scholarly journals Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Taoying Lu ◽  
Huiyan Zhang ◽  
Lingjia Yin ◽  
Jianxiong Cai ◽  
Meiling Li ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Acute Diarrhea ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Double Blind ◽  
Pediatric Tuina ◽  
Therapeutic Benefits ◽  
Appropriate Treatment ◽  
Traditional Chinese Medicine Therapy

Abstract Background Acute pediatric diarrhea is one of the most common causes of morbidity and mortality worldwide and seriously affects the health of children. Previous studies have shown that pediatric Tuina, a traditional Chinese medicine therapy, has potential therapeutic benefits for acute pediatric diarrhea. However, the evidence for its effectiveness is insufficient due to the lack of high-quality clinical studies. Our aim is to evaluate the efficacy of Chinese pediatric Tuina for children aged 0–6 years with acute diarrhea. Methods/design This study is a randomized, double-blind, sham-controlled trial. We will include 122 children with acute diarrhea from Dongguan Kanghua Hospital in Guangdong province, China. The patients will be allocated into either the pediatric Tuina group or the sham Tuina group in a 1:1 ratio. The treatment will last for 3 days followed by an 11-day follow-up period. Both groups will receive usual care. In addition, the experimental group will receive 15–25 min of Chinese pediatric Tuina, while the control group will receive 15–25 min of sham pediatric Tuina. Both groups will receive treatments once per day, for 3 consecutive days. Primary outcome measures are diarrhea days from baseline and diarrhea times on the third day. Secondary outcome measures are the global change rating and period of days when the stool character changes to normal. Safety assessments will be monitored during each visit. Discussion This clinical trial is designed to evaluate the efficacy of pediatric Tuina for children with acute diarrhea. We expect results to provide solid evidence and support for pediatric Tuina as an appropriate treatment for children with acute diarrhea. Trial registration ClinicalTrials.gov, NCT03005821. Registered on 29 December 2016.

scholarly journals Methotrimeprazine versus haloperidol in palliative care patients with cancer-related nausea: a randomised, double-blind controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029942 ◽  
Author(s):  
Janet Rea Hardy ◽  
Helen Skerman ◽  
Jennifer Philip ◽  
Phillip Good ◽  
David C Currow ◽  
...  
Keyword(s):  
Palliative Care ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Response Rates ◽  
Complete Response ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Double Blind ◽  
Intention To Treat ◽  
Point Reduction

ObjectivesMethotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.DesignDouble-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.Setting11 palliative care sites in Australia.ParticipantsParticipants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.InterventionsBased on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.Main outcome measuresA ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.ResultsResponse to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In theper protocolanalysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Completeper protocolresponse rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.ConclusionThis study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.Trial registration numberACTRN 12615000177550.

Effects of golf training on cognition in older adults: a randomised controlled trial

2018 ◽  
Vol 72 (10) ◽  
pp. 944-950 ◽  
Author(s):  
Hiroyuki Shimada ◽  
Sangyoon Lee ◽  
Masahiro Akishita ◽  
Koichi Kozaki ◽  
Katsuya Iijima ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Training Group ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Control Group ◽  
Logical Memory ◽  
Randomised Controlled

BackgroundAlthough research indicates that a physically active lifestyle has the potential to prevent cognitive decline and dementia, the optimal type of physical activity/exercise remains unclear. The present study aimed to determine the cognitive benefits of a golf-training programme in community-dwelling older adults.MethodsWe conducted a randomised controlled trial between August 2016 and June 2017 at a general golf course. Participants included 106 Japanese adults aged 65 and older. Participants were randomly assigned to either a 24-week (90–120 min sessions/week) golf-training group or a health education control group. Postintervention changes in Mini-mental State Examination (MMSE) and National Centre for Geriatrics and Gerontology-Functional Assessment Tool scores were regarded as primary outcome measures. Secondary outcome measures included changes in physical performance and Geriatric Depression Scale (GDS) scores.ResultsA total of 100 participants (golf training, n=53; control, n=47) completed the assessments after the 24-week intervention period. The adherence to the golf programme was 96.2% (51/53 participants). Analysis using linear mixed models revealed that the golf training group exhibited significantly greater improvements in immediate logical memory (p=0.033), delayed logical memory (p=0.009) and composite logical memory (p=0.013) scores than the control group. However, no significant changes in MMSE, word memory, Trail Making Test or Symbol Digital Substitution Test scores were observed. In addition, no significant changes in grip strength, walking speed or GDS were observed.ConclusionsGolf-based exercise interventions may improve logical memory in older adults, but no significant changes in other cognitive tests. Further follow-up investigations are required to determine whether the observed effects are associated with delayed onset of mild cognitive impairment or Alzheimer’s disease in older adults.Trial registration numberUMIN-CTR UMIN000024797; Pre-results.

Effect of Baduanjin exercise on cognitive function in patients with post-stroke cognitive impairment: a randomized controlled trial

2020 ◽  
Vol 34 (8) ◽  
pp. 1028-1039 ◽  
Author(s):  
Guohua Zheng ◽  
Yuhui Zheng ◽  
Zhenyu Xiong ◽  
Bingzhao Ye
Keyword(s):  
Cognitive Impairment ◽  
Cognitive Function ◽  
Outcome Measures ◽  
Daily Living ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Rehabilitation Treatment ◽  
Global Cognitive Function ◽  
Delayed Recognition

Objective: To investigate the effectiveness and safety of Baduanjin training on the cognitive function in stroke survivors with cognitive impairment. Design: A randomized, two-arm parallel controlled trial with allocation concealment and assessors blinding. Setting: Community centre of Fuzhou city, China. Subjects: A total of 48 participants were recruited and randomly allocated into the Baduanjin exercise intervention or control group. Interventions: The control group maintained original medication and rehabilitation treatment. The Baduanjin training group received 24-week Baduanjin training with a frequency of three days a week and 40 minutes a day based on original medication and rehabilitation treatment. Main outcome measures: The primary outcome was global cognitive function. Secondary outcome measures included the specific domains of cognition (i.e. memory, processing speed, execution, attention and visuospatial ability) and activities daily living. Results: In total, 41 (Baduanjin n = 22, control n = 19) participants completed 24-week treatment and data collection. Mean differences between groups at 24-week treatment were statistically significant for global cognitive function (MoCA: 2.54 (0.91 to 4.16)), execution (TMT-A: −42.4 (−75.0 to −9.8); TMT-B: −71.3 (−130.6 to −12.1)), memory (immediate recall: 2.11 (0.49 to 3.73); short-term delayed recognition: 2.47 (0.58 to 4.35) and long-term delayed recognition: 1.68(0.18 to 3.17)), attention (response time of alertness: −245.5 (−387 to −104)) and activities of daily living (modified Barthel Index). Conclusion: Regular Baduanjin training is associated with less loss of cognitive function in patients after stroke.

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Study Protocol ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-four participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800019239.Registered on 1st November 2018- Retrospectively registered, http://www.chictr.org.cn/. Keywords: Jiao-tai-wan, Insomnia, Traditional herbal medicine, Randomized controlled trial, Study protocol, Pattern identification Protocol version: Manuscript based on study protocol version 1.3, 1 November 2018.

scholarly journals Rehabilitation nursing for motor functional recovery of acute ischaemic stroke: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e037391
Author(s):  
Jianmiao Wang ◽  
Yuanyuan Chen ◽  
Yuping Zhang ◽  
Mei Li ◽  
Jingfen Jin
Keyword(s):  
Randomised Controlled Trial ◽  
Ischaemic Stroke ◽  
Outcome Measures ◽  
Functional Recovery ◽  
Acute Ischaemic Stroke ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Functional Impairments ◽  
Randomised Controlled

IntroductionStroke is the second-leading cause of death and disability in the world, and patients with stroke often suffer from functional impairments and need rehabilitation. Notably, there is much evidence that rehabilitation can lead to better mortality and morbidity outcomes. The evidence for the effectiveness of rehabilitation nursing, however, is limited. Thus, this study seeks to explore whether rehabilitation nursing is not inferior to usual rehabilitation for motor functional recovery in patients with acute ischaemic stroke.Methods and analysisWe will conduct an assessor-blinded parallel randomised controlled trial of patients who meet the inclusion criteria after stratification by weighted corticospinal tract lesion load. The experimental group will receive rehabilitation nursing by trained and qualified nurses (seven consecutive days, two sessions per day, 30 min each session). The control group will receive usual rehabilitation provided by therapists (seven consecutive days, two sessions per day, 30 min each session). The primary outcome measures are the Motor Assessment Scale, the Fugl-Meyer Assessment and the Action Research Arm Test. The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale. Primary and secondary outcome assessment will be performed before and after the intervention, and secondary outcome be assessed at 4 and 12 weeks follow-up. We will recruit 224 patients within a period of 12–18 months from a hospital in southeastern China.Ethics and disseminationThe study was approved by the Human Research Ethics Committee from the corresponding author’s hospital (approval Number is Ethical Review Study No. 2018 - 112). Peer-reviewed journals and presentations at national and international conferences will be used to disseminate the results.Trial registration numberNCT03702452.

scholarly journals Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e030501
Author(s):  
Qianyu Zhuang ◽  
Liyuan Tao ◽  
Jin Lin ◽  
Jin Jin ◽  
Wenwei Qian ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Opioid Consumption ◽  
Sequential Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Double Blind ◽  
Patient Reported ◽  
Total Knee

ObjectivesTo evaluate the morphine-sparing effects of the sequential treatment versus placebo in subjects undergoing total knee arthroplasty (TKA), the effects on pain relief, inflammation control and functional rehabilitation after TKA and safety.DesignDouble-blind, pragmatic, randomised, placebo-controlled trial.SettingFour tertiary hospitals in China.Participants246 consecutive patients who underwent elective unilateral TKA because of osteoarthritis (OA).InterventionsPatients were randomised 1:1 to the parecoxib/celecoxib group or the control group. The patients in the parecoxib/celecoxib group were supplied sequential treatment with intravenous parecoxib 40 mg (every 12 hours) for the first 3 days after surgery, followed by oral celecoxib 200 mg (every 12 hours) for up to 6 weeks. The patients in the control group were supplied with the corresponding placebo under the same instructions.Primary and secondary outcome measuresThe primary endpoint was the cumulative opioid consumption at 2 weeks post operation (intention-to-treat analysis). Secondary endpoints included the Knee Society Score, patient-reported outcomes and the cumulative opioid consumption.ResultsThe cumulative opioid consumption at 2 weeks was significantly smaller in the parecoxib/celecoxib group than in the control group (median difference, 57.31 (95% CI 34.66 to 110.33)). The parecoxib/celecoxib group achieving superior Knee Society Scores and EQ-5D scores and greater Visual Analogue Scale score reduction during 6 weeks. Interleukin 6, erythrocyte sedation rate and C-reactive protein levels were reduced at 72 hours, 2 weeks and 4 weeks and prostaglandin E2 levels were reduced at 48 hours and 72 hours in the parecoxib/celecoxib group compared with the placebo group. The occurrence of adverse events (AEs) was significantly lower in the parecoxib/celecoxib group.ConclusionsThe sequential intravenous parecoxib followed by oral celecoxib regimen reduces morphine consumption, achieves better pain control and functional recovery and leads to less AEs than placebo after TKA for OA.Trial registration numberClinicalTrials.gov (ID:NCT02198924).

scholarly journals Efficacy of acetaminophen with and without oxycodone for analgesia in nonoperative treatment of extremity fractures in adults: Protocol for a double-blind randomized clinical trial

2019 ◽  
Author(s):  
Tao Gao ◽  
Hongyi Zhu ◽  
Changqing Zhang ◽  
Yimin Chai ◽  
Cheng Guo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Nonoperative Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Double Blind ◽  
Randomized Controlled ◽  
Limb Fracture ◽  
Self Rating ◽  
Limb Fractures

Abstract Background: Opioids and acetaminophen are both widely used to relieve pain after nonoperative treatment of limb fractures, but evidence for superiority of opioids versus acetaminophen is lacking. In this study we aim to determine whether acetaminophen is noninferior to the acetaminophen/oxycodone combination for pain relief after nonoperative fixation of an extremity limb fracture. We hypothesize that acetaminophen is noninferior to the acetaminophen/oxycodone combination. Methods: A double-blind, randomized controlled trial will be conducted. Power analysis determined that 1,226 participants will be needed (p<0.05, power 90%). Patients with acute limb fracture who receive nonoperative treatment will be recruited and randomly allocated into two groups: the intervention group will receive oral oxycodone (5 mg)/acetaminophen (325 mg), and the control group will receive acetaminophen (650 mg) only. The primary outcome measure will be scores on the 11-point Numeric Rating Scale (NRS-11) over 14 days. Secondary outcome measures are scores on the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), EuroQol five dimensions’ questionnaire (EQ-5d), self-rated satisfaction with the analgesia produced, self-reported nighttime sleep duration, number of intervention or control pills used, total duration for taking intervention or control medication. Change of pain scores and the number of times that analgesic drugs were taken in the two groups will be statistically evaluated with t-student tests according to their fracture site. Discussion: This study will be a randomized controlled trial that is adequately powered to test the hypothesis that acetaminophen is noninferior to the combination of acetaminophen and oxycodone in relieving objectively measured pain after nonoperative treatment of limb fractures in adults. It is hopeful to provide a safe and effective analgesic plan for such patients. Trial Registration: ChiCTR registry: ChiCTR1800017015 ( http://www.chictr.org.cn/showproj.aspx?proj=28612). Registered on 8 July 2018. Keywords: Opioids, acetaminophen, fracture, nonoperative treatment.

scholarly journals Immediate effect of an acupressure strap simulating wrist-ankle acupuncture on menstrual pain in young women: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Shu-jie Zhai ◽  
Yi Ruan ◽  
Yue Liu ◽  
Zhen Lin ◽  
Chen Xia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Analgesic Effect ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Pain Intensity Score ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled

Abstract Background: Dysmenorrhea seriously affects the ability to perform normal social activities and decreases quality of life. Primary dysmenorrhea can be effectively treated with acupuncture. Based on the wrist-ankle acupuncture (WAA) theory, we designed a portable WAA point compression treatment strap that treats diseases by automatically applying pressure to acupuncture points. The proposed study aims to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. Methods: The study will be a randomized controlled trial conducted from 1 May 2019 30 May 2020 that includes 78 students from Shanghai University of Traditional Chinese Medicine who have primary dysmenorrhea and meet the eligibility criteria. Participants will be randomly divided into two groups in a 1:1 allocation ratio. The intervention group will use the acupressure wrist-ankle strap equipped with tip compression component parts on the internal side; the control group will use the non-acupressure wrist-ankle strap with the tip compression parts removed. All participants will be treated for 30 min on the first day of menstruation. The main outcome measures are the pain intensity score measured by the visual analogue scale, and the onset time of analgesia. The secondary outcome measures are the pain threshold at Yinlingquan (SP 9) , skin temperature at Guanyuan (CV 4) , and expectations and satisfaction of patients as investigated via the Expectation and Treatment Credibility Scale. Discussion: This trial will be the first study to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. The quality of this study is ensured by the strict randomization, non-acupressure control, and blinded design. The results may provide a potential alternative treatment for primary dysmenorrhea and evidence-based proof of the analgesic effect of WAA. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1900021727. Registered on 7 March 2019. http://www.chictr.org.cn/listbycreater.aspx

Transcranial Electric And Acoustic Stimulation For Tinnitus: Study Protocol For A Randomized Double-Blind Controlled Trial Assessing The Influence of Combined Transcranial Random Noise And Acoustic Stimulation On Tinnitus Loudness And Distress

2021 ◽  
Author(s):  
Mariana Lopes Martins ◽  
Tobias Kleinjung ◽  
Martin Meyer ◽  
Vitushika Raveenthiran ◽  
Zino Wellauer ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Neuronal Activity ◽  
Treatment Option ◽  
Brain Activity ◽  
Controlled Trial ◽  
Random Noise ◽  
Acoustic Stimulation ◽  
Secondary Outcome ◽  
Double Blind ◽  
Transcranial Random Noise Stimulation

Abstract Background: Tinnitus is the result of aberrant neuronal activity. As a novel treatment form, neuromodulation is used to modify neuronal activity of brain areas involved in tinnitus generation. Among the different forms of electric stimulation, transcranial Random Noise Stimulation (tRNS) has been shown to be a promising treatment option for tinnitus. In addition, recent studies indicate that the reduction in tinnitus can be more pronounced when different modalities of stimulation techniques are combined (“bimodal stimulation”). TRNS can be used in combination with acoustic stimulation (AS), a further treatment option recognized in the literature. The aim of the proposed study is to investigate whether simultaneous tRNS and AS improve levels of tinnitus loudness and distress. Methods: The intervention consists of bilateral HD-tRNS over the auditory cortex combined with the application of AS which is studied in a cross-over design. The visits will be performed in 26 sessions. There will be 20 treatment sessions, divided into two blocks: active and sham HD-tRNS. Within the blocks, the interventions are divided into Group A: HD-tRNS and AS, and Group B: HD-tRNS alone. Furthermore, in addition to the assessments directly following the intervention sessions, there will be six extra sessions performed subsequently at the end of each block, after a period of some days (Follow-ups 1 and 2) and a month after the last intervention (C). Primary outcome measures are analogue scales for evaluation of subjective tinnitus loudness and distress, and the audiological measurement of Minimum Masking Level (MML). Secondary outcome measures are brain activity as measured by electroencephalography and standardized questionnaires for evaluating tinnitus distress and severity. Discussion: To the best of our knowledge, this is the first study, which uses HD-tRNS combined with AS for tinnitus treatment. The cross-over design permits the comparison between HD-tRNS active vs. sham and with vs. without AS. Thus, it will be possible to evaluate the efficacy of the combined approach to HD-tRNS alone. In addition, the use of different objective and subjective evaluations for tinnitus enable more reliable and valid results. Trial registration: Swiss Ethics Committee (BASEC-Nr. 2020-02027); Swiss Federal Complementary Database (kofam.ch: SNCTP000004051); and ClinicalTrials.gov (clinicaltrials.gov: NCT04551404).

scholarly journals Efficacy of dioctahedral smectite in infants with acute diarrhea: a double blind randomized controlled trial

2009 ◽  
Vol 49 (1) ◽  
pp. 48 ◽  
Author(s):  
A. A. Made Widiasa ◽  
Soetjiningsih Soetjiningsih ◽  
Putu Gede Karyana
Keyword(s):  
Treatment Group ◽  
Acute Diarrhea ◽  
Cox Regression ◽  
Controlled Trial ◽  
Mean Difference ◽  
Control Group ◽  
Clinical Effects ◽  
Double Blind ◽  
Cox Regression Analysis ◽  
Dioctahedral Smectite

Background  Acute  diarrhea  is  a sudden diarrhea which lasts lessthan  seven days  on  babies and children.  The  standard  treatmentby  WHO  in managing acute diarrhea  is  still  not  satisfactory forparents whose infants and children suffering from the disease.Dioctahedral  smectite  is  expected  to  decrease  the  volume,frequency, and duration  of  diarrhea.Objective  To  assess the clinical effects  of  dioctahedral smectite ininfants with acute diarrhea.Methods  A double-blind, randomized clinical controlled trial wasperformed on six to  12  months-old infants who were hospitalizedin Sanglah Hospital, Denpasar due to acute diarrhea .The subjectswere divided into two groups.  The  treatment  group was givenstandard  management  with  adjuvant  dioctahedral  smectitewhile  and  control group was given standard management withplacebo.Results  From  68  infants enrolled in this study, the  mean  durationof  diarrhea was significantly shorter in treatment group comparedto placebo group  [39.03  hours (SD  2.03)  vs  70.58  hours (SD3.78),  mean  difference  31.6 (95%  CI  22.90  to  40.19), P=0.001].The  RRR was  50%,  and  ARR  was  29%.  Kaplan-Meier survivalanalysis showed  that  duration  of  acute diarrhea was shorter intreatment  group  [36  hours (SD  1.7)  versus 72 hours (SD  4.18),mean difference  36.0 (95%  CI  21.81  to  50.19),  log rank test,P<0.0001].  In multivariate Cox regression analysis, it was foundthat  dioctahedral smectite influenced the duration  of  diarrheain infants with acute diarrhea  [OR  4.403 (95%  CI  2.39  to  8.12),P<O.OOOl].Conclusion  Dioctahedral smectite  can  shorten the duration  ofacute diarrhea.

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