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临床试验/CTRI/2025/02/081276
CTRI/2025/02/081276尚未招募2 期

Randomised Controlled Trial To Study The Efficacy of Vasadi Ghanvati In Primary Hypothyroidism with Reference To Kaphaj Pandu.

Shraddha Dattatray Satre1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年3月17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
80
试验地点
1
主要终点
To evaluate the efficacy of oral administration of 250 mg Vasadi. Ghan Vati twice a day with madhu for 45 days in management of primary hypothyroidism with reference to Kaphaj pandu

研究概览

简要总结

This study is a randomised open labelled controlled clinical trial comparing the safety and efficacy of Vasari Ghan Vati 250 mg and Controlled Tablet Thyroxine 25 mcg for 45 days in 80 patients with primary hypothyroidism and effect on TSH, T3, T4 levels.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Cases of Hypothyroidism diagnosed according to classical features , Patients having TSH level between 4 to 20 mIU/L, Patients having T3 (0.8-2.0 ng/mL) and T4 (5.0-12.0 µg/dL), Those patients of newly diagnosed with Hypothyroidism.

排除标准

  • Patients having TSH level greater than 20 mIU/L, Recent thyroid surgery within 12 months, patients on prolonged medications more than 6 weeks with corticosteroid, thyroid replacement therapy, iron supplements, pregnant females and lactating mothers.

结局指标

主要结局

To evaluate the efficacy of oral administration of 250 mg Vasadi. Ghan Vati twice a day with madhu for 45 days in management of primary hypothyroidism with reference to Kaphaj pandu

时间窗: 15 days

次要结局

  • To study the etiopathogenesis of Kaphaj pandu in detailed according to Ayurveda and hypothyroidism in detail according to modern aspect(To study the properties and efficacy of Vasadi Ghan Vati with madhu.)

研究者

发起方
Shraddha Dattatray Satre
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shraddha Dattatray Satre

Siddhakala ayurved mahavidyalay, sangamner

研究点 (1)

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