CTRI/2023/11/059798招募中2 期
A Prospective, Interventional, Randomized, Double-Blind, Parallel, Multi-Arm, Controlled, Phase 2 Clinical Study to Evaluate the Efficacy and Safety of SlimSEB and ProbioSEB CSC3 in Overweight and Obese Subjects with the Risks of Type 2 Diabetes Mellitus - NA
Advanced Enzymes Technologies 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
- 2 期
- 状态
- 招募中
- 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/female participant of = 30 and = 65 years of age.
- •2. Participant who can and willing to provide written Informed Consent.
- •3. Participants meeting WHO defined criteria for overweight (BMI, 26-29.9 kg/m2) or obese (BMI, = 30 kg/m2).
- •4. Participant with the risks of type 2 diabetes mellitus (fasting glucose) for impaired fasting glycaemia [IFG, 6.1–7.0mmol/L (110–125 mg/dL)].
- •5. Participant / participant’s legally acceptable representative understands and can comply with clinical trial protocol requirements.
排除标准
- •1. Participant ? 30 or ? 65 years of age.
- •2. Participant with type 2 diabetes mellitus [(fasting glucose) = 7.0mmol/L (= 126 mg/dL)].
- •3. Participants with other comorbidities or metabolic syndrome or non-alcoholic steatosis.
- •4. Participants currently undergoing any weight loss treatment through diet restrictions or medicines and are not willing to refrain from that regime at least one month prior to enrollment.
- •5. Participant on aggressive diet attempts within last 3 months or addicted alcoholics and/or drug abusers.
- •6. Participant with current or history of treatment that may cause significant weight gain.
- •7. Participant with eating disorders, e.g., anorexia nervosa, bulimia nervosa and binge-eating disorder.
- •8. Participant with weight change of 5 kg since last 3 months.
- •9. Pregnant and/or nursing woman.
- •10. Participant with any clinically significant illness.
- •11. Participant contracted with COVID-19 infection.
- •12. History or presence of coronary, renal, pulmonary, and thyroid disease.
- •13. Active or a history of inflammatory bowel disease.
- •14. Has undergone any abdominal surgery, except for hernia repair or appendectomy.
- •15. Participants receiving medication for lowering serum cholesterol level.
- •16. Participants either used probiotic products within 6 weeks prior to screening in the current trial or currently receiving other probiotic products.
- •17. Participant who underwent antibiotics or systemic steroid or anti-psychotic therapy within 14 days prior to screening.
- •18. Participant with a history of hypersensitivity to any of the components of the investigational products or excipients used in the formulation of investigation product.
- •19. Participant who has participated in another trial with an investigational product within 1 month prior to this trial.
- •20. Participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
研究者
相似试验
尚未招募
Unknown
Clinical study to evaluate Efficacy and Safety of Clearstone syrup (sugar free)in Asymptomatic renal calculi patients.CTRI/2024/08/072127SBL Pvt. Ltd
已完成
2 期
A clinical trial to evaluate efficacy and safety of probiotics as immunomodulators in acute allergic rhinitis.CTRI/2020/09/027657Advanced Enzyme Technologies Ltd80
进行中（未招募）
2 期
Phase 2 Study to Evaluate the Effectiveness and Safety of Probiotics in Healthy Overweight and Obese patients with the Risks of Type 2 Diabetes Mellitus and Cardiovascular DiseasesCTRI/2021/08/035420Advanced Enzymes Technologies Ltd
已完成
2 期
A Clinical Study to Evaluate the Effectiveness and Safety of Bacillus coagulans LBSC in Patients with Irritable Bowel Syndrome.CTRI/2018/02/011654Advanced Enzymes Technologies Ltd40
尚未招募
3 期
To Evaluate the Efficacy and Safety of ANT-V Syrup to show antiviral action of upper respiratorytract like common cold and act as an immune booster to fight against infection, flu, fever, sorethroat, nasal and chest congestion Breathlessness in COVID-19 patients.CTRI/2020/11/028897Bhargava Phytolab Pvt Ltd