CTRI/2022/02/040565已完成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 Biomed2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in Standard TSH, T3, T4
研究概览
简要总结
Sixty healthy male or female subjects of age 18-60 will be assigned in 1:1 ratio to treatment with the test product, KSM-6 Ashwagandha capsules or Placebo in this double-blind, randomized, placebo-controlled study. All 60 enrolled subjects will be instructed to take two capsules of either KSM-66 Ashwagandha or Placebo twice a day one capsule after breakfast and one capsule after dinner for 56 days daily. Subjects will be required to use diaries to document the date, time and dosage of study treatments including any missed doses and the occurrence of any adverse events. The efficacy of investigational product will be assessed primarily with TSH, T4 and T3 in blood and secondarily with administration of THY questionnaire, SF 12, PSS 10, MMSE, PSQI and PGATT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
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 (4.6–10.0 mU/L), with fT4 within the reference range.
- •Participant who agree to take Investigational product (IP) till Day
- •Patients having capability of complete compliance and completion of followup .
- •Participant / participant’s legally acceptable representative understands and can comply with clinical trial protocol requirements.
排除标准
- •Patients Ë‚ 18 years or ˃ 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.
- •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.
- •Patients who are not willing to take investigational product.
- •Patients on dietary supplements/multivitamins or disease-specific oral nutrition supplements.
- •Patients with uncontrolled, unstable comorbidities.
- •Patients with pre-existing respiratory conditions or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease.
- •Any other condition which the principal investigator thinks may jeopardize the safety of patients with uncontrolled, unstable comorbidities.
- •Patients who had participated in other clinical trials during previous 3 months.
结局指标
主要结局
Changes in Standard TSH, T3, T4
时间窗: Baseline and Day 56
次要结局
- 1.Change in SF 12 (QoL) between baseline and end of treatment.(2.Change in QoL-THY between baseline and end of treatment)
研究者
研究点 (2)
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