CTRI/2025/03/081543已完成3 期
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of Selenium in the given Selenium formulation, L-Seleno Methionine 5000 Calcium hydrogen Phosphate Dihydrate (LSM -5000 CHPD) in normal healthy volunteers.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- o To assess the safety of the given Selenium formulation based on the IP compliance, signs of selenium toxicity, incidence of any AE/SAE due to the IP
研究概览
简要总结
LSM-5000 CHPD formulation in healthy volunteers through a randomized, double-blind design. The study will provide robust evidence to support the safe use of L-SeMet as a dietary supplement By demonstrating the safety and efficacy profile of the organic selenium formulation, the study hascontributed valuable insights to public health recommendations and inform strategies for preventing selenium deficiency-related health issues on a global scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female participants whose age above18 andbelow 49 years and having Body Mass Index BMI in the range of 18 to 25 kgm2
- •Participants must provide written and signed informed consent and comply with the requirements of the study.
- •Must be able to swallow oral medications for 30 days on a daily basis and comply with the study requirements as per the protocol.
- •In good health conditions as determined by study investigator through medical history, physical examination, vital signs, and laboratory tests.
- •Participants must consume Investigational Products only during the study.
- •He or She must refrain from consuming any prebiotic, postbiotic, vitamins, minerals & any other supplements during the study.
- •Female participant of childbearing potential must use an approved method of contraception and must be willing to continue its use throughout the study duration or female participant of non childbearing potential.
排除标准
- •Pregnant and lactating women and having the intention to be pregnant within the next six months 2.Drinking alcohol and smoking in the last three months.
- •3.Consumption of any other medications
- •History or presence of hepatic or gastrointestinal illnesses or other conditions that may interfere with the drugs absorption distribution excretion or metabolism.
- •prescription or over the counter including vitamins and minerals during the study.
- •History of renal pulmonary epileptic hematologic cardiovascular neurological or psychiatric illness and immunodeficiency diseases.
- •6.Blood Pressure 90/60mmHg and 140100mmHg.
- •Glycosylated Hemoglobin HbA1c 4 and 6.5% and Fasting Blood Glucose 70 and 110 mgdL
- •Lipid profile: Total Cholesterol 240 mgdL LDL Cholesterol LDLC 150 mgdL Triglycerides 200 mgdL
- •Thyroid TSH 0.35 & 6.0 µIUmL
- •History of malignancy
- •Subject with history of drug abuse or significant alcoholism.
- •Donation or loss of 450 mL or more of blood within the 3 months prior to ScreeningBaseline.
- •Known case on any form infections.
- •14.Subjects with concurrent serious hepatic disorder defined as Aspartate Amino Transferase AST andor Alanine Amino Transferase ALT Alkaline Phosphatase ALP1.5 times upper normal limitTotal Bilirubin 1.2 or Renal Disorders defined as S.
- •Creatinine 1.2mg/dL & EGFR 60 or less
- •Subject has participated in any clinical trial within the last 3 months.
- •2 Neurological Symptoms Fatigue, irritability and peripheral neuropathy tingling or numbness.
- •3 Dermatological Symptoms Hair loss (alopecia brittle nails and dermatitis.
- •5 Cardiovascular EffectsTachycardia or arrhythmia.
- •6 Liver and Kidney Dysfunction Elevated liver enzymes or impaired renal function.
- •Signs of Selenium deficiency like 1 Weak Immune Function Increased susceptibility to infections or a history of frequent illnesses and lab results during screening.
- •2 Muscle Weakness or Pain Myopathy or general muscle discomfort.
- •3 Fatigue: Generalized fatigue or low energy levels.
- •4 Cardiovascular Symptoms Potential signs of heart issues, particularly cardiomyopathy or heart failure.
- •5 Cognitive and Mood Changes: Anxiety, depression, or mental fogginess.
- •6 Thyroid Dysfunction Signs of hypothyroidism fatigue, weight gain, sensitivity to cold.
- •Any other condition that the Principal Investigator thinks may jeopardize the study.
结局指标
主要结局
o To assess the safety of the given Selenium formulation based on the IP compliance, signs of selenium toxicity, incidence of any AE/SAE due to the IP
时间窗: Day1 to Day30
次要结局
- To assess the improvement in Thyroid function T3 T4, TSH , Antioxidant activity (Glutathione Peroxidase) and Seleno-proteins by measuring the selenium levels (in serum and urine from the beginning till the end of the study period(Day1 to Day30)
研究者
Bharath Raj R
Mithra Multispeciality Hospital
研究点 (2)
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