A prospective, randomized, double blind, placebo controlled, clinical study to evaluate the efficacy and safety of DigeZyme in the management of Metabolic Health.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 4 Gut Health Questionnaire.
研究概览
简要总结
A prospective, randomized, double blind, placebo controlled study in 60 adult male or female patients with history of metabolic disorders will be conducted to evaluate the efficacy & safety of DigeZyme capsules. The efficacy and safety of DigeZyme capsules. The individual subject participation will be for 90 days. The primary assessments for the study will be body weight and body mass index, serum lipids, stool analysis and gut health questionnaire. The secondary assessments for the study will be quality of life questionnaire and adverse events. Follow up visit will be conducted after at least 15 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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 and/or female patients.
- •2 Age between 18 to 65 years.
- •3 BMI between 30 to 34.9 kg/m
- •4 Willing to come for regular follow-up visits.
- •5 Able to give written informed consent.
排除标准
- •1 Intake of over the counter weight loss agents,centrally acting appetite suppressants in the previous 6 months.
- •2 Pathophysiologic/genetic syndromes associated with obesity.
- •3 Patients on prolonged medication with corticosteroids,antidepressants,anticholinergics, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •4 Patients suffering from major systemic illness necessitating long term drug treatment.
- •5 Symptomatic patient with clinical evidence of heart failure.
- •6 History of HIV and other viral infections.
- •7 Alcoholics and/or drug abusers.
- •8 Prior surgical therapy for obesity.
- •9 H/o hypersensitivity to any of the trial drugs or their ingredients.
- •10 Pregnant/lactating woman.
结局指标
主要结局
4 Gut Health Questionnaire.
时间窗: 1 Body weight and BMI(Screening,Day45 & Day90) | 2 Lipid Profile(Screening,Day45 & Day90) | 3 Stool Analysis(Screening & Day90) | 4 Gut Health Questionnaire(Day0,Day45 & Day90)
3 Stool Analysis.
时间窗: 1 Body weight and BMI(Screening,Day45 & Day90) | 2 Lipid Profile(Screening,Day45 & Day90) | 3 Stool Analysis(Screening & Day90) | 4 Gut Health Questionnaire(Day0,Day45 & Day90)
1 Body weight and BMI.
时间窗: 1 Body weight and BMI(Screening,Day45 & Day90) | 2 Lipid Profile(Screening,Day45 & Day90) | 3 Stool Analysis(Screening & Day90) | 4 Gut Health Questionnaire(Day0,Day45 & Day90)
2 Lipid Profile.
时间窗: 1 Body weight and BMI(Screening,Day45 & Day90) | 2 Lipid Profile(Screening,Day45 & Day90) | 3 Stool Analysis(Screening & Day90) | 4 Gut Health Questionnaire(Day0,Day45 & Day90)
次要结局
- 1 Quality of Life Questionnaire.(2 Adverse Events.)