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Trial description |
14/04/2020 |
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The escalating outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is stretching health systems globally beyond comprehension. The ensuing corona virus disease 2019 (COVID-19) has become a challenging source of morbidity and mortality across the globe. Within four months of the COVID-19 virus outbreak well over 1.6 million people have been infected with a global mortality rate of over 5.9% (Global summary, 2020, as at April 11, 2020). Although there is a massive global rush to optimize prophylactic or therapeutic strategies, indigenous drugs have again taken a back stage of time. Intercedd Health product (IHP) Detox Tea (a validated marketed nutraceutical) could serve as an effective standalone or an adjuvant in the current treatment of COVID-19. The reason is that published reports have suggested a seemingly high efficacy of the major components of the IHP Detox tea in alleviating the symptoms of acute respiratory tract infections in both adults and children. However little is known about the role of IHP Detox tea when used as a standalone or co-administered with the currently being evaluated therapy for treatment of COVID-19. To our knowledge, there is no prior randomized trial on the effectiveness of IHP Detox Tea when co-administered with currently used therapy for treatment or prophylaxis of COVID-19.
Objectives
To determine the efficacy and safety of IHP Detox Tea, when used as adjuvants to the conventional therapy for treatment of novel COVID-19.
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The escalating outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is stretching health systems globally beyond comprehension. The ensuing corona virus disease 2019 (COVID-19) has become a challenging source of morbidity and mortality across the globe. Within four months of the COVID-19 virus outbreak well over 1.6 million people have been infected with a global mortality rate of over 5.9% (Global summary, 2020, as at April 11, 2020). Although there is a massive global rush to optimize prophylactic or therapeutic strategies, indigenous drugs have again taken a back stage of time. Intercedd Health product (IHP) Detox Tea (a validated marketed nutraceutical) could serve as an effective standalone or an adjuvant in the current treatment of COVID-19. The reason is that published reports have suggested a seemingly high efficacy of the major components of the IHP Detox tea in alleviating the symptoms of acute respiratory tract infections in both adults and children. However little is known about the role of IHP Detox tea when used as a standalone or co-administered with the currently being evaluated therapy for treatment of COVID-19. To our knowledge, there is no prior randomized trial on the effectiveness of IHP Detox Tea when co-administered with currently used therapy for treatment or prophylaxis of COVID-19.
Objectives: To determine the efficacy and safety of IHP Detox Tea, when used as adjuvants to the conventional therapy for treatment of novel COVID-19.
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14/04/2020 |
The funding source was inadvertently missed during the initial registration of the trial at pactr.org. We do apologize for the initial omission. |
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Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, Ikeja, , Nigeria, Commercial Sector / Industry, |
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14/04/2020 |
We inadvertently missed the funding source at the time of initial trial registration. We apologize. |
Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, Ikeja, , Nigeria, Commercial Sector / Industry, |
Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, Ikeja Lagos, , Nigeria, Commercial Sector / Industry, |
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Public title |
09/06/2020 |
Placebo will not be used again in this pilot study because the trialists and investigators felt placebo will be used in larger trials, and not in the pilot study stage. |
Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot placebo-controlled randomized trial |
Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot randomized trial |
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Official scientific title |
09/06/2020 |
Placebo will not be used again in this pilot study because the trialists and investigators felt placebo will be used in larger trials, and not in the pilot study stage. |
Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot placebo-controlled randomized trial |
Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot randomized trial |
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09/06/2020 |
Placebo agents for IHP Detox tea has been removed from the protocol for the pilot study. |
Masking/blinding used |
Open-label(Masking Not Used) |
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Masking / blinding |
09/06/2020 |
None of the caregivers, outcome assessors or participants will now be blinded because the placebo agent for IHP Detox tea has been removed from the protocol. |
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Intervention List |
09/06/2020 |
Placebo will not be used again in this pilot study because the trialists and investigators felt placebo will be used in larger trials, not in the present pilot study. |
Control Group, Placebo, Placebo (one teabag to be soaked in 100mls of warm water 12-hourly) in conjunction with conventional therapy for COVID-19 12-hourly , 4 weeks, Placebo (one teabag to be soaked in 100mls of warm water 12-hourly) in conjunction with conventional therapy for COVID-19 12-hourly for 4 weeks, 36, Placebo |
Control Group, Conventional therapy only, Conventional therapy for COVID-19 12-hourly , 4 weeks, Placebo (one teabag to be soaked in 100mls of warm water 12-hourly) in conjunction with conventional therapy for COVID-19 12-hourly for 4 weeks, 36, Placebo |
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Intervention List |
09/06/2020 |
Placebo will not be used again in this pilot study because the trialists and investigators felt placebo will be used in larger trials, not pilot study. |
Control Group, Conventional therapy only, Conventional therapy for COVID-19 12-hourly , 4 weeks, Placebo (one teabag to be soaked in 100mls of warm water 12-hourly) in conjunction with conventional therapy for COVID-19 12-hourly for 4 weeks, 36, Placebo |
Control Group, Conventional therapy only, Conventional therapy for COVID-19 12-hourly , 4 weeks, Conventional therapy for COVID-19 12-hourly for 4 weeks, 36, Historical |
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09/06/2020 |
International center for Ethnomedicine and drug development will now be the major funder for now. |
Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, Ikeja Lagos, , Nigeria, Commercial Sector / Industry, |
International Centre for Ethnomedicine and Drug Development and Neimeth International Pharmaceuticals Plc., 1 JB Leton Close, Off Abdullahi Ibrahim Crescent, Off TOS Benson, Okonjo Iweala Way, Utako District Abuja, / Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, ABUJA and Ikeja Lagos, , Nigeria, Commercial Sector / Industry, |
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09/06/2020 |
International center for Ethnomedicine and drug development will now be the major funder for now for efficiency. |
Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, Ikeja Lagos, , Nigeria, Commercial Sector / Industry, |
International Centre for Ethnomedicine and Drug Development and Neimeth International Pharmaceuticals Plc., 1 JB Leton Close, Off Abdullahi Ibrahim Crescent, Off TOS Benson, Okonjo Iweala Way, Utako District Abuja, / Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, ABUJA and Ikeja Lagos, , Nigeria, Commercial Sector / Industry, |
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Sponsors |
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09/06/2020 |
International center for Ethnomedicine and drug development will now be the major funder for now for efficiency. |
Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, , Ikeja, , Nigeria, Primary Sponsor, Commercial Sector/Industry, |
International Centre for Ethnomedicine and Drug Development and Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, , Ikeja, , Nigeria, Primary Sponsor, Commercial Sector/Industry, |
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09/06/2020 |
A new trialist. |
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Edamisan Olusoji TEMIYE , Department of Paediatrics, College of Medicine, Lagos University Teaching Hospital , Lagos, , Nigeria |
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09/06/2020 |
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Suleiman Alani AKANMU, Department of Haematology, College of Medicine, Lagos University Teaching Hospital , Lagos, , Nigeria |
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09/06/2020 |
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David Adewale OKE , Department of Medicine, College of Medicine, Lagos University Teaching Hospital , Lagos, , Nigeria |
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09/06/2020 |
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Sunday .A. OMILABU , Department of Medical Microbiology and Parasitology College of Medicine, Lagos University Teaching Hospital , Lagos, , Nigeria |
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09/06/2020 |
A new trialist |
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Iorhen Ephraim AKASE , Department of Medicine, College of Medicine, Lagos University Teaching Hospital, Lagos, , Nigeria |
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IPD description |
09/06/2020 |
PCV or HCT added because they are the same |
APPENDIX 1: PROFORMA: Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot placebo-controlled randomized trial
NAME OF DOCTOR................................................CODE NUMBER OF PATIENT………………………
(1). COMPUTER NUMBER OF PATIENT..........................(2) Educational level…………………………
(3). DATE OF RECRUITMENT......................(4) TIME..................(5) AGE.......................
(6.) Marital status: Married [ ] [single [ ] Divorced [ ](7.) LMP………..(8)Date of diagnosis..............
(9). Travel history Yes [ ] No [ ].................(10). Body weight-.............(11). Height: (cm)......................................................
TICK [X] OR WRITE WHICHEVER IS APPROPRIATE.
(12) Prior RETROVIRAL DISEASE STATUS
a.) Negative [ ] (b) Positive [ ]
(14). HIGHEST EDU LEVEL.................................(15.) OCCUPATION (Specify)..............................
(16). PREVIOUS Chronic infection? (a.) YES—-(b.) NO----- (16B) Known Hypertensive Yes [ ], NO [ ]
(18). FINDINGS AT CLINICAL EXAMINATION AT RECRUITMENT AND AT DISCHARGE ? TICK [√] below:
VARIABLE AT RECRUITEMNT PRESENCE ABSENCE VAS SCORE VARIABLE At 4 weeks/discharge PRESENCE ABSENCE VAS SCORE
Expectoration Expectoration
Nasal discharge Nasal discharge
Fever Fever
Sore throat Sore throat
Headache Headache
Cough Cause
Earache Earache
Malaise/fatigue Malaise/fatigue
Sleep disturbance Sleep disturbance
Diarrhea Diarrhea
19. SOME LABORATORY PARAMETERS
LABORATORY VARIABLE VALUES AT BASELINE VALUES IN DISCHARGE NORMAL RANGES
HIV
HBV
HCV
Na
K
Bicarbonate
Chloride
AST
ALP
ALT
Bilirubin
PCV
Hb
Wbc
Platelets
ANTIBODY TESTING
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APPENDIX 1: PROFORMA: Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot placebo-controlled randomized trial
NAME OF DOCTOR................................................CODE NUMBER oor OF PATIENT………………………
(1). COMPUTER NUMBER OF PATIENT..........................(2) Educational level…………………………
(3). DATE OF RECRUITMENT......................(4) TIME..................(5) AGE.......................
(6.) Marital status: Married [ ] [single [ ] Divorced [ ](7.) LMP………..(8)Date of diagnosis..............
(9). Travel history Yes [ ] No [ ].................(10). Body weight-.............(11). Height: (cm)......................................................
TICK [X] OR WRITE WHICHEVER IS APPROPRIATE.
(12) Prior RETROVIRAL DISEASE STATUS
a.) Negative [ ] (b) Positive [ ]
(14). HIGHEST EDU LEVEL.................................(15.) OCCUPATION (Specify)..............................
(16). PREVIOUS Chronic infection? (a.) YES—-(b.) NO----- (16B) Known Hypertensive Yes [ ], NO [ ]
(18). FINDINGS AT CLINICAL EXAMINATION AT RECRUITMENT AND AT DISCHARGE ? TICK [√] below:
VARIABLE AT RECRUITEMNT PRESENCE ABSENCE VAS SCORE VARIABLE At 4 weeks/discharge PRESENCE ABSENCE VAS SCORE
Expectoration Expectoration
Nasal discharge Nasal discharge
Fever Fever
Sore throat Sore throat
Headache Headache
Cough Cause
Earache Earache
Malaise/fatigue Malaise/fatigue
Sleep disturbance Sleep disturbance
Diarrhea Diarrhea
19. SOME LABORATORY PARAMETERS
LABORATORY VARIABLE VALUES AT BASELINE VALUES IN DISCHARGE NORMAL RANGES
HIV
HBV
HCV
Na
K
Bicarbonate
Chloride
AST
ALP
ALT
Bilirubin
PCV or HCT
Hb
Wbc
Platelets
ANTIBODY TESTING
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Trial Information |
Recruitment status |
08/07/2022 |
The trial has been completed |
Not yet recruiting |
Completed |