CTRI/2026/01/102426尚未招募2/3 期
Preclinical and Clinical Evalution of a Polyherbal Arka Formulation for the management of Hypothyroidism : An Integrative Ayurvedic Approch
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年5月13日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The clinical study ,which will take place at OPD and IPD of the IPGAE&R at SVSP hospital, is a single arm open level study for 4 weeks among 20 patients suffering form hypothyroidism. Primary Objective: To evaluate the anti-hypothyroid potential of a traditionally prepared Arka formulation containing Kanchanara bark, Varuna bark, and Trikatu through pharmacognostic, phytochemical, toxicological, and pharmacological (preclinical and clinical) studies. Secondary Objective: To develop a standardized, cost-effective, and safe polyherbal Ayurvedic formulation for the management of hypothyroidism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Recently diagnosed hypothyroidism (within 2–6 months) .
- •2.TSH equal and less than 10 mIU/L with subnormal T3/T4 levels 3.Presence of clinical signs and symptoms such as: Dry skin Weight gain Periorbital puffiness Cold intolerance Bradykinesia Decreased sweating Normal Thyroid Reference Range : TSH: 0.4–5.0 mIU/L T3: 1.2–2.8 nmol/L T4: 64–155 nmol/L.
排除标准
- •Confirmed or suspected hyperthyroidism
- •Neoplastic goitre, severe dyslipidemia, brittle nails, or excessive sluggishness
- •Known systemic illnesses (e.g., tuberculosis, diabetes mellitus, HIV)
- •Pregnant or lactating women
- •Any prior use of thyroid medication exceeding 2 months.
研究者
Dr Amit Kumar Taraphdar
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
研究点 (1)
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