Efficacy of Dual Parenteral Artemisinin-Based Combination Therapy for Cerebral Malaria in a Tripple Blinded Randomized Control Trial in Nigerian Children: DUAL PACT TRIAL

Abstract Background: Evidence exists as to the criticality of the first 24 hours in the management of cerebral malaria. This could serve as a potential safety net for improved outcomes with prompt treatment and utilization of effective therapy. The morbidity and the mortality rate (35%) with the current parenteral monotherapy for the initial treatment of cerebral malaria is unacceptably high. Combination therapy and a shorter course of effective medication have been shown to improve outcomes in human subjects in treatment of other diseases. This study outlines a protocol to conduct a triple blinded randomized control trial on cerebral malaria using dual parenteral medications compared to the current standard of monotherapy.Methods: This is a randomized control triple blinded trial consisting of an intervention and 2 control arms. Eligible and assenting children aged 6 months to 17 years will be recruited from 4 tertiary hospitals by random selection from the list of tertiary hospitals in Nigeria. Subjects will be concealed and allocated in parallel into three arms using random numbers generated from GraphPad Prism (version 9) by a Clinical Pharmacologist who has no link with the investigators, the patients, or the statistician. The parasite load and clearance, fever defervesence, C reactive protein, procalcitonin, blood glucose, electrocardiograms and time to regain consciousness will be monitored. The socio-demographic and clinical details of all patients will be documented. The study will be conducted in line with Declaration of Hesinki 2013. Appropriate statistical tools will be used for data collection and analysis.Discussion:The outcome of this analysis will give insight into the efficacy of dual parenteral antimalaria in the treatment of cerebral malaria among Nigerian children compared with standard of care. The safety profile of this intervention would also be highlighted. This may help inform Physicians on the optimal treatment for cerebral malaria to improve outcomes, prevent development of resistance, recrudescence, treatment failure and stimulate interest of pharmaceutical companies in the development of newer formulations of dual parenteral antimalarial combination therapies. Trial registration: This study was registered in the Pan Africa Clinical Trial Registry (PACTR202102893629864).

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Efficacy and safety of dual intravenous artesunate plus quinine compared to intravenous artesunate for cerebral malaria in a triple blinded parallel multisite randomized controlled trial in Nigerian children: DUAL PAQ TRIAL Protocol

Trials ◽

10.1186/s13063-021-05634-6 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Michael Abel Alao ◽

Adebola Emmanuel Orimadegun ◽

Olayinka Rasheed Ibrahim ◽

Abayomi O. Oyenuga ◽

Adanze Onyenonachi Asinobi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cerebral Malaria ◽

Controlled Trial ◽

Secondary Outcome ◽

Efficacy And Safety ◽

Current Standard ◽

Clinical Trial Registry ◽

Nigerian Children ◽

Randomized Controlled ◽

Tertiary Hospitals

Abstract Background Evidence exists as to the criticality of the first 24 h in the management of cerebral malaria. The morbidity and the mortality rate (35%) with the current intravenous monotherapy for the initial treatment of cerebral malaria are unacceptably high. Combination therapy and a shorter course of effective medication have been shown to improve outcomes in human participants in the treatment of other diseases. This study outlines a protocol to conduct a triple blinded parallel randomized controlled trial on cerebral malaria using dual intravenous medications compared to the current standard of monotherapy. Methods This is a parallel multi-site randomized controlled superiority triple blinded trial consisting of intravenous artesunate plus quinine and a control arm of intravenous artesunate only. Eligible and assenting children aged 6 months to 17 years will be recruited from 4 tertiary hospitals by random selection from the list of tertiary hospitals in Nigeria. Participants will be randomized and assigned in parallel into two arms using random numbers generated from GraphPad Prism (version 9) by a clinical pharmacologist who has no link with the investigators, the patients, or the statistician. The primary measurable outcome is survival at 12, 24, and 48 h post-randomization. A composite secondary outcome consists of the number of children that regained consciousness, parasitaemia and defervescence at 12 and 24 h post-randomization and haematological and inflammatory markers at 24 and 48 h post-randomization. Adverse events both solicited and unsolicited are recorded all through the study post-randomization. The study is approved by the State Research Ethics Review Committee. Data analysis will be performed in GraphPad Prism version 9. Discussion The outcome of this analysis will give insight into the efficacy and safety of dual intravenous antimalaria in the treatment of cerebral malaria among Nigerian children compared with the standard of care. The safety profile of this intervention will also be highlighted. This may help inform physicians on the optimal treatment for cerebral malaria to improve outcomes and reduce recrudescence and treatment failure. Trial registration Pan Africa Clinical Trial Registry PACTR202102893629864. 23/02/2021.

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Safety & Efficacy of Propranolol and Amitriptyline Combination Therapy in Migraine Prophylaxis: A Randomized Control Trial

Journal of National Institute of Neurosciences Bangladesh ◽

10.3329/jninb.v4i1.38272 ◽

2018 ◽

Vol 4 (1) ◽

pp. 3-7

Author(s):

Mohammad Ariful Islam ◽

Abdul Kader Shaikh ◽

Sk Mahbub Alam ◽

Dahlia Sultana ◽

Md Saiful Islam ◽

...

Keyword(s):

Adverse Effect ◽

Side Effects ◽

Combination Therapy ◽

Randomized Control Trial ◽

Visual Analogue Pain Scale ◽

Visual Analogue Pain ◽

Group A ◽

Randomized Control ◽

Group B

Background: Combination of propranolol and amitriptyline drugs an be effective for migraine prophylaxis.Objective: The purpose of the present study was to see the safety and efficacy of propranolol and amitriptyline combination therapy in migraine prophylaxis.Methodology: This study randomized control trial was conducted in headache clinic at Banghabandhu Sheikh Medical University (BSMMU), Dhaka, Bangladesh from July 2012 to June 2014 for a period of two (02) years. Migraine patients with or without aura of 16 to 50 years of age, patients not on any prophylactic medication and patients willing to take part in the study were included for this study. Patients meeting all the criteria was randomized for two (02) treatment groups designated as the group A who were treated with Amitriptyline and the group B who were treated with the combination of amitriptyline and propranolol. Patients was followed for a three months period during which they were instructed to maintain a headache diary. The primary outcome evaluated was the proportion of patients in each group that achieved a 50% reduction in the number of days with headache. Secondary outcomes was reduction of visual analogue pain scale score, the number of days with headache per month, frequency of side effects and the proportion of patients abandoning the study before the end of medication. The causes of noncompliance and side effects was individually registered.Result: A total number of 8 0patietns were recruited for this study. During 1st visit among the patients in group A, duration of pain 1-4 hours 1 (2.5.0%), 5-8 hours 16(13.3%) and 9-12 hours 14(35.0%). In group B, duration of pain 1-4 hours 0(0.0%), 5-8 hours 18(15.0%) 9-12 were 21(52.5%), above 13 hours pain duration were 1(2.5%) (p>0.05). Duration of pain was recorded in final follow up among the patients. In group A, duration of pain 1-4 hours 24(60.0%), 5-8 hours 14(35.0%), 9-12 hours 2(5.0%). In group B, duration of pain 1-4 hours 28(70.0%), 5-8 hours 12(30.0%), 9-12 hours were not found (p>0.05). In group A, no adverse effect was found 26(65.0%), drowsiness 6(15.0%), dryness of mouth 6(15.0%), constipation 2(5.0%), fatigue and bradycardia were not found. In group B, no adverse effect was found 29(72.5%), drowsiness, dryness of mouth and constipation were not found, fatigue and bradycardia were 7(17.5%) and 4(10.0%). Number of attack and headache before treatment and subsequent follow up with medication it was found that number of attach and headache gradually decrease (p<0.05).Conclusion: In conclusion there is a significant changes of number of headache and attach in the amitriptyline and combine group.Journal of National Institute of Neurosciences Bangladesh, 2018;4(1): 3-7

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“Technological proficiencies, engagement, and practical considerations for mHealth programs at an urban safety-net hospital emergency departments: randomized control trial” (Preprint)

JMIR Diabetes ◽

10.2196/23641 ◽

2020 ◽

Author(s):

Sean Treacy-Abarca ◽

Janisse Mercado ◽

Jorge Serrano ◽

Jennifer Gonzalez ◽

Michael Menchine ◽

...

Keyword(s):

Emergency Departments ◽

Randomized Control Trial ◽

Safety Net ◽

Hospital Emergency ◽

Safety Net Hospital ◽

Urban Safety ◽

Randomized Control ◽

Hospital Emergency Departments

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Combination therapy of dry cupping and Pece Kau'a (traditional therapy in Bima, West Nusa Tenggara Province in Indonesia) against blood pressure

International Research Journal of Engineering IT & Scientific Research ◽

10.21744/irjeis.v7n2.1301 ◽

2021 ◽

Vol 7 (2) ◽

pp. 56-62

Author(s):

Rini Hendari ◽

Dahlan D. Ahmad ◽

Martiningsih Martiningsih ◽

Julhana Julhana

Keyword(s):

Blood Pressure ◽

Combination Therapy ◽

Randomized Control Trial ◽

Health Centers ◽

Control Group ◽

P Value ◽

Group Approach ◽

Hypertensive Patients ◽

Nursing Services ◽

Randomized Control

This research aimed at investigating the influence of combination therapy of cupping and Pece Kau'a on hypertensive patients. The research design that was utilized was experimental design by a pretest-posttest control group approach. The population of this research was all patients who suffered from hypertension in Bima City, West Nusa Tenggara Province in Indonesia. The sample in this research was 60 respondents and this sampling utilized a randomized control trial. The results showed that combination therapy of dry cupping and Pece Kau'a on hypertensive patients could reduce the average of systolic and diastolic blood pressure with a p-value of 0.000. Therapy of dry cupping and Pece Kau’a is expected to be an alternative for medical action in nursing services both in hospitals and Public Health Centers. Besides, the combination therapy of dry cupping and Pece Kau’a could be developed more again.

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