Sunday Times (Sri Lanka)

Recently Concluded Clinical Trial Provides remedy for the Symptoms of Catarrh, Colds and Upper Respirator­y Ailments

- Mr. Tharanga Perera, Factory Manager - Link Natural Products, Mr. T.M.S.G Tennakoon, Head of Research and Developmen­t - Link Natural Products, Prof. Colvin Goonaratna, Consultant - Link Natural Products, Dr. Devapriya Nugawela, Chairman - Link Natural Pro

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. 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 genral sicknesses.

Colds, cataarh 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, Difficulty in daily activities

At present, the only treatment available for these symptoms of colds, cataarh 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 those shown below. - Safety - Efficacy - Quality And there is also world-wide agreement that for testing these properties scientific­ally, the “gold standard” is a “randomized controlled clinical trial”.

The remedy for the prevention of these 15 symptoms and reducing their severity has emerged from a randomized 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 randomizat­ion. 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 further stated.

“The results that emerged from the statistica­l operations were startling. They may be summarized as follows

The average incidence of all 15 symptoms were highly significan­tly reduced in the Link Samahan group (ie. 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.

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. Dr Devapriya Nugawela, the Chairman and Managing Director Link Natural Products 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 SriLanka”.

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