scholarly journals Clinical Trial to Analyze the Effect of Oral Intake of Phellinus Linteus(Sanghuang) Extract on Immune Function: A Study Protocol for a Randomized, Double-blind Controlled Trial

2021 ◽  
Author(s):  
Yong Ho Ku ◽  
Hyun Lee ◽  
Hwa Yeon Ryu ◽  
Jae Hui Kang
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Immune Function ◽  
Controlled Trial ◽  
Information Service ◽  
Laboratory Evaluation ◽  
Control Group ◽  
Phellinus Linteus ◽  
Research Information ◽  
Main Trial

Abstract Background: As Korea becomes an aging society, interest in health care has increased. In particular, there is an increasing demand for immune function improvement to prevent infectious diseases. Phellinus linteus (PL) has previously been shown to have immune-enhancing and anticancer effects. We aim to evaluate whether PL mycelium extract, cultured using the PL KCTC0399BP strain, has an increase in immune function using blood test indicators. This clinical trial is designed based on the results of a pilot study as the main trial.Methods: This clinical trial will be a randomized, double-blinded, placebo-controlled trial. Ninety-eight participants will be enrolled and randomly divided into two groups: experimental group (PL 1000 mg) and control group (placebo). Participants will be administered experimental food or placebo for 8 weeks. Blood tests will be performed before food intake and at 8 weeks after the start of the experiment. Laboratory evaluation items are as follows: natural killer cell activity, tumor necrosis factor-α, interferon-γ, interleukin (IL)-1β, IL-2, IL-6, IL-12, immunoglobulin (Ig)G1, IgG2, and IgM. We will mainly use the full analysis set to statistically analyze the effectiveness of treatment.Discussion: This study includes inclusion and exclusion criteria and a well-controlled intervention. This study evaluates the effect of PL extract on immune function and will contribute to knowledge on the value of PL as an immune function health functional food.Clinical research registration: This study has been registered at the Clinical Research Information Service (CRIS) of Korea: CRIS-KCT0005460. Registered , 12 October 2020, https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=17761&ltype=&rtype=Trial status: This clinical trial is in the recruitment stage. Recruitment began in October 21, 2020 and will be completed in March 2021. This trial was registered at the Clinical Research Information Service of South Korea on October 12, 2020. (CRIS-KCT0005460)

scholarly journals Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yong Ho Ku ◽  
Hyun Lee ◽  
Hwa Yeon Ryu ◽  
Jae Hui Kang
Keyword(s):  
Clinical Trial ◽  
Immune Function ◽  
Natural Killer Cell Activity ◽  
Controlled Trial ◽  
Killer Cell ◽  
Cell Activity ◽  
Laboratory Evaluation ◽  
Control Group ◽  
Phellinus Linteus ◽  
Main Trial

Abstract Background As the population of Korea ages, interest in healthcare has increased. In particular, there is an increasing demand for immune-function improvement to prevent infectious diseases. Phellinus linteus (PL) has previously been shown to exert immune-enhancing and anticancer effects. We aim to evaluate whether PL mycelium extract, cultured from the PL KCTC0399BP strain, can increase immune function, as measured using blood-test indicators. This clinical trial protocol is designed as the main trial and is based on the results of a pilot study. Methods This clinical trial is a randomized, double-blinded, placebo-controlled trial. Ninety-eight participants are enrolled and randomly divided into two groups: the experimental group (PL 1000 mg) and the control group (placebo). Participants are administered with experimental food or placebo for eight weeks. Blood tests are performed before trial initiation and 8 weeks later, at trial completion. Laboratory evaluation items are as follows: natural killer cell activity, tumor necrosis factor-α, interferon-γ, interleukin (IL)-1β, IL-2, IL-6, IL-12, immunoglobulin (Ig)G1, IgG2, and IgM. We will mainly use the full analysis dataset to statistically analyze the effectiveness of the treatment. Discussion This study evaluates the effects of PL extract on immune function and will contribute to knowledge on the value of PL as an immune-function–boosting functional food. Trial registration Clinical Research Information Service (CRIS) of Korea CRIS-KCT0005460. Registered on 12 October 2020

scholarly journals The effect of an eye mask on midazolam requirement for sedation during spinal anesthesia: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Seon Woo Yoo ◽  
Min-Jong Ki ◽  
Dal Kim ◽  
Yu Jin Oh ◽  
Jeongwoo Lee
Keyword(s):  
Spinal Anesthesia ◽  
Elective Surgery ◽  
Controlled Trial ◽  
External Environment ◽  
Information Service ◽  
Drug Effects ◽  
Control Group ◽  
Research Information ◽  
Moderate Sedation ◽  
Sleeping Pills

Abstract Background Midazolam is frequently used for sedation during spinal anesthesia. However, external environmental factors, such as bright surgical lights, may hamper patient relaxation, which may lead to an increase in the dose of midazolam required and the likelihood of adverse drug effects. We investigated whether using an eye mask to block the external environment could reduce midazolam requirements during spinal anesthesia. Methods Participants aged 18–‒80 years, scheduled for elective surgery under spinal anesthesia, were randomly divided into a masked group (wearing eye masks during surgery, n = 20) and a control group (no mask, n = 18). The sedation level was assessed using a modified Observer Assessment of Alertness and Sedation (MOAA/S) scale. Midazolam (1 mg) was incrementally administered every 5 min until moderate sedation (MOAA/S score of 3) was achieved. The bispectral index (BIS) was monitored, and the onset and maintenance times of a BIS < 80 were recorded. Results The two groups had similar demographic characteristics. The midazolam requirements were significantly lower in the masked group than in the control group (2.8 mg vs. 3.7 mg, P = 0.024). However, the onset and maintenance times for a BIS < 80 were similar. In addition, there were no significant differences in the incidence of side effects or patient satisfaction between the two groups. Conclusions Blocking the external environment with an eye mask during spinal anesthesia can reduce the requirement for sedatives, such as midazolam. Trial registration The trial was retrospectively registered with the Clinical Research Information Service (No. KCT0005528, 15/10/2020) entitled “Can we reduce an amount of sleeping pills just by blocking light?”.

scholarly journals Trends in Clinical Trial Registration in Dentistry: An Analysis of Registered Clinical Trials in the Clinical Research Information Service from 2013 to 2021 in South Korea

2021 ◽  
Vol 10 (3) ◽  
Author(s):  
Hye In Lee ◽  
Young-Ran Yoon
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
South Korea ◽  
Clinical Research ◽  
Information Service ◽  
Allocation Concealment ◽  
Research Information ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Quality Reporting

The Clinical Research Information Service (CRIS) in South Korea provides a clinical trial registry platform in which all clinical trials should be mandatorily and prospectively registered. However, to date, the registration status of clinical trials in the field of dentistry has not been investigated. Therefore, this study aimed to provide an overview of the methodological design and trends of the registered clinical trials over a period of nine years. Information about registered clinical trials in the field of dentistry from the CRIS was comprehensively collected from 2013 to 2021. The details assessed from the collected trials include: type of sponsors, recruitment status, study design, randomization, allocation concealment, single or multi-centric, retrospective or prospective registration, and publication status. A total of 65 registered clinical trials were identified. The number of clinical trials in dentistry in South Korea was found to be less; however, an increasing trend was observed in the recent three years. A majority of the trials were interventional (81.5%), single-centered (86.2%), and conducted on patients (81.5%) and in private hospitals (55.4%). A considerable number of trials had an unclear phase, were retrospectively registered, and rarely published. Regarding the quality, most trials have inadequately reported the method of randomization and allocation concealment. The number of clinical trials in dentistry is still low in South Korea, and most of them were registered retrospectively. A poor-quality reporting of methods at several specific areas was observed. It is necessary for dental investigators to raise awareness of the need to register clinical trials.

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 Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Yibo Li ◽  
Lili Zhu ◽  
Raoying Wang ◽  
Xingyue Yang ◽  
Xinqi Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Controlled Trial ◽  
Control Group ◽  
Health Maintenance ◽  
Ocular Symptoms ◽  
Thought Disorders ◽  
Multicenter Randomized Controlled Trial ◽  
Distant Visual Acuity

Abstract Background Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness, and other complications. At present, the solutions for myopia are glasses, medication, and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. Methods This is a prospective, randomized, multicenter clinical trial. One thousand one hundred forty primary and secondary school students aged 8–18 years old from 27 schools will be recruited and randomly divided into an experimental and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and −6.00D ≤ spherical lenses ≤ −0.50D and cylindrical lenses ≤1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter, and astigmatism. Discussion The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms, and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. Trial registration Chinese Clinical Trial Registry ChiCTR2000038642. Registered on 26 September 2020

scholarly journals Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Yu-yang Pang ◽  
Yan Li ◽  
Gang Kui ◽  
Yong Tang ◽  
Ming-juan Liao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Myeloproliferative Neoplasms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Complete Healing ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Leg Ulcers ◽  
Open Label ◽  
Chinese Herbal

Objective.The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.Patients and Methods.This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers. Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment. Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.Results.The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05). Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01). The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P< 0.01). Moreover, grade 3/4 side effects were observed in neither group.Conclusion.The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.

Effectiveness of spiritual care using spiritual pain assessment sheet for advanced cancer patients: A pilot non-randomized controlled trial

2019 ◽  
Vol 17 (1) ◽  
pp. 46-53
Author(s):  
Kaori Ichihara ◽  
Sayako Ouchi ◽  
Sachiko Okayama ◽  
Fukiko Kinoshita ◽  
Mitsunori Miyashita ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Pain Assessment ◽  
Spiritual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Assessment Sheet

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.

Effectiveness of Aromatherapy for Relief of Pain, Nausea, and Vomiting after Percutaneous Nephrolithotomy: A Randomized Controlled Trial

2020 ◽  
Vol 27 (6) ◽  
pp. 440-448
Author(s):  
Mojdeh Amirhosseini ◽  
Mahlagha Dehghan ◽  
Parvin Mangolian Shahrbabaki ◽  
Hamid Pakmanesh
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Percutaneous Nephrolithotomy ◽  
Complementary Therapies ◽  
Controlled Trial ◽  
The Other ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Analog Scale ◽  
Randomized Controlled

<b><i>Background:</i></b> Postoperative pain, nausea, and vomiting are common side effects of percutaneous nephrolithotomy. Nowadays, non-pharmacological and complementary therapies have been noticed. Therefore, a study was conducted to determine the effectiveness of lavender and clary sage on the pain, nausea, and vomiting after percutaneous nephrolithotomy. <b><i>Methods:</i></b> This is a randomized clinical trial study on 79 patients undergoing percutaneous nephrolithotomy. Patients were randomly divided into three groups of lavender aromatherapy (<i>n</i> = 27), clary sage aromatherapy (<i>n</i> = 26), and a control group (<i>n</i> = 26). Each of the intervention groups received the inhalation aromatherapy immediately and 3 and 6 h after the operation. Pain, nausea, and emetic episodes in patients of the three groups were measured before the intervention and 30 min after each intervention using a visual analog scale and checklist. <b><i>Results:</i></b> Pain decreased significantly in the clary sage aromatherapy group. Nausea had a downward trend in the two groups of aromatherapy. The lavender aromatherapy group had the lowest incidence of emetic episodes compared to the other groups. <b><i>Conclusion:</i></b> Regarding the annoying pain, nausea, and vomiting after percutaneous nephrolithotomy for patients, and taking into account the complications of drug therapy, the use of complementary non-pharmacological methods can help increase the comfort of patients.

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