Effects of individually chosen homoeopathic medicines on recurrent URTI in children

1996 ◽  
Vol 85 (01) ◽  
pp. 4-14
Author(s):  
J. Blommers ◽  
D.J. Kuik ◽  
L. Feenstra ◽  
P.D. Bezemer ◽  
E.S.M. De Lange-De Klerk
Keyword(s):  
Clinical Trial ◽  
University Hospital ◽  
Controlled Clinical Trial ◽  
Upper Respiratory Tract ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Upper Respiratory ◽  
The University ◽  
Current Standards

AbstractThe effects of homoeopathic medicines on children suffering from recurrent upper respiratory tract infection (URTI) were studied in a randomized double-blind placebo-controlled clinical trial conducted at the paediatric outpatients department of the university hospital of the Vrije Universiteit in Amsterdam from 1987 to 1992.The study was designed to meet both the requirements of proper homoeopathic practice and the current standards of a clinical trial. The purpose of a randomized placebo-controlled double-blind trial is to identify the effects of the agents under investigation by equalizing the effects of other factors that may influence outcome.The object of the trial, eligibility criteria, follow-up period, treatments and concurrent interventions, data collection and effect measures are discussed in the light of homoeopathic thinking.

scholarly journals Effect of polymerized type I collagen in hyperinflammation of adult outpatients with symptomatic COVID-19: a double blind, randomised, placebo-controlled clinical trial.

2021 ◽  
Author(s):  
Silvia Mendez-Flores ◽  
Angel Alexis Priego-Ranero ◽  
Daniel Azamar-Llamas ◽  
Hector Olvera-Prado ◽  
Kenia Illian Rivas-Redondo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Oxygen Saturation ◽  
Primary Outcome ◽  
Type I Collagen ◽  
Ambient Air ◽  
Controlled Clinical Trial ◽  
Type I ◽  
Double Blind ◽  
Duration Of Symptoms

BACKGROUND Currently, therapeutic options for ambulatory COVID-19 patients are limited. OBJECTIVE To evaluate the safety, efficacy and effect of the intramuscular administration of polymerized type I collagen (PTIC) on hyperinflammation, oxygen saturation and symptom improvement in adult outpatients with symptomatic COVID-19. DESIGN Double-blind, randomised, placebo-controlled clinical trial of PTIC vs placebo. SETTING Single Third-level hospital in Mexico City (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran) PARTICIPANTS Eighty-nine adult participants with a confirmed COVID-19 diagnosis and symptom onset within the 7 days preceding recruitment were included from August 31, 2020 to November 7, 2020 and followed for 12 weeks. Final date of follow-up was February 4, 2021. INTERVENTIONS Patients were randomly assigned to receive either 1.5 ml of PTIC intramuscularly every 12 h for 3 days and then every 24 h for 4 days (n=45), or matching placebo (n=44). MAIN OUTCOMES AND MEASURES The primary outcome was a mean reduction of at least 50% in the level of IP-10 compared to baseline. The secondary outcomes were mean oxygen saturation >92% while breathing ambient air and duration of symptoms. RESULTS Of 89 patients who were randomised, 87 (97.8%) were included in an intention-to-treat analysis; 37 (41.6%) were male and mean age was 48.5+/-14.0 years. The IP-10 levels decreased 75% in the PTIC group and 40% in the placebo group vs baseline. The comparison between treatment vs placebo was also statistically significant (P=0.0047). The IL-8 (44%, P=0.045), M-CSF (25%, P=0.041) and IL-1Ra (36%, P=0.05) levels were also decreased in the PTIC group vs baseline. Mean oxygen saturation >92% was achieved by 40/44 (90%), 41/42 (98%) and 40/40 (100%) of participants that received PTIC at 8, 15 and 97 days of follow-up vs 29/43 (67%), 31/39 (80%) and 33/37 (89%) of patients treated with placebo (P=0.001). The unadjusted accelerated failure time model showed that patients treated with PTIC achieved the primary outcome 2.70-fold faster (P<0.0001) than placebo. In terms of risk, the group of patients treated with PTIC had a 63% lower risk of having a mean oxygen saturation <92% vs placebo (P<0.0001). Symptom duration in patients treated with PTIC was reduced by 6.1+/-3.2 days vs placebo. No differences in adverse effects were observed between the groups at 8, 15 and 97 days of follow-up. CONCLUSIONS In this study, treatment with PTIC down-regulated IP-10, IL-8, M-CSF and IL-Ra levels, which could explain the PTIC effect on the higher proportion of patients with mean oxygen saturation readings > 92% and a shorter duration of symptoms as compared to patients treated with placebo. Although results are encouraging, larger randomised trials are needed.

scholarly journals Randomized clinical trial to assess the protective efficacy of a Plasmodium vivax CS synthetic vaccine

2021 ◽  
Author(s):  
Socrates Herrera ◽  
Myriam Arevalo-Herrera ◽  
Michelle Larmart-Delgado ◽  
Maria Alejandra Caicedo ◽  
Juliana Henao-Geraldo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Plasmodium Vivax ◽  
Malaria Infection ◽  
Protective Efficacy ◽  
Protein A ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Cell Responses ◽  
Controlled Human Malaria Infection

Abstract A randomized, double-blind, controlled clinical trial was conducted to assess the safety and protective efficacy of the Plasmodium vivax circumsporozoite (CS) protein. A total of 35 healthy adults, either malaria-naïve (n=17) or P.vivax semi-immune (n=18), were enrolled and immunized intramuscularly (i.m.) at months 0, 2, and 6, with the PvCS (150 μg) formulated in Montanide ISA-51 adjuvant. Most volunteers developed PvCS specific antibody and T-cell responses and were subjected to a P. vivax sporozoite controlled human malaria infection (CHMI) 30 days after the last immunization. Sterile protection was observed in five of 11 naïve (42%) and four of 11 semi-immune (36%) volunteers by showing no parasitemia during the 60 days follow-up, as did a semi-immune control (1/5) volunteer. All non-protected volunteers developed malaria symptoms 10-19 days after CHMI and were immediately treated with antimalarial drugs. This is the first study of a P. vivax sub-unit vaccine demonstrating sterile protection against P. vivax infection.

scholarly journals Hydroxychloroquine for SARS-CoV-2 positive patients quarantined at home: The first interim analysis of a remotely conducted randomized clinical trial

2021 ◽  
Author(s):  
Ravi K. Amaravadi ◽  
Lydia Giles ◽  
Mary Carberry ◽  
Matthew C. Hyman ◽  
Ian Frank ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Secondary Infection ◽  
University Of Pennsylvania ◽  
Symptom Improvement ◽  
Controlled Clinical Trial ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Link Type ◽  
Testing Center ◽  
At Home

ABSTRACTBackgroundOlder patients are at risk of increased morbidity and mortality from COVID-19 disease due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). There are few effective treatments for outpatients with COVID-19.ObjectiveTo evaluate the efficacy of hydroxychloroquine to reduce time in quarantine for symptomatic ≥40 years-old COVID-19 patients.DesignA randomized, double-blind, placebo-controlled clinical trial.SettingOutpatients with polymerase chain reaction confirmed COVID-19 at a University of Pennsylvania affiliated testing center between April 15, 2020 and, July 14, 2020.ParticipantsOut of 5511 SARS-CoV-2 positive patients, 1072 met initial eligibility criteria for telephone-based recruitment, but only 34 subjects were able to be randomized.InterventionsHydroxychloroquine 400 mg per twice daily (n=17) or matching placebo (n=17), taken orally for up to 14 days.MeasurementsThe primary outcome was the time to release from quarantine. Secondary outcomes included the participant-reported secondary infection of co-inhabitants, hospitalization, treatment-related adverse events, time to symptom improvement, and incidence of cardiac arrhythmia.ResultsThe median time to release from quarantine for HCQ-treated vs. placebo-treated participants was 8 days (range 4-19 days) vs. 11 days (4-18 days); z-score +0.58, p=n.s. This did not meet the pre-specified criteria for early termination, however, this study was terminated early due to lack of feasibility. There was no mortality in either study arm.LimitationSince this study was terminated early due to a lack of feasibility, no conclusion can be made about the efficacy of hydroxychloroquine as a treatment for COVID-19 patients 40 years of age or older quarantined at home.ConclusionThe design of this remotely conducted study could guide testing of other more promising agents during the COVID-19 pandemic.Trial registrationClinicaltrials.gov identifier: NCT04329923

scholarly journals Clinical efficacy of Tailin formulation combined with continuous low-dose antimicrobial therapy for recurrent urinary tract infection: study protocol for a multicenter, double-blind, randomized, controlled clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Tonglu Li ◽  
Yingru Xu ◽  
Xuezhong Gong
Keyword(s):  
Clinical Trial ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Post Treatment ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Treatment Changes

Abstract Background Given the increasing rates of antimicrobial resistance (AMR), recurrent urinary tract infection (rUTI) is becoming refractory more and more. Antibiotic prophylaxis including continuous low-dose antibiotic therapy (CLAT), is the common treatment for rUTI of the world. However, the presumably adverse reactions caused by CLAT alone should be paid more attention. Studies indicated that Chinese herbal medicine (CHM) might be an available treatment method for rUTI. Tailin formulation (TLF) is a herbal prescription developed for the treatment of rUTI in the 2000s in Shanghai Municipal Hospital of Traditional Chinese Medicine. Our previous studies have shown TLF could prevent urinary tract infection both in pyelonephritis (PN) rat model and in PN patients. Additionally, our published data demonstrated TLF is helpful to reduce the recurrence of rUTI and protect renal tubular function in clinic. In order to find a novel treating project for rUTI to increase the clinical curative effect, we thus try to combine TLF with CLAT to treat rUTI and design an optimized, pragmatically clinical trial to evaluate the efficacy and safety of this project. Methods/design This is a multicenter, double-blind, randomized, controlled clinical trial. We will enroll 200 eligible patients diagnosed with uncomplicated rUTI and then divide them randomly into two groups with a 1:1 ratio: TLF + CLAT group and placebo + CLAT group. This trial consists of two stages, a 12-week period of treatment and a 12-week period of post-treatment follow-up, respectively. The primary outcome will be the recurrence rate at the 12th week of the follow-up period; the second outcomes will be the post-treatment changes in renal and liver function; furthermore, traditional Chinese medicine (TCM) symptoms, non-infection-related physical signs, and subjective symptoms will be scored, and the number of episodes of each subject will be also recorded; meanwhile, vital signs indicators and serious adverse events (SAEs) will be monitored throughout the trial. Discussion This study will provide convictive research-derived data to evaluate clinical efficacy and safety of TLF combined with CLAT for rUTI, and provide an evidence-based recommendation for clinicians. Moreover, post-treatment changes in non-infection-related physical signs and subjective symptoms were included in the efficacy evaluation, which is important and more significant for assessing the clinical benefits for those rUTI patients. Trial registration Chinese Clinical Trial Registry ChiCTR2100041914. Registered on 10 January 2021. Protocol date and version: September 12, 2020; version 1.

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