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The purpose of this study is:
In general, patients will be observed during 24 weeks of trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietressa (2 tablets 3 times daily) for 24 weeks | Experimental | Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (2 tablets 3 times daily) for 24 weeks. |
|
| Dietressa (1 tablet 6 times daily) for 24 weeks | Experimental | Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (1 tablet 6 times daily) for 24 weeks. |
|
| Placebo (2 tablets 3 times daily) | Placebo Comparator | Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (2 tablets 3 times daily) for 24 weeks. |
|
| Placebo (1 tablet 6 times daily) | Placebo Comparator | Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (1 tablet 6 times daily) for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietressa | Drug | Comparison of different dosages (frequency) of drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment | assessed after 24 weeks of treatment | |
| Average Body Weight Change After 24 Weeks of Treatment | assessed after 24 weeks of treatment | |
| Average Relative Change in Body Weight After 24 Weeks of Treatment | assessed after 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Symptomatic (secondary) obesity:
Compliance with a diet prescribed and monitored by the doctor to reduce body weight within 6 months before enrollment.
Participation in the lifestyle modification program within 6 months before enrollment.
Patients who quit smoking within 6 months before enrollment, or intending to quit smoking during the period of participation in the trial, as well as intending to begin smoking during the trial.
Uncontrolled arterial hypertension (patients with 1-3 degree AH, receiving no adequate antihypertensive therapy).
Type 1 and 2 diabetes mellitus.
Edema syndrome with various etiology (chronic cardiac failure, nephrotic syndrome, hepatic cirrhosis).
Circulatory failure, IIА degree and above.
Decompensated cardiovascular disease, liver, kidney or gastrointestinal tract disease, metabolic, respiratory, endocrine, hematologic disease, peripheral vessel disease or another medical state. Oncological disease.
Diseases and states, which, in the investigator's opinion, may prevent the patient from participating in the trial.
Past history of bulimia / non-drug abepithymia.
Past history of any bariatric surgeries.
Lipoplasty underwent less then 1 year prior to screening visit, or cavitary surgery less then 6 months prior to screening visit.
Surgeries scheduled within 6 months.
Allergy to/intolerance of any of the drug components used during treatment.
Malabsorption syndrome, including congenial or acquired lactase or another disaccharidase insufficiency.
Administration of drugs specified as "Prohibited concomitant therapy", within 6 months before enrollment.
Pregnancy, breast-feeding, unwillingness to comply with contraception methods during the trial and within 30 days after completion of participation in the trial.
Drug and alcohol consumption (over 2 alc. units daily), mental diseases. Legal incapacity or limited legal capacity.
21. Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure.
22. Participation in other clinical trials within 3 months before enrolment in this trial.
23. Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips). 24. A patient is a part of the center's research staff, taking a direct part in the trial, or an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children or siblings, regardless of whether full blood or adopted.
25. The patient is employed with Scientific Production Firm Materia Medica Holding LLC, i.e. is the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | 350063 | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dietressa 1 | Dietressa: 1 tablet 6 times daily |
| FG001 | Dietressa 2 | Dietressa: 2 tablets 3 times daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo either (2 tablets 3 times daily) or (1 tablet 6 times daily) |
|
| assessed after 4, 8, 12, 16, 20 and 24 weeks of treatment |
| Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | 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. | baseline, 4, 12 and 24 weeks |
| 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 | 119991 | 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 | 127018 | Russia |
| Municipal Medical and Preventive institution "City Clinical Hospital No.10" | Nizhny Novgorod | 603011 | Russia |
| The State Budget Health Care institution of Nizhegorodskyi Region "Nizhegorodskaya Regional Clinical Hospital n.a. N.A.Semashko" | Nizhny Novgorod | 603126 | 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 | 344022 | Russia |
| St. Petersburg State Health Care institution "Municipal Hospital No.6" | Saint Petersburg | 191482 | Russia |
| St. Petersburg State Health Care institution "Municipal Hospital No.77 of Nevsky District", The City Diabetes Center | Saint Petersburg | 192177 | Russia |
| The Federal State Health Care institution L.G. Sokolov Memorial Hospital No. 122 of the FMBA (Federal Medical and Biological Agency). | Saint Petersburg | 194291 | 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 | 197022 | 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", Therapy Faculty Board | Saint Petersburg | 197022 | Russia |
| St. Petersburg state Health Care institution "Saint Venerable Martyr Elizaveta Municipal Hospital" | Saint Petersburg | 197706 | Russia |
| St. Petersburg State Health Care institution "Consultative and Diagnostic Center No. 85", Diabetes Center | Saint Petersburg | 198260 | Russia |
| The State Educational institution of High Professional Training "Bashkirsky State Medical University" of the Federal Agency for Health Care and Social Development, Department of Endocrinology | Ufa | 450000 | Russia |
| The State Educational institution of High Professional Training "Volgograd State Medical University" of Ministry of Health Care and Social Development of the Russian Federation | Volgograd | 400131 | Russia |
| The State Health Care institution "Voronezh Regional Clinical Consultative & Diagnostic Center" | Voronezh | 394018 | Russia |
| The State Health Care institution of Yaroslavl Region the Clinical Hospital | Yaroslavl | 150062 | Russia |
| FG002 |
| Placebo 3 |
Placebo: 1 tablet 6 times daily |
| FG003 | Placebo 4 | Placebo: 2 tablets 3 times daily |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dietressa 1 | Dietressa: 1 tablet 6 times daily |
| BG001 | Dietressa 2 | Dietressa: 2 tablets 3 times daily |
| BG002 | Placebo 3 | Placebo: 1 tablet 6 times daily |
| BG003 | Placebo 4 | Placebo: 2 tablets 3 times daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeter |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilogram |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kilogram/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment | Intention to treat | Posted | Number | percentage of participants | assessed after 24 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Average Body Weight Change After 24 Weeks of Treatment | Intention to treat | Posted | Mean | Standard Deviation | kilogram | assessed after 24 weeks of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Average Relative Change in Body Weight After 24 Weeks of Treatment | Intention to treat | Posted | Mean | Standard Deviation | percentage of body weight | assessed after 24 weeks of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Intention to treat | Posted | Number | percentage of participants | assessed after 4, 8, 12, 16, 20, and 24 weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment | Intention to treat | Posted | Mean | Standard Deviation | percentage of body weight | assessed after 4, 8, 12, 16, 20 and 24 weeks of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment | Intention to treat | Posted | Mean | Standard Deviation | waist hip ratio | assessed after 4,12 and 24 weeks of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention to treat | Posted | Mean | Standard Deviation | scores on a scale | baseline, 4, 12 and 24 weeks |
|
Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=493, Safety Population)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dietressa 1+2 | Dietressa 1: 1 tablet 6 times daily; Dietressa 2: 2 tablets 3 times daily | 3 | 410 | 160 | 410 | ||
| EG001 | Placebo 3+4 | Placebo 3: 1 tablet 6 times daily; Placebo 4: 2 tablets 3 times daily | 0 | 83 | 33 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine bleeding | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Pregnancy NOS | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
| |
| Intervertebral disc sequestration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Vertebral osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| iron-deficient anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment | mild disease |
|
| Сoronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Complaints about palpitations, sweating | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Autoimmune thyroiditis. Subclinical hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Epigastric pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dentalgia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Epigastric burning | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment | nausea after taking the drug before eating |
|
| Heaviness in the right hypochondrium | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Enzymatic insufficiency | Gastrointestinal disorders | MedDRA | Systematic Assessment | ulcerative disease |
|
| Сhronic gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment | acute exacerbation of a chronic disease |
|
| Frequent stool up to 3 times a day | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| exacerbation of chronic pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pastosity of the shins | General disorders | MedDRA | Systematic Assessment |
| |
| Acroedema | General disorders | MedDRA | Systematic Assessment |
| |
| Increase of ability to work | General disorders | MedDRA | Systematic Assessment |
| |
| Thirst perception | General disorders | MedDRA | Systematic Assessment | drinks more fluids |
|
| Hepatitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acute respiratory disease | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acute respiratory disease | Infections and infestations | MedDRA | Systematic Assessment | with tracheobronchitis |
|
| Acute bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acute laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acute rhinopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acute pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cold | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ligamentous injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | 1st metacarpophalangeal right hand joint |
|
| Increase in arterial pressure | Investigations | MedDRA | Systematic Assessment |
| |
| LDL increase | Investigations | MedDRA | Systematic Assessment |
| |
| C-reactive protein increase | Investigations | MedDRA | Systematic Assessment |
| |
| Glucose level increase | Investigations | MedDRA | Systematic Assessment |
| |
| Total cholesterol increase | Investigations | MedDRA | Systematic Assessment |
| |
| HDL increase | Investigations | MedDRA | Systematic Assessment |
| |
| Erythrocyte sedimentation rate increase | Investigations | MedDRA | Systematic Assessment |
| |
| Lymphocytosis level increase | Investigations | MedDRA | Systematic Assessment |
| |
| ALT increase | Investigations | MedDRA | Systematic Assessment |
| |
| Basophilia | Investigations | MedDRA | Systematic Assessment |
| |
| Erytrocytosis | Investigations | MedDRA | Systematic Assessment |
| |
| Leukocytosis | Investigations | MedDRA | Systematic Assessment |
| |
| Monocytosis | Investigations | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Investigations | MedDRA | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Feeling appetite suppressed, decreased feelings of hunger |
|
| Suppressing appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Suppressing appetite | Investigations | MedDRA | Systematic Assessment | Suppressing appetite, feeling of saturation, has become overeat |
|
| Hyperglycaemia fasting | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Glucose intolerance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypercholesteremia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | for sweet food |
|
| Periodic strong desire to eat something | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dorsopathy of a spine | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| gonarthrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | left |
|
| Stiffness in hands | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Lumbar osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Right shoulder joint arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Left hip joint arthrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Unpleasant sweetish taste in a mouth | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Vertebral radiculopathy with moderate musculo-tonic and pain syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Clinical anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Subclinical anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Increased anxiety on a scale HADS | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Mood changes: a tendency towards depression, aggressiveness | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Subclinical depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Clinical depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Increased depression on a scale HADS | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Exaggeratedly mood, unreasonable euphoria | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Unpleasant smell of urine | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hoarseness and throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Skin rash (allergic reaction) | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Increased brittleness of nails | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Atopic dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Xerosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertensic crisis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotonia | Vascular disorders | MedDRA | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Putilovskiy, MD, PhD, Clinical Research and Medical Information Director | Materia Medica Holding | +74952761571 | 302 | PutilovskiyMA@materiamedica.ru |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000605985 | Dietressa |
Not provided
Not provided
Not provided
| Male |
|
| Superiority |
| Cochran-Mantel-Haenszel | 0.0007 | Superiority |
|
|
|
|
|
|
|
|
|
|
| Placebo 4 |
Placebo: 2 tablets 3 times daily |
|
|
|