scholarly journals Effectiveness of Ayurved Siriraj Prasa-Nam-Nom Recipe on Breast Milk Volume in Early Postpartum Women: A Randomized, Double-Blind, Placebo- Controlled Trial

2022 ◽  
Vol 74 (1) ◽  
pp. 11-18
Author(s):  
Pharuhas Chanprapaph ◽  
Chantanat Thippayacharoentam ◽  
Apirada Iam-am ◽  
Natchagorn Lumlerdkij ◽  
Pravit Akarasereenont ◽  
...  
Keyword(s):  
Placebo Group ◽  
Breast Milk ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Serum Prolactin ◽  
Postpartum Women ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Early Postpartum ◽  
Milk Volume

Objective: To explore the effectiveness of Ayurved Siriraj Prasa-Nam-Nom (ASPNN) recipe on breast milk production in early postpartum women. Methods: Fifty-four normal vaginal term delivery mothers who had inadequate milk volume were enrolled into this randomized, double-blind, placebo-controlled trial. All participants received ASPNN or placebo 1,500 mg three times/day for 3 days in the hospital and 7 days at home. Primary outcomes, including breast milk volume, %creamatocrit, and level of prolactin, were evaluated on day 1 and day 3. Satisfaction scores, adverse effects, and types of breastfeeding were also determined. Results: On day 3, milk volume was increased in both groups. The median volume of ASPNN group was 19 ml, while that of the placebo group was 30 ml. The median %creamatocrit of ASPNN and placebo group were 7.17% and 6.98%, respectively. Mean serum prolactin levels of ASPNN and placebo group were 321.76 + 114.23 ng/ml and 323.78 + 116.68 ng/ml, respectively. Although the effects were not difference from the placebo, the reduction of prolactin in ASPNN was lower. Minor adverse effects included skin rash and mild diarrhea. Exclusive breastfeeding rate on day 11 in ASPNN and placebo group were 92.6 % and 88.5%, respectively. Conclusion: Short term ASPNN supplementation produce no direct effect on breast milk volume, creamatocrit, and serum prolactin. It was safe and might help maintaining serum prolactin. A future trial with more participants and longer period should be conducted to confirm the effect of ASPNN on breast milk quantity and quality.

Cinnarizine and sodium valproate as the preventive agents of pediatric migraine: A randomized double-blind placebo-controlled trial

Cephalalgia ◽  
2019 ◽  
Vol 40 (7) ◽  
pp. 665-674
Author(s):  
Man Amanat ◽  
Mansoureh Togha ◽  
Elmira Agah ◽  
Mahtab Ramezani ◽  
Ali Reza Tavasoli ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Effects ◽  
Confidence Interval ◽  
Children And Adolescents ◽  
Sodium Valproate ◽  
Medical Center ◽  
Controlled Trial ◽  
Migraine Prophylaxis ◽  
Double Blind ◽  
Double Blind Placebo

Background Few migraine preventive agents have been assessed in a pediatric population. We evaluated the safety and efficacy of cinnarizine and sodium valproate for migraine prophylaxis in children and adolescents. Methods We carried out a randomized double-blind placebo-controlled trial in the Children’s Medical Center and Sina hospital, Tehran, Iran. Eligible participants were randomly assigned in 1:1:1 ratio via interactive web response system to receive either cinnarizine, sodium valproate, or placebo. The primary endpoints were the mean change in frequency and intensity of migraine attacks from baseline to the last 4 weeks of trial. The secondary endpoint was the efficacy of each drug in the prevention of migraine. The drug was considered effective if it decreased migraine frequency by more than 50% in the double-blind phase compared with the baseline. Safety endpoint was adverse effects that were reported by children or their parents. Results A total of 158 children participated. The frequency of migraine attacks significantly reduced compared to baseline in cinnarizine (difference: −8.0; 95% confidence interval (CI): −9.3 to −6.6), sodium valproate (difference: −8.3; 95% confidence interval: −9.3 to −7.2), and placebo (difference: −4.4; 95% confidence interval: −5.4 to −3.4) arms. The decrease was statistically greater in cinnarizine (difference: −3.6; 95% confidence interval: −5.5 to −1.6) and sodium valproate (difference: −3.9; 95% confidence interval: −5.8 to −1.9) arms, compared to placebo group. Children in all groups had significant reduction in intensity of episodes compared to baseline (cinnarizine: −4.6; 95% confidence interval: −5.2 to −4.0; sodium valproate: −4.0; 95% confidence interval: −4.8 to −3.3; placebo: −2.6; 95% confidence interval: −3.4 to −1.8). The decrease was statistically greater in cinnarizine (difference: −2.0; 95% confidence interval: −3.2 to −0.8) and sodium valproate (difference: −1.5; 95% confidence interval: −2.7 to −0.3) arms, compared to the placebo group. Seventy-one percent of individuals in the cinnarizine group, 66% of cases in the sodium valproate group, and 42% of people in the placebo arm reported more than 50% reduction in episodes at the end of the trial. The odds ratio for >50% responder rate was 3.5 (98.3% confidence interval: 1.3 to 9.3) for cinnarizine versus placebo and 2.7 (98.3% confidence interval: 1.0 to 6.9) for sodium valproate versus placebo. Nine individuals reported adverse effects (three in cinnarizine, five in sodium valproate, and one in the placebo group) and one case in the sodium valproate group discontinued the therapy due to severe sedation. Conclusion Cinnarizine and sodium valproate could be useful in migraine prophylaxis in children and adolescents. Trial registration: IRCT201206306907N4.

The Effect of Ginger on Breast Milk Volume in the Early Postpartum Period: A Randomized, Double-Blind Controlled Trial

2016 ◽  
Vol 11 (7) ◽  
pp. 361-365 ◽  
Author(s):  
Panwara Paritakul ◽  
Kasem Ruangrongmorakot ◽  
Wipada Laosooksathit ◽  
Maysita Suksamarnwong ◽  
Pawin Puapornpong
Keyword(s):  
Breast Milk ◽  
Postpartum Period ◽  
Controlled Trial ◽  
Double Blind ◽  
Early Postpartum Period ◽  
Early Postpartum ◽  
Milk Volume

Double-blind, placebo-controlled trial of venlafaxine to treat behavioural disorders in cats: a pilot study

2021 ◽  
pp. 1098612X2110367
Author(s):  
Delphine Metz ◽  
Tiphaine Medam ◽  
Sylvia Masson
Keyword(s):  
Placebo Group ◽  
Pilot Study ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Specific Inhibitor ◽  
Human Medicine ◽  
Behavioural Disorders ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Treatment Groups

Objectives Venlafaxine, a specific inhibitor of both noradrenaline and serotonin, is commonly used in human medicine to treat depression, anxiety and social phobia. Its formulation in small granules renders it interesting to test on cats, which are usually reluctant to take medication. Venlafaxine was administered at 1 mg/kg for 60 days, using a double-blind, placebo-controlled protocol, to cats aged ⩾6 months exhibiting aggressiveness, fear or house-soiling. Methods After one cat’s withdrawal, 21 cats were included in the study: 11 in the venlafaxine group and 10 in the placebo group. Three consultations were conducted, on day 0, day 30 and day 60. Each visit consisted of (1) veterinarian- and owner-based scoring of the cat’s behavioural improvement; (2) scoring of the cat’s compliance with removal from its carrier and compliance with manipulation; and (3) owner scoring of the ease of administration and recording of the potential adverse effects of the treatment. Results Improvement was significantly higher in the venlafaxine group; as early as day 30, according to the veterinarian scoring, and at day 60, according to both the veterinarian and owner scoring. In contrast, neither the removal nor the manipulation scores were significantly different between the two treatment groups. Venlafaxine seemed to improve all three studied signs, as early as day 30 for fear and aggressiveness, and at day 60 for house-soiling. The adverse effects of venlafaxine were limited to drowsiness in one cat. All cats tolerated the treatment well during the 60-day period. Conclusions and relevance These results suggest that venlafaxine is efficient in treating several behavioural problems and is easy to administer. More studies should be conducted to explore its effects at different dosages on specific diagnoses.

scholarly journals Domperidone and maternal milk volume in mothers of premature newborns

2017 ◽  
Vol 57 (1) ◽  
pp. 18 ◽  
Author(s):  
Tengku Ellya Fazilla ◽  
Guslihan Dasa Tjipta ◽  
Muhammad Ali ◽  
Pertin Sianturi
Keyword(s):  
Placebo Group ◽  
Breast Milk ◽  
Milk Production ◽  
Controlled Trial ◽  
Maternal Milk ◽  
Premature Newborns ◽  
Breast Milk Production ◽  
Days Of Therapy ◽  
Significant Difference ◽  
Milk Volume

Background Mothers of premature newborns often have difficulty giving adequate breast milk volume to their infants. Domperidone is an antagonist of peripheral dopamine receptors and believed to increase breast milk production. In Indonesia, no study has been done to date on the effect of domperidone on maternal milk production in mothers of premature newborns.  Objective To evaluate the effect of domperidone on milk production in mothers of premature newborns who failed to lactate.Methods A randomized controlled trial was conducted from July to December 2012 in the Perinatology Unit, Haji Adam Malik Hospital, Medan. Mothers of premature newborns were given lactation counseling for 7 days in order to increase their milk production. Mothers who failed to lactate after that time were enrolled in the study. Fifty subjects were assigned to receive either domperidone or a placebo for 7 days. Milk volume was measured every 2 hours (from 7 am to 9 pm), in the 24 hours before starting therapy, and on the 7th and 10th days (the 10th day being 3 days after stopping therapy). Results This study involved 25 mothers in the domperidone groups and 25 others in placebo group. After 7 days of therapy, mean breast milk volume was significantly higher in the domperidone group than in the placebo group  [181.6 (SD 80.2) vs. 72.4 (SD 57.8) mL, respectively; 95%CI of differences 69.36 to 148.93; P=0.0001]. At day 10, breast milk production remained significantly higher in the domperidone group. Furthermore, in the domperidone group, no significant difference in mean breast milk volumes was noted between the 7th and 10th days (P=0.65). Conclusion In mothers of premature newborns who failed to lactate, domperidone therapy for 7 days causes significantly higher milk production compared to placebo. 

A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder

2011 ◽  
Vol 41 (10) ◽  
pp. 2159-2166 ◽  
Author(s):  
Y. Panahi ◽  
B. Rezazadeh Moghaddam ◽  
A. Sahebkar ◽  
M. Abbasi Nazari ◽  
F. Beiraghdar ◽  
...  
Keyword(s):  
Placebo Group ◽  
Post Traumatic Stress Disorder ◽  
Traumatic Stress ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Post Traumatic Stress ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Traumatic ◽  
The Mean

BackgroundUnlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.MethodSeventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.ResultsOn both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.ConclusionsThe results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.

scholarly journals Study protocol: a double blind placebo controlled trial examining the effect of domperidone on the composition of breast milk [NCT00308334]

2006 ◽  
Vol 6 (1) ◽  
Author(s):  
Marsha L Campbell-Yeo ◽  
Alexander C Allen ◽  
K S Joseph ◽  
Joyce M Ledwidge ◽  
Victoria M Allen ◽  
...  
Keyword(s):  
Breast Milk ◽  
Study Protocol ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease. A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

2021 ◽  
Author(s):  
Juan Manuel Figueroa ◽  
Monica Lombardo ◽  
Ariel Dogliotti ◽  
Luis Flynn ◽  
Robert P. Giugliano ◽  
...  
Keyword(s):  
Placebo Group ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Hospital Personnel ◽  
Culture Methods ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Efficacy ◽  
To Receive

Background Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and others medical providers were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 was significantly lower in the I-C group compared to placebo (1.0% vs 5.0%) (Odds Ratio 0.19 (95% confidence interval 0.05 to 0.77; p= 0.03). Workday loss in placebo group compared to I-C were 1.6% days / person (95% CI, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17.3% in the I-C group and 15.2% in the placebo group, p= 0.5). Interpretation I-C showed significant efficacy in preventing SARS-CoV-2 infection in hospital personnel dedicated to care patients with COVID-19 disease.

scholarly journals Topical Propranolol Improves Epistaxis Control in Hereditary Hemorrhagic Telangiectasia (HHT): A Randomized Double-Blind Placebo-Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3130
Author(s):  
Meir Mei-Zahav ◽  
Yulia Gendler ◽  
Elchanan Bruckheimer ◽  
Dario Prais ◽  
Einat Birk ◽  
...  
Keyword(s):  
Placebo Group ◽  
Hereditary Hemorrhagic Telangiectasia ◽  
Controlled Trial ◽  
Intravenous Iron ◽  
Common Adverse Event ◽  
Open Label ◽  
Two Phase ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Propranolol Group

Epistaxis is a common debilitating manifestation in hereditary hemorrhagic telangiectasia (HHT), due to mucocutaneous telangiectases. The epistaxis can be difficult to control despite available treatments. Dysregulated angiogenesis has been shown to be associated with telangiectases formation. Topical propranolol has demonstrated antiangiogenic properties. We performed a two-phase study, i.e., a double-blind placebo-controlled phase, followed by an open-label phase. The aim of the study was assessment of safety and efficacy of nasal propranolol gel in HHT-related epistaxis. Twenty participants with moderate-severe HHT-related epistaxis were randomized to eight weeks of propranolol gel 1.5%, or placebo 0.5 cc, applied to each nostril twice daily; and continued propranolol for eight weeks in an open-label study. For the propranolol group, the epistaxis severity score (ESS) improved significantly (−2.03 ± 1.7 as compared with −0.35 ± 0.68 for the placebo group, p = 0.009); hemoglobin levels improved significantly (10.5 ± 2.6 to 11.4 ± 2.02 g/dL, p = 0.009); and intravenous iron and blood transfusion requirement decreased. The change in nasal endoscopy findings was not significant. During the open-label period, the ESS score improved significantly in the former placebo group (−1.99 ± 1.41, p = 0.005). The most common adverse event was nasal mucosa burning sensation. No cardiovascular events were reported. Our results suggest that topical propranolol gel is safe and effective in HHT-related epistaxis.

scholarly journals l-Serine and EPA Relieve Chronic Low-Back and Knee Pain in Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Vol 150 (9) ◽  
pp. 2278-2286
Author(s):  
Ikuko Sasahara ◽  
Akiko Yamamoto ◽  
Masamichi Takeshita ◽  
Yasuyo Suga ◽  
Katsuya Suzuki ◽  
...  
Keyword(s):  
Placebo Group ◽  
Knee Pain ◽  
Medical Information ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
University Hospital ◽  
Active Group ◽  
Low Back ◽  
Double Blind ◽  
Double Blind Placebo

ABSTRACT Background Multisite pain, including low-back and knee pain, is a major health issue that greatly decreases quality of life. Objectives This study analyzed the effects of l-serine, which provides necessary components for nerve function, and EPA, which exerts anti-inflammatory properties, on pain scores of adults with pain in at least the low back and knee for ≥3 mo. Methods This was a randomized, double-blind, placebo-controlled, parallel-group study. The Japan Low Back Pain Evaluation Questionnaire (JLEQ) and Japanese Knee Osteoarthritis Measure (JKOM) were applied as primary outcomes. The Brief Pain Inventory (BPI) and safety evaluation were secondary outcomes. We enrolled 120 participants aged ≥20 y (36 men and 84 women: mean ± SD age = 40.8 ± 10.9 y). The participants were randomly allocated to either the active group (daily ingestion of 594 mg l-serine and 149 mg EPA) or placebo group. The study period consisted of 8-wk dosing and 4-wk posttreatment observation. ANCOVA between groups for each time point was conducted using the baseline scores as covariates. Results The JLEQ scores (active compared with placebo: 14.2 ± 11.2 compared with 19.0 ± 10.2) at week 8 were lower in the active group (P &lt; 0.001). The JKOM scores at week 4 (11.7 ± 9.0 compared with 13.9 ± 7.9), week 8 (10.4 ± 7.9 compared with 13.1 ± 7.1), and week 12 (10.3 ± 7.4 compared with 13.8 ± 7.5) were lower in the active group (P ≤ 0.04). Additionally, the active group had 11–27% better scores compared with the placebo group for BPI1 (worst pain), BPI3 (average pain), and BPI5D (pain during moving) at week 4 (P ≤ 0.028) and week 8 (P ≤ 0.019), respectively, and BPI5D was 23% better in the active group at week 12 (P = 0.007). No adverse events were observed. Conclusions l-Serine and EPA were effective for pain relief in adults with low-back and knee pain after multiplicity adjustment. This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN000035056.

scholarly journals Effect of Melatonin on Cognitive Function and Sleep in relation to Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Melissa Voigt Hansen ◽  
Michael Tvilling Madsen ◽  
Lærke Toftegård Andersen ◽  
Ida Hageman ◽  
Lars Simon Rasmussen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Placebo Group ◽  
Cognitive Function ◽  
Cognitive Dysfunction ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Sleep Efficiency ◽  
Mean Difference ◽  
Double Blind ◽  
Double Blind Placebo

Background.Sleep disturbances and cognitive dysfunction are common in patients with breast cancer. Disturbed sleep leads to poor cognitive performance and exogenous melatonin may improve sleep and attenuate cognitive dysfunction. We hypothesized that melatonin would improve sleep and cognitive function after surgery.Methods.This study reports secondary endpoints from a randomized, double-blind, placebo-controlled trial. Women, 30–75 years, were randomized to 6mg oral melatonin/placebo for 3 months. We assessed postoperative cognitive dysfunction (POCD) with a neuropsychological test battery, sleep with a diary, and sleep quality with VAS.Results. 54 patients were randomized to melatonin (n=28) or placebo (n=26); 11 withdrew (10 placebo, 1 melatonin,P=0.002). The incidence of POCD was 0% (0/20) [95% CI 0.0%; 16.8%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 2 weeks postoperatively (P=1.00) and 6.3% (1/16) [95% CI 0.0%; 30.2%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 12 weeks postoperatively (P=0.38). Sleep efficiency was significantly greater in the melatonin group; mean difference was 4.28% [95% CI 0.57; 7.82] (P=0.02). The total sleep period was significantly longer in the melatonin group; mean difference was 37.0 min [95% CI 3.6; 69.7] (P=0.03).Conclusion.Melatonin increased sleep efficiency and total sleep time but did not affect cognitive function. The dropout rate was significantly lower in the melatonin group. This trial is registered with Clinicaltrials.govNCT01355523.

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