A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY ADJUVANT EFFECT OF INDRAVARUNI MOOL CHURNA WITH LEVOTHYROXINE IN GALAGANDA WITH SPECIAL REFERENCE TO HYPOTHYROIDISM
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1 To study the adjuvant effect of indravaruni moola churna with levothyroxine on galaganda
研究概览
简要总结
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY ADJUVANT EFFECT OF INDRAVARUNI MOOL CHURNA WITH LEVOTHYROXINE IN GALAGANDA WITH SPECIAL REFERENCE TO HYPOTHYROIDISM
Introduction- The thyroid gland regulates growth, development, and metabolism through T3 and T4 hormones, and hypothyroidism—common in India—results from their deficiency, leading to reduced metabolic activity and myxedema. In Ayurveda, hypothyroidism correlates with Galganda, caused by Kapha and Vata vitiation with Agnimandya. This study aims to assess the adjuvant effect of Indravaruni mool churna, a Kapha-Pittahara drug, in managing Galganda with special reference to hypothyroidism
Null hypothesis There is no adjuvant effect of Indravaruni mool churna with levothyroxine in galaganda with special reference to Hypothyroidism
Alternate hypothesis There is adjuvant effect of Indravaruni mool churna with levothyroxine in galaganda with special reference to Hypothyroidism
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
- •Patients having age group between 18-60 years of either sex.
- •Patient fulfilling the laboratory diagnosis of hypothyroidism based on the levels of serum TSH, T3, and T
- •Patients having TSH level less than 20 mIU/L Patients having uncontrolled TSH level in spite adequate doses of levothyroxine(dose 25 mcg-100mcg) Patients having signs and symptoms of hypothyroidism.
排除标准
- •Individuals diagnosed with uncontrolled diabetes mellitus, ischemic heart disease, uncontrolled hypertension, myocardial infarction, cerebrovascular incidents, cardiac arrhythmias,and patients with active malignant diseases were not included in the study.
- •Lactating and pregnant women Patients having TSH level greater than 20mIUL.
- •Recent thyroid surgery.
- •Patients taking dose of levothyroxine 100mcg.
结局指标
主要结局
1 To study the adjuvant effect of indravaruni moola churna with levothyroxine on galaganda
时间窗: 0th 7th 45th day
次要结局
未报告次要终点
研究者
Dr Sakshi Sudhakar Wasnik
SMBT AYURVED COLLEGE AND HOSPITAL