| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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. |