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CTRI Number  CTRI/2024/05/067161 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to study the effect of Herbal formulation in the management of Dyslipidemia 
Scientific Title of Study   An Open Labelled Active Controlled Randomized Clinical study to evaluate the efficacy of Herbal formulation in the management of Dyslipidemia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidhi Maheshkumar Desai 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurveda 
Address  OPD 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  7567339032  
Fax    
Email  desaividhi091@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Janhavi Patharkar 
Designation  Associate Professor 
Affiliation  Parul Institute of Ayurveda 
Address  OPD 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9409117838  
Fax    
Email  Janhavi.patharkar260021@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Janhavi Patharkar 
Designation  Associate Professor 
Affiliation  Parul Institute of Ayurveda 
Address  OPD 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9409117838  
Fax    
Email  Janhavi.patharkar260021@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
OPD 116, Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia Vadodara Gujarat 391760 India 
 
Primary Sponsor  
Name  Parul Institute of Ayurved 
Address  Faculty of Ayurved, Parul University AP Limda TAL Waghodia DIST Vadodara Gujarat 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vidhi Maheshkumar Desai  Parul Institute of Ayurved  OPD 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia Vadodara Gujarat
Vadodara
GUJARAT 
7567339032

desaividhi091@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul Institute of Ayurved- Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Statin group medicineRosuvastatin 10 mg HS is used to lower bad cholesterol(LDL) and triglycerides(fats) in the blood, and to increase good cholesterol(HDL)
2Intervention ArmDrugOther than Classical(1) Medicine Name: Herbal formulation, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients of either gender between age 18 and 70 years (both years inclusive)
2.Patient having one or more abnormal lipid level in lipid profile investigation
3.Patients with BMI from 18.5 to 40 Kg/㎡ 
 
ExclusionCriteria 
Details  1.Patients have other disease such as uncontrolled diabetes mellitus and hypertension.
2.Dyslipidemia due to drugs e.g., glucocorticoids.
3.Patients have history of MI, heart failure, stroke in last 6 months.
4.Pregnant And lactating women.
5.Patients who are currently participating in any other clinical trials(since last 2 months).
6.Immunosuppressive patients –HIV.
7.Patients with infective diseases- active tuberculosis, hepatitis B.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparision of effect of Herbal formulation with statin in patients of dyslipidemia  Baseline,Day 15,Day 30,Day 45,Day 60,Day 75,Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the efficacy of herbal formulation with statin on Lipid profile, LFT,RBS
Compare the efficacy of Herbal formulation with statin on subjective criteria of Dyslipidemia 
Baseline,Day 15,Day 30,Day 45,Day 60,Day 75,Day 90 
 
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 
Date of First Enrollment (India)   17/05/2024 
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  

Lipids, such as cholesterol or triglycerides, are absorbed from the intestines and are carried throughout the body via lipoproteins for energy, steroid production, or bile acid formation. Major contributors to these pathways are cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, and high-density lipoprotein (HDL). An imbalance of any of these factors, either from organic or non-organic causes, can lead to Dyslipidemia. Dyslipidemia is the imbalance of lipids such as cholesterol, low-density lipoprotein cholesterol, (LDL-C), triglycerides, and high-density lipoprotein (HDL). This condition can result from diet, tobacco exposure, or genetic. it can lead to cardiovascular disease with severe complications. In the list of WHO for lifestyle disorders, cardiovascular diseases take the lives of 17.9 million people every year, 31% of all global deaths. Dyslipidemia is a disorder of lipoprotein metabolism, which can include overproduction or deficiency of lipoprotein or both. Dyslipidemia can be due to familial disorders as well. Autosomal dominant mutations cause most cases of familial hypercholesterolemia in LDL receptors, which causes an elevation in LDL-C levels. The physical exam is limited in Dyslipidemia disorders. Xanthomas are deposits of lipids on the skin and sometimes subcutaneous tissue. They are yellowish and can form into plaques, nodules, or plaques. They can present on the palmar crease, which suggests familial dysbetalipoproteinemia, eyelids, or tendons. They typically are associated with hyperlipidemia, and if seen, the patient should have screening for Dyslipidemia. Various terminologies are used for Dyslipidemia like, Rasagata Sneha-vriddhi, Raktagata Sneha vriddhi, Medo vriddhi, Medo-roga or Medo-dosha, Ama Medo dhatu and Kapha Medo Margavarana. But none of this term completely denotes Dyslipidemia. In such conditions, Charaka has mentioned that there can be no definite standardization of nomenclature of all diseases. The abnormalities in plasma lipoproteins are major risk factor for atherosclerosis. Hypercholesterolemia is directly proportional to atherosclerosis and ischemic heart disease. High cholesterol rarely showing symptoms, usually it is detected during routine blood test. Familial hypercholesterolemia may have distinct symptoms such as deposits of excess cholesterol that collect in the skin or eye tissue. Nodules in tendons in the hands or feet or rarely streaks in the hands are some other cholesterol deposits. Xanthomatosis  are yellow coloured, painless nodular masses on the body. Xanthelasma are yellowish plaques like lesions seen on the medial aspect of upper and lower eyelids, but also seen in normal individuals. Corneal arcus are greyish ring will appear along the periphery of cornea, but also seen in normal individuals.  Baddha meda ( bounded / unmovable ) are the fat which is not mobile and is stored in the form of fat at various places ( fat deposits/ omentum / muscle in the body ). Abaddha meda ( unboundable /movable ) are the fat which is mobile and circulate in the body along with in the form of lipids ( cholesterol , triglycerides , LDL , HDL , VLDL etc ).Prevalence of high cholesterol is 25–30% in urban and 15– 20% rural subjects and epidemiological studies have established a strong correlation between Premature Coronary Artery Disease / Cardiovascular disease and serum cholesterol levels. In general studies show that for each 1mg/dl decrease in LDL cholesterol in the plasma, there is about 2 percent decrease in mortality from atherosclerotic cardiovascular diseases. Therefore, appropriate preventive measures are valuable. Atorvastatin, Rosuvastatin used for treatment of Dyslipidemia, but they have side effect like elevated Transaminases, Myalgias, Arthralgias, Dyspepsia, Bloating, GI upset, Elevated Glucose, Elevated uric acid, Elevated liver function tests. Long term statin induced type 2 DM. International lipid panel- 2015 statin intolerance. Hence it is need of the day to find Ayurvedic remedy (herbal medication) for Dyslipidemia.

 
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