A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Qust Shirin (Saussurea lappa) compared with Levothyroxine in the Management of Qillat-i-Darqiyyat Asli (Primary Hypothyroidism)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary Outcome Measures
研究概览
简要总结
Hypothyroidism is a prevalent disorder in India, particularly among women, with significant regional and age-related variation. and poses a major public health concern. Although levothyroxine is the standard therapy, its improper use can lead to complications such as osteoporosis and cardiac issues. Traditional Unani medicine recognizes Qust Shirin (Saussurea lappa) for its hot and dry temperament and pharmacological properties including antioxidant, anti-inflammatory actions. Preclinical studies support its potential in restoring thyroid function, but clinical data remain limited. Hence, a well-designed clinical trial is warranted to assess the safety and efficacy of Qust Shirin in comparison with levothyroxine in managing primary hypothyroidism. Based on the above considerations, a clinical study titled A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Qust Shirin (Saussurea lappa) compared with Levothyroxine in the Management of Qillat-i-Darqiyyat Asli (Primary Hypothyroidism).has been designed**.**
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
- •Participants who meet the following criteria will be included in the study:
- •Individuals of any gender
- •Aged between 18 and 60 years
- •Participants diagnosed with symptomatic subclinical primary Hypothyroidism with elevated TSH(10-20mIU/L) and normal Free T4/T3)
- •Participants diagnosed with overt primary Hypothyroidism with elevated TSH (10-20mIU/L) and low free T4.
排除标准
- •The following participants will be excluded from the study:
- •Individuals aged Below 18 years or Above 60 years
- •TSH Level Less than 10mIU/L or More than 20mIU/L
- •Asymptomatic cases of Subclinical Primary Hypothyroidism
- •Severe or complicated cases of Overt Primary Hypothyroidism
- •Patients with Drug-induced Hypothyroidism
- •Individuals who have undergone thyroidectomy
- •Pregnant or Lactating Women
- •Patients with significant pulmonary, cardiovascular, hepatic, or renal diseases
- •Known cases of immunocompromised states (e.g., HIV/AIDS) or malignancies
- •Patients with Diabetes Mellitus
- •Individuals with a history of hypersensitivity to Qust Shirin
- •Patients unwilling or unable to comply with the treatment schedule.
结局指标
主要结局
Primary Outcome Measures
时间窗: At Baseline and 8 week
1.Change in Serum Thyroid Stimulating Hormone (TSH) Levels from baseline to 8 weeks of Treatment
时间窗: At Baseline and 8 week
2. Change in Serum Free Thyroxine (FT4) Levels from baseline to 8 weeks of Treatment
时间窗: At Baseline and 8 week
次要结局
- Monitoring Adverse Events (AEs)(Adverse effects related to either the Unani drug or control drug)
- 1. Changes in Laboratory Parameters from baseline and at week 8(2. Change in Serum Free Triiodothyronine (FT3) Levels from baseline to week 8)
研究者
Afifa Naz Sayyed Nasehuddin
National Research Institute of Unani Medicine for Skin Disorders Hyderabad