An Open Labelled Comparative RCT Study On Assessment Of Combined Efficacy Of Gomutra Mandooram,Ayugma Aragwadadhi Kashaya Basti and Guda Haritaki Rasayana In the Management Of Hypothyroidism(Kaphavataja Vikara)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- qualitive of life improvements
研究概览
简要总结
summary of the study
Hypothyroidism refers to any state that results in the deficiency of thyroid hormone, including hypothalamic or pituitary disease and generalized tissue resistance and autoimmunity to thyroid.it affects approximately one in 10 adults in the study population.female gender and older age were found to have significant association with hypothyroidism
Basti helps to convert dysbiotic state of intestinal flora in symbiotic stae so for that region considered basti in this study for intervention.basti acts at enteric nervous system and influences cellular level and stimulate HPT axis by virtue of thyroid gut connection by gut microbiota modulation.gomutra mandooram contains mandoora triphala, trikatu,chavya which are kaphavatajara,does amapachana,agnideepana and shothahara.guda haritaki is rasayana, promotes anabolism of healthy dhatu,does deepana ,doshanulimana so study is undertaken for assessment of combined efficacy of gomutra mandooram, ayugma aragwadhadi kashaya basti and guda haritaki rasayana in the management of Hypothyroidism
Objective of the study
- To evaluate the combined efficacy of gomutra mandooram, ayugma aragwadhadi kashaya basti and guda haritaki rasayana in the management of Hypothyroidism
- To assess the effect of modern ongoing treatment in the management of Hypothyroidism
- To compare the combined effect of gomutra mandooram, ayugma aragwadhadi kashaya basti and guda haritaki rasayana over modern ongoing treatment for hypothyroidism
Study design
Study type: randomised clinical trial, comparative prospective
Estimated enrollment -80
Interventional model-2 group assignment
Allocation -Randomized
Study duration -63 days
Masking-open
Follow up after-15 days
Assessment criteria
- High TSH level(as per report/evaluator)
- Symptoms like kesha chyuthi,klama,angamarda,aniyata arthava etc
- Correct of thyroid profile
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
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 who are diagnosed with Hypothyroidism with or without medicine and with or without washout period.
- •TSH value more than 5mIU/ml Subjects between the age of 18 to 60 years.
- •Subjects who are fit for Basti Karma.
- •Those subjects who are ready to sign informed consent form.
排除标准
- •Diagnosed cases of cardiac disease, congenital anomalies.
- •Patients suffering from congenital Hypothyroidism and carcinoma of the thyroid gland, Thyroid nodules,goiter, Thyroiditis, myxedema, and its complication, thyrotoxicosis, post-operative hypothyroidism, hypothyroidism post radio iodine therapy, hypothyroidism in pregnancy,lactating woman.
- •Also the subjects suffering from severe systemic disorders which interferes with course of intervention will be excluded.
- •Those who are not fit for Basti karma.
结局指标
主要结局
qualitive of life improvements
时间窗: 8 weeks
correction of TSH level
时间窗: 8 weeks
次要结局
- Correction of TSH level(Imrovement in QOL)
- Improvement of Hb%(Improvement of subjective parameters)