| CTRI Number |
CTRI/2021/04/032540 [Registered on: 05/04/2021] Trial Registered Prospectively |
| Last Modified On: |
08/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of the herbal supplementation on lipid profile |
|
Scientific Title of Study
|
“A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate Efficacy and Safety of Ayurvedic Medicine on The Abaddha Meda (Lipid Profile) Of Mild To Moderate Medodushti (Dyslipidemia) In Subjects Who Are at Risk For Hridroga (Cardiovascular Disease)’’ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Kumar |
| Designation |
M.D Scholar |
| Affiliation |
National Institute Of Ayurveda deemed to be university (De Novo) |
| Address |
PG Dept. of Rog Nidaan evam Vikriti Vigyan,NIA,deemed to be university (De Novo),Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413220802 |
| Fax |
|
| Email |
ravindra.v.dheeraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan kumar Godatwar |
| Designation |
Professor |
| Affiliation |
National Institute Of Ayurveda deemed to be university (De Novo) |
| Address |
PG Dept. of Rog Nidaan evam Vikriti Vigyan,NIA,deemed to be university (De Novo),Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9314502834 |
| Fax |
|
| Email |
pgodatwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Kumar |
| Designation |
M.D Scholar |
| Affiliation |
National Institute Of Ayurveda deemed to be university (De Novo) |
| Address |
PG Dept. of Rog Nidaan evam Vikriti Vigyan,NIA,deemed to be university (De Novo),Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413220802 |
| Fax |
|
| Email |
ravindra.v.dheeraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda deemed to be university, jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda deemed to be university jaipur |
| Address |
National institute of Ayurveda deemed to be university (De Novo) ,Madhav Vilas Palace, Amer Road Jaipur 302002 |
| Type of Sponsor |
Other [National Institute Of Ayurveda deemed to be university,jaipur ,ministry of AYUSH,govt. of India] |
|
|
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 Ravindra Kumar |
National Institute of Ayurveda, deemed to be university (De Novo) |
PG Dept. of Rog Nidaan evam Vikriti Vigyan, O.P.D Block,Amer Road, Madhav Vilas.
Jaipur
RAJASTHAN |
09413220802
ravindra.v.dheeraj@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayurvedic Medicine |
2 capsule of 500mg each Twice a day with luke warm water after meal for 120 days |
| Comparator Agent |
Placebo |
2 capsule Twice a day with luke warm water after meal for 120 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.As per ATP III guidelines; baseline LDL ranging 160- 189mg/dl, TC ≥200 mg/dL, TG ranging 150-199 mg/dL
2. Subjects in the age group of 21–70 years of both genders; Overweight/Class-1 obese (body–mass index [BMI]: 23–35 kg/m2), Subjects with low BMI but abnormal lipid profile or subjects having both or at least any one of the above diagnostic criteria will be selected for the study.
3. Ability to understand the risks/benefits of the protocol.
4. Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera ®, or double-barrier and have a negative pregnancy test at the Screening Visit. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
5. Subject should be available for duration of study period.
6. Willing to give written informed consent and willing to comply with trial protocol. |
|
| ExclusionCriteria |
| Details |
1. Participants with chronic diseases requiring continuous use of vasoactive drugs, diuretics, lipid-lowering or anti-diabetic drugs.
2. Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain.
3. Subjects having history of serious cardiovascular diseases such MI.
4. Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose 140-199 mg/dl.
5. Subjects with history of having thyroid disease.
6. Subjects having abnormal liver or kidney function test (ALT or AST) 2 times the upper limit of normal; elevated creatinine (male 125 μmol/L, female 110 μmol/L).
7. Subjects having abnormal findings on complete blood count.
8. Subjects having history of coagulopathies.
9. Subjects with Positive HIV test.
10. Subjects having history of high alcohol intake (2 standard drinks per day).
11. Subjects who are pregnant, breast feeding or planning to become pregnant during the study.
12. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
13. Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
14. Subjects participated in any other clinical trials within thirty (30) days prior to screening. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the lipid profile of the subjects who are at mild to moderate risk of Hridroga (cardiovascular disease). |
1. To assess the lipid profile of the subjects who are at mild to moderate risk of Hridroga (cardiovascular disease) after 120 days i.e at 6th visit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the safety and tolerability of ayurvedic medicine for the management of Medodushti (dyslipidemia) in the subjects who are at risk of Hridroga (cardiovascular disease). |
1. To assess the safety and tolerability of ayurvedic medicine for the management of Medodushti (dyslipidemia) in the subjects who are at risk of Hridroga (cardiovascular disease) after 120 days i.e at 6th visit. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
05/04/2021 |
| 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="5"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Medodushti (Dyslipidemia) which is a potential signal for unrecognized comorbidities such as obesity, metabolic syndrome, diabetes mellitus, hypertension, cardiovascular disease etc. It may be manifested by elevation of the total cholesterol, low-density lipoprotein cholesterol (LDL) and triglyceride (TGL) concentrations and decrease in the good high-density lipoprotein (HDL) cholesterol concentration in the blood. Hridroga (Cardiovascular Disease) is the leading cause of death, decreased quality of life and medical cost in india. most Hridroga (Cardiovascular Disease) are preventable through a healthy lifestyle and effective treatment of Medodushti (Dyslipidemia). therapeutic reduction of these lipid fractions is associated with improved outcome. The prevalence of medodushti (dyslipidemia) in India is not exactly known as it usually appears as subclinical case without symptoms. For every 1% increase in cholesterol level, there is 1–2% increase in the incidence of coronary heart disease. The data from the US national health examination survey conduct from 1999 to 2000 reported that 25% of adults either had total cholesterol ˃239.4 mg/dl or were taking a lipid lowering medication. According to the National Commission on Macroeconomics and Health, there would be around 62 million patients with coronary artery disease by 2015 in India and of these, 23 million would be patients younger than 40 years of age. Lifestyle modifications should always be a part of the management of dyslipidemia. There are scattered references available in Ayurveda which can be correlated to dyslipidemia. Lipids can be easily correlated to that of Medo Dhatu. Abnormal composition of Meda Dhatu is considered as Meda Dushti. Trial Ayurvedic medicine (Ayurvedic prepration) in capsule form by Oral route,2 capsule B.D. each capsule contains 500 mg of
medicine. |