Randomised double blind,placebo controlled evaluation of NANO KANCHANAR (Bauhinia variegata Linn)HYDRO ALCOHOLIC EXTRACT in HYPOTHYROIDISM
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- to study adjuvant effect of nano Kanchnar (Bauhinia variegata Linn) hydro-alcoholic
研究概览
简要总结
Hypothyroidism is a disorder that occurs when the thyroid gland does not make enough thyroid hormones to meet the body’s need. The thyroid hormone regulates metabolism—the way the body uses energy— and affects nearly every organ in the body. Without enough thyroid hormone, many of the body’s functions slowdown.
There is no direct description of hypothyroidism in Ayurveda but on the basis of its clinical presentation hypothyroidism can be correlated with dhatwagnimandya (ras and meda dhatwagnimandya). Samprapti Ghataka’s are Kapha Dushti, Dhatwagnimandya, Jatharagni Dushti Rasavaha - Medovaha Sroto- Dushti found mainly. So, Hypothyroidism is a Santarpanjanya Vyadhi
Kanchanara reduce the swelling of neck, increased serum thyroid hormone concentration, decreased Cholestrol and improve Thyroid histology Kanchnar is considered as a drug of choice for Granthi vikar and Galaganda, hence for the present study hydroalcoholic extract Kanchnar Twak is selected. Kanchnar stem bark has been investigated and reported to have anti-tumor property. Kanchnar extract, as standardized extracts, provide unlimited opportunities for uncovering new drug because of the unmatched availability of chemical diversity.
It is expected that by using Nano particles bioavailability, effectiveness is enhanced. The dosage of drug which is difficult to take will be reduced without reducing the quality and effect of the drug. As this will be a new dosage form of B.variegata stem bark, safety and efficacy which is established by previous studies in animal models, will be evaluated in cases of hypothyroidism.May increase bioavailability, easily palatable, effectiveness is more Reduced exploitation of plants as the size of herbal medicine is reduced. Increase the therapeutic value by reducing toxicity level of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s) a) Age: From 18 Year(s) Age To 60 Year(s) (inclusive of either age) b) Gender: Both c) Patients already diagnosed as hypothyroidism with/without medication d) Patients with primary hypothyroidism e) Patients with subclinical hypothyroidism(—)
入选标准
- •a) Age: From 18 Year(s) Age To 60 Year(s) (inclusive of either age) b) Gender: Both c) Patients already diagnosed as hypothyroidism with/without medication d) Patients with primary hypothyroidism e) Patients with subclinical hypothyroidism.
排除标准
- •a) Patients who have undergone any type of thyroid surgery.
- •b) Patients suffering from systemic diseases like IHD, PCOD, uncontrolled Diabetes Mellitus, uncontrolled HTN c) Immuno compromised diseases like HIV etc.
- •d) Patients suffering from congenital hypothyroidism e) Pregnant and lactating women.
结局指标
主要结局
to study adjuvant effect of nano Kanchnar (Bauhinia variegata Linn) hydro-alcoholic
时间窗: T3,T4,TSH levels at baseline and at the 12 weeks.
extract in comparison with placebo on the basis of T3,T4,TSH levels in management of hypothyroidism
时间窗: T3,T4,TSH levels at baseline and at the 12 weeks.
次要结局
- to study adjuvant effect of nano Kanchnar (Bauhinia variegata Linn) hydro-alcoholic(extract in comparison with placebo on the basis of standard gradation scale and Billewicz index for hypothyroidism in management of hypothyroidism at 4weeks,8weeks,12weeks.)
