An Exploratory single arm study on the efficacy of Moorvadi Agad in Garavisha janya dhatwagnimandya (Hypothyroidism)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in TSH level of the patient.
研究概览
简要总结
Type of study : Interventional
Purpose : Treatment/ Efficacy.
Timing : Prospective
End point : Effectiveness
Duration : 60 days
Sample size : 30 Patient
Criteria for selection : Clinically diagnosed and registered patients of Hypothyroidism with gara visha history attending the OPD of Dr. Sarvepalli Radhakrishnan Ayurveda University, Jodhpur, and from other government hospitals of Jodhpur will be taken.
Posology
Drug- Moorvadi Agad
Kalpana- Choorna
Dose- 3 gm
Route of administration- Oral
Time of administration -Thrice a day (Before Meal)
Anupana- Luke warm water or Takra or Dadhi mastu
Duration- 60 days
Follow up
1.Duration of clinical study will be 60 days.
2.All patients will be followed up once in 15th day regularly.
-
Improvements and other effects will be noted.
-
Clinical assessment will be done once in 15th day.
5.Pathya ahara and vihara will be noted during follow up
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •1.Patients between the age of 18-60 years of either sex.
- •Patient having history of consuming gara visha (as per mentioned in questionnaire) for a long period of time.
- •Patient having TSH level more than 5.4 µlt/ml and less than 15 µlt/ml will be taken.
- •Patients having sign and symptoms of Primary Hypothyroidism.
- •Patients who are already diagnosed as hypothyroidism and are under medication but still presenting with the increased TSH level.
- •Patient willing to give consent for clinical trial of either sex.
排除标准
- •1.Patients below 18 years and above 60 years of age.
- •2.TSH level below 5.5 µlt/ml & TSH level above 14µlt/ml.
- •3.Patients suffering from congenital hypothyroidism and secondary hypothyroidism.
- •4.Pregnant women, Lactating mother are excluded.
- •5.Patient diagnosed with hyperthyroidism, neoplasia, toxic goiter are excluded
- •Patients who have under gone any type of thyroid surgery.
- •Mentally ill/ Retarded patients.
- •Patients having diabetes mellitus and any systemic disorders or any congenital disorders are excluded.
结局指标
主要结局
Reduction in TSH level of the patient.
时间窗: 60 days
次要结局
- 1.Reduction in body weight, BMI(2.Changes in the general symptoms of hypothyroidism like general weakness, tiredness, hairloss,constipation, menstrual abnormality)
研究者
Dr Neelanjana Sen
Post Graduate Institute of Ayurved Jodhpur Rajasthan