CTRI/2022/02/040565进行中（未招募）3 期
A Prospective, Double Blind, Randomized, Parallel, Single-Center, Two-Arm, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of KSM-66 Ashwagandha® capsule (300 mg) on Subclinical Hypothyroidism
Ixoreal Biomed0 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
- 3 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
- •1.Adult males and females of ages >= 18 years and <=60 years .
- •2.Patients who can and willing to provide written Informed Consent.
- •3.Patients with diagnosis based on persistently elevated TSH levels (4.6â??10.0â??mU/L), with fT4 within the reference range.
- •4. Participant who agree to take Investigational product (IP) till Day 56.
- •5. Patients having capability of complete compliance and completion of followup .
- •6. Participant / participantâ??s legally acceptable representative understands and can comply with clinical trial protocol requirements.
排除标准
- •1. Patients Ë? 18 years or Ë? 60 years of age.
- •2.Patients on current prescription of levothyroxine, antithyroid drugs, amiodarone, or lithium
- •3.Patients having a history or presence of clinically relevant cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumor.
- •4.Patients with severe mental disorder.
- •5.Patients with recent thyroid surgery or radioiodine therapy within 1-year of the start date of the study.
- •6. Patients with recent hospitalization for major illness or elective surgery within 1- year of the start date of the study.
- •7.Female patients with pregnancy or lactation, intention to become pregnant, and/or not using appropriate contraceptive methods.
- •8.Patients with terminal illness.
- •9.Patients with history of alcoholism or substance abuse.
- •10. Patients who are not willing to take investigational product.
- •11. Patients on dietary supplements/multivitamins or disease-specific oral nutrition supplements.
- •12. Patients with uncontrolled, unstable comorbidities.
- •13. Patients with pre-existing respiratory conditions or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease.
- •14. Patients taking part in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements.
- •15. Any other condition which the principal investigator thinks may jeopardize the safety of patients with uncontrolled, unstable comorbidities.
- •16. Patients who had participated in other clinical trials during previous 3 months
研究者
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