| CTRI Number |
CTRI/2022/09/045325 [Registered on: 08/09/2022] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trail to evaluate the efficacy and safety of Vestige Flax Oil capsules in patients suffering from Dyslipidemia |
|
Scientific Title of Study
|
A prospective, multicenter, open label, active controlled, randomized clinical trial to evaluate efficacy and safety of Vestige Flax Oil capsules in patients suffering from Dyslipidemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-IR-VG-FLAX-2022/Version Number: 1.0/Dated: 19-May-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trail Operations |
| Affiliation |
IR Innovate Research Pvt. Ltd |
| Address |
C-120,3rd Floor, Noida Sector -02
C-120,3rd Floor, Noida Sector -02
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trail Operations |
| Affiliation |
IR Innovate Research Pvt. Ltd |
| Address |
C-120,3rd Floor, Noida Sector -02
C-120,3rd Floor, Noida Sector -02
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trail Operations |
| Affiliation |
IR Innovate Research Pvt. Ltd |
| Address |
C-120,3rd Floor, Noida Sector -02
C-120,3rd Floor, Noida Sector -02
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
|
Source of Monetary or Material Support
|
| Vestige Marketing Pvt Ltd., A-89, Okhla Industrial Area Phase II New Delhi 110020 |
|
|
Primary Sponsor
|
| Name |
Vestige Marketing Pvt Ltd |
| Address |
A-89, Okhla Industrial Area Phase II New Delhi 110020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Harsh Mittal |
Panchsheel Hospital Pvt. Ltd. |
Department of medicine, OPD room basement, Panchsheel Hospital, C-3/C-4A 64 A Opp. Gokulpuri Police Station, Yamuna Vihar, Delhi – 110053
North
DELHI |
9560506410
harshmittal86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
NIL |
NIL |
| Intervention |
Vestige Flax Oil capsules |
One Capsule to be taken 3 times a day orally after meals. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Subject is willing and able to give written informed consent.
2. Female subjects aged ≥ 18 and ≤ 65 years
3. The subjects will be considered to have dyslipidemia if they met 2 of the following 4 criteria:
• fasting total cholesterol concentration>200 mg/dL,
• fasting triglyceride concentration>150mg/dL,
• fasting LDL-cholesterol concentrations>100 mg/dL, or
• fasting HDL-cholesterol concentrations>40 mg/dL.
4. Patients who are taking lipid lowering drugs should continue the same dosage during the study.
5. Subject is willing, able, and likely to comply with all study procedures and restrictions.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history of CVD or other severe chronic disease or use of any drugs known to affect lipid metabolism.
2. Subjects who have used any antioxidant such as Vitamin E, vitamin C, Phytochemicals, and coenzyme Q10 within two months before trial.
3. Pregnant or lactating women
4. Patients with Homozygous Familial Hypercholesterolemia
5. AST or ALT level increases at least twice the upper limits of normal in patients
6. Subjects who had an administration of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial.
7. Any other condition that in the investigator’s judgment might interfere with study objectives.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Mean change in Low-Density Lipoprotein (LDL-C) from baseline to end of the study. |
Day 0 to Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Mean change in Total Cholesterol Concentration from baseline to end of the study.
• Mean change in High-Density Lipoprotein (HDL-C) from baseline to end of the study.
• Mean change in Triglyceride concentration (TG) from baseline to end of the study.
• Safety and tolerability of the study drug(s) will be assessed by the Clinical AEs occurring during entire duration of study.
|
Day 0 to Day 56 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2022 |
| Date of Study Completion (India) |
26/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Primary objective of this study was to evaluate the efficacy
of Vestige Flax Oil Capsule in patient suffering from dyslipidemia by the mean
change value of LDL-C (Low Density
Lipoprotein Concentration) from baseline (visit 1) to visit 2.
Subjects were randomized into two arms. i.e., group 1 (Vestiage flax oil
and SOC) and group 2 (SOC)
Group A (Flax Oil Capsules with
standard of care) showed significant alleviation in the mean value of
low-density Lipoprotein concentration (LDL-C) i.e., 79.04 (on visit 2) from
177.68 (on baseline -visit 1).
Group B (Standard of care alone): also
showed significant alleviation in the mean value of low-density Lipoprotein
concentration (LDL-C) i.e., 80.64 (on visit 2) from 168.56 (on baseline -visit
1).
Secondary objective of this study was to evaluate the safety &
tolerability of Vestige Flax Oil Capsules for treatment in patients suffering
from Dyslipidemia by evaluating follwoing parameters:
·
Mean Change in Total Cholesterol Concentration from baseline to
end of the study.
·
Mean change in High-Density Lipoprotein (HDL-C) from baseline to end of the
study
·
Mean change in Triglyceride concentration (TG) from baseline to end of the
study.
·
Safety and tolerability of the study drug(s) will be assessed by the
Clinical AEs occurring during entire duration of study.
Group A (Flax Oil Capsules with
standard of care) showed significant alleviation in the mean value of total
cholesterol concentration i.e., from 273.12 on baseline (visit 1) to 159.16 on
visit 2.
Group B (Standard of care alone): also showed
significant alleviation in the mean value of total cholesterol concentration
i.e., from 264.84 on baseline (visit 1) to 157.64 on visit 2.
Group A (Flax Oil Capsules with
standard of care) does not reflect any significant fluctuation in the mean value
of High-Density
Lipoprotein (HDL-C)
i.e., from 50.16 on baseline (visit 1) to 49.12 on visit 2.
Group B (Standard of care alone): also
showed a little fluctuation in the mean value of High-Density Lipoprotein
(HDL-C) i.e., from 53.72 on
baseline (visit 1) to 47.84 on visit 2.
Group A (Flax Oil Capsules with
standard of care) showed significant alleviation in the Triglyceride
concentration (TG) i.e.,
from 223.68 on baseline (visit 1) to 155.04 on visit 2.
Group B (Standard of care alone): also
showed significant alleviation in the Triglyceride concentration (TG) i.e., from 213.24 on baseline
(visit 1) to 163.4 on visit 2.
There was one adverse
event reported in Group B (SOC Arm) of the study which was not related to the
study drug.
Overall conclusions:
From current data set analysis of this proof-of-concept study it can be
concluded that Vestige Flax oil Capsule has shown promising results in
improving Dyslipidemia when used along with Standard of care. Study met its
primary and secondary endpoints with significant results. Vestige Flax oil
Capsule are also safe to be used as the study documented only 1 adverse event
in Group B (SOC arm) which was not related to study drug or any study related
procedures. However, double blind, placebo-controlled studies with larger
sample size, quality of life anlysis and increased duration of consumption can
be conducted to reproduce results like current study in consideration. Its
impact on various haematological and other parameters can also be evaluated in
future studies.
|