• Title/Summary/Keyword: randomized clinical trial

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Do Chamomile effect on duration, amount of bleeding, and interval of menstrual cycles?

  • Mollabashi, Elham Najafi;Ziaie, Tahereh;Bekhradi, Reza;Khalesi, Zahra Bostani
    • Journal of Pharmacopuncture
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    • v.23 no.1
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    • pp.25-29
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    • 2020
  • Objectives: Heavy menstrual bleeding has a significant effect on women's daily life and health consequences for theirs. Attention to women's and girls' menstrual health is critical for their health. This study presents the results of a novel research on the effect of chamomile capsule on the amount of bleeding, and the duration and interval of menstrual cycles. Methods: The current study was a randomized, double-blind, clinical trial, which was carried out on 118 female students living in dorms of Guilan University of Medical Sciences. The participants were divided into two groups of 59, each receiving either chamomile capsule 250 mg or placebo three times a day, for an interval beginning from 7 days before the starting menstruation till the next onset. Higham chart is the pictorial blood loss assessment to determine the amount and duration of menstrual bleeding. Data were analyzed using SPSS version 20. Alpha was set at 0.05 for all analyses. Results: The average amount of bleeding in the chamomile group decreased after taking the capsule (p = 0.001). However, statistical tests did not show any significant difference in terms of duration and interval between two bleeding in both the experimental and control groups (p > 0.05). Conclusion: The present study showed that the chamomile capsule decreases the amount of menstrual bleeding and can be used as a therapeutic method. Conclusion:The present study showed that the chamomile capsule decreases the amount of menstrual bleeding and can be used as a therapeutic method.

Quercus Brantii Lindl. Vaginal Douche Versus Clotrimazole on Vaginal Candidiasis - A Randomized Clinical Trial -

  • Moshfeghy, Zeinab;Asadi, Khadegeh;Akbarzadeh, Marzieh;Zare, Atefeh;Poordast, Tahereh;Emamghoreishi, Masoumeh;Najib, Fatemeh S.;Sayadi, Mehrab
    • Journal of Pharmacopuncture
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    • v.21 no.3
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    • pp.185-194
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    • 2018
  • Objectives: Vaginal Candidiasis with an approximate prevalence of 30% is the second cause of vaginal infections. Antifungal azole is the first treatment for Vaginal Candidiasis; however, some side effects have been reported for this chemical medicine. Based on the antifungal activity of Inner Stratum of Quercus Brantii (Q. Brantii), the aim of our study was to compare the effects of vaginal douche of Q. Brantii extract and clotrimazole on vaginal candidiasis symptoms before and after the treatments, in women. Methods: 89 non-pregnant women with positive KOH test which is capable of identifying the presence of hyphae and mycelium by adding KOH (10%), and a positive vaginal candidiasis culture were randomly divided into two experimental groups, using permuted block randomization method. One group received clotrimazole vaginal cream (1%) and the other group received vaginal douche of Q. Brantii extract. Groups were treated for 7 days and KOH tests and cultures were evaluated again. Data were analyzed via chi-square and independent t-test, using SPSS software. Results: According to the results, there were no significant differences between experimental groups for demographic characteristics like age (p=0.403), BMI (p=0.911), educational levels (p=0.862) and contraceptive methods (p=0.702). Moreover, significant differences were seen in vaginal discharge between the groups after the treatments (P=0.043). Conclusion: The results suggested that the therapeutic effect of vaginal douche of Q. Brantii extract was approximately similar to that of clotrimazole vaginal cream.

Ginseng for Reducing the Blood Pressure in Patients with Hypertension: A Systematic Review and Meta-Analysis

  • Hur, Myung-Haeng;Lee, Myeong-Soo;Yang, Hye-Jeong;Kim, Chan;Bae, Ik-Lyul;Ernst, Edzard
    • Journal of Ginseng Research
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    • v.34 no.4
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    • pp.342-347
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    • 2010
  • Ginseng is one of the most-widely used herbal remedies. This systematic review evaluates the current evidence for its use in the reducing blood pressure (BP) in patients with hypertension. Systematic searches of 12 electronic databases were conducted without language restrictions. All randomized clinical trials (RCTs) of ginseng as a treatment for hypertension were candidates for inclusion. Methodological quality was assessed using the Cochrane risk of bias. Five RCTs met the inclusion criteria. The risk of bias was low in most of the trials. Four of the included RCTs compared the effectiveness of ginseng to placebo. The meta-analysis of these data failed to show a statistically significant acute effect on systolic BP (SBP) or diastolic BP (DBP). However, subgroup analyses showed beneficial effects of Korean red ginseng (KRG) on both SBP (n=54, mean difference [MD], -6.52; 95% confidence interval [CI], -9.99 to -3.04; p=0.0002) and DBP (n=54, MD, -5.21; 95% CI, -7.90 to -2.51; p=0.0001). Two RCTs tested the long-term effects of ginseng for BP for 24hours. One of these trials failed to show any benefits of KRG compared to no treatment, and the other failed to show superior effects of North American ginseng compared to placebo. Adverse events with ginseng were none in one trial or not assessed. Collectively, these RCTs provide limited evidence for the acute effectiveness of KRG in the treatment of high BP. The total number of RCTs included in the analysis and the total sample size were insufficient to draw definitive conclusions. More rigorous studies are warranted.

Effects of Catgut -Embedding Therapy in Patients with Carpal Tunnel Syndrome: a Retrospective Pilot Study

  • You, Kyung-Gon;Kwon, Young-Dal
    • The Journal of Korean Medicine
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    • v.36 no.2
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    • pp.43-49
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    • 2015
  • Objectives: We evaluated the effect of the traditional Korean medical therapy of catgut-embedding therapy in patients with carpal tunnel syndrome (CTS). Methods: Thirteen patients(20 hands) with CTS underwent catgut-embedding therapy once per week for a total of 1-4 sessions. We measured the time to tingling in the fingers on performing Phalen's test. We also had patients use a visual analog scale (VAS) to indicate the severity of tingling. We also asked about the awakening time at night due to pain and tingling. We controlled the treatment as being limited to four sessions. Even if a patient had not been treated for four sessions, we ended the patient's treatment if symptoms resolved. Results: Patients who received catgut-embedding therapy showed significant improvements in the clinical symptoms of CTS. After treatment, in a total of 19 hands, the status of fourteen was changed from positive to negative in Phalen's test and the average of tingling occurrence time in that test was delayed. Among the 20 hands, the VAS in eight hands changed to zero and the average of VAS score decreased. Furthermore, in nine patients, four could sleep well without the use of a splint. Conclusions: Patients undergoing this traditional Korean medical therapy showed alleviation of finger tingling after even a single treatment. We thus concluded that this traditional Korean catgut-embedding therapy, may be effective for treating CTS. However, to confirm the effects of catgut-embedding therapy on CTS, further tests are required, including under the defined, strict conditions of a randomized controlled trial.

Effectiveness of Bee Venom Acupuncture on Shoulder Pain after Stroke (뇌졸중 환자의 견관절 통증에 대한 봉독약침의 임상효과)

  • Ko, Chang-Nam;Park, Sung-Wook;Jung, Woo-Sang;Moon, Sang-Kwan;Park, Jung-Mi;Cho, Ki-Ho;Kim, Young-Suk;Bae, Hyung-Sup;Min, In-Kyu
    • The Journal of Korean Medicine
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    • v.28 no.1 s.69
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    • pp.11-24
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    • 2007
  • Objectives : Hemiplegic shoulder pain is one of the common sequelae of stroke. Although many different methods of treatment are applied, none have yet been proved to be effective. In this study we assessed the effectiveness of bee venom in patients with shoulder pain after stroke. Methods : This study was a double blinded, randomized, placebo-controlled clinical trial. All subjects received either 0.6 ml bee venom injection (venom:saline = 1:10000) or 0.6ml physiological saline solution (placebo) at three acupoints. The effectiveness was assessed by visual analogue scale, pain rating score, Fugl-Meyer assessment and passive external rotation. Results : There were 24 patients in the venom group and 22 patients in the placebo group. The venom group5,hewed more effectiveness in VAS and PRS than the placebo group. Conclusions : This study suggests that bee venom injection has significant analgesic effect on hemiplegic shoulder pain. Further study based on multi-centers, larger population, and long term 1311ow-up is needed to confirm this suggestion.

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Effects of Korean Red Ginseng on Dry Mouth: A Randomized, Double-Blind, Placebo-Controlled Trial

  • Park, Jae-Woo;Lee, Beom-Joon;Bu, Young-Min;Yeo, In-Kwon;Kim, Jin-Sung;Ryu, Bong-Ha
    • Journal of Ginseng Research
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    • v.34 no.3
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    • pp.183-191
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    • 2010
  • Dry mouth is easily neglected if not associated with oral diseases. Consequently, xerostomatic patients often use unconventional therapies. In traditional Korean medicine, Korean red ginseng (KRG) has long been used to relieve dry mouth. However, no clinical trials have investigated whether KRG actually has an effect on dry mouth. This study was performed to evaluate the efficacy of KRG for dry mouth. We enrolled 100 volunteers with no obvious oral or salivary gland diseases and divided them into KRG and placebo groups. Each group was divided into six subgroups according to age and gender. The subjects received 6 g/day of KRG or placebo for 8 weeks. The dry mouth visual analog scale (VAS), salivary flow rate, and a dry mouth-related symptom questionnaire were evaluated at baseline and at 4 and 8 weeks. KRG treatment did not show any significant differences for any of the variables. However, KRG improved the dry mouth VAS at 4 weeks and dry mouthrelated symptoms at 8 weeks in women, but not in men. Subgroup analyses revealed that KRG markedly improved the dry mouth VAS in women of menopausal age (40 to 59 years) at 4 and 8 weeks. KRG may have beneficial effects for dry mouth in women, especially those of menopausal age, but not in men. Further investigation in post- and perimenopausal women is required to elaborate on these findings.

The Effects of Sciatic Nerve Mobilization on Hamstring Flexibility, Lower Limb Strength and Gait Performance in Patients With Chronic Stroke

  • Shin, Yun-hyeok;Chon, Seung-chul
    • Physical Therapy Korea
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    • v.22 no.4
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    • pp.8-16
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    • 2015
  • The purpose of this study was to evaluate the effects of mobilization of the sciatic nerve on hamstring flexibility, lower limb strength, and gait performance in patients with chronic stroke. This study was a randomized clinical trial with a crossover design. Sixteen subjects were recruited for this study. The subjects were randomly divided into two intervention groups and underwent either of the following two interventions: sciatic nerve mobilization or static stretching of the hamstring. We assessed hamstring flexibility, lower limb strength, and gait performance using a digital inclinometer, a hand-held dynamometer, and the 10-meter walk test, respectively. Subjects had a 24-hour rest period between each session in order to minimize carryover effects. Measurements for each test were assessed prior to and immediately after the intervention sessions. Using a two-way analysis of variance test with repeated measures, data from the two trials were analyzed by comparing the differences between both techniques. The level of statistical significance was set at .05. Sciatic nerve mobilization resulted in significantly better knee extensor strength (p=.023, from $15.32{\pm}5.98$ to $18.16{\pm}6.95kg$) and knee flexor strength (p=.011, from $7.80{\pm}4.80$ to $8.15{\pm}4.24kg$) in the experimental group than in the control group. However, no significant effects of static stretching of the hamstring were observed on hamstring flexibility from the ankle plantar flexion (p=.966) and ankle neutral positions (p=.210) and on gait performance (p=.396). This study indicated that the sciatic nerve mobilization technique may be more effective in muscle activation of the knee extensor muscle and knee flexor muscle than hamstring static stretching technique in patients with chronic stroke.

Effects of Education about Action Plans according to Self-Monitoring on Self-Management Adherence, Knowledge, Symptom Control, and Quality of Life among Adult Asthma Patients: A Randomized Controlled Trial (성인 천식환자의 자가감시 연계 활동계획서 교육이 자가관리 이행, 지식, 증상조절 및 삶의 질에 미치는 효과: 무작위대조시험설계)

  • Choi, Ja Yun;Kweon, Young-Ran
    • Journal of Korean Academy of Nursing
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    • v.47 no.5
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    • pp.613-623
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    • 2017
  • Purpose: This study was conducted to identify the effects of education regarding action plans according to a self-monitoring program on self-management adherence, knowledge, symptom control, and health-related quality of life (HRQoL) among adults with asthma. Methods: Thirty-four patients were randomly assigned to the intervention group and thirty-two to the control group in this study. A tailored 50-minute intervention based on the contents of self-monitoring and action plans developed by the National Heart Lung and Blood Institute was provided to the intervention group. Structured and well developed questionnaires were used to measure the dependent variables. Results: There were no differences in all general and clinical characteristics, and the dependent variables between two groups in the pre-test. In the post-test, there were differences in the level of self-management adherence (t=4.41, p<.001), knowledge (t=2.26, p=.027), symptom control (t=-2.56, p=.013), and total HRQoL (t=2.14, p=.036) between the two groups, although there was a difference only in the sub-domain of emotion (t=2.03, p=.047) in HRQoL. Conclusion: This study found that action plans according to self-monitoring that enhance a participatory interaction in the treatment and care could help patients with moderate to severe asthma to engagead equately in self-care, to control their symptoms, and to improve their HRQoL. Further studies are still needed to identify longitudinal effects of this program.

Efficacy of nonsurgical periodontal therapy on glycaemic control in type II diabetic patients: a randomized controlled clinical trial

  • Telgi, Ravishankar Lingesha;Tandon, Vaibhav;Tangade, Pradeep Shankar;Tirth, Amit;Kumar, Sumit;Yadav, Vipul
    • Journal of Periodontal and Implant Science
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    • v.43 no.4
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    • pp.177-182
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    • 2013
  • Purpose: Diabetes and periodontal disease are two common diseases with high prevalence rates. Recent evidence has shown a bidirectional relationship between diabetes and periodontitis. The aim of this study was to investigate the effects of nonsurgical periodontal therapy on glycemic control in type 2 diabetes mellitus patients. Methods: Sixty subjects aged 35-45 years with blood sugar controlled by oral hypoglycaemic agents were randomly divided equally among 3 groups: group A (scaling, mouthwash, and brushing), group B (mouthwash and brushing), and group C (brushing only). Glycated haemoglobin (HbA1c), fasting blood sugar (FBS), probing pocket depth (PPD), gingival index (GI), plaque index (PI), and the relevant drug history were recorded at baseline and after 3 months of intervention. Comparison of the mean difference among the variables was performed by parametric and nonparametric tests, which were further evaluated using multiple regression analysis. Results: The mean differences between the PPD, FBS, HbA1c, GI, and PI in groups A and B were found to be statistically significant (P<0.001). Multiple regression analysis in group A showed that out of all the independent variables, GI and frequency of drug administration independently (b=0.3761 and b=0.598) showed a significantly greater impact on HbA1c ($R^2$=0.832, P<0.05). Conclusions: Nonsurgical periodontal therapy can effectively decrease HbA1c levels in type 2 diabetes mellitus patients on medication.

Efficacy of Roux-en-Y Reconstruction Using Two Circular Staplers after Subtotal Gastrectomy: Results from a Pilot Study Comparing with Billroth-I Reconstruction

  • Kim, Tae-Gyun;Hur, Hoon;Ahn, Chang-Wook;Xuan, Yi;Cho, Yong-Kwan;Han, Sang-Uk
    • Journal of Gastric Cancer
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    • v.11 no.4
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    • pp.219-224
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    • 2011
  • Purpose: The Roux en Y method has rarely been performed due to longer operation time and high risk of complication, despite several merits including prevention of bile reflux. We conducted a retrospective review of the result of Roux en Y reconstruction using two circular staplers after subtotal gastrectomy. Materials and Methods: From December 2008 to May 2009, a total of 26 patients underwent Roux en Y reconstruction using two circular staplers after subtotal gastrectomy, and seventy-two patients underwent Billroth-I reconstruction. Roux en Y anastomosis was performed using two circular staplers without hand sewing anastomosis. We compared clinicopathologic features and surgical outcomes between the two groups. All patients underwent gastrofiberscopy between six and twelve months after surgery to compare the bile reflux. Results: No significant differences in clinicopathologic findings were observed between the two groups, except for the rate of minimal invasive surgery (P=0.004) and cancer stage (P=0.002). No differences in the rate of morbidity (P=0.353) and admission duration (P=0.391) were observed between the two groups. Gastrofiberscopic findings showed a significant reduction of bile reflux in the remnant stomach in the Roux en Y group (P=0.019). Conclusions: When compared with Billroth-I reconstruction, Roux en Y reconstruction using the double stapler technique was found to reduce bile reflux in the remnant stomach without increasing postoperative morbidity. Based on these results, we planned to begin a randomized controlled clinical trial for comparison of Roux en Y reconstruction using this method with Billroth-I anastomosis.