An Open Labelled, Randomized, Comparative Study Of Arjuna-Rasonadi yoga & Navaka guggulu On Medodushti With Special Reference To Dyslipidaemia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the levels at Day 60 from the baseline in:
研究概览
简要总结
Recruitment and selection of patients: -
Patients attending OPD, IPD of NIA and satisfying the selection criteria will be selected. All patients who voluntarily agree to participate and provide written informed consent for participation will be recruited in the study. During the study period, there will be 4 visits including the Screening visit.
Screening visit 1 (Day (-3 to day 0): -
Study discussions, pre- screening, ID proof verification & collection, and registration of subjects, Informed Consent, Medical History, physical examination, Concomitant Medication, Concurrent Illness, Complete blood count with ESR, RBS, Lipid Profile (Total Cholesterol, HDL, LDL, VLDL, Triglycerides), Liver Function Tests (Bilirubin-Direct & Total, Albumin, SGOT, SGPT, ALP) will be done.
Visit 2**(Recruitment)** (Day 1)****: -
The eligibility of the subject will be assessed. Eligible subjects will be called for Physical examination and vital signs will be recorded. concomitant medication, concurrent illness will be recorded.
Visit 3 (Day 30 ± 3)****: -
Physical examination will be done and vital signs will be recorded. Study medication will be dispensed to the subject for 30 days. History of concomitant medication, concurrent illness, AE information if any, compliance to treatment will be assessed and documented in the CRF.
Visit 4 (Day 60 ± 3)****: -
Physical examination of the subject will be done and vital signs will be recorded. history of concomitant medication, adverse events if any, Concurrent Illness, Blood Pressure, Complete blood count with ESR, Lipid Profile, Liver Function Tests. compliance to treatment will be assessed and documented in the case record for (CRF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Willing to give written informed consent and willing to comply with trial protocol.
- •2 Subjects in the age group of 18–70 years of both genders.
- •3 As per ATP III guidelines; baseline LDL ranging 160- 189mg/dl, TC ≥200 mg/dL, TG ranging 150-199 mg/dL.
- •4 Ability to understand the risks or benefits of the protocol.
排除标准
- •1 Participants with chronic diseases requiring continuous use of vasoactive drugs, diuretics, lipid-lowering or anti-diabetic drugs.
- •2 Subjects having history of diabetes (Type I or Type II) except other than the subject having the prediabetes condition with the random blood glucose 140-199 mg/dl.
- •3 Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain.
- •4 Subjects having history of serious cardiovascular diseases such MI.
- •5 Subjects having abnormal liver (ALT or AST) 2 times the upper limit of normal; 6 Subjects having abnormal findings on complete blood count.
- •7 Subjects having history of high alcohol intake (2 standard drinks per day).
- •8 Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •9 Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
- •10 Subjects participated in any other clinical trials within thirty (30) days prior to screening.
结局指标
主要结局
Change in the levels at Day 60 from the baseline in:
时间窗: Change in the levels at Day 60 from the baseline in: | 1.Lipid Profile (Total cholesterol, HDL, LDL, VLDL & TGL)
1.Lipid Profile (Total cholesterol, HDL, LDL, VLDL & TGL)
时间窗: Change in the levels at Day 60 from the baseline in: | 1.Lipid Profile (Total cholesterol, HDL, LDL, VLDL & TGL)
次要结局
- Change in the levels at Day 60 from the baseline in:(1 Total Cholesterol/ HDL ratio)