scholarly journals Efficacy and safety of electroacupuncture treatment in the prevention of negative moods in healthy young men after 30 h of total sleep deprivation: study protocol for a single-center, single-blind, parallel-arm, randomized clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bing Yan ◽  
Fu-chun Wang ◽  
Tian-shu Ma ◽  
Yan-ze Liu ◽  
Wu Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Deprivation ◽  
Health Concern ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Preventative Treatment ◽  
Blank Control Group ◽  
Total Sleep Deprivation ◽  
Time Points

Abstract Background Sleep deprivation (SD) among young adults is a major public health concern. In humans, it has adverse effects on mood and results in serious health problems. Faced with SD, persons may take precautionary measures to try and reduce their risk. The aim of this study is to evaluate the efficacy and safety of electroacupuncture (EA) for the prevention of negative moods after SD. In addition, we will do a comparison of the effects of EA on mood after SD at different time points. Methods This randomized controlled trial (RCT) will be performed at the First Affiliated Hospital of Changchun University of Chinese Medicine in China. The Standards for Reporting Interventions in Clinical Trials of Acupuncture 2010 will be strictly adhered to. Forty-two healthy male volunteers will be distributed into acupoints electroacupuncture (AE) group, non-acupoints electroacupuncture (NAE) control group, or blank control group. This trial will comprise 1-week baseline (baseline sleep), 1-week preventative treatment, 30-h total sleep deprivation (TSD), and 24-h after waking follow-up period. Participants in the AE group and the NAE control group during the preventative treatment period will be administered with EA treatment once daily for 1 week. Participants in the blank control group will not be administered with any treatment. The primary outcome will be the Profile of Mood States (POMS) Scale. Secondary outcome measures will include changes in the Noldus FaceReader (a tool for automatic analysis of facial expressions) and Positive and Negative Affect Schedule (PANAS) Scale. Total sleep deprivation will be 30 h. During the 30-h TSD period, participants will be subjected to 11 sessions of assessment. Adverse events will be recorded. Discussion This study is designed to evaluate the efficacy and safety of EA for the prevention of negative moods after SD. The results of this trial will allow us to compare the effects of EA on mood after SD at different time points. Moreover, the findings from this trial will be published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry Chi2000039713. Registered on 06 November 2020

scholarly journals Efficacy And Safety of Electroacupuncture Treatment In The Prevention of Negative Moods In Health Young Men After 30 Hours of Total Sleep Deprivation: Study Protocol For A Single-Center, Single-Blind, Parallel-Arm, Randomized Clinical Trial

2021 ◽  
Author(s):  
Bing Yan ◽  
Fuchun Wang ◽  
Tianshu Ma ◽  
Yanze Liu ◽  
Wu Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Deprivation ◽  
Health Concern ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Preventative Treatment ◽  
Blank Control Group ◽  
Total Sleep Deprivation ◽  
Time Points

Abstract •Background:Sleep deprivation (SD) among young adults is a major public health concern. In humans, it has adverse effects on mood and results in serious health problems. Faced with SD, persons may take precautionary measures to try and reduce their risk. The aim of this study is to evaluate the efficacy and safety of electroacupuncture (EA) for the prevention of negative moods after SD. In addition, we will do a comparison of the effects of EA on mood after SD at different time points.•Methods:This randomized controlled trial (RCT) will be performed at the First Affiliated Hospital of Changchun University of Chinese Medicine in China. The Standards for Reporting Interventions in Clinical Trials of Acupuncture, 2010 will be strictly adhered to. Forty-two healthy male volunteers will be distributed into acupoints electroacupuncture (AE) group, non-acupoints electroacupuncture (NAE) control group, or blank control group. This trial will comprise 1-week baseline (baseline sleep), 1-week preventative treatment, 30-hours total sleep deprivation (TSD), and 24-hours after waking follow-up period. Participants in the AE group and the NAE control group during the preventative treatment period will be administered with EA treatment once daily for 1 week. Participants in the blank control group will not be administered with any treatment. The primary outcome will be the Profile of Mood States (POMS) Scale. Secondary outcome measures will include changes in the Noldus FaceReader (a tool for automatic analysis of facial expressions) and Positive and Negative Affect Schedule (PANAS) Scale. Total sleep deprivation will be 30 hours. During the 30-hours TSD period, participants will be subjected to 11 sessions of assessment. Adverse events will be recorded.•Discussion:This study is designed to evaluate the efficacy and safety of EA for the prevention of negative moods after SD. The results of this trial will allow us to compare the effects of EA on mood after SD at different time points. Moreover, the findings from this trial will be published in peer-reviewed journals.•Trial registration:Chinese Clinical Trial Registry, Chi2000039713, registered on 06 November, 2020.

scholarly journals The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Outcome Measures ◽  
Vestibular Migraine ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

scholarly journals Efficacy and Safety of Modified Qing-Ying Decoction for Atopic Dermatitis in Children: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Mei Kwan LAI ◽  
Chi Him SUM ◽  
Connie YC KAM ◽  
Tianhe SONG ◽  
Pui Kuan CHEONG ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Atopic Eczema ◽  
Gut Microbiome ◽  
Secondary Outcome ◽  
Control Group ◽  
Placebo Control ◽  
Efficacy And Safety ◽  
Long Term Treatment

Abstract BackgroundAtopic Dermatitis (AD), also known as atopic eczema, is a chronic skin disease characterized by recurring episodes of itchiness with skin erythema and surface damages, such as dry skin, skin thickening and swelling. Long-term treatment with conventional medicine for subacute and moderate atopic eczema is not satisfactory. Evidence from randomized clinical trials suggests the effectiveness of Chinese medicine for the treatmement of AD. The purpose of this study is to explore the efficacy and safety of the modified Qing-Ying Decoction (mQYD) for the treatment of subacute and chronic AD in children through examining the clinical symptoms, quality of life, gut microbiome, and Chinese medicine (CM) body constitution.Methods/designThis is a parallel, randomized, placebo-controlled, double-blind clinical trial with a 12-week treatment and a 4-week follow-up period. A total of 64 participants will be randomly allocated to the treatment group receiving oral mQYD granules or the placebo control group receiving oral placebo granules. Eczema Area and Severity Index (EASI) score will be the primary outcome. Secondary outcome measures include change in symptoms using the Patient-Oriented Eczema Measure (POEM), the Children’s Dermatology Life Quality Index (CDLQI), and the use of concomitant medicines as well as the change in the gut microbiome and CM body constitution types after the 12-week treatment of the mQYD and 4-week follow-up compared to placebo control. Safety parameters include report of adverse events and pathology tests during the trial period.DiscussionThis is the first clinical trial of its kind to test the efficacy and gut microbiome of an innovative Chinese herbal formula modified from a famous ancient formula for the treatment of AD. The outcomes of this trial will provide clinical evidence on the effectiveness and safety of mQYD for the treatment of AD.Trial registrationClinicalTrials.gov, ID: NCT04419584. Registered on 28 July 2020.

Efficacy and Safety of Traditional Chinese Medicine in COVID-2019: A Study Protocol for an Open-Label, Multicenter Randomized Controlled Trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Zhengzhong Yuan ◽  
Xiaoqiong Pan ◽  
Jizhou Zhang ◽  
Jiahui Zhu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Measures ◽  
Lung Injury Score ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Introduction: The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. It directly leads to high morbidity and mortality, but also results in a devastating effect on the global economy. Unfortunately, there are no effective therapies or vaccines for it. Hence, we designed a randomized trial to evaluate the efficacy and safety of Traditional Chinese Medicine for treating patients with COVID-19.Methods and analysis: This is an open-label, multicenter randomized controlled clinical trial. One hundred and twelve patients infected by SARS-CoV-2 will be randomly assigned to the experimental or the control group in an equal ratio. The patients in control group will accept routine supportive clinically care including the therapies of anti-viral, anti-bacterial and ameliorating the related symptoms, while patients in the experimental group will be asked to take traditional Chinese medicine depending on the different stages of the disease for consecutive 14 days in addition to supportive care. All data will be gathered at baseline and on days 3, 7, 10 and 14. The primary outcome measures will be the time of Reverse Transcription PCR testing of respiratory tract sample turns to be negative. Secondary outcome measures will include Murray lung injury score, MuLBSTA score and TCM ( Traditional Chinese Medicine ) Syndrome Scoring System. A laboratory test will be taken before and after treatment to assess the safety of TCM.Discussion: The study may help to identify the the efficacy and safety of Traditional Chinese Medicine in treating COVID-2019.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000030759.Registered on March 13th 2020-Retrospectively registered, http://www.chictr.org.cn/.

scholarly journals Efficacy and Safety of Traditional Chinese medicine in patients with acute exacerbation of idiopathic pulmonary fibrosis: study protocol for randomized, controlled, exploratory clinical trial

2021 ◽  
Author(s):  
Hailong Zhang ◽  
Jiansheng Li ◽  
Wen Guo ◽  
Lu Wang ◽  
Dong Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Acute Exacerbation ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Arterial Blood

Abstract Background: At present, there is short of effective treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF). The treatment of IPF with Traditional Chinese medicine (TCM) has some advantages. However, the evidence is unclear whether TCM can be recommended as an effective therapy to treat AE-IPF. The purpose of the study is to explore the efficacy and safety of TCM for patients with AE-IPF.Methods: A randomized, double-blind, placebo-controlled, exploratory clinical trial will be performed. A total of 80 patients diagnosed AE-IPF will be randomized into the intervention or control group. In addition to conventional treatment, the intervention group will be treated with Kangxianhuanji granule, and the control group will be given a placebo granule. The administration frequency is 10g each time and two times daily. After 4 weeks of treatment, the patients were followed up for 12 weeks. The primary outcomes are treatment failure rate and all-cause of mortality. Secondary outcome measures will include the length of hospitalization, overall survival, acute exacerbation rate, intubation rate, Modified British Medical Research Council (mMRC) score, and the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis (SGRQ-I) score, and arterial blood gas analysis.Discussion: TCM may be beneficial in IPF. However, it has never been evaluated in patients with AE-IPF, who are incredibly prone to respiratory failure and have a high mortality rate. It is the first clinical trial to explore the efficacy and safety of TCM in the treatment of AE-IPF. This result will provide a basis for further study, which provide a high-quality evidence for the treatment of AE-IPF with TCM.Trial registration: Chinese Clinical Trial Registry, ChiCTR1900026289. Registered 29 September 2019, http://www.chictr.org.cn/index.aspx.

scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Effectiveness of Acromioclavicular Joint Mobilization and Physical Therapy vs Physical Therapy Alone in Patients with Frozen Shoulder: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Mohammad Rahbar ◽  
Sepideh Ranjbar Kiyakalayeh ◽  
Bina Eftekharsadat ◽  
Behzad Izadseresht ◽  
Neda Dolatkhah
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Randomized Clinical Trial ◽  
Shoulder Pain ◽  
Acromioclavicular Joint ◽  
Frozen Shoulder ◽  
Secondary Outcome ◽  
Control Group ◽  
Joint Mobilization ◽  
Active Abduction

Abstract Background: Frozen shoulder (FS) is a prevalent musculoskeletal condition characterized by an often prolonged pain, disability and limited active and passive range of motion (ROM), however its management remains challenging yet. The objective of this trial was to compare the efficacy of acromioclavicular joint mobilization and physical therapy versus physical therapy in treatment of FS.Methods: In this single-blind randomized clinical trial, patients with diagnosis of FS were randomly allocated into mobilization + physical therapy (n=28) as experiment group, and physical therapy (n=28) as control group in two outpatient clinics of Tabriz University of Medical Sciences, Iran. The primary outcomes were self-reported shoulder pain-related disability measured by the Shoulder Pain and Disability Index (SPADI) questionnaire and goniometric assessment of shoulder ROM. The secondary outcome was the Visual Analogue Scale (VAS). Measures were performed at the baseline, immediately and one month after beginning the treatments.Results: Totally 51 patients with 25.73 ± 6.88 years old of age completed the study and their data were analyzed. VAS, SPADI, pain and disability improved more significantly in experiment group compared to control group immediately [-4.63 (-5.58- -3.67) vs. -2.22 (-2.96- -1.47), p<0.001; -23.08 (-28.63- -17.53) vs. -13.04 (-17.93- -8.16), p=0.008; -26.00 (-31.71- -20.29) vs. -16.35 (-23.39- -9.31), p=0.034 and -21.25 (-29.11- -13.39) vs. -10.98 (-17.53- -4.43), p=0.042, respectively] and one month after beginning of treatment [-5.58 (-6.45- -4.72) vs. -3.61 (-4.60- -2.62), p<0.001; -33.43 (-40.85- -26.01) vs. -20.03 (-26.00- -14.07), p=0.001; --42.83 (-49.09- -36.57) vs. -25.57 (-33.92- -17.21), p<0.001 and -27.55 (-36.19- -15.94) vs. -16.58 (-24.48- -8.67), p=0.041, respectively]. Active abduction ROM was also improved more significantly immediately after treatment in experiment group compared to control group [25.83 (11.45- 40.13) vs. 10.17 (1.02- 19.15), p=0.025], however there were no significant differences between two groups concerning other measured ROMs immediately and one month after treatment (all p>0.05). Conclusions: Acromioclavicular mobilization along with conventional physical therapy was more efficient in decreasing pain and disability and improving active abduction ROM compared to physical therapy in patients with FS. These findings would suggest a new therapeutic method for shoulder disorders with pain and disability.Trial registrationwww.irct.ir, IRCT20100605004104N7, registered 06.01.2019 (https://www.irct.ir/trial/35900)

Effects of acupuncture on anthropometric and serum metabolic parameters in premenopausal overweight and obese women: a randomized, patient- and assessor-blind, sham-controlled clinical trial

2020 ◽  
pp. 096452842091225
Author(s):  
Koh-Woon Kim ◽  
Woo-Chul Shin ◽  
Min Sun Choi ◽  
Jae-Heung Cho ◽  
Hi-Joon Park ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Serum Lipid ◽  
Sham Acupuncture ◽  
Metabolic Parameters ◽  
Secondary Outcome ◽  
Control Group ◽  
Lipid Levels ◽  
Serum Lipid Levels

Objective: The aim of this study was to examine the effect of acupuncture on obesity-related parameters with regard to metabolomics. Methods: This two-arm parallel, patient- and assessor-blind, sham-controlled randomized clinical trial included 120 obese participants. Participants were randomized into two groups. The treatment group received a combined intervention of manual acupuncture (MA) plus electroacupuncture (EA), while the control group received a combination of sham acupuncture interventions consisting of sham MA plus sham EA for 6 weeks. The serum lipid levels were measured as the primary outcome measure and anthropometric parameters and serum metabolic profiles including amino acids and carnitines were measured as secondary outcome measures. Results: The serum lipid levels and anthropometric measurements did not significantly differ between groups, while body weight, body mass index (BMI), and waist circumference were improved within each group and the level of high-density lipoprotein cholesterol increased over time in the treatment group. There were no significant differences in amino acid levels between groups, while certain carnitine (C2, C4, C6, and l-carnitine) levels were significantly increased ( p < 0.05) in the treatment group compared to the control group. Conclusion: In summary, 6 weeks of acupuncture treatment did not affect anthropometric and serum metabolic parameters, with the exception of certain carnitines, when compared to sham acupuncture. The observation of increased carnitine levels in the acupuncture group could result in potential long-term benefits to obese individuals. Additional studies are needed to investigate the long-term effects of acupuncture on lipid metabolism and the underlying mechanism of action. Trial registration number: This study is registered at ClinicalTrials.gov (NCT02066090).

scholarly journals Efficacy and Safety of Socheongryong-Tang Among Atopic Dermatitis Patients With Respiratory Disorders: A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Ju Hyun Lee ◽  
Eun Heui Jo ◽  
Jee Youn Jung ◽  
Young-Eun Kim ◽  
Mi-Ju Son ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Safety Evaluation ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Inflammatory Skin Disease ◽  
Double Blinded ◽  
Study Participants ◽  
Experimental Group

Atopic dermatitis is a chronic inflammatory skin disease that affects the growth and development of children. The prevalence of atopic dermatitis has been continually increasing, and this has also been accompanied by rising socioeconomic costs. Interest has been growing in alternative medicine as a means of alleviating the burden of atopic dermatitis. This was a single-center, double-blinded, randomized, placebo-controlled investigator-led clinical trial including 60 atopic dermatitis patients. The participants were classified into an experimental group (30 persons) and a control group (30 persons), who were administered, respectively, socheongryong-tang or a placebo for 4 weeks. After 4 weeks of treatment, the participants visited the trial center again and assess their efficacy and safety. The researchers performed statistical comparisons of the changes in the SCORAD Index, amount and frequency of ointment use, and height and weight to assess the efficacy. To assess the safety, diagnostic tests and vital sign checks were performed at each visit, and the presence or absence of adverse events was observed. As a result, the frequency and the amount of steroid ointment application in both groups increased, but the experimental group showed less tendency (p = 0.081). Results of analyzing the children in the experimental group in relation to growth showed a significantly greater height growth than the control group (p &lt; 0.05). In addition, all study participants did not show any remarkable abnormal signs in the safety evaluation. In conclusion, compared to the control group, the experimental group, who took socheongryong-tang showed a tendency to be less dependent on steroid ointment and statistically significant increase in height.

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