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临床试验/CTRI/2022/04/041594
CTRI/2022/04/041594已完成2/3 期

A RANDOMIZED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF SHATPUSHPA CHURNA, DHANYAK SHUNTHI PANIYA AND NIDANA PARIVARJAN IN MANDAGNI WITH SPECIAL REFERENCE TO SUBCLINICAL HYPOTHYROIDISM.

NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月6日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Change in TSH value

研究概览

简要总结

Subclinical hypothyroidism (SCH) is biochemically defined as an elevated level of thyroid stimulating hormone (TSH) with normal level of free thyroxine (FT4) in the blood with minimal or no signs and symptoms of thyroid dysfunction. The most common cause of subclinical hypothyroidism is chronic autoimmune thyroiditis associated with antithyroid peroxidase antibodies (Hashimoto’s thyroiditis) but it can also occur due to other causes. Subclinical hypothyroidism can be classified as Mild Grade 1 SCH (upper limit of TSH 9.9 mIU/L) and severe grade 2 SCH (TSH ≥10mIU/L). Individuals with subclinical hypothyroidism are often asymptomatic, but clinical manifestations similar to overt hypothyroidism are present in milder form. Several meta-analyses of observational studies have revealed an association between SCH and coronary artery diseases.

There is no direct description of hypothyroidism or subclinical hypothyroidism  in Ayurvedic texts. There are many diseases which are not mentioned directly in Ayurveda texts and are called as Anukta vikar. Subclinical hypothyroidism is one of such disease. According to Acharya Charak,  it is not possible to name every disease but it is important to understand the possible pathogenesis of the disease in terms of Dosha, Dhatu, Mala & Agni because the vitiated Doshas due to difference in Nidana give rise to different disease at different places. Therefore, if a physician understands the Prakriti, Adhishthan and Samuthan vishesha of the disease it can be managed successfully.

On reviewing literature on SCH**,** it has been found that Subclinical Hypothyroidism in Ayurveda has been correlated with terms like Agnimandhya, Dhatwaagnimandhya, Raspradoshajvikara and Avranjanya vikara, the root cause of all these disorders being abnormality of Agni. However, there is a lack of scientific studies establishing an association of status of Agni and SCH.  With all these points in mind the current study has been planned with an aim to estimate the prevalence of Agnivaishamya in patients with Subclinical hypothyroidism and to study the effect of Agnideepan chikitsa in patients of Subclinical hypothyroidism with Mandagni.

In this study patients of subclinical hypothyroidism will be interviewed and an assessment of Agni will be done using Agni assessment questionnaire and Patients of subclinical hypothyroidism with Mandagni will be enrolled to study the effect of Shatpushpa Churna, Dhanyak Shunthi Paniya and Nidana Parivarjana on TSH level and symptoms of Mandagani.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

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.Patients between the age of 18-60 years of either sex. 2.Patients with subclinical hypothyroidism with TSH levels ranging from 5.5µIU/ml.
  • 20µIU/ml.
  • k/c/o Subclinical Hypothyroidism but still not taking Levothyroxine therapy. 4.Patients willing to take Ayurvedic medicine and sign the consent form. 5.Patients having symptoms of Mandagni.

排除标准

  • 1.TSH level above 20 µIU/ml.
  • 2.Patients already under Levothyroxine therapy.
  • 3.Patients suffering from congenital hypothyroidism, overt hypothyroidism, and secondary hypothyroidism.
  • 4.Patients of hyperthyroidism, neoplasia, toxic goitre are excluded.
  • 5.Patients who have undergone any type of thyroid surgery.
  • 6.Patients suffering from systemic diseases like cardiac problems, diabetes, carcinomas etc.
  • 7.Patients taking drugs known to alter thyroid hormone level (e.g., Amiodarone) 8.Patients who are pregnant or expecting pregnancy in next six months.
  • 9.Recent hospitalization for major illness, to exclude with ESS (Euthyroid Sick Syndrome).

结局指标

主要结局

Change in TSH value

时间窗: 60 DAYS

次要结局

  • Change in the symptoms of Mandagni(Change in general sign and symptoms associated with subclinical hypothyroidism.)

研究者

发起方
NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR
申办方类型
Research institution and hospital

研究点 (1)

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