A Randomized Controlled Clinical Trial to Study the Adjuvant Effect of Triphala Yoga in Galaganda with special reference to Hypothyroidism.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the adjuvant effect of Triphaladi Yoga on
研究概览
简要总结
Thyroid disorders are among commonest endocrine disorders in worldwide.The thyroid axis is involved in the regulation of cellular metabolism in virtually all nucleated cells.so the disorders of thyroid function have diverse manifestations.hypothyroidism is common presentation of thyroid function disorder.The overall prevalence of hypothyroidism is 10.95.
The present study aims to assess the adjuvant effect of Triphaladi yoga on subjective and objective parameters in the cases of Galaganda w.s.r. to hypothyroidism.
This study is done to see the adjuvant effect of Triphaladi yoga internally in management of Galaganda with special reference to hypothyroidism in 90 days of treatment duration of total 60 patients.the patients within the age roup of 18 to 60 years who fullfilled the clinical diagnostic criteria for hypothyroidism and had symptoms of galganda as mentioned in classics were selected irrespective of sex socio economic status and community,written consent from patient were taken prior to the study .computerized generated sampling technique for randomization was used.toral 64 patients will be selected and devided into group A and group B of which Group a trial group and G roup b control group.4 patients had withdrwan from the trial .triphla yoga in trial group A and tab levothyroxine in group b is was administrated .observations were made on day 0 day 30 th, day 60 th,day 90 th,and day 120 th.there was reduction in syptoms of galganda .statistical data calculation is pending .discussion will be drawn after statistical analysis.summary will be drwan and whole thesis work will be summarized .conclusion will be drwan strictly .on the basis of statistical analysis will be unbiased.
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 positive for Zulewski’s clinical score for hypothyroidism.
- •Patient fulfilling the laboratory diagnosis of hypothyroidism on the basis of serum TSH, T3 and T4 levels.
- •Patient’s serum TSH level between 4.5 μIU/ml to 20 μIU/ml 4)Total serum T3 and T4 level less than normal value.
- •Patients having uncontrolled TSH level in spite adequate doses of Levothyroxine.(dose between 25mcg/kg and 100mcg/kg) 6)Patients having signs and symptoms of Hypothyroidism.
排除标准
- •Patients with ischemic heart disease, uncontrolled hypertension, myocardial infarction, cerebrovascular event, cardiac arrhythmias, pregnancy and active malignant disease were excluded from the study.
- •Patients with altered thyroid hormone levels due to other conditions.
- •Patients having TSH level greater than 19.9mIU/L.
- •Patients suffering from diseases like HIV, TB, Encephalopathy, Goiter, Other endocrine disorders and other autoimmune disorders.lactating and pregnant women.
- •Patients taking dose of levothyroxine more than100mcg.
结局指标
主要结局
To assess the adjuvant effect of Triphaladi Yoga on
时间窗: 90 days
subjective and objective parameters in the cases of Galganda with special reference to hypothyroidism
时间窗: 90 days
Subjective criteria is
时间窗: 90 days
Zuleinskis clinical score
时间窗: 90 days
Objective criteria is
时间窗: 90 days
Reduction in TSH profile
时间窗: 90 days
次要结局
未报告次要终点
研究者
Dr Gauri Prakash Borude
SMBT Ayurveda College and hospital