• Title/Summary/Keyword: Placebo-controlled study

Search Result 354, Processing Time 0.028 seconds

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
    • /
    • v.25 no.3
    • /
    • pp.233-241
    • /
    • 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.

Study on the Anti-stress Effect of Chenwangbosim-Dan Extract∘Fermented Rice Extract (GABA ː gamma-aminobutyric acid 30%) Complex : A double-blind, randomized, placebo-controlled study (천왕보심단(天王補心丹)∘쌀발효추출물(GABAːgamma-aminobutyric acid 30%) 복합물의 항(抗)스트레스에 대한 유효성 연구ː무작위 배정 및 이중맹검)

  • Choyoung, Hong;Seo, Sang Gwon;Seunggon, Na;Hosong, Cho;Mi-Kyung, Lee;Mu Hyun, Jin;Seok-Seon, Roh;Youngsung, Ju
    • The Korea Journal of Herbology
    • /
    • v.38 no.2
    • /
    • pp.1-7
    • /
    • 2023
  • Objectives : From this study, we sight to identify Anti-stress effect of Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex Methods : In order to measure the degree of functional evaluation of tension relief due to stress, it was evaluated whether the psychological indicators VAS(Visual Analog Scale) and POMS(Profile Of Mood State) were improved. Which is generally used for stress measurement and has a high frequency of clinical use. All clinical trial subjects were required to take the drug once a day at 9 ± 30 min in the morning for 2 weeks. Results : After intake, the group that Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had a statistically significant improvement effect compared to before intake due to an improved 30.81% of the VAS scores. The POMS-T score improved 54.13%, the POMS-V score improved 117.5% and the POMS-F score improved 59%, which had a statistically significant effect compared to Placebo group (p<0.001). There is a significant difference between two group, so even considering the placebo effect, the anti stress effect was confirmed in the Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex intake group. Conclusions : The above results showed that the Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had an anti-stress effect. Therefore, it is expected to be developed as a safe and comfortable mental care health functional food that can reduce the risk of drug abuse.

Effects of Healing Beats program on patients' anxiety, stress, systolic blood pressure, heart rate and Bis Index after epidural blocking : A randomized controlled trial (Healing Beats 프로그램이 경막외강차단 시술 후 환자의 불안, 스트레스, 수축기 혈압, 심박동수 및 Bis Index에 미치는 효과 : 무작위대조군)

  • Bae, Ik Lyul;Song, Ji Ah
    • Journal of the Korea Academia-Industrial cooperation Society
    • /
    • v.21 no.7
    • /
    • pp.54-65
    • /
    • 2020
  • This randomized pre-post-controlled experimental study determined the effect on patients' anxiety, stress, systolic blood pressure, heart rate and Bis index when the Healing Beats program is applied after epidural blockage. The subjects were selected from the patients who visited the Department of Anesthesiology and Pain for the treatment of epidural blockage and volunteered through the recruitment announcement. A total of 74 sets of data were collected and analyzed with 25 subjects in the experimental group, 24 in the placebo group, and 25 in the control group. The data was analyzed using descriptive statistics, x2-tests, F-tests and repeated measures of ANOVA. As a result of the study, the general characteristics and variables of the experimental group, placebo group, and control group were all the same, and anxiety was measured twice before and after the study. There were significant differences between groups (F=27.175, p<.001), and stress (F=4.78, p<.001), heart rate (F=4.22, p<.001) and the Bis index (F=7.96, p<.001) were analyzed by variance according to population and time. There was a significant difference. However, there was no significant difference in systolic blood pressure (F=1.23, p=.298). In conclusion, the Healing Beats program can be used as an effective and effective intervention for sedation in clinical situations or stressful situations.

Effects of Aromatherapy on Menopausal Symptoms, Perceived Stress and Depression in Middle-aged Women: A Systematic Review (아로마테라피가 중년여성의 갱년기 증상, 스트레스 및 우울에 미치는 효과: 체계적 문헌고찰)

  • Kim, Shinmi;Song, Ji-Ah;Kim, Mi-Eun;Hur, Myung-Haeng
    • Journal of Korean Academy of Nursing
    • /
    • v.46 no.5
    • /
    • pp.619-629
    • /
    • 2016
  • Purpose: This study was a systematic review to evaluate the effects of aromatherapy on menopausal symptoms, perceived stress and depression in middle aged-women. Methods: Eight databases were searched from their inception September 8, 2015. Two reviewers independently performed the selection of the studies, data abstraction and validations. The risk of bias was assessed using Cochrane criteria. For analysis of the data, a meta-analysis of the studies was performed. Results: From the electronic databases, 73 articles were selected, and 19 removed due to duplication. After two reviewers read the abstracts of 54 studies, 34 studies were selected. Complete papers for 34 s were read and, 12 studies which met selection criteria were reviewed and the effects of aromatherapy on menopausal symptoms, stress and depression analyzed using meta-analysis with RevMan. In the 2 studies which included Randomized Controlled Trials testing of aromatherapy on menopausal symptoms and comparison of control and placebo groups were done. Aromatherapy massage was favorably effective in reducing the menopausal symptoms compared to the control group (n=118, MD=-6.33; 95% CI -11.51 to -1.15), and compared to the placebo group (n=117, MD=-4.14; 95% CI -7.63 to -0.64). Also aromatherapy was effective in reducing stress (n=72, SMD=-0.64; 95% CI -1.12 to -0.17) and depression (n=158, MD=-5.63; 95% CI -10.04 to -1.22). Conclusion: There is limited evidence suggesting that aromatherapy for middle-aged women may be effective in controlling menopausal symptoms, perceived stress and depression.

Effects of pumpkin seed oil and saw palmetto oil in Korean men with symptomatic benign prostatic hyperplasia

  • Hong, Hee-Ok;Kim, Chun-Soo;Maeng, Sung-Ho
    • Nutrition Research and Practice
    • /
    • v.3 no.4
    • /
    • pp.323-327
    • /
    • 2009
  • This study was to investigate the role of complementary and alternative medicine in the prevention and treatment of benign prostatic hyperplasia. For this purpose, a randomized, double-blind, placebo-controlled trial was performed over 12 months on 47 benign prostatic hyperplasia patients with average age of 53.3 years and international prostate symptom score over 8. Subjects received either sweet potato starch (group A, placebo, 320 mg/day), pumpkin seed oil (group B, 320 mg/day), saw palmetto oil (group C, 320 mg/day) or pumpkin seed oil plus saw palmetto oil (group D, each 320 mg/day). International prostate symptom score, quality of life, serum prostate specific antigen, prostate volume and maximal urinary flow rate were measured. In groups B, C and D, the international prostate symptom score were reduced by 3 months. Quality of life score was improved after 6 months in group D, while those of groups B and C were improved after 3 months, compared to the baseline value. Serum prostate specific antigen was reduced only in group D after 3 months, but no difference was observed in prostate volume in all treatment groups. Maximal urinary flow rate were gradually improved in groups B and C, with statistical significance after 6 months in group B and after 12 months in group C. None of the parameters were significantly improved by combined treatment with pumpkin seed oil and saw palmetto oil. From these results, it is suggested that administrations of pumpkin seed oil and saw palmetto oil are clinically safe and may be effective as complementary and alternative medicine treatments for benign prostatic hyperplasia.

Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial

  • Hajizadeh, Hila;Nemati-Karimooy, Atefeh;Majidinia, Sara;Moeintaghavi, Amir;Ghavamnasiri, Marjaneh
    • Restorative Dentistry and Endodontics
    • /
    • v.42 no.3
    • /
    • pp.168-175
    • /
    • 2017
  • Objectives: This double-blind randomized placebo-controlled clinical trial evaluated the ability of a desensitizing agent and a self-etch adhesive on cervical dentin sensitivity (CDS) after periodontal surgery. Materials and Methods: Ninety hypersensitive teeth of 13 subjects were included in the study. After periodontal surgery, the teeth of each posterior sextant treated with one of the following materials: G1: Clearfil $S^3$ Bond (Kuraray Dental), G2: Gluma Desensitizer (Heraeus Kulzer), and G3: placebo (water). The sensitivity was assessed using evaporative stimuli before treatment (baseline, T0), 1 day after treatment (T1), after 1 week (T2), and 1 month (T3) according to visual analog scale (VAS). Results: Following the treatment, all the 3 groups showed significant reduction of CDS in T1 compared to T0. Reduction of CDS between T1 and T2 was observed only in G1 but there was no significant difference between T2 and T3 in this group. Although we observed a significant difference in T3 compared to T1 and T2 in G2 and G3, comparison of treatment groups in each assessment time showed a significant difference only in T3. According to paired comparison, this was due to the difference between G2 and G3. Conclusions: Dentin sensitivity following periodontal surgery will decrease spontaneously over time, but treating the sensitive teeth with Gluma Desensitizer and Clearfil $S^3$ Bond can have some benefits.

Clinical Trial for the Heat-Rising Action of Ginseng and Cultivated Wild Ginseng to The Subject Diagnosed as Heat Pattern by Cold-Heat Patternization (한열변증을 통한 열증 대상자에 산양삼과 재배인삼의 상부 승열 작용에 대한 인체적용시험)

  • Yoo, Su-Jeong;Ko, Sung-Kwon;Kim, Hyeong-Jun
    • The Journal of Korean Obstetrics and Gynecology
    • /
    • v.30 no.4
    • /
    • pp.45-58
    • /
    • 2017
  • Objectives: The aim of this trial is to investigate the effect of Ginseng and Wild Cultivated Ginseng to Heat pattern subject. Methods: Eighty-nine Subjects were diagnosed as heat pattern by Cold-Heat Patternization and divided into Ginseng group (n=30), Wild Cultivated Ginseng group (n=31) and Placebo group (n=28) in their 1 st visit. In each visit, The researchers measured the subject's facial temperature using the infrared thermometer (Testo 835-T1). After that, The subjects were asked to mark the current score of flushing on the Visual Analogue Scale (VAS) and to complete the Chalder-Fatigue Scale (CFS) in each visit. The subjects took the test drug for one week and returned the remaining drug on the 2nd visit. The trial result was analyzed with one-way ANOVA using SPSS for Windows version 18. Results: 1. Systolic blood pressure was significantly lower in the Ginseng group and Wild Cultivated Ginseng group than in the control group (p=0.021). 2. There was no significant difference in facial temperature between each groups. 3. The current score of flushing showed the greatest decrease in the Ginseng group compared to the other groups but there was no significant difference (p=0.205). 4. The score of Chalder-Fatigue Scale was decreased in all groups but not statistically significant (p=0.180). Conclusions: This study showed that taking Ginseng extract and Wild Cultivated Ginseng extract do not affect to heat-rising reaction to the subjects diagnosed as heat pattern.

Impact of GNB3, ADRB3, UCP2, and PPAR${\gamma}$-Pro12Ala polymorphisms on Boiogito response in obese subjects : A randomized, double-blind, placebo-controlled trial (방기황기탕의 유전자 다형성에 따른 비만 치료 효과 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험)

  • Park, Jung-Hyun;Bose, Shambhunath;Lim, Chi-Yeon;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
    • /
    • v.12 no.2
    • /
    • pp.28-43
    • /
    • 2012
  • Objectives: The aim of the study was to investigate the efficacy of Boiogito for obesity. We examined the efficacy of Boiogito for obese patients and we expected the reaction of Boiogito would vary according to the single nucleotide polymorphism(SNPs). Methods: 111 subjects(body mass index${\geq}25m/kg^2$) were recruited and randomized to receive Boiogito(n=55) or Placebo(n=56) for 8weeks. Anthropometric factors, serum lipid profile, glucose, blood pressure(BP), pulse rate, resting metabolic rate and Korean version of obesity-related quality of life(KOQOL) scale measured at baseline and 8weeks. SNPs(${\beta}3$-adrenergic receptor(ADRB3), G protein ${\beta}3$(GNB3), peroxisome proliferator activated receptor gamma 2 gene(PPAR-${\gamma}2$), uncoupling protein(UCP2)) were conducted at baseline. Adverse reactions and safety outcome variables were also checked during trials. Results: Both groups showed significant improvement on obesity after treatment. Boiogito group decreased triglyceride than did control group and improved KOQOL. Boiogito showed a significant higher efficacy in C/T and T/T genotype of GNB3 gene / in Trp64 and Arg64 genotype of ADRB3 gene / in D/D genotype of UCP2 gene / in Pro/Pro genotype of PPAR-${\gamma}$ gene. Conclusions: Boiogito promoted obesity indexes without severe adverse reactions and proved its safety. Pharmacogenetical studies of Boiogito on obesity could be a effective method for the individualized treatment and prevention of obesity.

Effectiveness of hyaluronic acid in the management of oral lichen planus: a systematic review and meta-analysis

  • Manjushri, Waingade;Raghavendra S, Medikeri;Shamali, Gaikwad
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • v.22 no.6
    • /
    • pp.405-417
    • /
    • 2022
  • Oral lichen planus (OLP) is a chronic inflammatory immune-mediated condition that has been identified as a potentially malignant oral disorder. Various therapies have been proposed for its management as alternative to corticosteroids. However, no definitive treatment has been identified that can result in complete remission or minimal recurrence. Hyaluronic acid has recently been used as an alternative therapy for the management of OLP. This study aimed to systematically review the effectiveness of Hyaluronic acid in the management of symptomatic OLP. Online electronic databases and manual searches were performed for randomized controlled trials (RCTs) published in English between January 2010 and April 2022. RCTs were identified that compared the efficacy of hyaluronic acid and other interventional therapies at baseline and during follow-up. The Cochrane Risk of Bias tool was used to assess the quality of the included studies. Visual analog scale (VAS) scores, Thongprasom sign scores, lesion size, degree of erythema, clinical severity, and disease severity were assessed both quantitatively and qualitatively. Seven studies were analyzed. Five studies reported a high risk of bias while the remaining two studies reported an unclear risk of bias. The overall quantitative assessment of size, symptoms, degree of erythema, and sign score in OLP lesions treated with HA was not statistically significant compared to that in the control group (P > 0.05). In addition, subgroup analysis comparing HA with placebo or corticosteroids did not yield statistically significant (P > 0.05) results. Qualitatively, both HA and tacrolimus resulted in an effective reduction in signs and symptoms. Clinical/disease severity index/scores were inconsistent. A high degree of heterogeneity was observed among the included studies. None of the included studies reported the side effects of HA. These findings suggest that corticosteroids, tacrolimus, placebo, and HA could be equally effective in OLP management. The clinical/disease severity index or score reduction cannot be determined with certainty. Thus, OLP can be treated with HA as an alternative therapy. Owing to limited clinical trials on HA, high heterogeneity, and high risk of bias in the included studies, definitive conclusions cannot be derived.

The Effect of the Combination of Ginseng, Tribulus Terrestris, and L-arginine on the Sexual Performance of Men with Erectile Dysfunction: a randomized, double-blind, parallel, and placebo-controlled clinical trial

  • Reza Tahvilian;Mohammad Amin Golesorkhi;Farajollah Parhoudeh;Fatemeh Heydarpour;Hossein Hosseini;Hojjat Baghshahi;Hossein Akbari;Mohammad Reza Memarzadeh;Mehdi Mehran;Hosna Bagheri
    • Journal of Pharmacopuncture
    • /
    • v.27 no.2
    • /
    • pp.82-90
    • /
    • 2024
  • Objectives: Nitric oxide is the most important mediator of penile erection after the onset of sexual excitement. It activates cyclic guanosine monophosphate (cGMP), increasing penile blood flow. Most pharmaceutical medications prevent enzyme phosphodiesterase type 5 (PDE-5) from breaking down cGMP, thus keeping its level high. However, due to the adverse effects of pharmacological therapies, herbal drugs that improve sexual function have gained attention recently. This study aimed to investigate the combined effects of ginseng, Tribulus terrestris, and L-arginine amino acid on the sexual performance of individuals with erectile dysfunction (ED) using the 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire. Methods: Over three months, 98 men with erectile dysfunction were randomly assigned to receive either 500 mg of herbal supplements or placebo pills. Each herbal tablet contained 100 mg of protodioscin, 35 mg of ginsenosides, and 250 mg of L-arginine. Results: The results showed that the changes in the average scores of ILEF-5 within each group before and after the intervention indicated that all parameters related to the improvement of sexual function in patients with erectile dysfunction improved in the herbal treatment group (p < 0.001). The herbal group significantly improved IIEF-5 scores in nondiabetics (p < 0.05). However, there was no significant difference in the changes of IIEF-5 scores between the two intervention and control groups in diabetic patients. Conclusion: In conclusion, ginseng, Tribulus terrestris, and L-arginine have properties that increase energy and strengthen sexual function, making them suitable for patients with sexual disorders.