FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070818 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to evaluate the efficacy of yogaraja guggulu in Dyslipidemia (Medoroga).  
Scientific Title of Study   A Randomized open labelled controlled clinical study to evaluate the efficacy of Yogaraja guggulu in the management of Medoroga with special reference to 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 Krishna sai P  
Designation  PG Scholor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  8904377837  
Fax    
Email  krishnasaipalacherla@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sowmyashree U P 
Designation  Associate Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  9743893056  
Fax    
Email  upsprasad@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sowmyashree U P 
Designation  Associate Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore Bangalore KARNATAKA 560082 India


KARNATAKA
560082
India 
Phone  9743893056  
Fax    
Email  upsprasad@gmail.com  
 
Source of Monetary or Material Support  
OPD No 5, Dept of PG Studies in Kayachikitsa, sri sri college of ayurvedic science and research Hospital 21st Km Kanakapura Rd Udayapura PO OB Chudahalli Bengaluru 560082  
 
Primary Sponsor  
Name  Dr Krishna sai P 
Address  OPD No. 5 Dept of PG Studies in Kayachitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore-560082 
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 
DrKrishna sai p  sri sri college of ayurvedic science and research  Room number 304,Department of PG studies in Kayachikitsa,Sri Sri College Of Ayurvedic Science and Research,21st KM Kanakapura road,Udayapura post,Bengaluru Rural-560082,Karnataka,Bangalore Rural,KARNATAKA.
Bangalore Rural
KARNATAKA 
8904377837

krishnasaipalacherla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL 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 ArmDrugClassical(1) Medicine Name: Navakaguggulu, Reference: BhaishajyaRatnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: yogarajaguggulu, Reference: sharangdhara samhitha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Subjects of either gender between the age group of 21-60 years.
• Subjects who full fill the diagnostic criteria.
• Both obese and non obese subjects will be included.
• Subjects willing to participate with written informed consent, which is conveyed
in the language, which the subject can understand.
• Subjects with only Grade 1 & Grade 2 Dyslipidemia would be taken .
 
 
ExclusionCriteria 
Details  • Subjects who are on any medication for Dyslipidemia.
• Subjects with any uncontrolled systemic illness like Diabetes Mellitus,
Hypertension
• Pregnant and Lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Serum Lipid profile  before intervention- 0th day
after intervention- 30th day
follow up- 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   N/A 
Date of First Enrollment (India)   31/07/2024 
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 a disorder of lipoprotein metabolism,which may include lipoprotein overproduction or deficiency,or both. this leads to elevated total cholesterol,low density lipoprotein cholestrol(LDL-C) and triglycerides(TG) concentrations, and a decrease in the high density lipoprotein cholesterol(HDL-C) concentration in blood.
Dyslipidemia is a key independent risk factor for coronary heart disease(CAD),which in turn promotes the growth of Atherosclerosis and related cardiovascular events. Dyslipidemia has been strongly linked to the pathophysiology of cardiovascular diseases(CVDs).
About 25-30% of urban and 15-20% of rural individuals in india have dyslipidemia,2019.
Statins,cholesterol absorption inhibitors,fibrates,nicotinic acid,and others are frequently used drugs in the pharmacologocal intervention in dyslipidemia,but their use is associated with serious side effects like myalgias,arthralgias,dyspepsia,hepatic toxicity,and others.
Dyslipidemia can be understood in Ayurveda in terms of Medoroga,a disorder caused by medo dhatu vriddhi, which can lead to bahutwa and abaddhatwa of medo datu.
Given the prevalence and adverse effects of long tern use of contemporary interventions,it is necessary for more effective, and cost efficient medicines to control the illness and serve society.
Though numerous Ayurvedic formulations have been demonstrated to have anti-hyperlipidemic efficacy with no documented side effects, there is still scope for more research in this field.
Thus yogarajaguggulu,a medohara yoga,mentioned by Acharya sharangdhara, attributed with Hypolipidemic,Cardio protective and Hepatoprotective activity is taken for the present study.
Navakaguggulu consisting of maricha,pippali,shunti,harithaki,vibhitaki,amalaki,chitraka, and musta mentioned by bhaishajyaratnavali, being a proven drug for medoroga is taken as control drug.
E78.9 is the ICD-10-CM code used for diagnosing Disorder for lipoprotein metabolism,unspecified.
EF-3 is the specific code as per NAMASTE PORTAL (National Ayush Morbidity and standardized terminologies electrical portal) for Medoroga. 
 
Close