CTRI/2021/02/031551已完成未知
A Randomized, double-blind, placebo-controlled comparative clinical trial to evaluate the efficacy and safety of Probiotic Butter Spread (Probiotic Food) in Healthy Adult Subjects.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 101
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.Age: 18 to 60 years (both inclusive) at the time of consent.
- •2.Sex: Males and Non-pregnant/Non-lactating Females (preferably equal numbers of males and females).
- •3.Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit and agree to follow an accepted method of birth control for the duration of the study.
- •4.Stable weight (+/- 3 kg) for the last 3 months.
- •5.Subjects with BMI >18.4 and <25.0 kg/mÃ?² Normal to Overweight, as per Asian BMI guidelines will be included in the study.
- •6.Subjects with ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed.
- •7.Subjects willing to follow all study instructions and report to facility for all scheduled study visits.
- •8.Subjects with borderline high LDL cholesterol levels i.e. ââ?°Â¥ 130mg/dl and ââ?°Â¤ 160 mg/dl.
- •9.Subjects using a refrigerator for food storage and willing to store the product in a temperature controlled environment.
- •10.Subjects willing to provide blood, urine and stool samples as per study requirements.
- •11.Subjects willing to stay facility one day prior to study visit date to maintain overnight fasting state for every study visit.
排除标准
- •1.Subjects who admit to using any of the following drugs within the last 6 months:
- •a.Antibiotics, anti-microbial agent, steroids, anti-Inflammatory or drugs for IBD
- •b.Lipid lowering drugs
- •c.Drug that suppresses gastric acid or alters gastrointestinal motility
- •d.Cytokines
- •e.Immunosuppressive cytotoxic agents
- •f.Habitual consumers of antacids and laxatives
- •g.Commercial Probiotic consumed in form of capsules etc. on regular basis
- •2.Subjects having history of a gastrointestinal, vesicular or pancreatic disease.
- •3.Subjects with history of surgery of the gastrointestinal tract in the last 12 months.
- •4.Subject who are known Diabetic.
- •5.Subjects who admit to drinking more than 3 glasses of alcohol a day.
- •6.Subject who are having any condition of immunosuppression including HIV.
- •7.Subjects with known Cardiovascular Complications, including high Blood pressure.
- •8.Subjects with impaired renal function identified by serum creatinine ââ?°Â¥ 1.5 mg/dl for males and ââ?°Â¥ 1.4 mg/dl for female.
- •9.Subjects with history of any inter-current illness in the last 8 weeks.
- •10.Clinical evidence of active liver disease or serum alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN).
- •11.Female subjects who are Pregnant or lactating women.
- •12.Any individual who is staff and / or who is involved with conduct of this study.
- •13.Subjects who have participated in another study with any investigational product within 3 months of randomization.
研究者
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