Leading business house conducts diabetic tea trial on 150 subjects from slum colonies
A leading corporate house engaged in tea business in the country is understood to have surreptitiously conducted clinical trial of diabetic tea involving a small group of 150 subjects in a major slum area in Karnataka, it is learnt.
Informed sources said that the trial was conducted in utmost secrecy with apparently no formal permission from the regulatory authorities. As the tea trial is for a therapeutic purpose, a routine clearance from the DCGI is normally required.
The trial of the diabetic tea was conducted in five slum colonies of the state and was monitored by a medical college hospital, an informed source said. These slum locations are known to be soft targets for clinical trial companies as the subjects drawn from these slums are poor and illiterate and any adverse drug reactions could be hushed up by offering some cash.
The trial went on for a period of 21 days and 150 selected subjects were given the diabetic tea twice a day. The tea contained herbs, which is expected to control the sugar levels. Each patient was paid a fee of Rs 300 a day during the trial period, the source said.
The blood samples were drawn from 150 subjects before the trials and after. First sample was to confirm the blood sugar levels, which was between 180 to 250 mg of the selected subjects. The second sample was drawn on the 22nd day after the 21 day trial to check whether the diabetic tea had brought down the sugar levels.
Sources stated that the tea had a fairly positive impact on the sugar levels because all the 150 patients had shown readings varying between 110mg and 80mg .
While the selected subjects had no problems with the tea they consumed, the clinical investigators gave the tea to subjects who had no diabetics also as they were curious to taste it. These non-diabetics who drank the tea suffered from hypoglycaemia conditions like severe dizziness, profuse sweating, weakness and blurred vision. The sources said that these individuals were not provided any medical care but was given chocolates and glucose powder to control the symptoms by the clinical investigators.
As part of the trial requirements, blood samples were drawn out from over 600 people residing in five slum colonies to ascertain the blood sugar levels. Out of these, 150 were diabetics and to confirm their sugar levels, their blood samples were taken and tested for HIV. And it was found that 40 of these 150 diabetic patients are also suffering from HIV.