Role OF Guduchyadi Choorna With Madhu Along With Lifestyle Modifications In Dyslipdemia

Phase 3

Not yet recruiting

Conditions: Pure hypercholesterolemia. Ayurveda Condition: MEDOROGAH,

Registration Number: CTRI/2023/07/055365

Lead Sponsor: Government Ayurveda College Thiruvananthapuram

Brief Summary: Dyslipidemia iseither one or a combination of elevated total cholesterol, high LDL-C , low HDL-C, and elevated triglyceride . Dyslipidemia is amajor risk factor for coronary heart disease (CHD) . People with dyslipidemiaare at a twofold increased risk of developing CVD as compared to those withnormal lipid levels . CVD is becoming more prevalent globally and is one of theprominent causes of death . Raised levels of certain lipids in the bloodincrease the risk of atherosclerosis, which is recognized as the primary riskfactor for stroke, peripheral vascular, and CHD . Most (80%) of the lipid disorders areassociated with diet and lifestyle . Modifiable risk factors, including a diethigh in saturated or trans fats, sedentary lifestyle, smoking, and obesityincrease the risk of dyslipidemia . The prevalence of dyslipidemia is muchhigher among patients with coexisting cardiovascular risk factors such ashypertension, diabetes, or human immunodeficiency virus.According to WorldHealth Organisation(WHO) estimate in 2008 ,the prevalence ofdyslipedemia(defined as blood levels of TC190mg/dl)in the southeast Asia is30.3%, in Europe 53.7% and in America 47.7%. The prevalence of dyslipedemia isvery high in India also according to ICMR-INDIAB study,13.9% had hypercholestrolemia,29.5%had hypertriglyceridemia,72.3% had low HDL-C, 11.8% had high LDL-C levels and79% had abnormalities in one of the lipid parameters.Many interventional trialsreported to have hypolipidemic effect which give rapid temporary relief butcause long term side effects1. Herbals has much potential inpreventing lifestyle problems because of minimaladverse effects.Clinical importance of herbal drugs in the management ofdyslipidemis has received considerable attention in recent years.The studyaimed to explore the efficacy of Guduchyadi choornam with madhu along with Lifestyle modification indyslipidemia.In ayurveda ,it can be better correlated withmedodushti,associated with kaphadosa and dhatwagni mandhya,which is afunctional condition and just a precursor stage of medoroga and can be easilyreversible by effective regimen. Treatment of stoulya can be adopted fordyslipedemia which includeskapha , medohara ,deepana, pachana ,rukshana and lekhana karmas.Thestudy aimed to explore the efficacy of guduchi, triphalaand musta with madhu along with lifestyle modification in dyslipidemia.All thementioned drugs have the property mentioned above.

A Quaziexperimental study will be performed in 60 patients of bothsex,satisfying inclusion and exclusion criteria .Out of 60 patients , 30 eachwill be allocated to Intervention group(group 1) and Comparison group (Group2).The patients in the group 1 will be instructedto consume 6gm of Guduchyadichoorna with 12gm of madhu asanupana before food in morning and evening along with lifestyle modificationsuch as diet restrictions and exercise. Life style modification alone will beadvised to comparison group.The study period is fixed for 45 consequetive days.Theserum lipid profile will be analyzed before study and on 46th day and follow up will be done after the study period for 45 days .The data collected will be processed and conclusions will be made accordingly.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Serum total cholesterol between 200mg/dl-239mg/dl 2.on ATP guidelines having LDL between 130mg/dl-159mg/dl 3.triglycerides 150mg/dl-199mg/dl 4.HbA1c below 7%.

Exclusion Criteria

1.Known case of coronary Artery Disease 2.Known case of Thyroid and Renal disorders 3.Pregnant women and lactating women 4.Participants under any medication of dyslipidemia 5.Insulin dependent diabetic patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Changes in Serum Total Cholesterol	0th,46th, 90th day
2 Changes in LDL cholesterol	0th,46th, 90th day
3 Changes in Triglycerides	0th,46th, 90th day
4 HbA1C	0th,46th, 90th day

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Government Ayurveda Panchakarma Hospital
🇮🇳
Thiruvananthapuram, KERALA, India
Government Ayurveda Panchakarma Hospital
🇮🇳Thiruvananthapuram, KERALA, India
Anjana R
Principal investigator
08137887568
bhaskaranjana93@gmail.com