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临床试验/CTRI/2022/11/047606
CTRI/2022/11/047606已完成2 期

Randomised double blind,placebo controlled evaluation of NANO KANCHANAR (Bauhinia variegata Linn)HYDRO ALCOHOLIC EXTRACT in HYPOTHYROIDISM

Dean Faculty Of Ayurved Parul University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2022年1月12日最近更新:

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.)

研究者

发起方
Dean Faculty Of Ayurved Parul University
申办方类型
Private medical college

研究点 (1)

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