Clinical Trial to Assess the Efficacy and Safety of Fring Tablet in the Treatment of Obese Patients

Suh, Heuy Sun; Choi, Jun Young; Lee, Sun Nyu; Kim, Sang Man; Lee, Kyurae

Abstract

BACKGROUND: This clinical study is to prescribe 35mg Furing tablet(1 tablet) to obese people three times a day for 8 weeks, and evaluate its safety and the effect on weight loss.
METHODS
Among the obese people visited the clinic, aged between 18 and 65 with BMI(body mass index) of 25 and above or with BMI of 23 and above and men with a waist measurement of more than 90cm and women with a more than 80cm were selected as subjects. 70 people were chosen except those who had uncontrollable hypertension(SBP>150mmHg or DBP 100mmHg), severe liver or renal dysfunction, mental disorders, glaucoma, or showed a weight loss more than 10% three months before they visited the clinic. The first validation variable was weight loss: we checked patients' weights every time they visited the clinic(every four week). The second validation variables were the extent of weight loss, the waist-tohip ratio, BMI, percent body fat, changes in muscle mass, and serum lipid(Triglyceride, Total Cholesterol, High-Density Lipoprotein, Low-Density Lipoprotein). To evaluate safety of medication, we conducted clinical experiment eight weeks before and after, checked vital signs every time the subjects visited, and evaluated side effects during the study.
RESULTS
The average age of study groups was 38.9+/-11.7, gender consisted of four males(5.7%), 66 females(94.3%), and side effects were reported in six people(8.6%). After Furing was prescribed two months, subjects' weights were reduced by 5.9+/-2.9 %. The weight loss after the medication of Furing was so statistically significant that it recorded a 4.6 +/-2.3g decrease(P<0.0001). Other factors also reduced: waist measurement by 4.9+/-4.2cm; BMI by 1.7+/-0.9kg/m2 from 28.1+/-2.8kg/m2 to 26.4+/-2.8 kg/m2; percent body fat by 2.2+/-2.0%; muscle mass by 1.8+/-2.5kg. All of which indicated statistically significant difference. SBP and DBP also showed statistically significant difference, dropping by 6.9+/-13.2mmHg, 3.0+/-10.9mmHg, respectively(P<0.0001, P=0.025). Statistically significant decrease also appeared on serum lipid profile of total cholesterol(P < 0.0001), HDL(P=0.042), LDL(P=0.0004), Triglyceride(P=0.002). Total ten side effects were reported: two cases of dizziness(2.9%), epigastric pain(2.9%), and headache(2.9%), and one of lethargy(1.4%), hand tremor(1.4%), gastric discomfort(1.4%), and vertigo(1.4%).
CONCLUSION
There were limitations in this study that it had no placebo group and conducted within a short period of eight weeks. Yet, as far as the prescription of Furing is concerned, its weight loss effect was appropriate and it had few side effects.