| CTRI Number |
CTRI/2024/07/069846 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study of nutritional product in the participant in managing high cholesterol. |
|
Scientific Title of Study
|
Evaluation of safety and efficacy of nutritional product in patients with dyslipidemia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LS/24-25/003 Version 1.00 dated 1 June 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amol Gothwad |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
OPD room no 401 Fourth floor 314 B Telco Road Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
9766400243 |
| Fax |
- |
| Email |
amolgothwad01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishnavi Patil |
| Designation |
Project Coordinator |
| Affiliation |
Life Synergy |
| Address |
Office no 503, fifth floor, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner
Pune
MAHARASHTRA
411045
India |
| Phone |
9834585994 |
| Fax |
- |
| Email |
vaishnavilifesynergy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Patil |
| Designation |
Project Coordinator |
| Affiliation |
Life Synergy |
| Address |
Office no 503, fifth floor, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner
Pune
MAHARASHTRA
411045
India |
| Phone |
9834585994 |
| Fax |
- |
| Email |
vaishnavilifesynergy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Life Synergy office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner, Pune 411045, Maharashtra.
|
|
|
Primary Sponsor
|
| Name |
Life Synergy |
| Address |
Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner, Pune 411045, Maharashtra |
| Type of Sponsor |
Other [Nutraceutical product promoter] |
|
|
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 Amol Gothwad |
Lokmanya Medical Research Centre and Hospital |
OPD room no 401 Fourth Floor 314 B Telco Road Chinchwad
Pune
MAHARASHTRA |
9766400243
-
amolgothwad01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
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 |
| Intervention |
Group 1: Test product LSCM01 capsule. |
One LSCM01 capsule twice daily before food for 60 days. |
| Intervention |
Group 3: Test product LSCM01 capsule + Statin. |
One LSCM01 capsule twice daily + standard statin dose i.e. Atorvastatin 10 mg once daily for 60 days. |
| Comparator Agent |
Placebo |
One capsule twice daily before food for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and females aged 30 to 60 years both inclusive; 2.Clinically diagnosed with dyslipidemia, must exhibit specific fasting lipid profiles, meeting the following thresholds: 1.Fasting total cholesterol concentration 200 to 300 mg per dL 2.Fasting triglyceride concentration 150 to 250 mg per dL 3.Fasting LDL cholesterol concentration greater than 100 mg per dL 4.Fasting VLDL cholesterol concentration greater than 30 mg per dL 3.Participants with or without concomitant statin therapy; 4.Willing and able to follow dietary and lifestyle recommendations; 5.Participants with BMI 26 to 30 kg/m2 at screening; 6.Participants providing voluntary, written informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Pregnancy or lactation,
2.Presence of any significant comorbid condition like hypertension, diabetes,
3.Unstable angina, myocardial infarction or stroke within 3 months,
4.Body mass index (BMI) greater than 30 kg per meter square,
5.Severe liver disease (Child Pugh Class C) or ALT AST more than 3 times upper limit of normal (ULN),
6.Severe renal impairment (GFR less than 30 ml per min),
7.History of cancer within 5 years (except non melanoma skin cancer),
8.K C O uncontrolled hypothyroidism (TSH greater than 1.5 times ULN),
9.Demyelinating disorders,
10.Use of fibrates, niacin, fish oils or other lipid altering drugs,
11.Known hypersensitivity to study drug components,
12.Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment of changes in fasting lipid parameters (total cholesterol, LDL, VLDL, triglycerides, HDL).
2.Assessment of changes in biomarkers like hs-CRP, Apolipoprotein A, B, and creatine kinase. |
From Screening to end of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence and severity of adverse events.
2.Changes in anthropometric parameters like body weight, BMI, waist circumference.
3. Changes in glycemic profile fasting blood glucose, fasting insulin, HbA1c and HOMA-IR tests.
4. Assessment of systolic and diastolic blood pressure changes.
5. Changes in hematological and biochemical parameters.
6. Assessment of tolerability compliance. |
From Screening to end of the study. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 2 |
|
Date of First Enrollment (India)
|
13/07/2024 |
| 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="0"
Months="5"
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
|
The current study aims to investigate the potential of nutritional supplement in the management
of high cholesterol and related symptoms. |