| CTRI Number |
CTRI/2019/02/017743 [Registered on: 20/02/2019] Trial Registered Prospectively |
| Last Modified On: |
22/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Research Study on the effect of Eranda moola ( Roots of Ricinus communis) in the treatment of raised lipids level |
|
Scientific Title of Study
|
A Randomized Controlled Trial to evaluate the effect of Eranda Moola
(Root of Ricinus communis) in the management of Dyslipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil S Borkar |
| Designation |
Associate Professor |
| Affiliation |
Shri Gurudeo Ayurved College Gurukunj Ashram |
| Address |
Shri Gurudeo Ayurved College Gurukunj Ashram
Amravati
MAHARASHTRA
44902
India |
| Phone |
9822361760 |
| Fax |
07225224229 |
| Email |
sborkar25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil S Borkar |
| Designation |
Associate Professor |
| Affiliation |
Shri Gurudeo Ayurved College Gurukunj Ashram |
| Address |
Shri Gurudeo Ayurved Mahavidyalaya Gurukunj Ashram
Amravati
MAHARASHTRA
444902
India |
| Phone |
9822361760 |
| Fax |
07225224229 |
| Email |
sborkar25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil S Borkar |
| Designation |
Associate Professor |
| Affiliation |
Shri Gurudeo Ayurved College Gurukunj Ashram |
| Address |
Shri Gurudeo Ayurved Mahavidyalaya Gurukunj Ashram
Amravati
MAHARASHTRA
444902
India |
| Phone |
9822361760 |
| Fax |
07225224229 |
| Email |
sborkar25@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMM AYURVED MAHAVIDYALAYA SHIVAJI NAGAR ARNI ROAD YAVATMAL 445001 |
|
|
Primary Sponsor
|
| Name |
DMM Ayurved Mahavidyalaya |
| Address |
Shivaji Nagar Arni Road Yavatmal |
| Type of Sponsor |
Other [Grant in aid Ayurveda 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 Sunil S Borkar |
DEPARTMENT OF KAYACHIKITSA SHRI GURUDEO AYURVEDA RUGNALAYA |
GURUKUNJ ASHRAM 444902
Amravati
MAHARASHTRA |
9822361760
07225224229
sborkar25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of DMM Ayurved Mahavidyalaya Yavatmal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atorvastatin |
20 mg OD for 8 weeks |
| Intervention |
Root of Ricinus communis |
80 mg per kg body weight in morning on empty stomach with Honey for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with Direct LDL-C more than 130 at the time of screening
Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
1)Subjects not willing for trial
2)Subjects with Diabetes Mellitus Type I and Type 2 Diabetes Mellitus
3)Subjects with uncontrolled Hy
pothyroidism or Hyperthyroidism
4)Known cases of Severe/Chronic hepatic or renal disease
5)Known subject of any active malignancy
6)Subjects giving history of significant cardiovascular event less than 12 weeks prior to randomization
7)Subjects with uncontrolled or Malignant Hypertension
8)Subjects ECG demonstrating any signs of uncontrolled arrhythmia or acute ischemia
9)Subjects X- ray chest showing any active lesion of tuberculosis
10)Subjects having known HIV infection
11)Subjects using any other investigational drug within 1 month prior to recruitment
12)Pregnant and Lactating females
13)Subjects currently participating in any other Clinical study
14)Any other medical or surgical condition considered unsuitable for patient participation in the study as per Investigator’s judgment
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Effect on the change in direct LDL-C level at the end of study (08 weeks)
2)Effect on the change in Triglycerides levels at the end of study (08 weeks)
|
at the end of 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in Total Cholesterol Triglycerides LDL and HDL at the end of 4 and 8 weeks
2.Change in Body Weight BMI Waist circumference and Waist to hip ratio at the end of 4 & 8 weeks
3.Overall efficacy of the study and control product as per the physician at the end of 8 weeks
4.Safety assessment by assessing adverse drug reactions abnormal laboratories values at the end of 4 and 8 weeks
5.Overall safety assessment of the intervention as per the physician at the end of 8weeks
|
at the end of 4 and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
30/04/2019 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Borkar SS, Jaiswal SK. Classification of enlisted Ayurvedic lipid lowering herbs according to principle of Ayurveda. International Journal of Ayurveda and Pharma Research 2019;7(6):63-68 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Current study is open
labeled, two arms, randomized controlled clinical trial. Purpose of the Study: Recent
Population study shows higher prevalence of Dyslipidemia in overall Indian population along
with Hypertension and Diabetes. Dyslipidemia an unnoticed
clinical entity most of the time detected accidently. It is a need of time to explore natural origin
lipid lowering agent with good efficacy. So it is a matter of interest to evaluate the
effect of Erand Moola in management of Dyslipidemia. Complex or combined treatment modalities are
effective in management but it is difficult or expensive for patient to follow
or perform for long period of time. On the contrary compliance is best for
natural origin lipid lowering agent which is cost effective, handy and free
from side effects in the management of dyslipidemia. Acharya Bhavmishra, in his
text Bhavprakash mentioned the use of Eranda moola along with honey in Sthoulya and pharmacological study also proved its lipid lowering properties.
But still there is no clinical trial reported regarding the lipid lowering
activity of Eranda moola. Hence it is decided to evaluate the effect of Eranda
Moola as a lipid lowering agent in the management of dyslipidemia. Erand Moola is used in Ayurveda for Paachak, Shothghna,VataKaphaghna and Vrishya
properties since ancient time. Drug Safety and Toxicity study also established
its safe use. Hence it’s ethical to use Eranda moola in the management
of Dyslipidemia. |