| CTRI Number |
CTRI/2025/10/096023 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to evaluate the efficacy and safety of CitraFit™ in subjects with cardiovascular risk factors |
|
Scientific Title of Study
|
A Prospective, Randomized, Open Label Study to Evaluate the Efficacy and Safety of CitraFit™ in Reducing Cardiovascular Risk Factors |
| Trial Acronym |
CitraFit™ - Cardiovascular Risk Factors |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poojari Haribabu |
| Designation |
Assistant Prof of Cardiology |
| Affiliation |
Government Medical College & Govt General Hospital Old RIMSGGH |
| Address |
Government Medical College & Govt General Hospital, Srikakulam - 532001 Andhra Pradesh, India
Department of Cardiology
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8527345991 |
| Fax |
|
| Email |
gghsrikakulam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Hemantkumar Manikyam |
| Designation |
Chief Scientific Officer |
| Affiliation |
Ziran India |
| Address |
Ziran India, Head Office F1-F2, Shiv Pavilion. Near Ram Mandir, Sangli, Maharashtra 416416
Sangli
MAHARASHTRA
416416
India |
| Phone |
8956983151 |
| Fax |
|
| Email |
DrHemanth@ziranindialab.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikrant Tripathi |
| Designation |
Director |
| Affiliation |
Clinfinite Solutions |
| Address |
Clinfinite Solutions,
2nd Floor, G Tower, Gachibowli Road, Serilingampally, Hyderabad, Telangana - 500019
Hyderabad
TELANGANA
500019
India |
| Phone |
7874033093 |
| Fax |
|
| Email |
tripathi.vh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil |
| Ziran India Limited, F1/F2, Shiv Pavilion, Near Ram Mandir, Sangli, Maharashtra, 416416. |
|
|
Primary Sponsor
|
| Name |
Ziran India |
| Address |
Ziran India Head Office: F1/F2, Shiv Pavilion, Near Ram Mandir, Sangli, Maharashtra, 416416. |
| Type of Sponsor |
Other [Nutraceutical Manufacturing Company] |
|
|
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 Poojari Haribabu |
Government Medical College and Govt General Hospital (Old RIMSGGH) |
Department of Cardiology Srikakulam 532001 Andhra Pradesh India
Srikakulam
ANDHRA PRADESH |
8527345991
gghsrikakulam@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: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CitraFit TM |
Nutraceutical capsules, twice a day for 90 days |
| Comparator Agent |
Statins |
Standard of care for 90 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who voluntarily participate in this study by signing their Informed Consent Form (ICF) in the local language prior to any study-mandated procedure
Males or females aged 35 to 65 years at the time of signing the ICF
Subjects diagnosed with increased Cardiovascular Risk Factors, evidenced by laboratory investigations conducted within 6 months prior to the screening visit and confirmed again during the screening visit. The criteria include
Total Cholesterol more than 1.5 times ULN
Triglycerides more than 1.5 times ULN
High-Density Lipoprotein more than 40 mg per dL
Low-Density Lipoprotein more than 130 mg per dL
Subjects who are on statins should be on a stable dose at least for 3 months prior to the screening visit for Arm 1 and Arm 2
Subjects who are newly diagnosed (treatment-naive) are taken for Arm 3.
Type 2 diabetes subjects stable on treatment for last 2 months.
Subjects ready to discontinue the use of supplementations including vitamins glucosamine chondroitin herbals or any other ongoing nutritional supplements
Willing to comply with all the study-related activities |
|
| ExclusionCriteria |
| Details |
Currently participating in another investigational study
Female subjects who are pregnant or lactating.
History of severe allergies to Citrus Bioflavonoids or similar supplements.
Concomitant use of medications known to interact with herbal remedies.
Severe psychiatric disorders.
Subjects with a planned or anticipated surgery during the study period.
Subject history of any respiratory or breathing disorders.
Subjects with HIV Positive status.
Alcohol intake more than 2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers.
Clinically significant or abnormal laboratory results other than those
relevant to the study indication during screening.
Diagnosis of Type 1 diabetes, recent surgery, liver diseases, jaundice, kidney issues, use of antidepressants, sleep disorders, psoriasis, and
inflammatory diseases like rheumatoid arthritis, inflammatory bowel disease, Crohn’s disease, ulcerative colitis, asthma, chronic
obstructive pulmonary disease (COPD) and any other inflammatory diseases which in the opinion of the Principal Investigator (PI) may impact the outcome of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
"Change in Serum TG levels from baseline to end of treatment
Change in TC levels from baseline to end of treatment
Change in LDL Levels from baseline to end of treatment
Change in HDL levels from baseline to end of treatment
Change in Serum NO levels from baseline to end of treatment
Change in SBP from baseline to end of treatment" |
Day 0 and 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety and Tolerability Monitoring adverse events (and overall tolerability of CitraFit
Improvements in Risk Factor Control Stability of lipid profiles blood pressure and cardiovascular health
Exercise tolerance improvement as measured by TMT parameters exercise duration METs achieved ST segment changes heart rate recovery
Changes in oxygen saturation using pulse oximeter monitoring |
Day 0 and 90 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/10/2025 |
| Date of Study Completion (India) |
31/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
| This is
a prospective, randomized, open label clinical study designed to evaluate the
efficacy and safety of CitraFit™ in adults with cardiovascular risk factors.
A total of 80 subjects will be enrolled and randomized into three groups:
placebo/standard of care (20), standard of care + CitraFit™ (30), and
CitraFit™ alone (30). The treatment duration will be 90 days, with a total
study duration of 8 months. The primary outcomes include changes in serum
triglycerides, total cholesterol, LDL cholesterol, and systolic blood
pressure. Secondary outcomes will assess safety and tolerability. |
|