A randomised comparative clinical study to evaluate the efficacy of Gandamalakandan rasa and Kanchanar Guggulu along with Tumbi taila nasya in the management of Hypothyroidism.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- PRIMARY OUTCOME
研究概览
简要总结
Need of the Study
Prevalence of hypothyroidism in India is 10%.The prevalence ratio of male:female is 1:6. Thyroid hormone is required for the normal functioning of each and every tissue of the body. Hence, its deficiency manifests as multisystem involvement. The only treatment available in modern medicine is in the form of synthetic hormone Levothyroxine. Even after years of treatment,it is associated with the failure to provide relief in clinical manifestations.Moreover ,excessive thyroid replacement carries the 2 7 potential for serious long term metabolic complications (e.g., accelerated osteoporosis). Thyroid hormone increases bone mineral resorption.The net effect of excessive thyroid hormone is increased bone resorption and a subsequent decrease in bone density i.e.osteoporosis. Looking to the pathogenesis and complications of hypothyroidism, it requires a systemic and radicle therapy for which Ayurveda may provide a ray of hope through its holistic approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.TSH levels from 5.6mIU/L to 19.9mIU/L 2.Patients having signs and symptoms of Hypothyroidism 1)weight gain 2)cold intolerance 3)fatigue 4)dry skin 5)dry hair 6)menorrhagia 7)constipation 8)hoarseness of voice 9)alopecia 10)aches and pains 11)muscle stiffness 12)deafness 13)depression 14)infertility 15)psychosis 16)periorbital edema 17)anaemia 18)bradycardia 19)hypertension 3.Nasya Arha (Patients suitable for Nasya).
排除标准
- •1.Patients having TSH level greater than 19.9mIU/L 2.Recent thyroid surgery (within 12 months) 3.Patients suffering from diseases like 1)HIV 2)TB 3)Encephalopathy 4)Goiter 5)Other endocrine disorders and other autoimmune disorders 6)Lactating and pregnant women 7)Uncontrolled Diabetes Mellitus 8)uncontrolled Hypertension.
结局指标
主要结局
PRIMARY OUTCOME
时间窗: (DAY-0) (DAY-29) (DAY-57)
Improvement in the signs and symptoms of hypothyroidism.
时间窗: (DAY-0) (DAY-29) (DAY-57)
(after 4 weeks and 8 weeks)
时间窗: (DAY-0) (DAY-29) (DAY-57)
次要结局
- Improvement in quality of life in Hypothyroidism patients.