Comments /4769 Views / Friday, 3 August 2012 00:10
Says recently concluded clinical trial provides remedy for symptoms of catarrh, colds and upper respiratory ailments
Hidden among the lush greenery away from the hustle and bustle of city life the Link Natural production facility rejuvenates the herbal medicine industry by linking it with new technology while retaining the its roots.
|From left: Link Natural Products Factory Manager Tharanga Perera, Head of Research and Development T.M.S.G Tennakoon, Consultant Prof. Colvin Goonaratna, Chairman Dr. Devapriya Nugawela, Director Prof. Tuley De Silva and MAS Linea Aqua CEO Sarinda Unamboowe|
The manufacturing process of all generic ayurvedic pharmaceuticals and herbal healthcare at Link is done with precision and great care under hygiene standards. The production process of every product is guided by a highly experienced team of professionals with the contribution of the management team.
After it was established in 1982, the company has experienced immense growth with over 200 items in their product line. Being a research oriented company Link has given numerous products to both local and international markets.
In 1995 the company launched the herbal remedy Samahan that became a well known brand in the country as well as beyond local shores. Comprising of 14 herbal ingredients, Link Samahan is proved clinically and scientifically as a remedy to prevent and cure a number of general sicknesses.
Colds, catarrh and viral inflammations of the throat are far and away the commonest ailments that afflict human beings. They give rise to a large number of symptoms which interfere with our daily lives in several ways.
In addition, the following symptoms have important commercial considerations and negative effects on the national economy: Excess sneezing, headache, watery nasal discharge, body aches and pains, nose block, tearing and scratchy eyes, irritation of the throat, scratchy/blocked ears, hoarse voice, tiredness, cough, loss of appetite, throat pain, feverishness, and difficulty in daily activities.
They affect our lifestyles in several ways. In adult men and women these symptoms adversely affect, our office work, household tasks (including parenting, helping with school homework, and spending quality time with our children), and social activities. They may also affect our leisure activities such as sports and hobbies.
If we have to frequently consult doctors, then out-of-pocket expenses for the consultations, laboratory tests and medications will strain our personal budgets.
|Refining the ingredients at the Link Natural Products factory|
In the context of the highly competitive examination system that prevails in Sri Lanka, the effect of these troublesome symptoms by way of lost students’ study time and concentration, acquires particular significance.
At a higher level, staff absenteeism, their decreased efficiency and productivity, and the resulting loss of man-hours can have deleterious commercial outcomes for a particular company or institution, and negative outcomes for the national economy.
At present, the only treatment available for these symptoms of colds, catarrh and throat inflammation is to take prescribed or self-selected medicines and rest at home for some days. There is no medicine to prevent them or minimize their occurrence.
New scientific clinical research has provided the ideal remedy.
It is accepted world-wide that the three essential properties that any medicinal product must have are: Safety, efficacy and quality.
There is also worldwide agreement that for testing these properties scientifically, the “gold standard” is a “randomised controlled clinical trial”.
The remedy for the prevention of these 15 symptoms and reducing their severity has emerged from a randomised controlled clinical trial done in Sri Lanka, on a Sri Lankan medicinal product.
A trailblazer RCCT had been conducted by Professor Colvin Goonaratna, a former Chairman of the State Pharmaceuticals Corporation (1994 to 2001) and a Senior Professor of the Faculty of Medicine in the Colombo University, together with Professor Roshini Sooriyarachchi of the Department of Statistics of the same University, on the highly popular herbal medicine product Link Samahan.
The results of their RCCT have been published in the prestigious Ceylon Medical Journal ( CMJ 2012; 57 : 19 – 32), which conforms to the highest international editorial standards, and is listed in and abstracted by the Index Medicus, Biosis, Embase, CABI and Elsevier Scopus. The professors recruited over 800 healthy volunteers for this study, which lasted for 12 weeks.
A “test group” which comprised 386 volunteers took one sachet of Link Samahan daily during this period, dissolved in hot water, and a “control group” of 415 volunteers took a cup of plain tea daily at about the same time. Allocation to the “control group” or the “test group” was by statistically acceptable randomisation.
During this period each volunteer recorded daily on a specially designed and colour-coded form whether or not they had any one or more than one of these 15 symptoms, and if they had, the severity of the relevant symptom as mild, moderate or severe. This is how Professor Colvin Goonaratna tells the rest of the story.
“We had to obtain approval from the Ethical Review Committee of the Sri Lanka Medical Association (SLMA) and register the approved trial with the Sri Lanka Clinical Trials Registry (SLCTR), a primary national registry directly linked on-line to the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). The SLCTR provides on-line open access to the essential features of all registered clinical trials in Sri Lanka,” stated Professor Goonaratna.
“With over 800 volunteer participants, recording daily the status of 15 symptoms and their severity over a period of 84 days, at the end of our RCCT, several million bits of data had to be carefully entered by trained data entry operators, and their entries had to be checked for accuracy. The ‘cleaned’ data were independently reviewed and statistically analysed by a team of experts under the supervision and guidance of Professor Roshini Sooriyarachchi, at the Statistics Department of the Colombo University” he added.
Noting that the results that emerged from the statistical operations were startling, he said they may be summarised as follows:
“The average incidence of all 15 symptoms was highly significantly reduced in the Link Samahan group (i.e. test group) when compared to the ‘control group’. Even the symptoms that occurred (much less frequently) in the Link Samahan group, as indicated above, were less severe than in the control group that did not take Samahan.
|Packing Link Samahan into boxes manually at the Factory in Dompe|
“There is no other medicinal product in either the allopathic (i.e. Western) or in any other system of medicine, which has been shown by a scientifically acceptable RCCT to prevent (by reducing their incidence) and reduce the severity of all the 15 symptoms simultaneously, except Link Samahan. Our RCCT is the largest ever RCCT of any kind of medicinal product in Sri Lanka, and the largest RCCT for an herbal product in entire Australasia. The simple remedy for minimizing the 15 symptoms and their severity is to take one sachet of Link Smahandaily in hot water, tea or coffee.”
The Managing Director of Linea Aqua Sharinda Unamboowe states that the RCCT was conducted at their garment factory and that during the trial and after that time, absenteeism was much lower and the productivity was much higher among the employees who took Link Samahan daily than in those who did not take it. As a result, Unamboowe now encourages his employees to take one sachet of Link Samahan daily.
Link Natural Products (Pvt) Ltd. has won the President’s Export Award as selected by the Sri Lanka Export Development Board from year 2005 to date, because it exports Link Samahan to many countries including Canada, Japan, India, Switzerland, Malaysia and the USA.
At present the annual sales of Link Samahan exceeds 100,000,000 sachets, of which over 35,000,000 are export sales. Expatriates returning to their domiciles after holidaying in Sri Lanka, unfailingly take back a bag full of Link Samahan with them. Link Natural Products Chairman and Managing Director Dr. Devapriya Nugawela asserts that the principal reason for undertaking this RCCT were the sustained reports of the beneficial effect of taking one sachet of Link Samahan daily in reducing the symptoms of colds and cataarh from people who took it in hot water, tea or coffee.
“These consumer observations have now been confirmed unequivocally by a large RCCT, performed after ethical committee approval and SLCTR registration, now published in the prestigious Ceylon Medical Journal. It is a matter of pride for our company and for Sri Lanka.”
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