An Open Labelled Active Controlled Randomised Clinical Evaluation Of Nasya With Katutumbi Taila and Rasapachaka Yoga In The Management Of Hypothyroidism.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To compare the effect of Nasya with Katutumbi taila and Rasapachaka Yoga in patients on the basis of T3, T4, TSH and LIPID PROFILE.
研究概览
简要总结
Hypothyroidism is a prevalent endocrine disorder characterized by insufficient production of thyroid hormones, leading to a wide range of metabolic, physiological and psychological disturbances. There is no direct description of hypothyroidism in Ayurveda but based on its clinical presentation hypothyroidism can be correlated with Galaganda. In ayurveda, Galaganda occurs when there is vitiation of kapha and Vata doshas, predominantly Kapha which further results in a disturbance of Meda and Majja dhatus, resulting in the formation of Galaganda. The thyroid gland is situated in Urdhwajatrugata Sthana, which is a Kapha Sthana, for elimination of Kapha, Shirovirechana has been described by Acharyas. Hence the management of hypothyroidism by Nasya may be a better choice. Nasya has a direct influence on the functioning of the thyroid gland. Hence in the current study, it is proposed to evaluation of both Shodhana – Nasya with Katutumbi Taila and Shamana- Rasapachaka yoga in comparision with standard control in the management of Hypothyroidism. This study focus on early screening and assessment of hypothyroidism through T3, T4,TSH, LIPID PROFILE and Billewicz diagnostic index and Zulewski clinical score as well as management of hypothyroidism through Nasya followed by Rasapachaka yoga. Katutumbi taila and Rasapachaka yoga preparation will be done. Pharmacological evaluation and standardization through GCMS, LCMS and HPTLC. In trial group Nasya will be done for 7 days followed by Rasapachaka yoga given in dosage of 2 gm BD for 23 days, this cycle will be repeat in next month while in control group Tablet Thyrox given in morning at empty stomach.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of either gender between age group 20 to 60 years.
- •Patient already diagnosed as hypothyroidism with or without medication as well as newly diagnosed.
- •Patient fulfilling the criteria of diagnosis according to billewicz diagnostic index and zulewski clinical score for hypothyroidism.
- •Patient with serum TSH value greater than 4.5 microIU per ml.
- •Patient with total serum T4 and total serum T3 value less than normal value and within normal value.(Total serum T4 is 4.5 to 12.5 microgram per dl and Total serum T3 is 80 to 220 nanogram per dl).
排除标准
- •Patients who have undergone any type of thyroid surgery.
- •Patients suffering from Hashimoto’s thyroiditis.
- •Patients suffering from immunocompromised diseases.
- •Patients with active infective diseases like Tuberculosis, Hepatitis B.
- •Pregnant and lactating women.
- •Patients who are currently participating in any other clinical trials (since last 2 months).
- •Patients suffering from congenital hypothyroidism and secondary hypothyroidism.
结局指标
主要结局
To compare the effect of Nasya with Katutumbi taila and Rasapachaka Yoga in patients on the basis of T3, T4, TSH and LIPID PROFILE.
时间窗: T3, T4, TSH and LIPID PROFILE-On the screening visit and 60th day
次要结局
- To compare the effect of Nasya with Katutumbi taila and Rasapachaka Yoga in patients on the basis of subjective parameters.(On the screening visit, 15th day, 30th day and 60th day)
- To study the safety of Nasya with Katutumbi taila and Rasapachaka yoga in(patients of hypothyroidism.)
研究者
Dr Pooja Vekaria
Parul Institute of Ayurved