Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: Ayurvedic Medicine: 2 capsule of 500mg each Twice a day with luke warm water after meal for 120 days
Control Intervention1: Placebo: 2 capsule Twice a day with luke warm water after mea
Sponsors
National Institute Of Ayurveda deemed to be university jaipur
Eligibility
Inclusion criteria
Inclusion criteria: 1.As per ATP III guidelines; baseline LDL ranging 160- 189mg/dl, TC >=200 mg/dL, TG ranging 150-199 mg/dL 2. Subjects in the age group of 21â??70 years of both genders; Overweight/Class-1 obese (bodyâ??mass index [BMI]: 23â??35 kg/m2), Subjects with low BMI but abnormal lipid profile or subjects having both or at least any one of the above diagnostic criteria will be selected for the study. 3. Ability to understand the risks/benefits of the protocol. 4. Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera ®, or double-barrier and have a negative pregnancy test at the Screening Visit. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. 5. Subject should be available for duration of study period. 6. Willing to give written informed consent and willing to comply with trial protocol.
Exclusion criteria
Exclusion criteria: 1. Participants with chronic diseases requiring continuous use of vasoactive drugs, diuretics, lipid-lowering or anti-diabetic drugs. 2. Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain. 3. Subjects having history of serious cardiovascular diseases such MI. 4. 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 mg/dl. 5. Subjects with history of having thyroid disease. 6. Subjects having abnormal liver or kidney function test (ALT or AST) 2 times the upper limit of normal; elevated creatinine (male 125 μmol/L, female 110 μmol/L). 7. Subjects having abnormal findings on complete blood count. 8. Subjects having history of coagulopathies. 9. Subjects with Positive HIV test. 10. Subjects having history of high alcohol intake (2 standard drinks per day). 11. Subjects who are pregnant, breast feeding or planning to become pregnant during the study. 12. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 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 other clinical trials within thirty (30) days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the lipid profile of the subjects who are at mild to moderate risk of Hridroga (cardiovascular disease).Timepoint: 1. To assess the lipid profile of the subjects who are at mild to moderate risk of Hridroga (cardiovascular disease) after 120 days i.e at 6th visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the safety and tolerability of ayurvedic medicine for the management of Medodushti (dyslipidemia) in the subjects who are at risk of Hridroga (cardiovascular disease).Timepoint: 1. To assess the safety and tolerability of ayurvedic medicine for the management of Medodushti (dyslipidemia) in the subjects who are at risk of Hridroga (cardiovascular disease) after 120 days i.e at 6th visit. | — |
Countries
India
Contacts
Public ContactDr Ravindra Kumar
National Institute Of Ayurveda deemed to be university (De Novo)
Outcome results
None listed