| 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
|
|
|
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
|
|
|
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 (Non Ayurveda) | | - | Statin group medicine | Rosuvastatin 10 mg HS is used to lower bad cholesterol(LDL) and triglycerides(fats) in the blood, and to increase good cholesterol(HDL) | | 2 | Intervention Arm | Drug | Other 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. |