| CTRI Number |
CTRI/2024/02/063163 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| 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
|
Ayurvedic and allopathic management along with diet and yoga in dyslipidemia |
|
Scientific Title of Study
|
Efficacy of Integrated Ayurveda Protocol in Dyslipidemia A randomized controlled clinical trial |
| 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 ASHUTOSH |
| Designation |
PG SCHOLAR |
| Affiliation |
KAHERs SHRI BMK AYURVEDA MAHAVIDYALYA SHAHPUR, BELAGAVI, KARNATAKA |
| Address |
Dept of Kayachikitsa KAHERs SHRI BMK AYURVEDA MAHAVIDYALYA SHAHPUR BELAGAVI KARNATAKA
Belgaum KARNATAKA 590003 India |
| Phone |
7015706390 |
| Fax |
|
| Email |
doctoashu@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SUKETHA KUMARI |
| Designation |
READER |
| Affiliation |
KAHERs SHRI BMK AYURVEDA MAHAVIDYALYA SHAHPUR, BELAGAVI, KARNATAKA |
| Address |
Dept of Kayachikitsa KAHERs SHRI BMK AYURVEDA MAHAVIDYALYA SHAHPUR BELAGAVI KARNATAKA
Belgaum KARNATAKA 590003 India |
| Phone |
9483637757 |
| Fax |
|
| Email |
sukethashetty411@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR SUKETHA KUMARI |
| Designation |
READER |
| Affiliation |
KAHERs SHRI BMK AYURVEDA MAHAVIDYALYA SHAHPUR, BELAGAVI, KARNATAKA |
| Address |
Dept of Kayachikitsa KAHERs SHRI BMK AYURVEDA MAHAVIDYALYA SHAHPUR BELAGAVI KARNATAKA
KARNATAKA 590003 India |
| Phone |
9483637757 |
| Fax |
|
| Email |
sukethashetty411@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE SHRI BMK AYURVEDA HOSPITAL SHAHPUR BELAGAVI KARNATAKA OPD NO 6 OPD NO 3 |
|
|
Primary Sponsor
|
| Name |
DR ASHUTOSH |
| Address |
KAHERs SHRI BMK AYURVEDA MAHAVIDYALYA SHAHPUR BELAGAVI KARNATAKA |
| Type of Sponsor |
Other [] |
|
|
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 |
| Dr Ashutosh |
KLE Shri BMK Ayurveda Hospital and research centre Shahpur Belagavi |
KAHERs Shri BMK Ayurveda Hospital and research centre Shahpur Belagavi Dept of Kayachikitsa OPD no 6 OPD no 3 Belgaum KARNATAKA |
7015706390
doctoashu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for research on human subjects Shri BMK Ayurveda Mahavidyalaya and Hospital Shahapur Belagavi 590003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: medorogah, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Atorvastatin | Tablet Atorvastatin 10mg once a day orally after food with water for 90 days along with Exercise protocol and Dietary intervention | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varikshamla, Reference: Bhavprakash nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: Capsules Varikshamla with luke warm water along with ayurveda dietary intervention and yoga sculpt protocol |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed subjects of Dyslipidemia not on any medications
Subjects with Dyslipidemia (Total Cholesterol to HDL Ratio greater than or equal to 5 )
Patient with age group between 18 to 70 |
|
| ExclusionCriteria |
| Details |
Patient who are diagnosed to have systemic disorders like diagnosed with Diabetes mellitus Uncontrolled Hypertension Systolic more than 140mmhg and Diastolic more than 90mmhg and any serious systemic illness
Pregnant and Lactating women
Drug induced Dyslipidemia
Patient who are having a past history of Stroke MI Severe Pulmonary dysfunctions which interfere with the treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be based on Total cholesterol HDL ratio |
Baseline 90th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome will be based on Small dense LDL particles size Insulin resistance parameter (TG to HDL-C ratio) Very low density lipoprotein and Serum triglyceride levels Anthropometry and QoL- SF36 |
Small dense LDL particles size Insulin resistance parameter (TG to HDL-C ratio) Very low density lipoprotein and Serum triglyceride levels (baseline and 90th day)
Anthropometry and QoL- SF36 (baseline 30th 60th and 90th day)
|
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/04/2024 |
| 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 Applicable |
| 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 the imbalance of lipids such as cholesterol low-density lipoprotein cholesterol(LDL-C) triglycerides and high-density lipoprotein cholesterol(HDL-C) This condition can result from lifestyle factors tobacco exposure genetic and obesity can lead to cardiovascular disease with severe complications It is a prime reason for morbidity and mortality worldwide Abnormal cholesterol levels are estimated to cause 18% of the global CVDs (Cardiovascular diseases) and 56% of the global Ischemic Heart Diseases (IHD) For every 1% reduction in lipid level the risk of heart diseases reduces by 2.5% Dyslipidemia is an established risk factor for atherosclerotic disease An estimated 17.9 million people died from CVDs in 2019 representing 32% of all global deaths Out of the 17 million premature deaths (under the age of 70) due to noncommunicable diseases(NCDs) in 2019 38% were caused by CVDs According to National Commission on Macroeconomics and Health (NCMH) a Government of India undertaking there is around 62 million patients with CVD in 2015 among which 23 million patients would be younger than 40 years of age In 2016 India reported 63% of total deaths due to NCDs of which 27% were attributed to CVDs CVDs also account for 45% of deaths in the 40-69 year age group Despite considerable advances during the past 40 years there is increasing awareness among scientists epidemiologist and clinicians that current approaches to evaluate Coronary Heart Disease(CHD) risk in asymptomatic individual is sub optimal limiting HDL-C and LDL-C as therapeutic target Results of the Canadian cardiovascular studies suggests that Total cholesterol to HDL ratio was better and cumulative marker for Dyslipidemia The total cholesterol/HDL ratio is a superior measure of risk for coronary heart disease compared with either total cholesterol or LDL cholesterol level Measurements of sdLDL size and LDL size have the potential to improve coronary disease risk assessment as well as decisions about LDL treatment intensity since they account for aspects of lipid atherogenicity that are incompletely reflected by values of LDL-C sdLDL size and non–HDL-C were more closely associated with the occurrence of future CAD than levels of LDL-C Whereas sdLDL size was related to CAD risk There is no direct reference of dyslipidemia in Ayurveda but the pathophysiology and presentation of dyslipidemia can be correlated to that of Medoroga Atisthoulya In comprehensive Ayurveda literature medoroga has been synonymously defined to Sthaulya Only Adhamalla while mentioning on sharangdhara samhita tried to differentiate between the two types of medo roga 1 Medo roga adiposity including its clinical features (Sthaulya) 2 Medo dosha lipid disorders where meda acts as an etiological factor in the genesis of other diseases The conventional drug therapy has limitation as lipid lowering drugs like statin and fibrates cause Myalgia increase blood glucose level Insulin Resistance headache dizziness digestive system problems when used for longer duration and in high doses So there is a need of alternate and safer therapies with fewer or no side effects Various studies on Ayurveda medications herbs shown results in dyslipidemia Mostly drugs are Amala Tikta Kashaya and Katu in Rasa Laghu and Ruksha in Guna and Katu and Amala in Vipaka and thus pacifies the vitiated Kapha Dosha which is dominant in the pathogenesis of dyslipidemia It also depletes the excessively produced Rasa Mamsa Meda Vasa Sweda and Kleda which are all similar in attributes to Kapha Dosha Hence herbal formulations proved to have a better effect in dyslipidemia Diet has been recognized as playing a key role in the control of noncommunicable chronic diseases Specific foods and food components emerge as potential adjuvant strategies in the reduction of the risk of dyslipidemia Food components were revealed to act upon the different metabolic pathways that influence lipid disorders in humans They are believed to have the potential to ultimately become prominent in the future treatment and primary prevention of dyslipidemias and thereby in the control of CVDs The improvement in lipid profile with practice of physical activity could be due to increased hepatic lipase and lipoprotein lipase This would increase the uptake of triglycerides by adipose tissue and affect the lipoprotein metabolism Vrikshamla (Garcinia indica Linn) has various pharmacological activities including antioxidant anti-obesity anti-inflammatory hepatoprotective cardioprotective These characteristics are consistent with the previously reported activity of abundant phytochemical components such as garcinol HCA cyanidin-3-sambubioside and cyanidin-3-glucoside isolated from Vrikshamla (Garcinia indica Linn) These studies suggest the potential of Vrikshamla (Garcinia indica Linn) as a promising therapeutic agent for controlling and preventing various diseases However given that most of the trials have been conducted either in vitro or in vivo further study at the clinical level is needed to establish the efficacy and safety of Garcinia indica in humans So far no comparative clinical study has been published using conventional antidyslipidemic protocol and Integrated Ayurveda protocol involving small dense LDL as an assessment parameter |