The purpose of this study is: * To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients. * To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks of therapy in reducing body weight in obese patients. * To compare clinical efficacy of two dosage patterns for Dietressa (1 tablet 6 times daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.
In general, patients will be observed during 24 weeks of trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
493
Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment
Time frame: assessed after 24 weeks of treatment
Average Body Weight Change After 24 Weeks of Treatment
Time frame: assessed after 24 weeks of treatment
Average Relative Change in Body Weight After 24 Weeks of Treatment
Time frame: assessed after 24 weeks of treatment
Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
Time frame: assessed after 4, 8, 12, 16, 20, and 24 weeks of treatment
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
Time frame: assessed after 4, 8, 12, 16, 20 and 24 weeks of treatment
Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment
Time frame: assessed after 4,12 and 24 weeks of treatment
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
36 items of the questionnaire are grouped into eight subscales. The subscales are grouped in two scales: the "physical component of health" and "mental health component". The scores of each scale range between 0 and 100: the higher the score, the better the quality of life and the better the patient's health. The instruction is not given completely because of the large volume. For more information, see: Ware J.E., Snow K.K., Kosinski M., Gandek B. SF-36 Health Survey. Manual and interpretation guide //The Health Institute, New England Medical Center. Boston, Mass.-1993. In this instruction is explained how eight subscales are combined to compute a total score.
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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
The State Educational institution of High Professional Training I.M. Sechenov First Moscow State Medical University of Ministry of Health Care and Social Development of the Russian Federation, 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: baseline, 4, 12 and 24 weeks