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临床试验/CTRI/2022/05/042402
CTRI/2022/05/042402尚未招募2 期

Experimental and Pilot Clinical Evaluation of safety and efficacy of Nano Kanchanara (Bauhinia variegata Linn) Twak Extract in Hypothyroidism

Dean Faculty Of Ayurved1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年12月5日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
12
试验地点
1
主要终点
Effect on level of TSH value

研究概览

简要总结

Hypothyroidism is a hypo-metabolic clinical stateresulting from inadequate production of thyroid hormone for prolonged period orrarely, from resistance of the peripheral tissue to the effect of thyroidhormones. Primary hypothyroidism is a dysfunction in the thyroid gland and,it can be sub-clinical or overt. Due to easily stimuli like stress and anxiety, the global incidence of hypothyroidism is increasing. Kanchanara reduce the swelling of neck, increased serum thyroid hormoneconcentration, decreased cholesterol and improve thyroid histology. Kanchanara stem bark has been investigated and reported tohave anti-tumor property.  Kanchanara extract, as standardized extracts, provide unlimited opportunitiesfor uncovering new drug because of the innumerable availability of chemical composition. Prevalence rate of Hypothyroidism in developed countries is 4.6% . Where as inIndia it is 10.95%. Incidence rate of hypothyroidism is more infemales (15.86%) than males (5.02%).  Lacunas in current management. HRT is the single available treatment& Long-term metabolic complications of HRT. Increaseddosage and continuous medication make the patient drug dependent tillthe end of the life. So therefore need to find new drug which willprevents further lacunas hence extraction of  Kanchanar Twak willhelp to concentrate the chemical constituent in a soluble form and by using Nanotechnology we will able to level up herbs bioavailability,effectiveness and also able to reintroduce other component that were discardeddue to poor characteristics.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of either gender with age group 20-60 Years (both years inclusive) 2) Elevated level of serum TSH more than normal range (i.e. 0.4 -5.0 μIU/ml) 3) Patients having clinical features of hypothyroidism- a.
  • Puffiness of face and eyelids b.
  • Peripheral edema c.
  • Dry coarse skin d.
  • Breathlessness e.
  • Constipation f.
  • Weakness g.
  • Lethargy h.
  • Muscle ache j.
  • Menstrual abnormality k.

排除标准

  • Known case of any chronic and severe systemic disorder including IHD, CVA, uncontrolled Hypertension, uncontrolled diabetes, CRF, Active Malignancy Disease 2)Pregnant and lactating females 3)Known case of congenital hypothyroidism and secondary hypothyroidism.

结局指标

主要结局

Effect on level of TSH value

时间窗: The efficacy of treatment will be assessed on the level of TSH value at baseline and at the end of 90 days

次要结局

  • 1) Effect on subjective parameter on the basis of Billewicz Diagnostic Index and a standard gradation scale.(2) BMI)

研究者

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

研究点 (1)

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