How far with the clinical trials of your natural cure for COVID-19?
The clinical trials have not yet started. I said ‘trials’ because we anticipate sequence of trials because we are dealing with more than one product. Luckily, we have already a National Agency for Food and Drug Administration and Control (NAFDAC) listed product which we want to subject to clinical evaluation against COVID-19. The clinical trial titled: “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”. To be conducted by an independent research group led by Vice Chancellor (VC) of Nnamdi Azikiwe University Awka, Anambra State. The study is planned to be carried out in the Nigeria Centre for Disease Control (NCDC) COVID-19 isolation site in Lagos or other suitable site.
The trial has been registered with the Pan African Clinical Trials Registry: at www.pactr.org with registration number of PACTR202004761408382 (Approval date: 15 April 2020). We shall then undertake the full clinical trials of Andrographolide, the Active Pharmaceutical Ingredient (API), which will be registered as a drug.
Because of cost, the objectives of the clinical trial on the IHP Detox tea are limited to testing the feasibility and acceptability of an emergency trial in the context of COVID-19 pandemic, and to collect data on the safety and effectiveness of the dietary supplement in reducing mortality and viral load in patients with COVID-19. The proposed trial actually stands out and may not directly influence the design of future studies on the pure compound, Andrographolide, which is a drug whereas IHP-Detox Tea is a dietary supplement.
The possible endpoints will include clinical disease progression, treatment-limiting adverse events, and the emergence of serious laboratory abnormalities such as elevated liver enzymes etc. Quality of life (QOL) assessments will also be conducted at baseline, and weekly during the study to assess patients’ perception of their QOL. Of course, it is entirely up to the investigators.
Now, the big surprise on the clinical trials of the proposed remedy: It may interest you that one of the plants that yielded the active compound has been clinically evaluated in several studies. In one of the published reports, Andrographis has been clinically evaluated about 33 times in full blown clinical trials. A meta-analysis, indicated that the trials (when combined) involved 7175 patients in cohorts on the use of A. paniculata for symptomatic relief of acute respiratory tract infections in both children and adults. I will give you the paper to read for yourself.
You will find that A. paniculata therapy consistently shortened the duration of dry persistent cough, sore throat and sick leave/time to resolution when compared with usual care. The combination of Andrographis, Garcinia kola and Psidium guajava leaves in the already NAFDAC listed IHP -Detox Tea is an exciting product for the management of this pandemic. Especially as possible pre- and post-exposure prophylaxis as literature on them suggest. Furthermore, the specially ‘cured’ tea has been in human use since 2016 without any reported case of adverse effects. I hope you understand what I mean when I say that the tea is cured.
What are the constituents of this product?
We actually patented three active compounds: Andrographolide from Andrographis panicultata, Akiluvir (from Garcinia kola) and Alstonine from Picralima nitida seeds. I am really surprised at your question because the whole idea of a patent is full disclosure. We had screened thousands of plant extracts for various biological activities. Many of them including black seed oil, neem, lemon grass, citrus leaves and peel, turmeric, many other spices and herbs, etc. showed some antiviral activity but these three compounds exhibited remarkable antiviral activities and significantly inhibited the growth of Severe Active Respiratory Syndrome (SARS) coronavirus in laboratory studies.
Fortuitously, we had developed since 2016 a product called IHP – Detox Tea that contains two of the most active antiviral and anti-inflammatory agents, which we had earlier patented. We replaced Picralima nitida with Psidium guajava because of the anti-psychotic properties observed with Alsonine, which we have reported in many academic papers. In fact, if you Google Alstonine now the Wikipedia definition will include its antipsychotic properties, which was first identified by our group for the management of schizophrenia.
Schizophrenia is a serious mental disorder in which people interpret reality abnormally. Schizophrenia may result in some combination of hallucinations, delusions, and extremely disordered thinking and behavior that impairs daily functioning, and can be disabling. People with schizophrenia require lifelong treatment.
You have presented the product to the Minister of Science and Technology and Minister of State for health. What is the feedback?
The Minister of Science and Technology and his counterpart in the Ministry of Health were quite receptive and encouraging. They showed genuine interest in our work. However, I didn’t go to them for financial support or endorsement. I merely offered a possible solution to a pandemic, which Africa was unprepared for. We have received some private sector interest in the products but our interest is in actually saving lives. Perhaps, more interest should have been shown and followed.
The World Health Organisation (WHO), NCDC and other medical experts have dismissed herbal cure claims for COVID-19. They argue that you cannot claim cure for a disease that just emerged. What is your take on this?
They are either ignorant or mischievous. I heard all the comments but I have been through a lot in my 70 years that I ignore such uninformed comments. I waited and in few weeks they learnt that novel coronavirus was not novel after all. One eminent virologist didn’t not even know that COVID-19 was caused by SARS – Coronavirus 2. Labels don’t impress me. What you don’t know you don’t know even if you are United Nations Organisation (UNO), WHO or NCDC. The saying my people perish for lack of knowledge is very true in this case. Perhaps, many lives could have been saved.
The lead molecule, Andrographolide is really one of the most studied natural products in history. In our patent, we showed that in vitro inhibition of the growth of Ebola virus (Zaire) with EC50 activity of 10 µM which is twenty-five-fold the activity of the control Favipiravir (EC50 = 250µM) in the Crystal violet (Plaque reduction/ Neutral red (Toxicity) assay. It also showed significant activity against Dengue fever virus with EC50 value of 0.56 µg/ml in the Visual (Cytopathic effect/ Toxicity) Assay and EC50 of 0.58 µg/ml in the Neutral Red (Cytopathic effect/ Toxicity) Assay (comparable to the values obtained with 6-Azauridine as the positive control EC50 = 0.32 µg/ml and 0.38 µg/ml in the respective bioassays; and against SARS Coronavirus.
Andrographolide had an EC50 of 1.2 µg/ml in the Visual (cytopathic effect/toxicity) assay and 1.1 µg/ml in the Neutral Red (cytopathic effect/toxicity) assay. The compound exerts several immune-modulatory properties. In experimental models, it effectively reduced the levels of pro-inflammatory cytokines such as IL-1𝛽, IL-6, GMCSF, and TNF-𝛼. The compound has a good pharmacokinetics profile and relatively non-toxic even at high doses making it an ideal experimental drug for the treatment of viral infections, with possible application in the control of the Novel Coronavirus, COVID-19. I hope this data is not too heavy for a newspaper but it has become necessary to address the ignorant.
How far with your relationship with local researchers especially those at Nnamdi Azikiwe University Awka?
Local? That is the core of our problem. We are all scientists, local or foreign. Our programme has been enriched greatly by the team led by Prof. Charles Esimone. I have learnt a lot from him and his colleagues.
Presently you said you are working with Anambra and Imo State governments in containing the viruses. Do you success stories to share?
Not that I said. I am a member of the COVID-19 Taskforce in both States. It is really a great honour to participate in that role at this time.
What are your recommendations on how best to contain the virus?
With our rather limited resources and the dilapidated health infrastructure that have been neglected for decades, the country has actually done well. As I indicated at my meeting with the ministers, now is the time to plan for the next viral outbreak. We should continue to strengthen existing health state infrastructure and systems rather than grapple with establishment of ad-hoc systems. The restrictions imposed on movement of people, for example should not only be to slow the transmission of the virus and reduce the overall size of any possible outbreak but also to afford the healthcare personnel sufficient time to train on how to deal with infection clusters and surges as they occur.
The preventive measures advocated by healthcare experts such as regular washing of hands with soap and water, the use of hand sanitizers where possible and the observation of social distancing should be followed. I support the use of facemasks whenever we are outside our homes or receiving guests. We are enforcing the ban on gathering of people for whatever reason, especially markets and social gathering. History teaches us that viral pandemics sometimes follow a W curve, with unexpected surges, coming when restrictions are relaxed prematurely. Perhaps, more importantly we should eat foods and take herbs that strengthen the immune system, such as IHP- Immunovit. This is not advert, but public assistance.
There is fear of a second wave of COVID-19. How true is this and how can this be averted?
I am not a virologist or public health expert but scientific evidence points that possibility. That is what I mean by ‘W’ curve.
Have you effectively used your product to treat or prevent COVID-19 in Nigeria?
That is what the clinical trial is all about. I am not a traditional healer or an orthodox doctor so I don’t treat people. IHP -Detox Tea has been in public use since 2016. The potent antiviral activities of two of the major active ingredients of the tea namely, Andrographolide and GB1 on SARS Corona virus were recently validated by in vitro studies carried out by the United States (US) National Institute of Health (NIH).
IHP Detox Tea have, thus, shown proven pharmacological efficacy in several of the conditions, which supports its potential beneficial use in COVID-19 patients. Apart from the proven antiviral effects of the components of IHP Detox Tea, the immune boosting and adaptogenic effects of the major phytochemical constituents will definitely contribute to better prognosis of COVID-19 patients placed on the proposed therapy. That is what the pilot clinical study will establish or disprove.
Are you in the favour of extension of lockdowns in Lagos, Abuja and others?
No answer. Not read sufficient literature on that.
This pandemic has defied the Western world. What lessons are there for us to learn?
That all human systems are vulnerable and that we are perhaps more interconnected than we hitherto believe.
Are you collaborating with NAFDAC, Nigerian Institute for Pharmaceutical Research and Development (NIPRD), Federal Institute for Industrial Research Oshodi (FIIRO) and Nigerian Institute for Medical Research (NIMR)?
Not really. But we have good collaboration with Raw Materials Research and Development Council (RMRDC) in Abuja: very fruitful collaboration. Our joint work, at the inspiration of DG, won the first prize in the Nigerian Science Fair for our work on local production of Lovastatin.
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