Dinacarya: , Ritucarya: , Acara Rasayana:, Other:30 participants will be instructed to follow Lifestyle modifications daily for a period of 90 days., Pathya/Apathya:yes, Pathya:Fruits, Vegetables, Lentils, Beans, Unprocessed maize, Millet, Wheat, Brown Rice, Less than 5gm iodized salt per day, Foods high in soluble fiber such as banana, oats, apple, guava, avocado, barley, berries, flax, chia seeds, ladies finger, figs, coconut, almonds, wallnut, egg white, low fat milk products, Fish-Tuna, salmon, mackerel, sardine, Vegetable oil, Skin out chicken, Green tea-1 cup
Exercise at least 30 minutes brisk walking daily morning., Apathya:Red meat, organ meat, sausage, cold cuts, Animal viscera like liver, brain, kidney, spleen, Shell fish, Foods made by reheated oil, Heavy oily foods, Foods high in cream and cheese, Saturated fats such as palm oil, Margarine, ghee, Junk foods, Alcohol, Smoking.
2
Intervention Arm
Lifestyle
-
-
Dinacarya: , Ritucarya: , Acara Rasayana:, Other:30 participants will be instructed to consume Mudga Yusha - 192ml before breakfast along with Lifestyle modifications daily for a period of 90 days., Pathya/Apathya:yes, Pathya:Fruits, Vegetables, Lentils, Beans, Unprocessed maize, Millet, Wheat, Brown Rice, Less than 5gm iodized salt per day, Foods high in soluble fiber such as banana, oats, apple, guava, avocado, barley, berries, flax, chia seeds, ladies finger, figs, coconut, almonds, wallnut, egg white, low fat milk products, Fish-Tuna, salmon, mackerel, sardine, Vegetable oil, Skin out chicken, Green tea-1 cup
Exercise at least 30 minutes brisk walking daily morning. , Apathya:Red meat, organ meat, sausage, cold cuts, Animal viscera like liver, brain, kidney, spleen, Shell fish, Foods made by reheated oil, Heavy oily foods, Foods high in cream and cheese, Saturated fats such as palm oil, Margarine, ghee, Junk foods, Alcohol, Smoking.
Inclusion Criteria
Age From
30.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Participants irrespective of sex
Participants in the age group of 30-60 years
On the basis of ATP â…¢ Guidelines, either having variation in Serum total cholesterol 200mg/dL - 239mg/dL
Having LDL Cholesterol between 130mg/dL - 159mg/dL
Having Triglycerides between 150mg/dL - 199mg/dL
Having HDL Cholesterol less than 40mg/dL
Participants who are willing to give informed consent
ExclusionCriteria
Details
Participants with chronic systemic illness
Known case of Renal disorders under medications
Known case of Dyslipidemia under medications
Pregnant women and lactating mothers
Known history of allergy to Mudga(Green gram)
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Serum Total Cholesterol, LDL Cholesterol, Triglycerides, HDL Cholesterol
0th day, 91st day
Secondary Outcome
Outcome
TimePoints
Body Mass Index
0th day, 91st day
Target Sample Size
Total Sample Size="60" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3/ Phase 4
Date of First Enrollment (India)
28/06/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Dyslipidemia is the disorder of lipoprotein metabolism, including lipoprotein overproduction or deficiency. These disorders may be manifested by elevation of the serum total cholesterol, low-density lipoprotein (LDL) cholesterol and triglyceride concentrations, and a decrease in the high-density lipoprotein (HDL) cholesterol concentration. It is one of the commonest presentation & major cause for various lifestyle disorders. Treating early borderline dyslipidemia is one of the key factors for prevention of CVD and atherosclerosis. A combination of exercise and diet therapy can be considered to be particularly advantageous because diet and exercise elicit complementary effect on lipid profiles. Being a metabolic disorder, Dyslipidemia can be very well managed by diet and exercise.
In Ayurvedic classics, most of the scholars have considered Dyslipidemia under the heading of medoroga. Dietary interventions with legumes received special attention around the world because of the hypocholesterolemic and liver-protective properties of legumes. In Ayurveda, Mudga is explained as a pathya in medoroga. In Ayurvedic classics under the Kritannakalpana, Yusha is mentioned. Mudga Yusha and lifestyle modifications can reduce errors in cholesterol metabolism. This study aims to assess the add on effect of Mudga Yusha with lifestyle modifications in dyslipidemia.
A Quasi experimental study will be performed in 60 participants irrespective of sex , satisfying inclusion and exclusion criteria. Out of 60 participants, 30 each will be allocated to study group (Group 1) and control group (Group2).The participants in group 1 will be instructed to consume 192ml of Mudga yusha before breakfast along with Lifestyle modifications such as dietary restrictions and exercise for 90 days while Lifestyle modifications alone will be advised to Control group. The study period is 90 days. Through serum lipid profile investigation, the outcome measurements will be analyzed before and after the study (0th and 91st day).