A Phase IV, Multicenter, Randomized, Single Blind, Placebo-Controlled clinical study to evaluate the efficacy and safety of KiOnutrime-CsG capsules manufactured by KitoZyme for the treatment of excess weight, weight control.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Reduction of body weight on day 45 and 90 versus baseline.
研究概览
简要总结
A Phase IV, Multicenter, Randomized, Single Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy And Safety of KiOnutrime-CsG capsules for the treatment of excess weight, weight control. eligible subjects will be enrolled into study as per 2:1 randomization ratios. Total of 90 male or female subjects will be enrolled in the study. Out of 90 subjects, 60 subjects will be enrolled into treatment group and 30 in placebo group. Subjects should take one capsule of Investigational product (KiOnutrime- CsG capsules) or placebo 15 minutes before breakfast and two capsules of Investigational product (KiOnutrime- CsG capsules) or placebo 15 minutes before lunch and dinner, each time with a large glass of liquid (water) for 90 days. Subjects will be evaluated for physical examinations including vital signs, body weight measurements and upper abdominal circumference, hip circumference, waist circumference and waist:hip ratio, body composition (body fat, muscle mass, bone mass, BMI, visceral fat). Questionnaire for quality of life measurement as per SF-36 scale. Blood sample will also be collected to measure safety parameters HbA1c level, safety parameters (SGPT, SGOT, creatinine and urea) and lipid Profile (TG, HDL, LDL and VLDL). KiOnutrime-CsG Active ingredient: 500 mg chitosan (biopolymer N-acetyl-D-glucosamine and D-glucosamine) from Aspergillus niger mycelium and other components: magnesium stearate, silica
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects with 18 – 65 years of age (both inclusive).
- •2.Subject/legally acceptable representative (LAR) of subject willing to sign and date written informed consent to participate in the study.
- •However, if the subject/LAR of subject is illiterate, the impartial witness will sign the ICF.
- •3.Subjects with BMI of 26 to 35 (both inclusive).
- •4.Subject has clearly visible fat on intended treatment area(s), which in the investigators opinion, may benefit from the treatment(s).
- •5.Willingness to comply with the study schedule and procedures.
排除标准
- •1.Subject has history of surgical procedure(s) in the area of intended treatment in the past 6 months.
- •2.Subject has history of invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past one year.
- •3.Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past one month.
- •4.Subject on stable dose of metformine, pioglitazone or on glucagon-like peptide analogues.
- •5.Subject has a history of bleeding disorder or is taking any medication that in the investigators opinion may increase the subjects risk of bruising.
- •6.Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
- •Subjects with the history of allergy to chitosan or other similar molecule.
- •Subject with treatment of fat soluble vitamins and minerals or other dietary aids.
- •9.Subjects with uncontrolled Diabetes Mellitus (HbA1c > 10%)
- •Subjects with uncontrolled Hypertension ( > 160 / 100 mm Hg)
- •Subjects on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, anticoagulants or any other drugs that may have an influence on the outcome of the study.
- •Subject have inflammatory diseases of the gastrointestinal tract (e.g. acid reflux disease, gastritis, ventricular or duodenal ulcers, Crohn’s disease, ulcerative colitis, diverticulitis), signs of intestinal obstruction (impending or existing mechanical or paralytic ileus), gastroparesis in diabetics with neuropathy, intestinal polyps and existing severe digestive disorders (constipation).
- •Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period, or is breast feeding or in preparations used in the treatment of menopause disorders.
- •Participation in any other clinical trial during last 30 days.
- •Subject is taking or has taken diet pills or supplements within the past 30 days.
- •Alcoholics and/or drug abusers.
- •Smoking or Consumption of tobacco products.
结局指标
主要结局
Reduction of body weight on day 45 and 90 versus baseline.
时间窗: Day 45 to 90
次要结局
- • Mean change in body fat, muscle mass, bone mass, BMI, visceral Fat.(• Mean change in lipid profile.)