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Clinical trial finds herbo-mineral drug effective as tocolytic agent
R BabyManoj - Mysore
A new herbo-mineral drug, Evatone, recently developed by a Bangalore-based
herbal pharmaceutical company may help extend pregnancy among women who are
likely to deliver prematurely (pre-term labour).
 The
clinical trial was conducted by a team of senior gynaecologists based in Mysore,
which incude Dr S Kamalamma and Dr Harini Kantharaj. “The drug has shown
promising results as a tocolytic agent in idiopathic pre-term labour cases,”
Dr Kamalamma informed Express Pharma Pulse.
If further studies validate its efficacy, the drug will be a boon to millions
of women and new borns as the existing tocolytic agents like sympathomimetics
eg., ritordine, calcium channel blockers and magnesium sulphate having a number
of side-effects can be done away with.
‘‘Most of the other tocolytics have their own harmful side-effects
and administration which requires close monitoring in a well equipped place.
The result of our study indicates that Evatone suppresses the uterine contractions,
which is rever-sible. It does not have any harmful side-effects and does not
require close monitoring like other tocolytic agents’’, Dr Kamalamma
said.
Pre-term labour is a major challenge confronting obstetricians
and perinatologists worldwide. The World Health Organization (WHO) defines pre-term
labour as ‘the labour which sets before 37 completed weeks of pregnancy.’
Of all the human pregnancies, 5-10 per cent culminate in pre-term labour.
‘‘Despite substantial advance in perinatal medicine, only a little
progress has been made to reduce the frequency of pre-term delivery. Our study
included 200 cases having warning signs of pre-term labour with idiopathic cause
where pre-term labour might be due to incr-eased production of prostaglandins.
Hundred cases were between 28 and 33 weeks of gestation and the remaining 100
cases were between 34 and 37 weeks of gestation. In these cases, all the other
probable causes of pre-term labour were ruled out; all patients were admitted,’’
Dr Kamalamma added.
Explaining the dosage used for the trials she said, ‘‘We started with
20 ml. Every hour 10 ml was administered for four hours, followed by a 10 ml
every fourth hour for five days. Then 15 ml thrice a day for the rest of the
pregnancy. All the cases were given dexamethesone separately for lung maturity.’’
Overwhelmed by the success of the clinical trial, Dr Kamalamma is planning more
trials to validate the drug further. Currently, the success rate of the drug
is 67 per cent. ‘‘Out of the two hundred cases, between 28 and 37
weeks of gestation, 134 cases responded to our treatment and pregnancy continued
for an average 2.5 weeks more,’’ she explained.
Dr Kamalamma had also presented a paper on the clinical trial during the ‘7th
World Congress and 15th Indian Conference on Reproductive and Child Health’
held in Chennai.
rbmanoj@expressindia.com
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