* To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients (BMI 35,0-39,9 kg/m2). * To assess clinical efficacy of Dietressa in the dose of 6 tablets daily after 24 weeks of therapy in reducing body weight in obese patients (BMI 35,0-39,9 kg/m2).
In general, patients will be observed during 24 weeks of trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
331
Percentage of Patients With at Least 5% Weight Loss.
Based on medical records.
Time frame: 24 weeks
Average Absolute Weight Change
Based on medical records.
Time frame: On baseline and after 24 weeks
Average Relative Weight Change
Based on medical records.
Time frame: On baseline and after 24 weeks
Percentage of Patients With at Least 5% Weight Loss.
Based on medical records.
Time frame: On baseline and after 4, 8, 12, 16, 20, 24 weeks of treatment
Average Absolute Weight Change
Based on medical records.
Time frame: After 4, 8, 12, 16 and 20 weeks of treatment
Average Relative Weight Change
Based on medical records.
Time frame: After 4, 8, 12, 16 and 20 weeks of treatment
Change in Waist Circumference, Waist Circumference/Hip Circumference.
Based on medical records.
Time frame: After 4, 12 and 24 weeks of treatment
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
Based on medical records. The short version of the SF-36 quality of life questionnaire is completed at visits 1, 2, 4, 7. The SF-36 questionnaire form consists of 11 sections, in each of which it is required to circle one number on each line. The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical activity score of the SF-36. Items 5-8 primarily contribute to the mental health score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline
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The State Educational institution of High Professional Training Kuban State Medical University of Ministry of Health Care and Social Development of the Russian Federation, Department of Clinical Pharmacology
Krasnodar, Russia
First Moscow State Medical University named after I.M. Sechenov/Endocrinology Faculty
Moscow, Russia
The State Budget Health Care institution of Moscow the City Clinical Hospital No. 11 of the Administration of Health Care of Moscow City
Moscow, Russia
Municipal Medical and Preventive institution "City Clinical Hospital No.10"
Nizhny Novgorod, Russia
The State Budget Health Care institution of Nizhegorodskyi Region "Nizhegorodskaya Regional Clinical Hospital n.a. N.A.Semashko"
Nizhny Novgorod, Russia
The State Educational institution of High Professional Training "Rostov State Medical University" of Ministry of Health Care and Social Development of the Russian Federation, Department of Endocrinology
Rostov-on-Don, Russia
St. Petersburg State Health Care institution "Municipal Hospital No.6"
Saint Petersburg, Russia
St. Petersburg State Health Care institution "Municipal Hospital No.77 of Nevsky District", The City Diabetes Center
Saint Petersburg, Russia
The Federal State Health Care institution L.G. Sokolov Memorial Hospital No. 122 of the FMBA (Federal Medical and Biological Agency).
Saint Petersburg, Russia
The State Educational institution of High Professional Training "St. Petersburg State Medical University n.a. I.P. Pavlov of the Federal Agency for Health Care and Social Development", Faculty Surgery Board
Saint Petersburg, Russia
...and 7 more locations
Time frame: On baseline and after 4, 12, 24 weeks of treatment