T1), and follow-up (T2). Repeated measures ANOVA and 2-way mixed-model ANOVA were used to evaluate group, time, and interaction effects.ResultsBoth the EA and AC groups showed significant improvements in hand and feet VAS and WHOQOL-BREF scores compared with those of the control group posttreatment (T1). Notably, the EA group demonstrated sustained benefits at follow-up (T2), with significant reductions in feet VAS scores and positive changes in several WHOQOL-BREF domains. Interaction effects between group and time were observed, indicating that the changes in the EA and AC groups were meaningfully different form those in the control group. The control group also exhibited a statistically significant reduction in the VAS scores at follow-up (T2), likely due to the natural variability of cold extremity symptoms and psychological factors.ConclusionThis study demonstrated that EA and AC are effective in alleviating the symptoms of CHHF and enhancing the quality of life compared to no treatment. EA showed long-lasting effects than those of AC, suggesting its potential to regulate the autonomic nervous system. These findings provide a foundation for expanding non-pharmacological treatment options for CHHF and offer clinical guidance on the use of EA and AC.

Project description:Introduction: Gastroesophageal reflux-induced chronic cough (GERC) is one of the most common etiologies of chronic cough. Despite the growing prevalence and interest in GERC, no effective treatment is currently available. In our study, we used a combination of herbal medicines, Ojeok-san (OJS) plus Saengmaek-san (SMS), for the treatment of GERC. Methods: We conducted a pilot, randomized, placebo-controlled, parallel-arm, single-center clinical trial to assess the feasibility of our study protocol, as our study is the first herbal medicine trial for GERC. All enrolled participants were randomly assigned to either the intervention or placebo group in a 1:1 ratio and were administered trial drugs three times a day for 6 weeks, with an evaluation visit performed every 2 weeks for their efficacy and safety assessment until the follow-up visit (week 8). We evaluated the severity and frequency of cough, cough-specific quality of life, airway hypersensitivity, and reflux-related gastrointestinal symptoms, as well as pattern identification, to investigate the complex mechanisms of reflux cough syndrome. Results: A total of 30 participants were enrolled, and 25 completed the study at Kyung Hee University Korean Medicine Hospital from 26 December 2018 to 31 May 2021. OJS plus SMS significantly improved the cough diary score (CDS), cough visual analog scale, Korean version of the Leicester Cough Questionnaire, Hull Airway Reflux Questionnaire, and Gastrointestinal Symptom Rating Scale after the treatment compared to the baseline. Notably, OJS plus SMS showed significant efficacy in the daytime and total CDS compared with the placebo. Only one adverse event was observed during the trial, and no serious adverse events occurred. Additionally, we achieved successful results in feasibility outcomes by exceeding the ratio of 80%. Conclusion: We confirmed the feasibility of our trial design and demonstrated the potential of OJS plus SMS in relieving the severity of cough and GI symptoms in GERC patients with safe and successful feasibility results. We anticipate that our study results will be used as the basis for further large-scale, well-designed, confirmatory trials to evaluate the safety and efficacy of OJS plus SMS in GERC. Clinical Trial Registration: [https://cris.nih.go.kr], identifier WHO International Clinical Trials Registry Platform, Clinical Research Information Service [KCT0003115].

Project description:BACKGROUND:Gastroesophageal 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. Because 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/DESIGN:This is a study protocol of a randomized, double-blind, placebo-controlled, single-center pilot trial. After a 1-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 a 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, which are the frequency and severity of cough, will be recorded using a cough diary. The secondary outcome measures will include a cough visual analogue scale, the Leicester Cough Questionnaire (Korean version), the Gastrointestinal Symptom Rating Scale, the Hull Airway Reflux (hypersensitivity) Questionnaire, the Pattern Identification for Chronic Cough Questionnaire, the 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 the use of herbal medicines for 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 a scientific basis for the combination of herbal medicines. This study will also provide 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.

Dataset Information

Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study.

Background

Methods

Discussion

Trial registration

Publications

Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study.

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