CTRI/2014/08/004901已完成4 期
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.
Corona Remedies Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female subjects with 18 â?? 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.
- •7. Subjects with the history of allergy to chitosan or other similar molecule.
- •8. Subject with treatment of fat soluble vitamins and minerals or other dietary aids.
- •9.Subjects with uncontrolled Diabetes Mellitus (HbA1c > 10%)
- •10. Subjects with uncontrolled Hypertension ( > 160 / 100 mm Hg)
- •11. 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.
- •12. Subject have inflammatory diseases of the gastrointestinal tract (e.g. acid reflux disease, gastritis, ventricular or duodenal ulcers, Crohnâ??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).
- •13. 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.
- •14. Participation in any other clinical trial during last 30 days.
- •15. Subject is taking or has taken diet pills or supplements within the past 30 days.
- •16. Alcoholics and/or drug abusers.
- •17. Smoking or Consumption of tobacco products.
研究者
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