scholarly journals The Effect of An Aloe-Based Polyherbal Formulation in Adults with Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled, Six-Months Clinical Follow-up Trial

2022 ◽  
Author(s):  
Gholam Reza Ghayour Razmgah ◽  
Seyed Mousal-Reza Hosseini ◽  
Homa Hajimehdipoor ◽  
Mehdi Saberi Firoozi ◽  
Haniye Kashafroodi ◽  
...  
Keyword(s):  
Functional Constipation ◽  
Controlled Clinical Trial ◽  
Medical Sciences ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Polyherbal Formulation ◽  
Gastrointestinal Problem ◽  
Significant Difference ◽  
Rome Iii

The most common functional gastrointestinal problem in the world is functional constipation. "Ayarij-e-Faiqra (AF)" is a polyherbal formula that has been recommended by Persian Medicine as an efficent purgative agent . The purpose of this study was to evaluate the effect of AF on functional constipation using a double-blind, placebo-controlled clinical trial. According to the Rome III classification, 79 adults with functional constipation were included in this trial. The diagnostic criteria were according to the Rome III classification. Patients with constipation symptoms who referred to the traditional medicine clinic of Shahid Beheshti University of Medical Sciences from April 2014 to September 2016 were randomly allocated to the AF and placebo groups. The AF and placebo groups received AF and placebo for three months, respectively and followed up for another three months. During the study, the treatment efficacy was assessed by a questionnaire. AF treatment significantly decreased most of the symptoms by 84% at the end of the first month (p < 0.05) and by 90% at the end of the third month in comparison to placbo group (p < 0.001). However, three months after the end of the intervention, the frequency of constipation symptoms in both groups was not statistically significant. Based on the satisfaction questionnaire, the treatment satisfaction score during the intervention was increased to 9 in the AF group, but no significant difference was found between the two groups three months after the intervention (p > 0.005). Although AF could be beneficial for treating functional constipation without significant side effects, changing patients’ lifestyles has  great importance in this process.

scholarly journals Validation Study of Kim's Sham Needle by Measuring Facial Temperature: An N-of-1 Randomized Double-Blind Placebo-Controlled Clinical Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Sanghun Lee ◽  
Nara Lim ◽  
Sun Mi Choi ◽  
Sungchul Kim
Keyword(s):  
Thermal Imaging ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Infrared Thermal Imaging ◽  
Double Blind Placebo ◽  
Control Intervention ◽  
Significant Difference ◽  
Double Blinded ◽  
Stimulation Of

Introduction. In 2008, Kim's sham needle was developed to improve the quality of double-blinded studies. The aim of this study is to validate Kim's sham needle by measuring facial temperature.Methods. We designed “N-of-1” trials involving 7 smokers. One session was composed of 2 stimulations separated by a 2 h washout period. Six sessions were applied daily for all subjects. Infrared thermal imaging was used to examine the effects of acupuncture (HT8, KI2) on facial temperature following smoking-induced decrease.Results. All subjects demonstrated decreased temperatures after sham needle treatment, but 5 of the 7 subjects showed increased temperatures after real needle treatment. 6 of the 7 subjects showed a significant difference(P<0.05)between treatments with real and sham needles. Thus, the physiological stimulation of Kim's sham needle is different from that of a real needle, suggesting that Kim's sham needle is a potential inactive control intervention.

Riluzole for treatment of men with methamphetamine dependence: A randomized, double-blind, placebo-controlled clinical trial

2018 ◽  
Vol 33 (3) ◽  
pp. 305-315 ◽  
Author(s):  
Mohammad-Hadi Farahzadi ◽  
Ehsan Moazen-Zadeh ◽  
Emran Razaghi ◽  
Mohammad-Reza Zarrindast ◽  
Reza Bidaki ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trials ◽  
Specific Treatment ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Urine Test ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Methamphetamine Dependence ◽  
Significant Difference

Background: Riluzole is a glutamate regulator and effective in treatment of neuropsychiatric conditions. Aims: We assessed riluzole for treatment of methamphetamine dependence. Methods: In this randomized, double-blind, placebo-controlled clinical trial, male outpatients with methamphetamine dependence who were 18–65 years old received either 50 mg riluzole ( n=34) or placebo ( n=54) twice daily for 12 weeks. Patients were excluded in case of comorbid serious medical conditions or neurologic disorders, comorbid psychiatric disorders other than methamphetamine dependence requiring specific treatment interventions, simultaneous positive urine test result for substances of abuse other than methamphetamine, smoking >3 days per week, simultaneous consumption of medications which are contraindicated or have interaction with riluzole. Results: Concerning primary outcomes, the cumulative mean number of attended weekly visits was higher in the riluzole arm compared with the placebo arm approaching a statistically significant difference (riluzole, median (range)=13.00 (2.00–13.00); placebo=4.00 (2.00–13.00); Mann-Whitney U=505.00, p-value=0.073), and the weekly measured rate of positive methamphetamine urine test results was significantly lower in the riluzole arm by the end of the study (riluzole=1 (5.00%), placebo=9 (45.00%), p-value=0.004). Patients in the riluzole arm experienced significantly greater improvement on all the craving, withdrawal, and depression measures regarding mean score changes from baseline to endpoint. No significant difference was detected between the two arms in terms of incidence of adverse events. Conclusion: Future randomized clinical trials are needed to investigate proper dosing strategy in a more inclusive sample.

scholarly journals A novel botanical formula improves eye fatigue and dry eye: a randomized, double-blind, placebo-controlled study

2020 ◽  
Vol 112 (2) ◽  
pp. 334-342 ◽  
Author(s):  
Juntao Kan ◽  
Min Wang ◽  
Ying Liu ◽  
Hongyue Liu ◽  
Liang Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Dry Eye ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Eye Fatigue ◽  
Nutritional Strategy ◽  
Significant Difference ◽  
Break Up

ABSTRACT Background With the frequent use of video display units, eye fatigue is becoming more common globally. An alternative nutritional strategy is needed to prevent the aggravation of eye fatigue symptoms. Objectives The objective was to evaluate the protective effect of a novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry on adults with eye fatigue in a randomized, double-blind, placebo-controlled clinical trial. Methods We randomly allocated 360 participants into 4 groups to receive placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein) once daily for 90 d. Each participant had 3 visits at baseline (V1), 45 d (V2), and 90 d (V3) during the study. Results Intervention with the formula improved individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing. Compared with placebo, the formula at all 3 doses significantly decreased the total score of eye fatigue symptoms and increased the visuognosis persistence time at both V2 and V3. According to the Schirmer test, both 10-mg and 14-mg lutein formula groups had improved tear secretion at V3 compared with the placebo. The keratography results indicated that the first tear break-up time, average tear break-up time, and tear meniscus height were significantly increased after formula intervention. The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits. Conclusions Our botanical formula improves eye fatigue, dry eye, and macular function without changing the retinal structure, and thus it could serve as an effective nutritional strategy in improving eye fatigue without causing serious side effects. Clinical Trial Registry: chictr.org.cn (ChiCTR1800018987).

Double blind placebo controlled clinical trial of homoeopathic medicines in HIV infection

1998 ◽  
Vol 87 (02) ◽  
pp. 86-88 ◽  
Author(s):  
DP Rastogi ◽  
VP Singh ◽  
Vikram Singh ◽  
SK Dey ◽  
K Rao
Keyword(s):  
Placebo Group ◽  
T Cell ◽  
Hiv Infection ◽  
Cd4 T Cell ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Cell Numbers ◽  
Significant Difference ◽  
Hiv Aids

AbstractA 6 month study comprising of a Double-blind Placebo-controlled trial of homoeopathic medicines in HIV/AIDS under 2 separate schemes (I) Asymptomatic HIV infection and (II) Persistent generalised lymphadenopathy (50 subjects each) was undertaken from June 1995 to February 1997. As soon as a subject had undergone 6 months of study, they were put on an indicated medicine. Unblinding of the schemes was done only when the last subject had undergone 6 months of study. Changes in the CD4+ T cell numbers in each case before, during and after completion of the study, was taken as the main criterion to assess the outcome of the treatment. Preliminary studies in Scheme I after unblinding, show practically no significant difference in changes in number of CD4+ T cells in subjects of both the placebo and the medicine group. Studies in Scheme II after unblinding, show a significant improvement in CD4+ cell numbers (Upward trend) in the subjects of the medicine group compared to the placebo group. Significantly, after 6 months of study, 5 subjects of the placebo group under Scheme II and 4 from Scheme I with an initial downward trend of CD4+ T cell, have shown an increase in CD4+ T cell count after administration of the indicated homoeopathic medicine in a period of 15–30 days. The study confirms a positive role of homoeopathic medicines in improving immune status of HIV/AIDS patients.

Intravenous Tranexamic Acid for Subdural and Epidural Intracranial Hemorrhage: Randomized, Double‐Blind, Placebo-Controlled Trial

2019 ◽  
Vol 14 (4) ◽  
pp. 286-291 ◽  
Author(s):  
Pouya Ebrahimi ◽  
Javad Mozafari ◽  
Reza Bahrami Ilkhchi ◽  
Mohammad Ghasem Hanafi ◽  
Maryam Mousavinejad
Keyword(s):  
Tranexamic Acid ◽  
Intracranial Hemorrhage ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Subdural Hemorrhage ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Epidural Hemorrhage ◽  
And Control

Background: Recovery of patients with traumatic brain injury largely depends on the reduction in secondary brain damage. The present study aims at investigating the effect of Tranexamic Acid (TXA) administration within the first hours of brain trauma in the emergency department (ED). Methods: This randomized, double-blind, placebo-controlled clinical trial was carried out in patients with subdural and epidural hemorrhage. Patients with any type of bleeding were assigned into two groups of TXA and 0.9% normal saline as placebo. The rate of intracranial hemorrhage after surgery was assessed by CT-scan and amount of hemoglobin (Hb) was measured immediately before surgery and after 6 hours of surgery. Results: A total of 80 participants were randomly assigned into four groups of 20 people. There was a significant difference in the mean of intraoperative bleeding during surgery in patients receiving TXA and placebo in both SDH (Subdural hematoma) and EDH (Epidural Hemorrhage) groups (P= 0.012). The Hb drop amount had no significant difference with placebo (P< 0.0001). No complications were observed in any of the intervention and control groups during the study as well. Conclusion: The use of TXA may reduce bleeding, however, based on the results of this study, such effect was not statistically significant in controlling the epidural and subdural hemorrhage, but clinical trials with a higher sample size are suggested for further investigation in this regard.

Effectiveness of Probiotics in the Management of Functional Constipation in Children: A Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Vol 15 (1) ◽  
pp. 1-6
Author(s):  
Tjokronegoro Srihati Dyah Permatasari ◽  
Advani Najib ◽  
Firmansyah Agus
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Functional Constipation ◽  
Parent Report ◽  
Number Needed To Treat ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bowel Movements ◽  
Rome Iii ◽  
Constipation Severity

A randomized, double-blind, placebo-controlled trial was conducted to assess the efficacy of probiotics (L. acidophilus, B. longum, and S. thermophylus 2 × 109 cfu/day) in 78 children aged 4–10 years old with functional constipation (Rome III criteria) at several schools in Jakarta, Indonesia. The case finding used a validated parent-report questionnaire. Subjects were randomly assigned to receive either oral probiotics (L. acidophilus, B. longum, and S. thermophylus 1 × 109 cfu/day) or placebo twice a day for 4 weeks. There were more subjects in the probiotics group who had improvement in stool consistency (P = 0.022) and difficulty/painful defecation (P = 0.009) than in the placebo group. Other symptoms (frequency of bowel movements, withholding behavior, fecal incontinence, and presence of stool mass in abdomen) also improved, but no statistically significant differences were found. Constipation severity significantly improved in the probiotics group (P = 0.026). Overall improvement (defined as decrease of constipation severity score >60% at the end of evaluation) was higher in the probiotics group than the placebo group (31/39 versus 18/39, P = 0.002) with number needed to treat (NNT) of 3 (95%CI 2;8). The present study shows that probiotics (L. acidophilus, B. longum, and S. thermophylus 2 × 109 cfu/day) are effective in the management of functional constipation in children.

scholarly journals Intravenous dexamethasone to prevent the recurrence of benign headache after discharge from the emergency department: a randomized, double-blind, placebo-controlled clinical trial

CJEM ◽  
2006 ◽  
Vol 8 (06) ◽  
pp. 393-400 ◽  
Author(s):  
Eric Y. Baden ◽  
Curtis J. Hunter
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Controlled Clinical Trial ◽  
Self Medication ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Headache Therapy ◽  
Urban Level ◽  
Headache Recurrence

ABSTRACTObjective:To evaluate whether the addition of intravenous (IV) dexamethasone to standard emergency department (ED) benign headache therapy would reduce the incidence of headache recurrence at 48–72 hours.Methods:This randomized, double-blind, placebo-controlled clinical trial of adult patients presenting with the chief complaint of headache was conducted in the ED of 2 academic, urban Level 1 hospitals. Headache evaluation and therapy were determined by the treating physician, and, before discharge, patients were administered either 10 mg of IV dexamethasone or placebo. The treatment groups had similar baseline characteristics, abortive therapy, IV fluids and degree of pain relief achieved before discharge. Patients were contacted 48–72 hours following discharge and asked whether their headache was “better,” “worse” or “remained unchanged” when compared with their symptoms at discharge. Those whose headaches were “worse” or “unchanged,” and those who reported a return of headache after being pain free at discharge were considered to be treatment failures and classified as having had a recurrence. The patient's headache at follow-up was further categorized as severe (i.e., provoking another physician visit or interfering with daily activity) or mild (i.e., requiring self-medication or no treatment).Results:Fifty-seven patients met the inclusion criteria and 2 were lost to follow-up, leaving 55 for analysis. At follow-up, 9.7% (3/31) of those receiving dexamethasone had headache recurrence, versus 58.3% (14/24) of those receiving placebo (p&lt; 0.001). Four dexamethasone recipients (12.9%) had severe headaches at follow-up compared with 8 (33.3%) in the placebo group (p= 0.14).Conclusions:In this study, IV dexamethasone reduced headache recurrence at 48–72-hour follow-up. Given its excellent safety profile and likely benefit, IV dexamethasone should be considered for ED headache patients after standard evaluation and therapy.

Acetylcysteine in the treatment of subacute sinusitis: A double-blind placebo-controlled clinical trial

2017 ◽  
Vol 96 (1) ◽  
pp. E7-E21 ◽  
Author(s):  
Mehrzad Bahtouee ◽  
Gholamhosein Monavarsadegh ◽  
Mohammadjavad Ahmadipour ◽  
Mazyar Motieilangroodi ◽  
Niloofar Motamed ◽  
...  
Keyword(s):  
Clavulanic Acid ◽  
Normal Saline ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Common Disease ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Amoxicillin Clavulanic Acid

Sinusitis is a common disease with harmful effects on the health and finances of patients and the economy of the community. It is easily treated in most of its acute stages but is associated with some management difficulties as it goes toward chronicity. Therefore, we tried to improve the treatment of subacute sinusitis by using acetylcysteine, which is a safe mucolytic and antioxidant agent. Thirty-nine adult patients with subacute sinusitis proved by computed tomography (CT) were enrolled in a double-blind, placebo-controlled trial. They received oral amoxicillin-clavulanic acid and normal saline nasal drops for 10 days and oral pseudoephedrine for 7 days. In addition, the patients received acetylcysteine (600 mg orally, once daily) in the intervention group or placebo in the control group for 10 days. A paranasal CT scan was taken at baseline and 30 days after patients finished the treatment and was evaluated quantitatively by Lund-Mackay (LM) score. Symptoms and some aspects of quality of life also were assessed at baseline and 14 days after initiation and 30 days after termination of the treatment via the Sino-Nasal Outcome Test questionnaire. The groups showed no significant difference in LM score after treatment. A positive correlation was observed between the LM and SNOT-20 scores. We concluded that adding oral acetylcysteine to amoxicillin-clavulanic acid, pseudoephedrine, and intranasal normal saline has no benefit for the treatment of subacute sinusitis.

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