To evaluate the effectiveness and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment
Ingested, Space Occupying hydrogel capsules is indicated to aid in simple obesity treatment with a Body Mass Index (BMI) of 28-40 kg/m2,using under the guidance of a physician.This clinical trial seek to evaluate the efficacy and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
440
During the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10\~20 minutes before lunch and dinner, and drink at least 500ml of water
During the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10\~20 minutes before lunch and dinner, and drink at least 500ml of water
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Weight loss percentage from baseline at Week 24
Calculation formula:Weight loss percentage from baseline = (weight at Week 24 after enrollment of subject - baseline weight) / baseline weight×100%
Time frame: 24 weeks
Response rate of weight loss at week 24 after enrollment
Calculation formula:Weight loss response rate = Number of subjects with ≥5% weight loss percentage from baseline/total number of subjects ×100%.
Time frame: 24 weeks
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The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Third XiangYa Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Luoyang, China
QILU Hospital Of Shandong University
Jinan, Shandong, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China