CTRI/2023/08/056846尚未招募3 期
Clinical Study on treatment tolerability, medication adherence and safety of Ayurvedic formulations in the management of Dyslipidemia - NI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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. Participants of any Gender in the age group of 18 to 60 years preferring Ayurveda medications for Dyslipidemia
- •2. Patients willing to provide written informed consent.
- •3. Participants of Dyslipidemia having the lipid values of Total Cholesterol (TC) more than 200 mg/dl, Low-Density Lipoprotein (LDL-C) more than 100 and less than 189 mg/dl, high density lipoprotein (HDL-C) less than 60 mg/dl or Triglycerides (TG) more than 150 less than 499 mg/dl.
排除标准
- •1. Known patients of Dyslipidemia due to familial or genetic causes.
- •2. Patients on any medications that are known to influence weight and/or lipids within the last 3 months.
- •3. Patient using the medications as systemic corticosteroids (nasal and inhaled corticosteroids are permitted), drugs such as thiazides, beta-blockers, retinoids, highly active antiretroviral agents, cyclosporine, tacrolimus, estrogen and progestins, and glucocorticoids, bile acid resins, prescription omega-3 fatty acids, cyclical or non continuous hormone therapy (estrogen or testosterone) excepted stable oestroprogestative or progestative contraception i.e. started at least three months preceding the screening visit, Patient taking antioxidant agents within 6 weeks prior to screening.
- •4. Patients with history of hepatic dysfunction (elevation in AST or ALT of >2 times the laboratory reference),
- •5. Patients with renal dysfunction (S. Creatinine >1.2mg/dl).
- •6. Patients suffering from major systemic illnesses necessitating long-term treatment (Psycho-neuro-endocrinal disorders, uncontrolled bronchial asthma, cardiovascular disease, cerebrovascular disease, Severe chronic pulmonary disease, thyroid disorders, endocrine diseases, Local, systemic acute or chronic infectious illness, psychiatric illness, tuberculosis, HIV, malignancy, etc.
- •7. Known cases of uncontrolled Diabetes mellitus (Glycosylated hemoglobin (HbA1c) 8% or greater).
- •8. Uncontrolled hypertension sitting BP =160 systolic or =100 mmHg diastolic
- •9. Female participants who are pregnant, intend to become pregnant, are breastfeeding, or not willing to use effective contraceptive precautions during the study.
- •10. Known cases of Smoking, drug abuse and alcoholism
研究者
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