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临床试验/CTRI/2023/10/058711
CTRI/2023/10/058711尚未招募不适用

A Randomized Controlled Clinical Study To Evaluate Add On Effect Of Varunmoola Kwath Ghana Vati With Thyroxine In Hypothyroidism.

PDEAs College Of Ayurved And Research Centre Nigdi Pune1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月28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
60
试验地点
1
主要终点
1.To Study efficacy of Varunmoola kwath Ghanavati with Thyroxine in the management of hypothyroidism for 60 days.

研究概览

简要总结

Non Communicable diseases are the leading cause of adult mortality and morbidity worldwide. Hypothyroidism is a metabolic disorder as it involves the underproduction of hormones that play a role in metabolism  Hypothyroidism is believed to be a common health issue in India, as it is worldwide. The most common presentations of thyroid disorders are hypothyroidism, hyperthyroidism,and enlargement if thyroid gland. widespread availability of thyroid function tests has led to the increasingly frequent identification of patients with abnormal results who either are asymptomatic or have non-specific complaints such as tiredness and weight gain.Untreated hypothyroidism can lead to a number of health issues, Heart problems, Mental health   issues (Depression), Peripheral neuropathy, Myxoedema, Infertility, Birth defects3.  42 million people in India have thyroid disorders and hypothyroidism is the most common of thyroid disorders in India, affecting one in ten adults.The prevalence of hypothyroidism in India is 11%, compared with only 2% in the UK and 4·6% in the USA4.Over 8% of Indian is at a higher future risk of getting affected, and 1/3rd of the hypothyroid patients is unaware of the condition Reduced Production of thyroid hormone is the central feature of the clinical state termed hypothyroidism. Primary hypothyroidism which is due to disease of thyroid itself ,accounts for approximately 99% of cases, with  less than 1% being due to TSH deficiency known as central or secondary hypothyroidism.In adult hypothyroidism clinical features can largely be explained by the reduced metabolic rate and symptoms of hypothyroidism develop gradually. Skin is pale and cool and

reduction in sweat and sebaceous secretion causes dryness and coarseness, decrease in exercise tolerance , cold intolerance, weight gain. In modern medicine the treatment for hypothyroidism is the administration of thyroxine in the form of tablet, orally. Acharya Charak emphasized that nomenclature of the diseases is not much important to treat the diseases, rather he insists on diagnosis of the constitutional status and plan the treatment accordingly.  On reviewing the clinical presentation from all classical texts it is found that in hypothyroidism there is abnormality of Jatharagniand Dhatwagni along with abnormality of Kapha and VataDosha as well as Rasavaha, Raktavaha,Medovaha, Shukravahaand Manovaha Srotases. Dosha-Dushyasamoorchhana in various Dhatus results in the systemic manifestation of the disease. Thus, the line of treatment involves Deepana, Pachana, SrotoshodhanaandKaphavata shamana8.  At this present moment hormone replacement therapy is available for hypothyroidism, there is and there is need of time to find proper and efficient supportive Ayurvedic  treatment modality for hypothyroidism ,Therefore i Have select this topic. For that I have choose to give VarunmoolaKwath GhanaVati orally along with Thyroxine. Thyroxine is used to treat an underactive thyroid gland (hypothyroidism). It replaces or provides more thyroid hormone, which is normally produced by the thyroid gland9, Therefore it will be taken as a control group.

This varunmoola kwath ghanvati described in vangasen samhita.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

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

入选标准

  • Diagnosed cases of Hypothyroidism on the basis of TSH Levels (TFT will be done) 2) Patients S.TSH level above normal value and involving symptoms of hypothyroidism from subjective criteria (puffiness of face, oedema, dry and coarse skin, breathlessness, constipation, fatigue, hair fall) 3) Age between 20 to 60 years.

排除标准

  • Pregnancy, lactating mother 2)patient having associated diseases as ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes, known case of MI, Cerebrovascular events, cardiac arrhythmias, malignancy, hyperthyroidism 3) patients with any known infective disease 4) known case of major systemic diseases such as TB, AIDS, IHD, CA, Renal and cerebral diseases, thyroid CA, partial thyroidectomy, congenital thyroid disorders and other major endocrinal disease, morbidly obese patients.

结局指标

主要结局

1.To Study efficacy of Varunmoola kwath Ghanavati with Thyroxine in the management of hypothyroidism for 60 days.

时间窗: 60 days study with four follow ups on 15th,30th,45th and 60th day

2.To give maximum symtomatic relief to patient after 60 days of treatment.

时间窗: 60 days study with four follow ups on 15th,30th,45th and 60th day

次要结局

  • To observe adverse drug reaction if any.(60 days study)

研究者

发起方
PDEAs College Of Ayurved And Research Centre Nigdi Pune
申办方类型
Private medical college

研究点 (1)

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