To study the efficacy of Hinguvachadi vati in comparison with Kanchanara guggulu in Hypothyroidism: A controlled randomized clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvements noticed in reduction of signs and symptoms in patients diagnosed with Hypothyroidism with Zulewski’s scale.
研究概览
简要总结
A controlled clinical study on the efficacy of Hinguvachadi vati in comaparison with Kanchanara guggulu in the management of Hypothyroidism in adults of age group 18-60 years for a period of 45 days. During this study period 30 subjects diagnosed with Hypothyroidism will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group)15 subjects in each group respectively. Group A (Trial drug/Intervention group) includes 15 subjects qualifying inclusion criteria of the current study will be administered Hinguvachadi vati orally in the dose of 2g TID followed by ushnajala pana for 45 days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 45th day and after trial on 60th day and 75th day. Group B (Control Drug/Comparator Group) includes 15 subjects qualifying inclusion criteria of the current study will be administered Kanchanara guggulu 1g TID followed by ushnajala pana for 45 days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 45th day and after trial on 60th day and 75th day. The primary outcome measure will be improvements noticed in reduction of signs and symptoms in patients diagnosed with Hypothyroidism with Zulewski’s scale after 45 days. The secondary outcome measure will be improvement noticed in the thyroid profile levels along with quality of life through ThyPro39 scale questionnaire after 45 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients fulfilling the diagnostic criteria between the age of 18 years to 60 years with irrespective sex, caste and religion.
- •Thyroid stimulating hormone (TSH) level more than 4.25mIL/ml (preferably upto 60mIU/ml)
- •Fresh cases and patients on medication of hypothyroidism maintaining the manufacturer and batch compulsorily with persisting signs and symptoms and altered quality of life.
排除标准
- •Patients with age below 18years and above 60 years.
- •If serum TSH level more than 60uIL/ml.
- •Patients who have under gone any type of thyroid surgery.
- •Patients with congenital and secondary hypothyroidism.
- •Patients suffering from systemic diseases like Cardiac disorders, uncontrolled Diabetes, uncontrolled Hypertension, Carcinoma and Sepsis.
- •Drug induced hypothyroidism, Myxedema coma, neoplasia and toxic goiter.
- •Pregnant and lactating women.
结局指标
主要结局
Improvements noticed in reduction of signs and symptoms in patients diagnosed with Hypothyroidism with Zulewski’s scale.
时间窗: 0th day (baseline), 45th day, 60th day and 75th day
次要结局
- Improvements noticed in the thyroid profile levels along with Quality of life.(0th day (baseline), 45th day, 60th day and 75th day)
研究者
Dr Ananya D R
Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital