Randomised comparative clinical controlled assessment Of Vyoshadi Guggulu and Thyroxine Sodium Tablet in 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
- 70
- 试验地点
- 1
- 主要终点
- 1.To assess the symptomatic relief.
研究概览
简要总结
The current study aimed as randomised control parallel group trial comparing the efficacy Vyoshadi Guggulu and Thyroxine Sodium Tablet in the management of Hypothyroidism.Total 70 diagnosed patients of Hypothyroidism are equally divided into two groups,namely experimental and control group.The symptoms of Hypothyroidism weight gain in last 6 months,loss of hairs,dyspnoea,puffiness on face.Vyoshadi guggulu 12gm used as experimental group medicine for single use at night time will be given for 6 weeks. Thyroxine Sodium Tablet(As per TSH level 1.6mcg/body weight)used as control group medicine for single use at morning(empty stomach) will be given for 6 weeks. The study will be conducted for 6 weeks.
clinical assessment after every 2 weeks.
Hypothyroidism is one of the most common thyroid disorders in india,affecting one in ten adults.In Ayurveda parlance,this is attributed as the function of agni(system related to metabolism).In modern science,the treatment of hypothyroidism is done by thyroxine hormone therapy for long time but this medication can lead to several side effects like chest pain or discomfort,difficult or laboured breathing,extreme fatigue,irritability etc.However in recent times,hypothyroidism can be well managed with ayurvedic medication.Vyoshadi Guggulu has deepan pachan quality which pops body metabolism and also have thyroid stimulatory properties.
The content of Vyoshadi Guggulu are easily available and cost effective in nature hence selected for the present study.
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 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Serum Ultrasensitive level 5 – 15 micro IU/ML 2.Freshly diagnosed cases of Hypothyroidism.
- •3.Subject having one or more classical symptoms.
- •4.Patient of either gender.
- •5.Age 18 years and 40 years.
排除标准
- •1.Immunocompromised patients or patients on immunocompressive drugs .
- •2.Patients suffering from life threatening diseases.
- •3.Pregnancy and lactating mother.
- •4.K/C/O Thyroid Neoplasia.
- •5.Progressive cases of Myxoedema coma.
结局指标
主要结局
1.To assess the symptomatic relief.
时间窗: The Study will be conducted for 6 weeks. | Clinical Assessment after every 2 weeks.
2.To observe the changes in TSH level.
时间窗: The Study will be conducted for 6 weeks. | Clinical Assessment after every 2 weeks.
次要结局
- 1.To observe the association of hypertriglyceremia in Hypothyroidism & effect of Vyoshadi Guggulu on it.(2.To study the Probable mode of action of Vyoshadi Guggulu in management of Hypothyroidism.)
研究者
Dr Haresh Dattatray Sable
,Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College