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临床试验/CTRI/2024/12/078232
CTRI/2024/12/078232尚未招募不适用

Open labelled comparative clinical Study of ayurveda treatement protocol with thyroxine in Hypothyroidism

Dr Krutika R Hupare1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
1. To develop a protocol for Ayurvedic management of Hypothyroidism.

研究概览

简要总结

The Modern system of medicine is still exploring medicine for better and more effective management of hypothyroidism synthetic thyroid hormone derivatives may bring the value of thyroid stimulating hormone (TSH) and T4 to normal range, but the increased dosage and continuous medicine make the patient drug dependent till the end of life .

The purpose of the study is to develop a protocol for the ayurvedic management of Hypothyroidism in terms of alleviation of sign and symptoms and to maintain serum concentration of T3, T4 without rise in serum TSH at normal level.Hypothyroidism is a commonly prevailing disorder in adult Indian population .It is estimated that about 42 million people suffer from thyroid disorder in India , of which hypothyroidism is most common with a prevalence of 5.4%4.Hence this topic is selected to study the trial drug Shaddharana Churna is a polyherbal formulation which act on rasa dushti ,kapha dusti. It causes Aampachan so that Jatharagnideepna and Dhatwagnideepna will be achieved In this way all the contents of Shaddharana churna helps to break the above Samprapti of Hypothyroidism by correcting dysfunction of Agni.In hypothyroidism the main pathology is present in thyroid gland, which is situated in the Urdhvajatru. Pratimarsha Nasya of Nirgundi Taila is choosen for Nasya Karma.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • newly diagnosed subject who are not on any medications and willing to take ayurvedic treatment already diagnosed subject who are under thyroxin medicine and willing to take ayurvedic medications subjects having serum TSH leval more than 4.5 micro international units per ml.

排除标准

  • Congenital hypothyroidism or anatomical deformity related to thyroid gland.
  • Rapid progressive cases of Myxoedema.
  • Pregnancy and Lactation.
  • Individual with ischemic heart diseases, uncontrolled hypertension, myocardial infarction,cerebrovascular event, cardiac arrhythmias, active malignant disease, patient having PCOD or other hormonal disturbance excluded from study.

结局指标

主要结局

1. To develop a protocol for Ayurvedic management of Hypothyroidism.

时间窗: 90 days

2.To assess effect on different clinical parameters such as Peripheral edema, Dry and coarse skin, Breathlessness, constipation, Lethargy, Hair loss, Weight gain in Hypothyroidism.

时间窗: 90 days

3.To assess the effect on changes in Thyroid profile.

时间窗: 90 days

次要结局

  • 1. To develop a protocol for Ayurvedic management of Hypothyroidism.

研究者

发起方
Dr Krutika R Hupare
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Krutika Rajendra Hupare

10 Kayachikista Department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India

研究点 (1)

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