Clinical Study on Ayurvedic formulations in the management of Dyslipidemia
- Conditions
- Health Condition 1: E785- Hyperlipidemia, unspecified
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Assessment of the tolerability through reported incidence of treatment-emergent adverse events & serious adverse events. <br/ ><br>2. Assessment of treatment adherence through self-reported compliance log & used medication containers/strips. <br/ ><br>Timepoint: 30th day, 60th day and 90th day
- Secondary Outcome Measures
Name Time Method 1. Proportion of participants who withdrew/dropped out from the study due to adverse events and/or poor tolerability <br/ ><br>2. Change in the laboratory safety parameters (CBC, LFT, KFT) from baseline <br/ ><br>3. Change in parameters of Lipid profile (LDL, Total Cholesterol, HDL, Triglycerides, VLDL <br/ ><br>4. Changes in the Atherogenic Indices viz. Atherogenic Indices of plasma (AIP), Castelli Risk Index I(CRI I), Castelli Risk Index II (CRI II), Atherogenic Coefficient (AC), Non high density lipoprotein (non-HDLc)(NHC) <br/ ><br>5. Number of participants who achieved the optimal/desirable values of lipids (TC less than 200mg/dl, LDL less than100 mg/dl, HDL more than & equal to 60 mg/dl, TG less than150 upto 499 mg/dl) as per National Cholesterol Education Program Adult Treatment Pane (ATP III)Timepoint: 1. Baseline, 30th day, 60th day, 90th day <br/ ><br>2. Baseline, 90th day <br/ ><br>3. Baseline, 90th day <br/ ><br>4. Baseline, 90th day <br/ ><br>5. Baseline, 90th day