A Randomized Controlled Clinical Trial to Study Effect of Kanchnar Shunti Ghanvati and Thyroxine 25 MCG in patients of Primary Hypothyroidism
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1)to assess the changes in subjective and objective parameters of hypothyroidism with the effect of kanchnar shunthi vati after treatment.
研究概览
简要总结
primary hypothyroidism is a relatively common endocrine disorder that affects people worldwide .hypothyroidism is posing a major health challenge in both developing as well as developed world. there is 2-5% prevelance of hypothyroidism in developed world .major portion of hypothyroidism remains undetected . incidence of hypothyroidism is more in females. (6:1) and is a leading cause of infertility in elderly patients.the incidence of hypothyroidism increases with age.modern allopathic medicine manages hypothyroidism primarily through harmone replacement therapy.does have certain limits .although levothyroxine remains standerd treatment ,it may cause adverse effects such as palpitations ,arrythmia,weight loss, angina,depression, and infertility.furthermore its use is restricted in patients with certain co morbidities like ischemic heart diasease espcially when treated concurrently with anticoagulants like heparin. modern medicine focuses on managing symptoms rather than adressing potential root causes like autoimmune dysfunction or lifestyle factors .from an ayurvedic perspective ,hypothyroidism is not identified as a single entity in classical texts .itstead it is interpreted through the lens of dosha imbalance and related conditions .based on ayurvedic principle,the clinical features of primary hypothyroidism suggest a dushti (vitiavtion)of kapha and vata doshas along with meda and rasa dhatus. in later stages ,other dhatus may become involved as well .to explore alternative management approaches ,the ayurvedic formulation kanchnar shunti ghanvati has been selected for evaluation due to its vata-kapha imbalancing and deepana (digestive stimulant)properties .it is speecifically indicated in galganda making it relevant for hypothyroid conditions.
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
- •patient fullfilling the laboratory diagnosis of hypothyroidism on the basis of serum TSH ,T3 and T4 levels 2)patients having TSH level less than 10 mlU/l 3)patients having uncontrolled TSH level in spite of adequate doses of levothyroxine 4)patients having signs and symptoms of hypothyroidism .
排除标准
- •patiet with ischemic heart diasease ,uncontrolled hypertension,myocardial infraction,cerebrovascular event, cardiac arrthmias,pregnancy and active malignant diasease were excluded.
- •patient with altered thyroid harmone levels due to other conditions such as under nutrition,malignant neoplasm or nonthyroidal illness (low t3 syndrome) 3) patient havinh TSH level greater than 10 mlU/l 4) recent thyroid surgery within 12 months 5) patient suffering from diasease like HIV,TB,Encephalopathy,Goitre,other endocrine disorders, and other auto immune disorders.
结局指标
主要结局
1)to assess the changes in subjective and objective parameters of hypothyroidism with the effect of kanchnar shunthi vati after treatment.
时间窗: Time period will be 1 year
2) to assess the changes in subjective and objective criteria
时间窗: Time period will be 1 year
assessment of objective parameters
时间窗: Time period will be 1 year
1)TSH LEVELS
时间窗: Time period will be 1 year
2)Weight
时间窗: Time period will be 1 year
次要结局
未报告次要终点
研究者
Dr Mayuri Sunil Patil
SHREE SAPTASHRUNGI AYURVED MAHAVIDYALAY
