Professor Maurice Iwu, the Chairman, Imo State government instituted COVID-19 management committee with a major in Pharmacognosy has disclosed that, there are plans for the clinical trail of his Covid-19 treatment drug.
“The trial has been registered with the Pan African Clinical Trials Registry (PACTR). It has also been approved by the National Health Research Ethics Committee of Nigeria (NHREC)” he said
The trial has also been registered with World Health Organization’s (WHO) International Clinical Trials Platform (ICTRP).
The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.
This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base.
According to the data available on PACTR seen by Investogist, the title of the trial is “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” with the acronym “IHP Detox tea trial”.
The trial was registered with PACTR on 13 April 2020. The anticipated trial start date and trial end date is 1 May 2020 and 31 August, 2020 respectively.
The anticipated number of participants in the trial is 72, however recruitment for the trial is yet to start.
The eligibility criteria for participants is adult patients with confirmed clinical and laboratory diagnosis of COVID-19. Patients with normal liver and renal function markers with age range of minimum 18 years and maximum 64 years for both male and female.
Excluded from the criteria are; 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.
The primary outcome for the trial is the mean-time to negative test to COVID-19 for first negative test or discharge and presence of immune determinants within 10 days of recruitment.
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The secondary outcome for the trial includes proportion of patients with persisting respiratory symptoms (cough, expectoration, nasal discharge, headache, fever, sore throat, ear ache, malaise/fatigue and sleep disturbance) at two and four weeks of therapy.
The recruitment centres are listed as LUTH Lagos Isolation Center and University of Abuja Teaching Hospital Isolation Centre.
The trial will be funded by Neimeth International Pharmaceuticals Plc, a company listed on the Nigerian Stock Exchange.
The study design
The intervention assignment will be Parallel: different groups receive different interventions at same time during study and allocation will be at random.
The 72 participants of trial will be divided into experimental group and control group with 36 people in each.
The experimental group will be given 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.
The control group will be given 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.
In an interview with Vanguard published on 24 May, Prof Iwu said the clinical trial will be conducted by an “independent research group led by the VC of Nnamdi Azikiwe University, Awka.” He also said that it will be carried out by the NCDC in Covid-19 treatment sites located in Lagos, Kano or other suitable sites
“When we announced to the world about three months ago that we have a treatment for Covid – 19 based on solid scientific evidence and patents, nobody even bothered to examine our data” he said.
When asked about update in adapting the herbal preparation he developed for Ebola in the treatment of Covid-19, he said that what he developed is “not a herbal preparation” and that it has been “tested in 2014/2015 against SARS Coronavirus and the retested again in 2020 against SARS CoV-2, which is the virus that causes Covid-19”
Prof Iwu, the former Independent Electoral Commission (INEC) Chairman is a medical scientist and majored in pharmacognosy at the University of Nigeria, Nsukka, he is also the President, Bioresources Development Group (BDG); International Centre for Ethnomedicine and Drug Development (InterCEDD), Nsukka, and Bioresources Institute of Nigeria at Umunna, Onu-Imo, Okigwe, Imo State.