The Nova Story
Find out the story behind the development of the World's First Phyllanthus Niruri Standardized Extract
The NOVA Phyllanthus Research : Efficacy First
Our story dates back to 1997 at the back of a pharmacy where our founder had an idea to develop an effective product for people who are suffering from liver injuries by using a local plant known as Phyllanthus niruri.
Phyllanthus is known for its diverse medicinal use in treating various ailments which includes liver disease by various cultures over the world.
The Company founder started the long and winding road to find the medicinal values of Phyllanthus niruri from the back of his pharmacy.
Finding The Elusive Compound
He screened through more than 500 fractions of the plant extracts and tested the liver protective effect of each fraction.
A long term safety test was conducted where the test specimens were fed with active fractions of Phyllanthus, 20 times the normal dose for up to 9 months. At the end of the study, all the vital organs were safe and the results were within parameters.
After three years of product formulation, he successfully developed a delivery system to increase the absorption of all the compounds in the active fraction of Phyllanthus niruri. Today, this broad-based delivery technology is known as Phytomatrix Formulation.
The product was tested at 30°C for two years to ensure it is stable and safe to be consumed throughout its shelf life.
During his 10 years of research, he faced challenging situations and failures, but the sense of purpose and tenacity were on full display and he delivered a product that is approved for clinical trial in patients.
The Biggest Clinical Trial
In 2021, Hepar-P completed its randomised, placebo-controlled, double-blinded, multi-centred trial in non-alcoholic fatty liver disease (NAFLD) patients. The results provide clear evidence on the safety and efficacy of Hepar-P in improving the liver stiffness (fibrosis) score and lowering elevated liver-specific enzyme ALT.
This continuous research on Phyllanthus niruri underpins Nova’s core belief to provide evidence-based products to improve people’s health while propelling us closer to Nova’s goal of a world free from chronic diseases.
The Legend Of Phyllanthus
Traditionally, Phyllanthus is known for its diverse medicinal use in treating various ailments by many cultures worldwide. The plant has demonstrated its abilities to protect the liver from injury, expel kidney stones, assist digestive issues, improve respiratory functions, act against viral infections, cause diuresis, improve skin disorders and sugar control. Since the 1960's, there has been a growing number of scientific journals published on Phyllanthus. To date, there are over 300 published scientific journals about this plant.
Early use of Phyllanthus niruri dates back almost 300 years in India. The plant was being used in the Ayurvedic medical practice to treat jaundice, liver problems, digestive issues, respiratory complications and skin diseases.
In 1988, a major breakthrough on Phyllanthus occurred when Dr. Baruch Blumberg reported that the plant could clear up the chronic carrier state of Hepatitis B in humans. In this study, he reported that an extract of Phyllanthus cleared the Hepatitis B virus surface antigen from 22 of 37 chronic Hepatitis B Virus patients in only 30 days. Dr. Blumberg was the winner of the 1963 Nobel Prize for discovering the Hepatitis B virus.
Phyllanthus, also known as Chanca Piedra or "stone breaker", has been used by the indigenous people of the Amazon for generations as a remedy for gallstones and kidney stones. These people also use Phyllanthus to improve liver detoxification functions to support good liver health.
In China, Phyllanthus, also known as "yexiazhu", was commonly used in traditional Chinese medicine to treat jaundice and diarrhoea. It is also known to be beneficial in the treatment of Hepatitis B. The beneficial effect of Phyllanthus in Hepatitis B has been published in more than 30 scientific journals in China.
Finding The Elusive Active Compounds
Since the mid-1960s, Phyllanthus has been the subject of research in determining the active compounds responsible for its medicinal activities. Despite the amount of research, the active compounds remained elusive to scientists. The identity and quantity of the compounds were difficult to determine for several reasons. One of them was the inconsistent number of active compounds present in the plant. This inconsistency is influenced by multiple factors, such as environment, weather, soil, harvest time, storage conditions and processes. This inconsistency, along with the quantity of the active compounds, can greatly affect the efficacy of the final product.
In 1997, our founder started the long and winding road from the research laboratory at the back of his pharmacy to find the medicinal values of Phyllanthus niruri. He invested all his resources and started this risky research. Many researchers consider research as risky because exploring new discoveries or ideas may not lead to positive outcomes. However, his focus on establishing a liver protection product that is effective and scientifically backed made the adversaries seem small.
The starting point for the research was to identify the active compounds in the plant. Our founder screened through more than 500 fractions of the plant extracts and tested the liver-protective effects of each fraction on animals. After identifying the active fractions, he began to determine the quantity required of each active fraction to achieve the maximum beneficial effects. This was carried out by testing more than 300 fractions at different dose levels on rats.
Another important part of his study was to determine the product’s safety. The long-term safety tests include the 6-month safety study on rats and the 9-month safety study on rabbits. The animals were fed with the active fractions of Phyllanthus at levels more than 20 times the normal dose used for human consumption. At the end of the studies, all the vital organs and blood parameters were checked to ensure that the products were safe even at high doses.
Furthermore, the product required a unique delivery system to ensure it is well absorbed when taken orally. One of the biggest challenges in formulating herbal-based products is the diverse nature of the active fractions, which contain many compounds with different chemical properties and, hence, different absorption characteristics.
After three years of research, he had successfully developed a unique delivery system that could increase the solubility and subsequent absorption of all compounds present in the active fraction. This versatile delivery technology, known as Phytomatrix, can be used in many different herbal products to improve their solubility and absorption.
Finally, the product was tested for its stability and shelf life. It was left at a temperature of 30°C for 2 years during the stability test to ensure that the product remains stable and safe for consumption throughout its shelf life.
Translating Plant To Pill
For over 10 years, our founder had spent the best parts of his life developing an effective herbal product containing Phyllanthus niruri. There were times during his research that forced him to face challenging situations and failures, including technological inadequacies, negative findings and lack of financial resources. In the face of these challenges, his sense of purpose and tenacity drove him on and finally, he delivered a product that is approved for clinical trials.
The Efficacy First business principle has become Nova’s life-long guiding principle and is deeply rooted in our Four Promises to our customers.
Commenced The Biggest Clinical Trial To Prove The Safety And Efficacy Of Hepar-P
In 2018, Nova began Hepar-P’s biggest clinical trial, and completed its first ever randomised, placebo-controlled, double-blinded, multi-centred clinical trial in patients with non-alcoholic fatty liver disease (NAFLD). This trial was conducted at 3 sites in Malaysia, namely Hospital Sultanah Bahiyah in Alor Setar, Hospital Ampang, and Hospital Selayang, and adheres to the gold standard for evaluating the safety and efficacy of a product for medical purposes.
It was led by 3 Hepatologists and Gastroenterologists as clinical investigators, while Datuk Dr Muhammad Radzi Abu Hassan, the National Head of Gastroenterology and Hepatology at the Ministry of Health, was the national principal investigator.
At the end of the study, the trial results demonstrated the effectiveness and safety of Hepar-P in improving liver stiffness and lowering elevated specific enzyme (ALT), while remaining safe and well-tolerated throughout the 52 weeks of the study.