CTRI/2023/06/054492已完成3 期
Protocol Title: A prospective, randomized, doubleblind, placebo controlled, parallel groupstudy to evaluate the safety and efficacy of Dose for your Liver (Dietary Supplement) onLiver function and other associated health markers in healthy volunteers. - Nil
EETHO BRANDS INC0 个研究点目标入组 130 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
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
- •Participants are eligible to participate in the study only if they qualify all the
- •inclusion criteria mentioned below.
- •1. Able to provide written informed consent.
- •2.Able and willing to comply with the protocol, including availability for all scheduled study v isits.
- •3. Literate Male and female individuals aged between 18 and 6 0 years (complete), as of the screening date, both
- •4. Female subject s with negative urine pregnancy test Only for female s who had not completed 1 year after menopause & had not gone through hysterectomy or bilateral tubal ligation)
- •5. Participants with liver function test markers within upper normal limits.
排除标准
- •Participants will be excluded from the study if they fulfil any of the following criteria:
- •1. High grade fever defined as body temperature = 40°C.
- •2. Participants with known or suspected hypersensitivity or intolerance to herbal products like turmeric, dandelion, ginger, or organic milk thistle extract
- •3. Has hyper sensitivity to Dose for your Liver (Dietary Supplement/ Investigational Product) or related class of drugs or to any of the excipients of the formulation.
- •4. Participants with liver function test markers above normal limits
- •5. Has presence of any liver related disease or abnormalities
- •6. Are addicted alcoholics and/or drug abusers.
- •7. Has history or presence of coronary, renal, pulmonary and thyroid disease.
- •8. Has used hypolipidemic medications as well as any drug known to affect hepatic function 4 weeks prior to randomization
- •9. Participants with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
- •10. Participants with history of immunocompromised state immune system with/without organ transplant
- •11. Has difficulty in swallowing and retaining oral formulation.
- •12. Is known HBsAg positive, HCV and/or HIV positive. Has hereditary defects of iron, copper and alpha 1 antitrypsin deficient subjects.
- •13. Has hypothyroidism, obstructive sleep apnea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection that are known to have indirect impact on Liver functions
- •14. Had condition or was in a situation that, in the investigator’s opinion, had put the subject at a significant risk, had confounded study results, or had interfered significantly with the subject’s participation in the study
- •15. Those who are not willing to abstain from other home-based remedies that include decoctions or any other form of dietary supplements during the entirety of study participation period.
- •16. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, or other medications within one week of the start of the study.
- •17. Those who have severe mental illnesses, such as dementia, Parkinson’s disease, Alzheimer’s Disease, depression or anxiety disorders, or those who are currently taking psychoneurological
- •drugs, such as antidepressants.
- •18. Those who have participated in other clinical trials within 30 days, prior to the screening visit or plan to participate in other clinical trials during the trial period.
- •19. Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco.
- •20. Females who are pregnant/planning to be pregnant/lactating
研究者
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