An open labelled randomized comparative clinical trial of Pippali Churna and Shad-dharana Churna in the management of Hypothyroidism
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
- Improvement in sign and symptoms
研究概览
简要总结
Hypothyroidism is one of the most common and challenging disease in today’s era. Hypothyroidism is a condition in which the thyroid gland does not produce enough Thyroxine(T4) and Tri-iodothyronine (T3). The prevalence of Hypothyroidism in India is about 11% of population. It is more prevalent in women than in male. Women are affected approximately six times more frequently than men.
Hypothyroidism may result from inadequate function of the gland itself (primary Hypothyroidism), inadequate stimulation by thyroid-stimulating hormone from the pituitary gland (secondary Hypothyroidism), or inadequate release of Thyrotropin releasing hormone from the brain’s hypothalamus (tertiary Hypothyroidism). Hashimoto’s Thyroiditis is the most common type, which have an autoimmune pathology. The other causes include thyroid radioactive iodine therapy, surgical removal of thyroid gland, drug induced, TSH deficiency etc.
Hypothyroidism is the second most common endocrine disorder observed all over world in present era. The standard treatment in Allopathy for Hypothyroidism is thyroid hormone supplement therapy with levothyroxine.
Management of Hypothyroidism with the modern drugs may bring the value of TSH and Thyroxine(T4) to normal range. The prolonged and increased dose of synthetic thyroxine may cause serious long term side effects or any other acute or chronic complications. So, to decrease the dosage of levothyroxine and to get rid of lifetime medication, we have a scope for Ayurvedic medicine. Thyroid hormone act as catalyst for metabolism in whole body. In Hypothyroidism, deficiency of thyroid hormone occurs which causes imbalance in metabolism leading to Dhatwagnimandya in terms of Ayurveda. The symptoms are Kapha-Vatapradhana. So, as per principles of Ayurveda, treatment should be Kapha Shamana, Vata Shamana and Agni dipana.
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
- •Patient having clinical features of Hypothyroidism or patient who is already taking levothyroxine medicine.
- •Chronicity of Hypothyroidism below 10 years.
- •S.TSH>5 mIU/L.
排除标准
- •Patient with the age below 18 years and above 60 years.
- •Patients having any other major systemic diseases like Cancer, Tuberculosis, Type I Diabetes mellitus, Malignant hypertension, Thyrotoxicosis, Asthma, Heart disease, Pregnancy or any other debilitating disease which may lead to fatal condition for the patient at any time.
- •Patient having history of peptic ulcers, bleeding ulcers etc.
- •Patient with congenital or secondary Hypothyroidism or goiter.
- •Patients taking medicine for Hypothyroidism for more than 10 years.
- •If S.TSH level is more than 100mIU/L.
结局指标
主要结局
Improvement in sign and symptoms
时间窗: 56 days
次要结局
- Results will be assessed on the basis of TSH score(56 days)
