跳至主要内容
临床试验/CTRI/2025/03/082554
CTRI/2025/03/082554尚未招募2/3 期

A RANDOMIZED OPEN-LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIBHITAKI CHURNA IN MANAGEMENT OF SUBCLINICAL HYPOTHYROIDISM.

Dr Mali Shruti Yuvraj1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1. Significant decrease in serum TSH level.

研究概览

简要总结

Hypothyroidism is a common endocrinological disease affecting the population worldwide. The annual risk of developing clinical Hypothyroidism is ~4%. The global prevalence of hypothyroidism is about 5-10% in women and 0-1% in men. The prevalence of Hypothyroidism in an epidemiological study in eight cities of India is 10.95%.

Hypothyroidism is not a single disease entity but involves multiple systems in the pathogenesis. In the initial stages, symptoms seem to be vague and are often missed to diagnose. Instead, they are treated for PCOD, Infertility, Hyperlipidemia, Depression, etc. The condition of the patient worsens later on by affecting multiple systems. Hence hypothyroidism is an important public health issue.Subclinical Hypothyroidism refers to biochemical evidence of thyroid hormone deficiency in patients who have few or no apparent clinical features of hypothyroidism.Hormone Replacement Therapy (Levothyroxine) is the only available treatment in contemporary medicine. It brings the value of TSH (Thyroid Stimulating hormone) and T4 (Thyroxine) to the normal range but increases in dosage, continuous medication makes the patient drug dependent till the end of life. The major risk of Levothyroxine therapy is over-replacement with anxiety, muscle wasting, osteoporosis, and atrial fibrillation as adverse effects.

Though there is no direct reference regarding nomenclature similar to hypothyroidism in Ayurveda, the condition can be diagnosed based on the clinical presentation. An Anukta vyadhi can be appropriately managed by understanding the pathogenesis in terms of Dosha, Dhatu, Mala, and Agni. Analyzing the above factors, according to the Ayurveda Principles, we can identify the vitiation of Kapha and Vata dosha along with Rasa, Mamsa, and Meda dhatu in manifesting Hypothyroidism.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects with Serum TSH level 4.2mIU/ml to 9.9mIU/ml and Normal serum T3,T4 levels
  • Subjects willing to participate with written informed consent, conveyed in language subject can understand.

排除标准

  • Subjects who have undergone any type of thyroid surgery.
  • Subjects who are on Hormone Replacement Therapy.
  • Subjects with uncontrolled hypertension and diabetes mellitus.
  • 4.Subjects with Coronary artery diesease.
  • Subjects with Congenital, Autoimmune, and Secondary hypothyroidism.
  • Pregnant and lactating women.

结局指标

主要结局

1. Significant decrease in serum TSH level.

时间窗: 0th day- Pretest assessment of subjective and objective parameters | 15th day - assessment during trial period – subjective parameters | 30th day - Post test assessment - subjective and objective parameters | 45th day – Follow up assessment – subjective parameters

次要结局

  • To conduct a detailed literary review of Subclinical Hypothyroidism.(To record & report any adverse effect during the study period.)

研究者

发起方
Dr Mali Shruti Yuvraj
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Mali Shruti Yuvraj

Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore

研究点 (1)

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