A double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of Ashwagandha and Selenium combination as a supplement in patients with subclinical hypothyroidism.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. Mean change in Serum TSH levels.
研究概览
简要总结
After completion of screening assessments. All eligible patients who meet the Inclusion and Exclusion criteria will be enrolled in the study.
The trial participants are randomly assigned to either of the two study arms on a 1:1 ratio and the participating subjects are advised to take a capsule that may contain either Ashwagandha + Selenium combination or a Placebo for a period of 90 days
Visit 1- for Screening (Day -5), –Visit-2 (Day 0)- for Randomization/Enrollment, Visit 3- (Day 30 ± 5 days) for 1st follow-up; Visit 4-(Day 60) ± 5 days for 2nd follow up and Visit 5-(Day 90-±5 days) for last visit.
Blood samples for Hematology, Liver function, Renal function, Lipid profile, FBS & HbA1c will be collected at visit 1 & visit 5.
Thyroid function test (Serum TSH, serum T3, serum T4) will be done at visit 1, visit 3, visit 4 & visit 5. Samples for Anti Thyroid Peroxidase test will be collected at visit 2 & visit 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Male and Female participant age ≥18 and ≤ 60 years
- •Patients with serum T3, T4 within Normal Range but serum TSH to be more than Normal (≥ 4.6 µIU/mL.
- •â‰¤ 10 µIU/mL)
- •Participant should be willing to provide a written and signed informed consent and comply with requirements of the trial.
- •Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol.
排除标准
- •Patients under any allopathic or non-allopathic treatment for Subclinical or clinical hypothyroidism.
- •Patients suffering from any other systemic illness viz.
- •diabetes, HTN, liver disorders, cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumor.
- •Patients undergoing treatment for any other systemic illness.
- •Lactating Women & women of childbearing potential who are not willing to follow a reliable and effective contraceptive measure during the study.
- •Patients with Polycystic ovary syndrome (PCOS).
- •BMI ≤18.5 or ≥35 kg/m
- •History of chronic smoking and Alcoholics (Inability to control drinking due to both physical & emotional dependence on alcohol characterized by uncontrolled drinking & preoccupation with alcohol).
- •Those who have participated in any other clinical trial within the last 3 months from the date of visit 1 or who plan to participate in any other study during the clinical trial period.
- •Any other condition that the Principal Investigator thinks may jeopardize the study.
结局指标
主要结局
1. Mean change in Serum TSH levels.
时间窗: 1. Screening Visit to Day 90
次要结局
- 1. Mean change in Serum T3 levels.(2. Mean change in Serum T4 levels)