New Developments in Clinical Trial of African herbal medicine for Malaria

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The Nigeria Natural Medicine Development Agency (NNMDA) and Pax Herbal Clinic and Research Laboratories (Paxherbals), are into a partnership that will enhance the scientific practice of herbal medicine in Nigeria.  The two parties, through a memorandum of understanding, agreed to collaborate in the establishment of frame work for increased cooperation in clinical trials and public health research collaboration in the areas of Natural products, Natural Medicine, Traditional Medicine Knowledge and Practice, Intellectual Property Rights, Science and Engineering, Agricultural Practices and any other related field of work approved by the Parties’ respective authorities. Similar partnership to advance the cause of natural medicine has been agreed on with the malaria research unit at the University of Port Harcourt, Nigeria.

Focusing of Malaria

As a matter of priority, the two parties decided to collaborate in the design of a framework for clinical trial of PAX anti-malarial herbal medicine called Malatreat.  The decision was based on the fact that malaria still constitutes a major health challenge in Africa. It is a shame indeed that despite the fact that Nigeria is blessed with many scientists, researchers and herbal experts, they are yet to develop a standardized herbal medicine for malaria. This is a challenge which NNMDA, the University of Port-Harcourt and PAXHERBAL seek to confront.

Although herbal medicines offer a wide diversity of medicinal properties and have proven to be a boom for therapies, its clinical evidence mapping is largely lacking and thus cannot be integrated into Nigerian public health structures. Also, there is a high prevalence of malaria in Nigeria, and clinical evidence mapping of herbal anti-malarias might be the innovation to improve malaria control and elimination programs.

The Malaria Challenge vs. Paxherbal Malatreat

Malaria is a national challenge in Nigeria requiring urgent intervention. The WHO documents that Nigeria uses herbal medicines in 60% of cases of early febrile diseases perceived to be malaria. Also, in the few systematic herbal medicine clinics across Nigeria and the many treatment homes existing in almost every hamlet, malaria and febrile conditions are the most encountered diseases by Traditional Medicine Practitioners (TMPs).

The NNMDA and PAXHERBALS decided to draw up a proposal that seeks to evaluate the Pax-herbal anti-malaria (Malatreat) in use at the clinic and research laboratories of paxherbals and its environs, Ewu-Esan in Edo state Nigeria by utilizing a prospective observational study design.

According to Pharmacist Ogar, a research fellow at NNMDA, and a key designer of the clinical trial proposal, few or no studies have illustrated methods to engage herbal medicine clinics in Africa and perhaps none in Nigeria on ways to describe and evaluate clinical use of herbal medicines as anti-malarial in patients. Observational clinical studies could be carried out to estimate the efficacy and toxicities of herbal anti- malarias in clinical protocols and thus document any adverse effects.  This should provide the needed opportunity to measure patient outcome in malaria patients exposed to the herbal drug in a clinical setting.

 

Paxherbal maltreat was first registered by NAFDAC in 2008 as Paxherbal Malsol and has consistently passed regular tests and evaluation. It has a long history of safety and has been evaluation for toxicity, and have been certified safe for human consumption. 12 more Paxherbal products were further approved by NAFDAC in 2010. With over 36 registered herbal products for various diseases such as diabetes, High blood pressure and Arthritis, PaxHerbals has the highest number of NAFDAC approved herbal supplements in Nigeria.

According to director of Paxherbals, Fr. Anselm Adodo, if herbal practitioners in Nigeria and Africa want to be respected and integrated into the national health care system as healthcare providers, they will need to upgrade their practice through research and innovation. Most often, herbal practitioners do more of boasting and making bogus claims about their products, rather than engage in serious scientific work.

Paxherbal, ISTH and NNMDA Partnership

Recently, the Irrua Specialist Teaching hospital in Irrua (ISTH), Edo State, expressed interest in the proposal and have teamed up with PAXHERBAL and NNMDA to carry out this innovative and historic study.  Such initiative is historic and revolutionary, and will be the first of its kind in Nigeria. The involvement of ISTH, a federal government specialist teaching hospital, in the research proposal also shows that conventional medical practitioners in Nigeria are willing to explore herbal medicine provided attention is given to rigorous research. Of course there will always be antagonists to any such partnership, but experience has shown that the future belongs to the people, and organizations, who are open to new possibilities and innovations.

The three organisations, NNMDA, PAXHERBAL and ISTH are currently working round the clock to acquire all the needed permissions, including ethical clearance, in line with best international practice. The short-term goals of the project are

  • To Evaluate the effect of Pax-herbal anti-malaria (Malatreat) on Plasmodium falciparum 
  • To acquire evidence basis for utilization of the anti-malaria and to acquire necessary preliminary clinical data for the design of wide-scale Randomized Clinical Trial of the herbal therapy.
  • To prospectively review the clinical outcome from treatment of malaria patients with PAX herbal Malatreat and to    quantify   the   degree   of   parasitaemia   reduction   and antigenecity at every level of administration of Paxherbal Malatreat.
  • To determine clearance rate of parasitaemia in the bloodstream of patients’ administered Paxherbal malatreat.
  • To estimate the therapeutic efficacy and clinical safety of Paxherbal malatreat.
  • To acquire necessary clinical data for the design of Randomized Clinical Trial of the herbal therapies.

In September 2017, Paxherbals forged a new partnership with Nigeria’s foremost medical research institute, the National Institute of Medical research (NIMR), to carry out clinical trials on some of the herbal products produced by Paxherbals, such as the malatreat for malaria, Diatea for Diabetes, Bitter tea for Hypertension and many others. Part of the partnership involves jointly setting up an herbal clinic and research unite at the institute, a very historic and significant move in the nation’s healthcare system.

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