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KMID : 0378019850280100063
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New Medical Journal
1985 Volume.28 No. 10 p.63 ~ p.67
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Clinical trials for Drotaverine hydrochloride(No-Spa^(®)) on pain and functional disorders caused by spasms of the smooth muscles
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Abstract
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The purpose of this report is to assess the clinical effectiveness and any possibility of untoward reactions of Drotaverine hydrochloride (No-Spa®) in the application of Internal Medicine department for pains and functional disorders caused by spasms of the smooth muscles. 67 patient(male : 37 patients, female : 30 patients) were experienced in this study.
Average age of male is 40.3 years old, that of female is 38.7 years old.
Their clinical symptoms are gastro-duodenal ulcer (22 patients 32.8%), gastritis(20 patients 29.85%), colitis(25 patients 37.31%)
This study was done as an double-blind clinical trial at out patient clinic of internal medicine of Chonnam university hospital. Patients were given 1 tablet(40mg of Drotaverine hydrochloride: No-Spa® 1 tablet or lactose tablet: as placebo), three times a day.
After 4 days treatment, we can get following results;
1) The general effect of drug for gastro-duodenal ulcer was excellent in 5 cases(31.2%), good in 11 cases (68.75%),. whole patients treated with Drotaverine hydrochloride showed good response.
2) The general effect of drug for gastritis was excellent in 8 cases(57. 14%), good in 5 cases (35. 72%), fair in 1 cases(7.14%), 13 cases(92.86%) treated with Drotaverine hydrochloride showed good response.
3) The general effect of drug for colitis was excellent in 7 cases(38. 89%) good in 9 cases: (50%), fair in 2 cases(11.11%), 16 cases(88.89%) treated with Drotaverine hydrochloride showed good response.
4) 45 cases(93. 75%) in treatment group showed good response compared to 1 case(5.26%) in control group.
Although dry mouth was experienced in 1 case in patient with colitis, this symptom was rapidly relieved.
Otherwise no significant untoward side-effect of the drug was noted in this trial.
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