CTRI/2021/10/037363进行中（未招募）4 期
Prospective Interventional Study to Determine the Effectiveness of ORSL�® Variants as an Adjuvant to help restore Oral Fluid, Electrolytesand Energy (FEE) Along With Standard of Care Medication Treatment in Recovery for Subjects With Fever And/Or General Weakness in Out-Patient Setting Among the Indian Population
Johnson and Johnson Pte Limited0 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
- 4 期
- 状态
- 进行中（未招募）
- 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
- •Subjects ââ?°Â¥18 years of age
- •- Able to comprehend and willing to sign an ICF and to comply with all aspects of the study
- •- Subjects should be willing and able to respond to subjective questions
- •- Subjects must have scores <3 in both energy and hydration on the ââ?¬Å?Aided Recovery Scaleââ?¬? at the time of the screening (baseline) visit
- •- Subjects diagnosed in the preceding two weeks with acute febrile illness (e.g. URTI, viral illness) and/or generalized weakness/fatigue due to acute non-diarrheal illness
排除标准
- •- Subjects needing in-patient hospitalisation
- •- Subjects who have undergone any GI surgeries, which are known to affect absorption anytime in the past
- •- Women who have a positive pregnancy test at screening
- •- Subjects with pre-existing medical conditions that may impact study measurements or ability to comply with study procedures, including but not limited to malabsorption syndrome, congestive heart failure, cirrhosis, hepatic failure, malignancy, sepsis,
- •chronic infections like Tuberculosis, Chronic obstructive pulmonary disease, Syndrome of inappropriate antidiuretic hormone secretion, renal failure, etc.
- •- Participation in any clinical trials in the last 3 months
- •- Use of any other oral rehydration solution and/or ORSLÃ?®variants as adjuvant and/or any other ready to drink solution in the last 48 hours.
- •- Use of any medications which might interact with ORSLÃ?® variants as per physician discretion
- •- Subjects with nausea, vomiting, diarrhoea, suspected or confirmed malaria, dengue or
- •typhoid confirmed by culture positive test, active COVID-19 disease, subjects in convalescence post COVID-19 <3 weeks and off steroid <2 weeks
- •- Subjects presenting with a urinary tract infection (UTI)
- •- Subjects who, in the Investigatorââ?¬•s opinion, are not suitable to take part in the study
- •- Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., Principal Investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson & Johnson subsidiaries, contractors of
- •Johnson & Johnson, and the families of each)
研究者
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