Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004761408382 Date of Approval: 15/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 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
Official scientific title 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
Brief summary describing the background and objectives of the trial 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IHP Detox tea trial
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2020
Actual trial start date
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IHP Detox tea One teabag of IHP Detox Tea to be soaked in 100mL of warm water 12 hourly in combination with conventional therapy 4 weeks Standard doses of IHP Detox Tea (one teabag to be soaked in 100mls of warm water 12 hourly) will be administered in conjunction with conventional therapy for COVID-19 12-hourly for 4 weeks. 36
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
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients with confirmed clinical and laboratory diagnosis of COVID-19. Patients with normal liver and renal function markers. Pregnant, lactating and breastfeeding women. Patients with diabetes or with serious ailments of heart, liver, kidney or brain. Chronic medical disorders including HIV/AIDS, Cancers, etc. Subjects who have any allergy or were allergic to any of the medication to be used. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 09/04/2020 National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Garki, Abuja P.M.B. 083, Garki-Abuja Abuja 434001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The mean time to negative test to COVID-19. first negative test or discharge
Primary Outcome Presence of immune determinants. within 10 days of recruitment
Secondary Outcome Proportion of patients with persisting respiratory symptoms (cough, expectoration, nasal discharge, headache, fever, sore throat, earache, malaise/fatigue and sleep disturbance) at two and four weeks of therapy
Secondary Outcome Incidence of any adverse events (such as diarrhea, nausea, vomiting and colitis) within 10 days of commencement of therapy
Secondary Outcome Mean levels of renal function parameters (serum electrolyte, urea and creatinine). at two weeks after initial therapy
Secondary Outcome Mean levels of liver function parameters (AST, ALT and ALP) and lipid profiles. at two weeks after initial therapy
Secondary Outcome Proportion of patients discharged from hospital or deaths at 2 weeks and 4 weeks of therapy
Secondary Outcome Effects (if any) on CD4+ and CD8+ counts of both Study Arms at two weeks and 4 weeks of therapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LUTH Lagos Isolation Center Ishaga Rd, Idi-Araba, Lagos Lagos Nigeria
University of Abuja Teaching Hospital Isolation Center Gwagwalada-Zuba, Gwagwalada Abuja Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
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
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Centre for Ethnomedicine and Drug Development and Neimeth International Pharmaceuticals Plc. Ikeja Industrial Estate, 1 Henry Carr St, Ikeja Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Joseph Ikechebelu Nnewi Onitsha Road Nnewi Nigeria
George Eleje Nnewi Onitsha Road Nnewi Nigeria
Jude Duru Lagos University Teaching Hospital is a tertiary hospital in Idi-Araba, Surulere, Lagos State Surulere Nigeria
George Chukwuma Okofia Campus Awka Nigeria
Festus Okoye Along Enugu-Onitsha Expressway, Ifite Road, 420110, Awka Awka Nigeria
Kenneth Ngwoke Nnamdi Azikiwe University, Enugu-Onitsha Expressway, Ifite Road, 420110, Awka Awka Nigeria
Godwin Nchinda CIRCB BP 3077, Messa Yaounde, Yaounde Cameroon
Henrietta Ogbunugafor Nnamdi Azikiwe University, Enugu-Onitsha Expressway, Ifite Road, 420110, Awka Awka Nigeria
Edamisan Olusoji TEMIYE Department of Paediatrics, College of Medicine, Lagos University Teaching Hospital Lagos Nigeria
Suleiman Alani AKANMU Department of Haematology, College of Medicine, Lagos University Teaching Hospital Lagos Nigeria
David Adewale OKE Department of Medicine, College of Medicine, Lagos University Teaching Hospital Lagos Nigeria
Sunday .A. OMILABU Department of Medical Microbiology and Parasitology College of Medicine, Lagos University Teaching Hospital Lagos Nigeria
Iorhen Ephraim AKASE Department of Medicine, College of Medicine, Lagos University Teaching Hospital Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charles Esimone co.esimone@unizik.edu.ng +2348062835781 Nnamdi Azikiwe University, Enugu-Onitsha Expressway, Ifite Road, 420110, Awka
City Postal code Country Position/Affiliation
Awka Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries George Eleje georgel21@yahoo.com +234806811744 49 Nnewi Onitsha Road, NAUTH Nnewi
City Postal code Country Position/Affiliation
Nnewi Nigeria Senior Lecturer and Consultant
Role Name Email Phone Street address
Public Enquiries Jude Duru jduruonweni2203@hotmail.com +2348037212638 Ishaga Rd, Idi-Araba
City Postal code Country Position/Affiliation
Idi Araba Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 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 Clinical Study Report,Informed Consent Form It will be available from July 2020 to October 2020 Open access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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