CTRI/2018/12/016613已完成未知
A Randomized, Controlled, Multi-Centric, Clinical Study to Evaluate Efficacy and Safety of Honey in Health and Fitness Related Parameters in Healthy Human Volunteers
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 113
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. Healthy human volunteers of either sex in age group of 18 to 60 years (both the ages inclusive)
- •2. Subjects willing to provide informed consent and ready to come for follow-up visits
排除标准
- •1. Subjects with BMI greater or equal to 29
- •2. Presence of clinically significant abnormal laboratory, X-ray, ECG findings at screening.
- •3. History of drug addiction (less than one year)
- •4. Subjects suferring from Diabetes and Hypo or Hyper Thyroidism
- •5. Subjects with uncontrolled hypertension (HT) and known cases of Congestive heart failure (CHF), Unstable angina pectoris, Myocardial infarction (MI)
- •6. Pregnant and lactating mothers
- •7. Chronic Alcoholics/ Alcohol Abuse
- •8. Subjects having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV
- •9. Known hypersensitivity to any of the ingredients used in IP
- •10. Immunologically compromised individuals
- •11. Subjects participated in another clinical study within 3 months before recruitment.
- •12. Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigatorâ??s judgment.
研究者
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