• Title/Summary/Keyword: Placebo-controlled study

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Assessment of the Effectiveness of a Film-Forming Cream in the Management of Oral Aphthous Ulcers: A Placebo-Controlled Randomized Clinical Trial

  • Simone Marconcini;Giacomo Oldoini;Annamaria Genovesi;Enrica Giammarinaro
    • Journal of dental hygiene science
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    • v.23 no.2
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    • pp.88-92
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    • 2023
  • Background: Aphthous stomatitis is a common disease of the oral mucosa and its pathogenesis is associated with several risk factors. Frequently, minor ulcers are idiopathic in nature and often resolve naturally. However, those ulcers are painful and sensibly compromise patients' eating. There are different treatment strategies for the clinical management of oral aphthae. Methods: The present study assessed the efficacy of a film-forming cream in accelerating the healing and diminishing the pain associated with minor aphthae in a randomized fashion design. The test product (AphtoFix®) was compared with placebo cream in a cohort of patients with a diagnosis of minor recurrent stomatitis. Patients were randomly distributed into two groups and were followed for 10 days. The primary outcomes included the number of days until symptoms were relieved and the number of days to complete healing. Results: Thirty-six patients completed the follow-up, eighteen per group. All lesions eventually healed within day 10. However, patients in the test group experienced significantly less pain, already from day 1. Patients in the test group also showed a faster healing rate of the lesion with an average of 7 days against the 9 days required for patients in the control group. Conclusion: The present study supported the utility of a film-forming in cream in relieving the patient from symptoms associated with aphthous stomatitis already at day 1 of product use. Patients also displayed faster healing of the lesions when compared to the control group. Further studies with greater sample size and patient stratification according to age and risk factors are recommended to support the present findings.

The Effects of Coenzyme Q10 Supplementation on Oxidative Status and Lipid Profile in Migraine Patients: A Randomized Double-Blinded Controlled Clinical Trial

  • Monireh Dahri;Atefeh Sarafan Sadeghi;Naseh Pahlavani;Elyas Nattagh-Eshtivani;Mazyar Hashemilar;Mohammad Asghari-Jafarabadi;Hanieh Barghchi;Ali Tarighat-Esfanjani
    • Clinical Nutrition Research
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    • v.12 no.4
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    • pp.257-268
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    • 2023
  • Migraine is a common neurological disease correlated with oxidative stress and lipid profile disorders. The present study was designed to determine the effects of Coenzyme Q10 (Co-Q10) supplementation on oxidative status and lipid profile in migraine individuals. This clinical trial was conducted on 84 females aged 18-50 years, diagnosed for episodic migraine according to the International Headache Society. Subjects were randomized to receive either Co-Q10 supplement (400 mg/day) or placebo for 12 weeks. Lipid profile and oxidative stress indices including malondialdehyde (MDA) and total antioxidant capacity (TAC) were measured before and after intervention in both groups. Also, anthropometric indices, dietary intakes, and clinical features were collected. Data analysis was conducted using SPSS version 16. Seventy-seven of the participants, with mean age of 33.70 ± 7.75 years, completed the study. After 12-week intervention, Co-Q10 led to a significant decrease in MDA levels compared to placebo (p = 0.009), with no effect on TAC levels (p = 0.106). A significant increase in serum Co-Q10 concentration and high-density lipoprotein cholesterol (HDL-C) level in Co-Q10 group was observed, but no significant differences were found in other lipid profile variables (low-density lipoprotein cholesterol, triglycerides and total cholesterol). Among anthropometric variables, Co-Q10 only caused a significant reduction in body fat percentage (BFP), but we did not find any significant changes in others. A 12-week Co-Q10 supplementation led to significant improvement in clinical features, BFP, and HDL-C level among migraine individuals.

Alternation of Topical Heat and Cold for Chronic Low Back Pain : A Randomized Controlled Pilot Trial

  • Choi, Young Doo;Jo, Su Jeong;Jung, Chan Yung;Kim, Kap Sung;Lee, Seung Deok
    • Journal of Acupuncture Research
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    • v.33 no.2
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    • pp.77-87
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    • 2016
  • Objectives : This is a pilot study for a large randomized controlled trial to investigate the efficacy and safety of a newly developed contrast therapy device-- alternating topical heat and cold -- for patients with chronic low back pain. The main objective of this study is to confirm the feasibility of the study design. Methods : The design was a randomized, 2-arm, parallel-group, single-blind, placebo controlled trial. Patients in each group received real or sham contrast therapy in an acupuncture point 10 times over four weeks. The primary outcome measure was pain intensity on a 100-mm visual analogue scale (VAS). The secondary outcomes were back-related dysfunction based on the Oswestry Disability Index (ODI), the Roland-Morris disability questionnaire (RMDQ), and range of motion of lumbar spine based on the modified Schober test (mSchober test), Finger-to-Floor distance (FTF distance), and Finger-to-Thigh distraction (FTT distraction). Results : A total of 30 subjects with chronic low back pain were randomly assigned to a contrast therapy group (n=15) or a sham group (n=15). A repeated-measures analysis of variance showed statistically significant group time interaction for VAS, RMDQ, mSchober test and FTF distance (p<0.05). The treatment group showed significant improvement in pain intensity and functional disability as compared to the sham group. Conclusion : Contrast therapy may be an effective and safe treatment for chronic low back pain.

Effects of an electric toothbrush combined with 3-color light-emitting diodes on antiplaque and bleeding control: a randomized controlled study

  • Kwon, Chakyoung;Lee, Jae-Mok;Suh, Jo-Young;Seo, Seung-Jun;Lee, Youngkyun;Kim, Yong-Gun
    • Journal of Periodontal and Implant Science
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    • v.50 no.4
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    • pp.251-259
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    • 2020
  • Purpose: This randomized controlled study aimed to evaluate the effects of an electric toothbrush with 3 colors of light-emitting diodes (LEDs) on antiplaque and bleeding control. Methods: This randomized, placebo-controlled, double-blinded, parallel-group clinical trial included 50 healthy adults with gingivitis, who were randomly assigned to 2 groups. The experimental group used electric toothbrushes with 3 colors of LEDs and the control group used the same electric toothbrush as the experimental group, but with LED sources with one-hundredth of the strength. The subjects used the electric toothbrush 3 times a day for 4 minutes each time. As clinical indices, bleeding on marginal probing (BOMP), the Löe-Silness gingival index (GI), and the Turesky-Quigley-Hein plaque index (QHI) were assessed at baseline, at 3 weeks, and at 6 weeks. Results: There were significant decreases in all clinical indices (BOMP, GI, QHI) in both the experimental and control groups compared to baseline at 3 weeks and at 6 weeks. In a comparison between the experimental and control groups, no statistically significant differences were observed for any clinical indices at 3 weeks (P>0.05). However, at 6 weeks, statistically significant differences were observed between the experimental and control groups in BOMP and GI, which are indicators of gingival inflammation (P<0.05). Conclusions: This study demonstrated that an electric toothbrush combined with 3-color LEDs reduced gingival bleeding and inflammation after 6 weeks.

Review of Randomized Controlled Trials Research of Gyejibongnyeong-hwan and Gyejibongnyeong-hwan gagam for Chronic Pelvic Inflammatory Disease (만성 골반 염증성 질환의 계지복령환 및 계지복령환 가감방 투여에 대한 중의학 연구 동향 : 무작위 대조군 임상 연구를 중심으로)

  • Yeon-Soo Jung;Young-Jin Yoon;Hee-Yoon Lee;Jang-Kyung Park
    • The Journal of Korean Obstetrics and Gynecology
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    • v.36 no.3
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    • pp.78-94
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    • 2023
  • Objectives: The purpose of this study is to review the trends of clinical trials of traditional herbal medicine Gyejibongnyeong-hwan for chronic pelvic inflammatory disease in CNKI. Methods: We searched relevant studies using Chinese National Knowledge Infrastructure (CNKI). Data retrieval was carried out by December 20th, 2021. We analyzed characteristics of study subjects, treatment period, composition of prescription, outcome and adverse event of selected studies and the risk of bias was assessed by using Cochrane's risk of bias tool. Results: Among the total 988 studies, 10 studies met the inclusion criteria. All of the studies were randomized controlled studies and written in Chinese. In all studies, Gyejibongnyeong-hwan was effective in improving chronic pelvic inflammatory disease. Conclusions: This study suggests that Gyejibongnyeong-hwan can be effective in treating chronic pelvic inflammatory disease compared to antibiotics treatment. Further large and well-established randomized placebo controlled trials will be needed.

Visceral fat and body weight are reduced in overweight adults by the supplementation of Doenjang, a fermented soybean paste

  • Cha, Youn-Soo;Yang, Ji-Ae;Back, Hyang-Im;Kim, Soo-Ran;Kim, Min-Gul;Jung, Su-Jin;Song, Won O;Chae, Soo-Wan
    • Nutrition Research and Practice
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    • v.6 no.6
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    • pp.520-526
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    • 2012
  • Various forms of fermented soybean products are well documented for their health benefits. The efficacy of anti-obesogenic effect of Doenjang, one of the most commonly used seasonings in Korean cuisine, has been reported only in animal models; thus, an evaluation of Doenjang needs to be conducted in human studies. We aimed to test the hypothesis that Doenjang supplementation reduces body weight and changes body composition in overweight adults. A total of 51 overweight adults participated in this study. A group of males with BMI ${\geq}23kg/m^2$ and waist to hip ratio (WHR) ${\geq}$ 0.90, and a group of females with BMI ${\geq}23kg/m^2$ and WHR ${\geq}$ 0.85 were randomly assigned to either a Doenjang supplement (9.9 g dry/day) group or a placebo group for a 12-week randomized, double-blind and placebo-controlled study. Anthropometric parameters, abdominal fat distribution by computerized tomography (CT) and blood components were measured before and after the intervention period. After the 12-week study, the Doenjang supplementation group had significant reductions in body weight (kg), body fat mass (kg) and body fat (%) compared to the placebo group, the supplementation of Doenjang resulted in a significant reduction in visceral fat ($cm^2$), although no changes were observed in total and subcutaneous fat are as ($cm^2$), serum lipid profiles and dietary intakes. The present study demonstrated that daily supplementation of 9.9 g dry/day of Doenjang for 12 weeks reduces body weight and visceral fat in overweight adults.

The Effect of Health Functional Food on Body Weight Reduction (건강기능식품의 체중 감량 효과)

  • Joo, Nam-Seok
    • Archives of Obesity and Metabolism
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    • v.1 no.2
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    • pp.59-65
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    • 2022
  • Obesity is a serious health concern, which has been linked to an increased risk for cardiovascular diseases and some cancers. The traditional obesity control program is expensive. Moreover, it is difficult to maintain a healthy body weight as well as reduce body fat. The long-term use of effective and tolerable medication is carefully recommended to control body weight. In addition to obesity control medications, health functional foods, related to body weight control, have become popular in the commercial market. Known mechanisms include lipolysis, appetite control, inflammation reduction, and lean body mass maintenance. Previous clinical trials have documented the efficacy of some health functional foods; however, there are limitations. Studies on the potential roles and efficacy of some health functional foods, including caffeine, green tea, protein supplement, probiotics, and arginine, were reviewed. More large-scale and randomized placebo-controlled trials should be conducted eventually.

Effect of Kinesiology Taping of the Middle Back on Static Balance in Hemiplegic Stroke Patients: A Pilot Study

  • Kim, Bokyung
    • Journal of International Academy of Physical Therapy Research
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    • v.12 no.2
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    • pp.2354-2358
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    • 2021
  • Background: Stroke is a neurological disorder characterized by an impaired static balance. A change in poor posture after stroke may worsen static balance. The balance control through an upright posture may include kinesiology taping of the middle back. Objectives: To investigated the effect of kinesiology taping of middle back on static balance in patients with stroke. Design: A randomized controlled trial. Methods: A total of 10 patients with stroke were divided into two groups. The experimental and control groups received kinesiology taping and placebo taping of the middle back, respectively. After 24 h, static balance (i.e., sway area and path length) was measured in closed eyes condition. Results: The experimental group (kinesiology taping group) showed a significant decrease in sway area and path length after the intervention. In addition, kinesiology taping group showed a significant decrease in sway area and path length compared to the control group. Conclusion: Kinesiology taping of the middle back can improve static balance in stroke patients.

Adverse Effects of Ephedra According to Sasang Typology in Healthy Adults : A Double-Blind Randomized Controlled Trial (마황복용 후 사상체질별 이상반응에 관한 임상연구 : 무작위배정 이중맹검시험)

  • Lee, Tae-Ho;Hsing, Li-Chang;Yang, Chang-Sop;Kim, Lak-Hyung;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.30 no.1
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    • pp.144-152
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    • 2009
  • Background : Ephedra (Ephedra sinica) has been widely used to treat respiratory disease in traditional medicine of East Asia for over a hundred years. Despite safety concerns raised by some, the use of ephedra in traditional medicine is documented over more than 1,800 years. It is well established that ephedra is one of the central medicines in Korean 'Seseng constitution' medicine. In Sasang constitution medicine, all humans can be divided into one of four types: Soeumin, Soyangin, Taeumin or Taeyangin, and each constitution type has their own typical characteristics. Accordingly, it is hypothesized that the adverse effects of ephedra differ depending on the Sasang constitution classification. Objectives : The aim of this study was to determine adverse effects of ephedra which is classified as a Taeumin herb, and to observe whether the response differs or not. according to Sasang constitution classification. Methods : The study design was a double-blind randomized controlled trial. The subjects were healthy adults 20 - 50 years old who agreed to participate in this study. They were allocated through randomization to either ephedra group (N=55) or placebo group (N=24). where ephedra extract (6 g of dried ephedra) and placebo with similar opaque capsules were given twice for one day. To compare the adverse events of ephedra according to Sasang constitution classification, we analyzed blood pressure (systolic and diastolic), pulse rate, the morning questionnaire, and patient's global assessment scale score for well known adverse events: palpitation, headache, sweating, tiredness, dyspepsia, and dry mouth. Results : After ingestion of ephedra, the pulse rate had a significant increase in all constitution types. The changes of diastolic pressure in Soeumin and the changes of pulse rate in Soeumin, Soyangin and Taeumin had a significant increase in the ephedra over the control group. In the ephedra group, the palpitation and dyspepsia score of the patients' global assessment scale had a significant increase in Soeumin, with palpitation and sweating score increasing in Soyangin. Others observations were insignificant results. Conclusion : The results of this study may confirm that the physical responses or adverse effects of herbs differ for each type of Sasang constitution. Future studies using other herbs will be required to ascertain the herbal drug reaction of Sasang constitutions.

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The Effect of Glasthma Syrup in Asthma: a study protocol for a triple-blind randomized controlled trial

  • Derakhshan, Ali Reza;Saeidinejat, Shahin;Khadem-Rezaiyan, Majid;Asnaashari, Amir-Mohammad-Hashem;Mirsadraee, Majid;Salari, Roshanak;Jabbari-Azad, Farahzad;Jalali, Shima;Jalali, Shabnam
    • Journal of Pharmacopuncture
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    • v.25 no.3
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    • pp.233-241
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    • 2022
  • Objectives: Asthma is a chronic disease, and the demand for herbal medicines in this field has increased in recent years. The new findings highlight the role of the gut-lung axis in the pathophysiology of asthma. Hence, this study will evaluate the safety and efficacy of Glasthma syrup, an herbal formula based on Persian medicine, in improving asthma and regulating intestinal permeability. The formula consists of five herbal ingredients that have anti-inflammatory effects on the respiratory tract, also known as gut tonics. Methods: The study will be conducted as a placebo-controlled, triple-blind, randomized trial. It will consist of a 4-week intervention followed by a 4-week follow-up period. The target sample size is 20 patients with moderate asthma aged 18 to 60 years. Eligible participants will be randomly assigned to either the experimental group or the control group in equal numbers. Patients in the experimental group will take Glasthma syrup (7.5 mL, twice a day), while patients in the control group will take a matching placebo. Both groups will receive a 4-week combination of a long-acting beta2 agonist and a leukotriene modulator as standard of care. Inhaled corticosteroids can be used as rescue medication as needed. Results: The primary outcomes are asthma symptom scale, lung function, and intestinal permeability. Secondary outcomes include quality of life, symptom recurrence rates, and blood tests. A safety assessment will also be conducted during the trial. Conclusion: In this trial, the effects of Glasthma syrup in patients with moderate asthma will be examined. The study will also assess the effects of the formulation on the gut-lung axis by simultaneously monitoring the gut permeability index, asthma symptoms, and lung function.