When we decided to develop a ground-breaking hangover remedy that actually worked, we knew we would need specific expertise to bring Clænsian Hangover Remedy to the market. We embarked on a journey to identify distinguished experts in the field to assist us to succeed. Dr. Les Baxter, a highly regarded professional, emerged as the pivotal figure in our new venture. Once on board, Dr. Baxter convened a team of accomplished product developers, regulators, and compliance experts from various corners of Australia. It is through their combined expertise and dedication that Clænsian Hangover Remedy has come to fruition, marking a significant milestone in the research and development of hangover remedies for the world. This innovative remedy is the culmination of rigorous research and development processes, proudly brought to life entirely within the borders of Australia. We sat down with Dr Baxter to ask him about the process of developing an effective hangover remedy.
CLÆNSIAN: Dr. Baxter, thank you for your time today. What was the motivation to embark on the journey of developing Clænsian Hangover Remedy?
LB: You and I had a discussion regarding hangover remedies currently on the market. Most of them either container artificial ingredients, or the ingredients lacked robust clinical, pharmacological, or traditional use evidence of efficacy. What we wanted to develop was a product that we could personally commit to and have confidence that the ingredients would actually be efficacious, and this efficacy would be robust and defensible based on either clinical/laboratory studies or an acceptable history of traditional use.
We also needed the ingredients to be natural, free from artificial or potentially harmful chemicals and with a negligible risk of containing allergens or toxins. Thus, we selected ingredients that were readily available, but also in wide use across a range of products including foods, nutraceuticals, and complementary medicines. Finally, a hangover is the body’s reaction to alcohol poisoning. It is complicated and there are a range of physiological effects and symptoms. We wanted to develop a product, which would work across a range of physiological processes and provide relief for many of the effects of hangover.
CLÆNSIAN. Could you provide a brief overview of the key components and formulation that make Clænsian unique in addressing the issue of hangovers and how and why you selected them?
LB: Kudzu (dry flower) is the key ingredient in Clænsian and was selected because of its long traditional history of broadly relieving the symptoms of hangover. It is a natural plant extract with a well-documented history of safe use with few apparent side-effects. The active ingredients of Kudzu kelp to break down acetaldehyde a toxic by-product of alcohol metabolism in the body. The B-group vitamins, riboflavin (B2), nicotinamide (B3), and pantothenic acid (B5), are the second group of ingredients. Clinical studies have shown that Vitamins B2, B3, and B5 are efficacious in reducing hangover symptoms. In particular, they help to maintain energy levels and maintain general wellbeing. They are antioxidants, which reduce free radicals, and relieve weariness and fatigue. B-group vitamins are also co-enzymes, which are essential in the body for energy, cell respiration and carbohydrate, protein, and fat metabolism. They are readily ‘flushed’ from the body by alcohol consumption, so need to be replaced. Siberian Ginseng is the fifth ingredient in Clænsian, which helps protect the liver. In addition to helping the body cope with stress, Ginseng acts as an antioxidant. Ginger root, the sixth ingredient, also protects the liver, reduces nausea, and helps to maintain general health and well-being. The final ingredient is Turmeric, an antioxidant. Turmeric aids the breakdown of alcohol, helps the liver to toxicity alcohol, maintains general wellbeing, supports liver health, and acts as an antioxidant. Together, these ingredients act to relive the worst symptoms of a hangover.
CLÆNSIAN. The market for hangover remedies is quite competitive. What sets Clænsian apart from other products in terms of its formulation and potential benefits for consumers?
LB: The efficacy and safety of each ingredient is backed by supporting and robust traditional records of scientifically robust clinical studies. The concentrations of the active ingredients within Clænsian are within a strict range to ensure efficacy but also ensure safety and freedom from potential side effects. Robust literature reviews have been undertaken to ensure product safety. Every key ingredient in Clænsian Hangover Remedy contributes to the effectiveness of the capsules. There are no gimmicky unproven or anecdotal ingredients, or fillers. Clænsian is designed to be a broad-spectrum hangover remedy, which effectively addresses a wide range of hangover symptoms. Clænsian does not just concentrate on one symptom of hangover, leaving you to suffer with the other hangover symptoms.
CLÆNSIAN: How did you approach the scientific research process in developing Clænsian to ensure its effectiveness and safety, and what specific challenges did you encounter during the initial stages of research and development? How did you overcome them?
LB: The first step in the development of Clænsian was a detailed technical literature review, which evaluated the literature on the physiology of hangover and the plethora of hangover ‘cures’ and remedies cited in the literature. There is no such thing as a hangover ‘cure’, by the way. The aim was to develop a formulation that we could add to the Australian Register of Therapeutic Goods as a listed medicine (complementary medicine). To be eligible for listing, we needed to be able to demonstrate efficacy based on traditional use and clinical studies, as well as product safety, including freedom from potential interactions of the ingredients and freedom from allergens. During the review process, only ingredients with incontrovertible proof of efficacy, based on traditional use or clinical studies, were considered for inclusion. In addition, the ingredients were required to be natural, safe, in common use, and readily available. The next step was to conduct a thorough review of supporting technical literature to determine whether there was acceptable supporting traditional and/or clinical evidence of efficacy and safety. From this exhaustive research and the subsequent studies, which took almost a year, we developed the final list of potential ingredients for Clænsian Hangover Remedy. Sourcing high potency, quality, active ingredients was an initial challenge, which we accomplished in partnership with our GMP contract pharmaceutical manufacturer.
CLÆNSIAN. Can you elaborate on the traditional and scientific evidence, and any studies that have been conducted to validate Clænsian's effectiveness in reducing hangover symptoms?
LB: Essentially, we are dealing with herbal plant extracts. Registration as a Listed Medicine on the Australian Register of Therapeutic Goods requires that efficacy and safety must be ensured through evidence based on either traditional medicinal claim, clinical claims, or both. With traditional claims, there must be a well-documented traditional history of the use of the specific ingredient for the specific indication being claimed, together with any side-effects or safety issues. This evidence is sourced from herbals and historical literature. Clinical and technical claims are based on clinical studies and replicated trials, which are scientifically robust. For instance, the efficacy and safety claims for Kudzu and Ginger are based on traditional indication, while the claims for the B-group vitamins, Siberian Ginseng, and Turmeric are based on clinical and technical evidence.
CLÆNSIAN. What steps were taken to ensure that Clænsian is safe for consumption and free from adverse side effects?
LB: The safety of Clænsian has been determined by a detailed literature review of traditional, clinical, and technical claims for each ingredient, together with a review of potential interactions between the ingredients, and allergen studies. The ingredients comprising Clænsian have a long history of use across a wide range of food, pharmaceutical, and complementary medicinal products. Consumers can take comfort in the knowledge that the safety data for Clænsian is robust, and the safety of the ingredients is well documented. In addition, we have developed a robust and thorough pharmacovigilance management plan which focuses on identifying adverse ingredient issues arising from new research, any issues associated with Clænsian manufacturing process, identification of any adverse reactions to Clænsian.
CLÆNSIAN. In terms of commitment, could you share some insights into the time and resources invested in perfecting Clænsian's formulation and effectiveness?
LB: This is a difficult question to answer. The development of Clænsian has been more of professional interest (and at times an obsession). The rationale for the product, together with the opportunity to work with an interesting array of natural and sustainable ingredients and the opportunity to work with experts from several fields of expertise has been very motivational. Personally, I have spent several months working on the Clænsian formulation, but it has really been a team approach with input from a range of very experienced specialists.
CLÆNSIAN. Clænsian's development likely involved a multidisciplinary approach. How did you assemble a team of experts to contribute to the research and formulation process?
LB: The development of Clænsian was a team approach, which utilised individuals and groups with a range of skill sets and expertise. The Clænsian team developed the rationale for the product and identified the initial ingredients list. A product formulation and safety specialist then fine-tuned the formulation, prepared the evidence folder for the product claims, and carried out a thorough products safety review. Our Regulatory Compliance consultant ensured that all parts of the formulation and manufacturing process met the high standards associated with listing the product on the Australian Register of Therapeutic Goods as a listed product. Finally, the contract manufacturer’s specialist team identified sources of the product ingredients and ensured that all ingredients and product components met the exacting standards of Good Manufacturing Process. Even our bottles needed to be tested for compliance and suitability before they were manufactured to our strict requirements. There were also label designers and other skilled professionals working in the background.
CLÆNSIAN. Looking ahead, what are your plans for further research and development in the field of complementary remedies, and what can consumers expect from Clænsian in the future?
LB: Clænsian is an interesting product. Firstly, it has many general health and well-being benefits over and above what has been initially claimed for Clænsian Hangover Remedy, such as promoting liver health. Secondly, Clænsian could be regarded as a ‘scaffold’ or ‘foundation’ remedy. By this I mean that several of the components, such as the B-group vitamins, Turmeric, Ginger, and Siberian Ginseng are bioactive across a range of health indications and physiological effects. What this means, is that by adding some additional ingredients or by substitution one of two of the current ingredients, the product readily lends itself to the efficient development of new, but related products that can provide benefit for several health indications, for example sleeplessness.
CLÆNSIAN: Thank you, Les.
Dr. Les Baxter's leadership and the collaborative efforts of our team of experts have played an instrumental role in making Clænsian Hangover Remedy a reality. Their commitment to quality and compliance has ensured that the product adheres to the highest standards, making it a testament to the excellence of Australian innovation and manufacturing. We take pride in the fact that Clænsian is a product entirely conceived, developed, and manufactured in Australia. As we look forward to the positive impact Clænsian is poised to have on everyone in need of an effective, easy to use, hangover remedy, we acknowledge the expertise, dedication, and collaboration that has made this venture a resounding success. Clænsian Hangover Remedy stands as a testament to the capabilities of Australian professionals and the potential for innovation on a global scale.