CTRI/2018/05/013618已完成3 期
A randomized, single centric, single arm, open label study to evaluate the efficacy and safety of Thyro-Q in Hypothyroid patients on thyroid hormone therapy - Thyro-Q
Shashik Research Pharma Private Limited0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male/ Females subjects between 18-60 years
- •2. Subjects able to communicate effectively.
- •3. Subjects willing to provide written informed
- •4. In the judgment of the Principal
- •Investigator, able to comply with protocol
- •requirements.
- •5. Ability to schedule and attend monthly
- •visits for the duration of the study.
- •6. Primary hypothyroidism >=6 months
- •7. Thyroxine dose >=50 mcg/day
- •8. No change in thyroxine dose in past 2 months
- •9. Serum TSH of 0.1-4.8 mU/L
- •10.Adequate contraceptive measures for women
- •of childbearing age
排除标准
- •1. Contraindications or Hypersensitivity to
- •study product.
- •2. History or presence of any medical condition
- •or disease according to the discretion of
- •the Investigator.
- •3. No contraindications to exercise as outlined
- •by the American Endocine society (ACS).
- •4. Subjects who are under herbal supplements
- •within seven (7) days prior to screening.
- •5. Subjects having history of asthma.
- •6. Subjects having history of cardiovascular
- •7. Subjects having history of diabetes (Type I
- •or Type II) except other than the subject
- •having the pre-diabetes condition with the
- •fasting blood glucose between 100 to 125
- •mg/dl or random blood glucose > 140-199
- •8. Subjects having BP above 180/100 or below
- •9. Subjects having hyperthyroid disease.
- •Subjects having abnormal findings on
- •complete blood count
- •10.Subjects with HIV Positive.
- •11.Subjects having history of high alcohol
- •intake (2 standard drinks per day).
- •12.Subjects having history of psychiatric
- •disorder that may impair the ability of
- •subjects to provide written informed
- •13.Any other condition that, in the opinion of
- •the investigator, would adversely affect the
- •subjectâ??s ability to complete the study or
- •its measures.
- •14.Subjects participated in any clinical study
- •within thirty (30) days prior to screening.
研究者
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