| CTRI Number |
CTRI/2025/12/099581 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study on the effectiveness and safety of a new herbal composition (JOFP-002) for managing metabolic syndrome in adults. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo controlled, Parallel Group Clinical Study to evaluate Efficacy and Safety of a Novel herbal composition JOFP-002 in subject with metabolic syndrome. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Akash Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Chennai Meenakshi Multispeciality Hospital |
| Address |
Chennai Meenakshi Multispeciality Hospital Ltd.
Clinical research department, Basement, Old No 149, new No 70, Luz Church road, Mylapore, Chennai, Tamil Nadu, 600004, India
Chennai
TAMIL NADU
Chennai
TAMIL NADU
600004
India |
| Phone |
9944066192 |
| Fax |
|
| Email |
drakashkumar93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Akash Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Chennai Meenakshi Multispeciality Hospital |
| Address |
Chennai Meenakshi Multispeciality Hospital Ltd.
Clinical research department, Basement, Old No 149, new No 70, Luz Church road, Mylapore, Chennai, Tamil Nadu, 600004, India
Chennai
TAMIL NADU
Chennai
TAMIL NADU
600004
India |
| Phone |
9944066192 |
| Fax |
|
| Email |
drakashkumar93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Akash Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Chennai Meenakshi Multispeciality Hospital |
| Address |
Chennai Meenakshi Multispeciality Hospital Ltd.
Clinical research department, Basement, Old No 149, new No 70, Luz Church road, Mylapore, Chennai, Tamil Nadu, 600004, India
Chennai
TAMIL NADU
Chennai
TAMIL NADU
600004
India |
| Phone |
9944066192 |
| Fax |
|
| Email |
drakashkumar93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jeeva Organic Private Limited |
|
|
Primary Sponsor
|
| Name |
Jeeva Organic Private Limited |
| Address |
Jeeva Organic Private Limited
DLF Cybercity, DCB-705, 7th Floor
Infocity Ave, Patia, Bhubaneswar
Odisha 751024
|
| 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 P Akash Kumar |
Chennai Meenakshi Multispeciality Hospital Limited |
Clinical research department, Basement, Old No 149, new No 70, Luz Church road, Mylapore, Chennai, Tamil Nadu, 600004, India
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9944066192
drakashkumar93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ChennaiMeenakshiMultispecialityHospitalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E782||Mixed hyperlipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
JOFP-002 |
JOFP-002 is a standardized 500 mg herbal capsule developed to support metabolic health through a synergistic blend of Cinnamon and Ginger extracts. It is to be taken twice daily before food for 56 days. |
| Comparator Agent |
Placebo |
Placebo is 500 mg inert capsule identical to intervention. It is to be taken twice daily before food for 56 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male or female subjects between 18 to 65 years of age
Ability to understand the risks/benefits of the protocol
Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy
Confirmed diagnosis of metabolic syndrome as per ATP-III guidelines. This includes the presence of at least 3 or more of the following 5 factors: (As per modified NCEP ATP III guidelines-specific for South Asia)
Including
Abdominal waist circumference greater than 90 (males), greater than 80 cm (females) and
Increased blood pressure (greater than or equal to 130 per 85 mm Hg)
Serum triglycerides greater than or equal to 150 mg per dL
Serum HDL cholesterol less than 40 mg per dL (males), less than 50 mg per dL (females)
Elevated fasting blood glucose greater than or equal to 100 mg per dL
Subjects agree to maintain the activity dairy
If Former smoker (previously smoked greater than or equal to 10 cigarettes per day for at least 1 year, cessation for at least 6 months
Willing to give written informed consent and willing to comply with trial protocol
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Change from baseline to end of the study in
Serum triglycerides
Fasting blood glucose
|
Day -7, Day 28, Day 56, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline to end of the study in
Serum LDL
Total Cholesterol
Serum HDL
Blood Pressure
Abdominal waist circumference
Change in Body weight
Change in Glycosylated haemoglobin (HbA1c)
|
Day -7, Day 28, Day 56, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/12/2025 |
| 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 Applicable |
| 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
|
Metabolic syndrome is a condition that includes high blood
sugar, increased waist size, high blood pressure, and abnormal cholesterol
levels. This study is being conducted to evaluate the effectiveness and safety
of a new herbal formulation, JOFP-002, in people with metabolic syndrome.
Participants will be randomly assigned to receive either JOFP-002
or a placebo. The study will assess changes in blood sugar, cholesterol, blood
pressure, body weight and waist circumference. Safety will be monitored through
regular health check-ups and laboratory tests. |