• COVID-19 positive patients who took IHP Detox Tea ‘appeared to convert to negative status’ in relatively shorter time compared to those who did not
• WHO team visits clinical trials site, on ground for presentation of results, yet to make official statement on findings
Doctors have, in clinical trials, demonstrated that a blend of three local plants- King of bitters, bitter kola and guava- could be safely used to prevent, treat and ‘cure’ hospitalised COVID-19 patients.
King of bitters is locally called Jogbo because of its bitterness but popularly called Mejemeje (seven-seven) among Yoruba speaking natives in Nigeria.
The medical doctors are from the College of Medicine, University of Lagos (CMUL) and Lagos University Teaching Hospital (LUTH), Idi-Araba, Lagos State, and Nnamdi Azikiwe University Teaching Hospital (NAUTH) Awka, Anambra State.
Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.The presentation of the findings was made at CMUL/LUTH on Monday April 11, 2022 during the visit of the World Health Organisation (WHO) team to Nigeria to evaluate clinical trials conducted in the country for COVID-19 using traditional medicine or herbal medicinal products.
The key outcome was that the IHP Detox Tea studies at CMUL/LUTH and NAUTH were the only ones approved by the National Agency for Food and Drug Administration and Control (NAFDAC) undertaken in the country during the pandemic.
The IHP Detox Tea clinical trials showed clearly that the herbal product was effective in the treatment of COVID-19. With no single death recorded in the treatment group against three deaths in the control.
The work was a multidisciplinary project done as collaboration between University of Lagos (UNILAG), Nnamdi Azikiwe University (NAU), Awka, Anmabra State and Intercedd Health Products (IHP)- a subsidiary of BDG.
Summary of preliminary findings of CMUL/LUTH team, concluded: “COVID-19 positive patients who took the product appeared to convert to negative status in a relatively shorter time compared to those who did not. It appears that COVID-19 participants on IHP Detox Tea may be discharged earlier that those in control group.
“The IHP Detox Tea appears to be generally safe as one of the two participants with severe complaints could not be directly linked to the Tea with certainty.”
The clinical trial is titled “Special Blend of Andrographis paniculata; Garcinia kola and Psidium guajava L. [Myrtaceae]] for the Treatment of Coronavirus Disease [COVID-19]: A Study Pilot for a Randomised Clinical Trial and Primary Care.”
The Principal Investigator of the researchers from CMUL and LUTH, Prof. Edamisan Olusoji Temiye, is a Consultant Paediatric Oncologist/Haematologist.
Co- Investigators include: Professor/Consultant Haematologist, Suleiman Alani Akanmu; Professor/Consultant Cardiologist, David Adewale Oke; Professor/Consultant Medical Virologist, Sunday A. Omilabu; Senior Lecturer/Consultant Infectious Diseases, Prof. Iorhen Ephraim Akase; Associate Professor/Consultant Epidemiologist, Prof. Oluwakemi Odukoya; and Dr. Emmanuel Okafor as Study Manager.
A co-principal investigator of the study and a consultant Obstetrician and Gynaecologist at NAUTH, Dr. George Eleje, also presented results of clinical trials on “Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of COVID-19: a pilot randomised trial.”
The study concluded: “IHP Detox Tea has, 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.”
Regional Adviser, Traditional Medicine, WHO/African Region (AFRO), Ossy M.J. Kasilo, who was on a mission to Nigeria to Monitor Clinical Trials of Traditional Medicine-Based Therapeutics Proposed for the Treatment of COVID-19, between April 11 and 15, 2022, was at the public presentation of the research findings in CMUL/LUTH.
The discoverer and founder of IHP Detox Tea and Chief Executive Officer (CEO)/Founder of BDG, Prof. Maurice Iwu, was also at the public presentation.
Following approval by NAFDAC, with number A7-1951L, the IHP Detox Tea has been produced and marketed in Nigeria since 2016. Some components of IHP Detox tea like Andrographis paniculata have been shown to alleviate symptoms of acute respiratory tract infections in both adults and children, in addition to immune-stimulatory properties and anti-cancer activities components.
Earlier studies in 2017 had demonstrated that IHP Detox Tea has antiviral activities on earlier strains of coronavirus, Ebola virus, Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) and Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
Severe Acute Respiratory Syndrome Coronavirus type two (SARS-CoV2) is the causative agent for COVID-19. Given its demonstrated ability to alleviate symptoms of acute respiratory tract infections in both children and adults, we hypothesise that IHP Detox Tea could have therapeutic or prophylactic properties against SARS-CoV-2 infection
Consequently, the researchers and the discoverer proposed to conduct a randomised clinical trial to assemble data supporting the beneficial or deleterious effect of IHP Detox Tea when co-administered with conventional therapy for treatment and prevention of COVID-19
The Guardian had last year reported that BDG, Abuja, Nigeria; International Centre for Ethnomedicine and Drug Development (InterCEDD) Nsukka, Nigeria, had submitted the previously NAFDAC listed IHP Detox tea for clinical trials.
Iwu, is a professor of pharmacognosy and President and Chief Executive Officer (CEO) of BDG, Abuja; International Centre for Ethnomedicine and Drug Development (InterCEDD) Nsukka, Enugu State and Bioresources Institute of Nigeria, Umuna, Onu-Imo, Okigwe, Imo State.
In his presentation, he said: “IHP Detox Tea has been in public use since 2016 and the reports from users of the products have been overwhelmingly positive.
“There are over 140 cases of people who used IHP Detox Tea and reported conversion from SARS CoV -2 positive to negative results. There are reports of many symptomatic cases that were resolved. Several health professionals use IHP – Detox Tea as possible pre- and post exposure prophylactic.
“But all these reports are treated as ‘anecdotal’ until the products are subjected to controlled clinical trials, which was conducted at LUTH with the approval of NAFDAC.”
The clinical trial was to be undertaken at the Nigeria Centre for disease Control (NCDC) COVID-19 isolation site in Lagos, Nigeria and has been registered with the Pan African Clinical Trials Registry: at www.pactr.org with registration number PACTR202004761408382.
The identified main bioactive phyto-constituents of the Andrographis paniculata are andrographolides while kolaviron; Garcinia biflavonoids has been reported in Garcinia kola.
The hypothesis is that combination regimen consisting of IHP Detox Tea and conventional care for COVID-19 are more efficacious than conventional care alone.
The study was conducted among patients being managed for COVID-19 at the LUTH COVID treatment centre. Study population are adult patients aged 18-60 years with clinical and laboratory diagnosis of the COVID-19 disease. Only patients admitted onto the COVID treatment wards were recruited.
Inclusion criteria were adult patients with confirmed clinical and laboratory diagnosis of COVID-19 disease and with the normal liver and renal function profiles; are between the ages of 18-60 years.
The Cycle Threshold (CT) for COVID-19 at recruitment must not be higher than 25. The patients must have signed off the written informed consent.
Criteria for exclusion were: pregnant, lactating and breastfeeding women; patients with serious ailments of heart, liver, kidney or brain; patients with chronic medical disorders including Human Immuno-deficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), cancers etc.; subjects who have any allergy or were allergic to any of the medication to be used; and comatose patients or those unable to consume orally.
All participants underwent routine medical examination including: pulse rate; body weight; blood pressure; and general examination to ascertain the presence of and severity of the COVID-19 disease.
Eligible patients were sequentially allocated to receive either the IHP Detox Tea (one teabag to be soaked in 100mls of warm water 12 hourly) in combination with the conventional therapy (the intervention group) and conventional therapy alone plus 100 ml of plain warm water (the control group).
Drugs administration was given for 28 days. Trained nurses were responsible for the drugs administration, while trained research assistants were responsible for data collection, drug auditing and all other aspects of the study. Study investigators are responsible for ensuring adherence to the study protocol.
Procedure for administration was: put one tea bag in a 100ml cup of water. Soak for eight to10 minutes; allow to cool, and drink warm. Drink 12 hourly.
Control therapy was the conventional therapy for COVID-19 as per the Nigeria NCDC treatment protocol for four weeks, plus 100 ml of warm water given 12 hourly.
All the participants were followed up. During each follow-up weekly visit, participants were assessed for level of compliance and adverse events. In-patients were continually monitored until discharge or death. Follow up monitoring for Adverse Event (AE) eight weeks post discharge.
There was daily monitoring of vital signs: pulse, body weight, blood pressure, body temperature, and oxygen saturation in percentage. The trial also has a NAFDAC clinical trial authorisation certificate.
The product was received on October 8, 2020. 75 persons were screened; 52(26 to each arm) people were recruited and randomised.
Date of first recruitment was January 12, 2021. Date of last recruitment was October 2021.
Number of withdrawals/dropouts is 19. Primary reasons for drop out: traveled out of the State, no longer interested and death.
The presence of premorbid conditions such as hypertension and diabetes mellitus were not different in both the intervention and the control groups.
However, when other co-morbidities such as arthritis, hypercholesterolaemia were added, more participants in the control groups had significantly more pre-morbid conditions.
According to the researchers, only the two participants who had what appeared to be side effects: one patient complained of abdominal pain, which started on Day 11. Pain seemed to occur shortly after taking the tea, however pain persisted even when the tea was discontinued. (Tea was discontinued for three days). Patient took no treatment for abdominal pain, which spontaneously resolved after a few days (Male, 42 years).
Another patient reported frequent stooling with traces of blood of one-day duration on Day 33. Spontaneously resolved (Male, 57 years). Three deaths occurred, in total, among patients in the control arm on days three, seven and nine.
Meanwhile, Kasilo said the objectives of the mission to Nigeria were to: review the country progress in the development of traditional medicine-based therapeutics proposed for COVID-19 treatment; monitor the level of implementation of the WHO recommendations on good clinical practice for evaluating the safety and efficacy of traditional medicine-based therapeutics; identify bottlenecks on the implementation of the WHO/ African Vaccine Regulatory Forum (AVAREF) guidelines on the reviews and decisions on clinical trial approval processes of the products in emergencies; discuss regulatory challenges with the National Regulatory Authorities, National Ethics Committees and National Scientific Committees on COVID-19 and agree on the way forward; advocate for conducting multicenter clinical trials and facilitating collaboration between institutions; identify areas for strengthening of national capacity for development of a plan of action with WHO technical support; document best practices in the conduct of clinical trials of traditional medicine-based therapeutics, lessons learnt and possible solutions to address the challenges encountered and way forward; and develop a statement or press release on the findings of the mission including recommendations in collaboration with the WHO country offices and national authorities which will be released towards the end of the mission.
As written by Chukwuma Muanya of Guardian News
IHP Detox Tea, IHP Bitters, Garcinia IHP and many other products of IHP are available at Nature’s Emporium stores and Leading Pharmacies Nationwide.
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