An open labelled controlled clinical trial to study the effect of Shigru patra churna in the management of Primary Hypothyroidism
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Reduction in signs and symptoms and decreasing TSH level in Primary Hypothyroidism
研究概览
简要总结
Hypothyroidism is a medical condition characterized by the inadequate production
of thyroid hormones by the thyroid gland. These hormones are thyroxine (T4) and
triiodothyronine (T3). Galaganda primarily arises from Kaphaavritavata, exhibiting symptoms such as
Shaitya, Gaurava, and Shopha, which can be associated with weight gain and
edema commonly seen in hypothyroidism. The prevalence of hypothyroidism in Maharashtra is 10.95%. Shigru patra churna has Kapha Vatahara , Deepan,
Shothahara & Medohara properties, with specific indication in
galaganda. The assessment of effect of Shigru patra churna in patients of primary hypothyroidsim is the chief objective of the study with the replacement of the
modern drugs by a safe and effective alternative in Ayurveda. Moringa oleifera dry leaf powder is a source of the essential amino
acid tyrosine, which is crucial for the synthesis of thyroid hormones.The patients within the age group of 18- 50 years who fulfills the clinical diagnostic criteria for Primary Hypothyroidism & having symptoms of Primary Hypothyroidism as mentioned in classics are selected irrespective of sex, socio-economic status, and community, written consent from patient will be taken prior to study. Total 70 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (Control group). Group A - shigru
patra churna 4 gm BD & Group B- tab . Thyroxine 50 µgm will be given to patients. Both drugs will be administered for 90 days. Observations will be done on day 0,day 30 day 60, day 90 . Result of study will be drawn on the basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient fulfilling the laboratory diagnosis of primary hypothyroidism based on the levels of serum TSH, T3, and T
- •2.Patients having TSH level less than 15 mIU/L 3.Patient who are freshly diagnosed as hypothyroidism.
- •4.Patients who are already diagnosed Hypothyroidism and under Thyronorm (Levothyroxine) medication 50 µgm but presenting with diagnostic criteria are included.
排除标准
- •1.Individuals diagnosed with diabetes mellitus, ischemic heart disease, uncontrolled hypertension, myocardial infarction, cerebrovascular incidents, cardiac arrhythmias, those who are pregnant, and patients with active malignant diseases were not included in the study.
- •2.Individuals exhibiting modified thyroid hormone levels as a result of various conditions, including under nutrition, malignant neoplasms, or non-thyroidal illnesses (commonly referred to as low-T3 syndrome).
- •3.Patients having TSH level greater than 15 mIU/L.
- •4.Recent thyroid surgery (within 12 months).
- •5.Patients suffering from diseases like HIV, TB, Encephalopathy, Goiter, Other endocrine disorders and other autoimmune disorders.
结局指标
主要结局
Reduction in signs and symptoms and decreasing TSH level in Primary Hypothyroidism
时间窗: 3 months
after ingestion of Shigru patra churna
时间窗: 3 months
次要结局
- Where the trial group stands in comparison with(control group)