Effect of the herbal supplementation on lipid profile

Not yet recruiting

Conditions: Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH,

Registration Number: CTRI/2021/04/032540

Lead Sponsor: National Institute Of Ayurveda deemed to be university jaipur

Brief Summary: *Medodushti* (Dyslipidemia) which is a potential signal for unrecognized comorbidities such as obesity, metabolic syndrome, diabetes mellitus, hypertension, cardiovascular disease etc. It may be manifested by elevation of the total cholesterol, low-density lipoprotein cholesterol (LDL) and triglyceride (TGL) concentrations and decrease in the good high-density lipoprotein (HDL) cholesterol concentration in the blood. *Hridroga* (Cardiovascular Disease) is the leading cause of death, decreased quality of life and medical cost in india. most *Hridroga* (Cardiovascular Disease) are preventable through a healthy lifestyle and effective treatment of *Medodushti* (Dyslipidemia). therapeutic reduction of these lipid fractions is associated with improved outcome. The prevalence of *medodushti* (dyslipidemia) in India is not exactly known as it usually appears as subclinical case without symptoms. For every 1% increase in cholesterol level, there is 1â€“2% increase in the incidence of coronary heart disease. The data from the US national health examination survey conduct from 1999 to 2000 reported that 25% of adults either had total cholesterol Ëƒ239.4 mg/dl or were taking a lipid lowering medication. According to the National Commission on Macroeconomics and Health, there would be around 62 million patients with coronary artery disease by 2015 in India and of these, 23 million would be patients younger than 40 years of age. Lifestyle modifications should always be a part of the management of dyslipidemia. There are scattered references available in Ayurveda which can be correlated to dyslipidemia. Lipids can be easily correlated to that of Medo Dhatu. Abnormal composition of Meda Dhatu is considered as Meda Dushti.

Trial Ayurvedic medicine (Ayurvedic prepration) in capsule form by Oral route,**2 capsule B.D**. each capsule contains 500 mg ofmedicine.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

1.As per ATP III guidelines; baseline LDL ranging 160- 189mg/dl, TC â‰¥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.
Ability to understand the risks/benefits of the protocol.
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 Â®, 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.
Subject should be available for duration of study period.
Willing to give written informed consent and willing to comply with trial protocol.

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 Î¼mol/L, female 110 Î¼mol/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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the lipid profile of the subjects who are at mild to moderate risk of Hridroga (cardiovascular disease).	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 Outcome Measures

Name	Time	Method
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).	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.

Trial Locations

Locations (1): National Institute of Ayurveda, deemed to be university (De Novo)
🇮🇳
Jaipur, RAJASTHAN, India
National Institute of Ayurveda, deemed to be university (De Novo)
🇮🇳Jaipur, RAJASTHAN, India
Dr Ravindra Kumar
Principal investigator
09413220802
ravindra.v.dheeraj@gmail.com