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CTRI Number  CTRI/2024/10/074613 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 19/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurveda Management of disturbed fat metabolism W S R to increased triglyceride levels with Trikatu churna  
Scientific Title of Study   Effect of Trikatu choorna in the management of Medo Dushti W.S.R to Primary Hyper Triglyceridemia An open lable clinical trial 
Trial Acronym  Disturbed fat metabolism 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradnya Prakash Hemke 
Designation  PG Scholar 
Affiliation  Kahers Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 
Address  Department of Dravyaguna KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka 590003

Belgaum
KARNATAKA
590003
India 
Phone  9405747253  
Fax    
Email  pradnyahemke98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Chougale 
Designation  Professor and HOD of Department of Dravyaguna 
Affiliation  Kahers Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 
Address  Department of Dravyaguna KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka 590003

Belgaum
KARNATAKA
590003
India 
Phone  9964749993  
Fax    
Email  punarjeevam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arun Chougale 
Designation  Professor and HOD of Department of Dravyaguna 
Affiliation  Kahers Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 
Address  Department of Dravyaguna KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka 590003


KARNATAKA
590003
India 
Phone  9964749993  
Fax    
Email  punarjeevam@gmail.com  
 
Source of Monetary or Material Support  
Kahers Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka, India 590003 
 
Primary Sponsor  
Name  Dr Pradnya Prakash Hemke  
Address  KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka 590003 
Type of Sponsor  Other [Self] 
 
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 Pradnya Prakash Hemke  KLE Shri B M K Ayurveda Hospital  Vishuddha,OPD no 3,KLE Ayurveda Hospital,Shahapur,Belgavi Karnataka, India 590003
Belgaum
KARNATAKA 
9405747253

pradnyahemke98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Ethics Committee for Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E781||Pure hyperglyceridemia. Ayurveda Condition: MEDOVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Trikatu Churna, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: -Warm Water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Triglyceride level-Borderline 150-199mg/dl
Individuals of either sex between 20-60 years of age
BMI-More than 25
Individual fulfilling subjective criteria

 
 
ExclusionCriteria 
Details  Thyroid disorder
Hypertension
Diabetes
Kidney disease
Other systemic and genetic disease
Pregnant and lactating women
Grishma rutu
Pitta prakopita individual
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate efficacy of Trikatu churna in Medo dushti through triglyceride levels.  Baseline and 42nd day  
 
Secondary Outcome  
Outcome  TimePoints 
To assess improvement in other lipid parameters along with subjective parameters.  Baseline 21st day and 42nd day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/01/2025 
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  

The term dyslipidaemia denotes disorders of lipid metabolism Majority of the population is following inappropriate fatty diet regimen and sedentary lifestyle which may lead to a state of dyslipidaemia Dyslipidaemia denotes the state where there can be overproduction or decrease in production of lipoprotein The crude HTG prevalence rates were 29.6% in global population 36.9% in men and 23.8% in women The sex and age adjusted HTG prevalence rates were 27.0% in global population34.6% in men and 21.4% in women A fifth of the female adult population and more than a third of the male population had HTG The prevalence rates of various fasting dyslipidaemia in the first phase of ICMR INDIAN study restricted to urban and rural populations in 4 states in India was hypercholesterolemia in 13.9%, high triglycerides in 29.5% low HDL cholesterol in 72.3% and high LDL cholesterol in 11.8% 79%men and women had abnormalities in at least one of the lipid parameters Triglycerides are fatty acids and denotes the main lipid component of dietary fat They store unused calories and provide your body with energy  According to AMERICAN HEART HEALTH(AHA)factors affecting the triglyceride includes Diet Exercise level Diabetes  Inflammatory disease  Alcohol consumption  Obesity  Medications  Age  Sex  Pregnancy  The normal level of triglycerides in blood 150mg/dl (Acc National Cholesterol Education Program Adult Treatment Panel III) Normal <150 Borderline 150-199 High 200-499 Very high >500 Hypertriglyceridemia (HG) is an independent risk factor with more prevalence than hypercholesterolemia and its attributes to cardiovascular disease (CVD) and pancreatitis Hence it becomes imperative to search for new triglyceride (TG) lowering agents In Ayurveda  medodushti is pathological event which causes sthoulya which comes under Ashtanindita  The Ayurvedic description of Medodushtijanya Sign and  Symptoms bears a remarkable resemblance to the current texts explanation of dyslipidemia  As stated According to Ayurveda a diet high in Shleshma Vardhak Ahara Vihara and low in exercise lead to Agnidushti which in turn causes an excess of Sama Meda to form  As a result Medovriddhi  and  Medodushti  appears   Acharya Sushruta explained TRIKATU which consist of 3 drugs PIPALLI (PIPER LONGUM)  MARICH (PIPER NIGRUM) SHUNTHI (ZINGIBER OFFINCINALE) as kaphomedaghna  Sharangdhar explains trikatu as dipana shleshma MEDOGHNA6 kushta pinasnashanam which means drugs which do agni dipana and reduces excess of meda The drugs present in trikatu mainly has KATU RASA and USHNA VEERYA  Katu rasa will scrape the meda in the strotas and usna veerya will do pachan of the meda  Building certainty on simple formulation and minimal expenses with high compelling treatment is need of the time  Keeping this in view trikatu choorna capsule with compelling dose is considered for the ongoing review

 
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