A Comparative Clinical Study to evaluate the effect of Shakotaka Taila Pratimarsha Nasya with Krimighnadi Kashaya and Phalatrikadi Kashaya in the management of Primary Hypothyroidism with Obesity

Dr Shruthi Shivarama2 个研究点分布在 1 个国家目标入组 140 人开始时间: 2025年6月2日最近更新: 2024年7月4日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方
入组人数: 140
试验地点: 2
主要终点: Pratimarsha nasya with Shakotaka Taila and Krimighnadi Kashaya efficacy in treating primary hypothyroidism with obesity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this clinical study is to compare the effects of Krimighnadi kashaya and Phalatrikadi kashaya as an oral medication and Shakotaka Taila as Pratimarsha nasya in te management of primary hypothyroidisim with obesity. 140 subjects satisfying diagnostic and inclusion criteria will be divided into 2 groups of 70 subjects each. Intervention will be given for 8 weeks. Post 8 weeks of intervention, the subjects will be assessed for changes in regards to subjective, diagnostic criteria, assessment criteria scales assessed. Formulating safe, effective, non drug dependent formulation in management of primary hypothyroidism with obesity. Improving quality of life in present condition.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant Blinded

入排标准

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

入选标准

•Subjects fulfilling the diagnostic criteria.
•Both fresh and treated cases of hypothyroidism will be included.
•Freshly detected and untreated cases of hypothyroidism.
•Established and treated cases of hypothyroidism also who are ready to discontinue the earlier medication with Flush out period of 15 days.
•Patients with hypothyroidism BMI more than
•Subjects with serum TSH more than 5 to less than 10 ml IU/L and more than 10ml Primary Hypothyroidis with decrease fT4 and fT
•Who signed the informed consent.

排除标准

•Subjects with congenital hypothyroidism, chronic history of hypothyroidism more than 5 yrs and secondary hypothyroidism or tertiary hypothyroidism.
•subjects with any chronic systemic disorders like cerebrovascular accidents, ischemic heart diseases, uncontrolled diabetes mellitus, uncontrolled hypertension, any active malignancies, chronic renal failure, radiation therapy etc which interrupt the present intervention.
•Subjects who have undergone thyroid surgery.
•Pregnant and lactating women.
•Diagnosed cases of neoplastic conditions, toxic goiter, drug induced hypothyroidism will also be excluded.
•Who doesnâ€™t sign the informed consent.

结局指标

主要结局

Pratimarsha nasya with Shakotaka Taila and Krimighnadi Kashaya efficacy in treating primary hypothyroidism with obesity