CTRI/2022/06/042963已完成2 期
AN OPEN LABEL, BALANCED, RANDOMIZED, MULTICENTER, AND PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECT A FOOD (MAYONNAISE), ENRICHED WITH DOCOSAHEXAENOIC ACID (DHATG) (AS THE TRIGLYCERIDE ESTER), HAS ON THE CELL MEMBRANE FATTY ACID RATIO OF BLOOD CELLS OF SICKLE CELL PATIENTS RANGING IN AGE FROM 6 ââ?¬â?? 40 YEARS OF AGE.
RAJALAKSHMI HOSPITA0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- •Male and non-pregnant female patients 6 ââ?¬â?? 40 years of age
- •Ã¯â??· Confirmed diagnosis of sickle cell disease. All sickle cell disease genotypes are eligible
- •Ã¯â??· Experienced at least 1 VOC within the preceding 12 months prior to Screening, as
- •determined by medical history
- •Ã¯â??· If receiving HU/HC or erythropoietin stimulating agent, must have been receiving the
- •drug for at least 6 months prior to Screening
- •Ã¯â??· Hemoglobin ââ?°Â¥4.0 g/dL. Absolute neutrophil count ââ?°Â¥1.0 x 109/L and platelet count ââ?°Â¥75 x
- •Ã¯â??· Adequate renal and hepatic function as defined:
- •Ã¯â??§ GFR ââ?°Â¥45 mL/min/1.73 m2 calculated by CKD-EPI
- •ALT ââ?°Â¤3 x ULN
- •Ã¯â??§ Direct (conjugated) bilirubin ââ?°Â¤2 x ULN
- •Ã¯â??§ ECOG performance status ââ?°Â¤2
- •Ã¯â??· Willing to comply with all requirements of this study protocol as well as instructions by
- •the study personnel.
- •Ã¯â??· No other clinically significant abnormal finding onMedical history, physical
- •examination (including but may not be limited to an evaluation of the cardiovascular,
- •gastrointestinal, respiratory, musculoskeletal and central nervous systems).
排除标准
- •History of stem cell transplant
- •Ã¯â??· Acute VOC ending 7 days prior to first dosing
- •Ã¯â??· Ongoing hospitalization prior to Screening
- •Ã¯â??· Received blood products within 30 days to first dosing
- •Ã¯â??· Participating in a chronic transfusion program (pre-planned series of transfusions for
- •prophylactic purposes)
- •Ã¯â??· If the patient has undergone any experimental oral intervention within the last 24 hours.
- •Ã¯â??· History of alcohol addiction or abuse.
- •Ã¯â??· Patient who had participated in any other study within the 90 days of study
- •Ã¯â??· Females likely to become pregnant during conducting of the study
- •Ã¯â??· Pregnant and Lactating females.
- •Consumption of tobacco containing products Tobacco and tobacco products (like
- •Khutkha, Pan/ Pan Masala, Beedi, Cigarettes) for at least 24.00 hours prior to screening
- •and throughout the entire study
- •Ã¯â??· Consumption of vaping products
- •Ã¯â??· Any other major illness in the last 03 months or any other significant ongoing chronic
- •medical illness.
- •Ã¯â??· Evidence of allergy or known hypersensitivity to Omega 3 fatty acid (DHATG) in
- •Mayonnaiseand its components.
- •Ã¯â??· Any allergy to mayonnaise and its components
- •Ã¯â??· History of dehydration from diarrhea, vomiting or any other reason within a period of
- •48.00 hours prior to study check-in of each visit.
- •Ã¯â??· Patients with any condition which in the opinion of the investigator makes the patient
- •unsuitable for inclusion
- •Ã¯â??· Patients with Malignancy or a history of malignancy
- •Ã¯â??· Patients with Positive results for HIV or Hepatitis B or C
研究者
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