CTRI/2022/08/044979进行中（未招募）未知
A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of Orally administered NUV001 nutraceutical supplement in Sickle Cell Disease (SCD) patients.
GD SARLNUVAMID0 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
- 未知
- 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
- •1.Men or women over 18 to 65 years, both inclusive.
- •2.Non-smokers.
- •3.BMI > 18 kg/m2
- •4.Patients diagnosed with sickle cell disease (documented by haemoglobin electrophoresis) and carrying SS or Sbeta0 versions of the beta globin gene (documented by genotyping, known through medical history).
- •5.Haemoglobin levels between 5.5 and 10.5 g/dl during Screening (for newly diagnosed or patients not on any treatment for SCD).
- •6.If the patient has been treated with an anti-sickling agent within three months of the Screening visit, the therapy must have been continuous for at least three months with the intent to continue for the duration of the study.
- •7.Available to attend on an outpatient basis for visits provided for in the protocol and able to complete the data collection documents (compliance and quality of life scale)
- •8.Patient or the patient’s legally authorized representative has given written informed consent.
排除标准
- •1.Patients with known or suspected allergy to any ingredient of the food supplement (NMN, Isomalt, Magnesium stearate etc.)
- •2.Patient having consumed vitamin or food supplements containing niacin, tryptophan, NMN or NR during the month before selection.
- •3.Patient has a significant medical condition that required hospitalization (other than sickle cell crisis) within two months of the screening visit.
- •4.Patient has prothrombin time INR > 2.0.
- •5.Patient has serum albumin less than 3.0 g/dl.
- •6.Patient has received any blood products within three months of the Screening visit.
- •7.Patients hospitalized for acute vaso-occlusive crisis within one month of the Screening visit.
- •8.Patient has clinically significant, cardiovascular or liver disease or renal insufficiency or lymphopenia , evident in medical history (with clinically significant abnormal results on the Screening bioassays for eg.: Complete blood count, Aspartate transaminases, Alanine transaminases, Gamma glutamyl transferase, Alkaline Phosphatase, Bilirubin, Creatinine, Creatinine Phosphokinase, Blood Glucose, HbA1c, Lipid Profile).
- •9.Patient with diagnosed cancer in the past 2 years.
- •10.Patients participating simultaneously in another clinical research protocol or having recently participated in another research for which the exclusion period has not been completed.
- •11.Pregnant, lactating or parturient women.
- •12.Persons deprived of their liberty by a judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than that of research.
- •13.Majors under legal protection or unable to express their consent.
- •14.People in an emergency situation unable to express their prior consent.
研究者
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