Single arm clinical study to assess the efficacy of Hingwashtak churna in the management of Hypothyroidism
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine the efficacy of Hingwashtak Churna in management of Hypothyroidism.
研究概览
简要总结
In Ayurveda Agni is main factor which directly related with thermogenesis and metabolic activities in body. The main action of thyroid hormone is to act as a spark to start up body metabolism at cellular level. In Ayurveda it can be correlated with action of Agni, which brings about all the chemical reaction and transformation in the body. Agnimandya is one of the most common disorder of Agni that is hypofunctioning of Jatharagni which affect the Dhatwagni, due to this there is formation of “Ama†which leads diseased condition. The normal and abnormal function of thyroid gland and Agni are similar. Also the symptoms of hypothyroidism are similar to Vata, Kapha Vriddhi and Pitta Kshay, Ama, Agnimandya.
Today people suffering with Hypothyroidism taking synthetic thyroid hormone derivatives which brings abnormal values of serum TSH and T4 to normal range but if there is increased dosage and continuous medication for years together gradually develops complaints of increase the appetite, insomnia, heart palpitations. The prevalence rate of Hypothyroidism in India is 11%.5 Women’s are affected approximately six times more than men’s.
To carry out the therapeutic maneuver, formulation “Hingwashtak Churna†have been tried to have a check on the diseased condition. Most of the drugs in this formulation have Deepana, Pachana, Ushna etc. qualities which stimulates body metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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
- •Patients irrespective of gender economic class caste religion.
- •Patients which are newly diagnosed with Hypothyroidism.
- •Patients with known case of Hypothyroidism without taking any synthetic thyroid hormone derivatives for atleast 3 months, having only signs and symptoms of Hypothyroidism will be taken.
- •Patients with higher TSH level i.e. Range of serum TSH is in between 5.5 μIU/ml to 20 μIU/ml.
- •Patient have fulfilling criteria such as 1 Cold intolerance 2 Hoarseness of voice 3 Loss of Appetite 4 Constipation 5 Sleepiness 6 Tiredness 7 Generalized aches and pain 8 Muscle cramps.
排除标准
- •Age below 18 year and about 60 year.
- •Systemic illness like TB.
- •Patient suffering from goiter.
- •CNS disorder, neurological disorders etc.
- •Thyrotoxicosis, thyroidectomy and other endocrine disorder.
- •HIV, cardiac disorder, malignancy, renal failure, pregnant women and lactating women.
- •Surgery induced and drug induced Hypothyroidism.
- •Patients with serum T.S.H. level i.e range of serum TSH is less than 5.5 μIU/ml and greater than 20 μIU/ml.
- •Patients on any synthetic thyroid hormone derivatives.
结局指标
主要结局
To determine the efficacy of Hingwashtak Churna in management of Hypothyroidism.
时间窗: 3 months
次要结局
- 1)To study Hypothyroidism in detail.(2)To study Agni in detail.)
研究者
Sayali Sanjay Supanekar
LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur