| CTRI Number |
CTRI/2025/10/095931 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Investigational Products in Adults with Newly Diagnosed Dyslipidemia |
|
Scientific Title of Study
|
An open-label, parallel-group study to evaluate the safety and efficacy of
investigational products in adults with newly diagnosed dyslipidemia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/25-26/014 Version: 1.00; Dated, 19th August 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramshyam Agarwal |
| Designation |
Principal Investigator |
| Affiliation |
Health Nexus Medical Research |
| Address |
2nd Floor, Health Nexus Medical Research, Near Hotel Keys, Morwadi, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8087282022 |
| Fax |
- |
| Email |
ramshyam.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Ganu |
| Designation |
Managing Director |
| Affiliation |
Mprex Healthcare Pvt. Ltd. |
| Address |
Office 813, Sai Millenium, Mumbai Pune Bypass Rd Flyover,Kate Wasti, Punawale, Pune.
Pune
MAHARASHTRA
411033
India |
| Phone |
8554912644 |
| Fax |
- |
| Email |
drgayatri@mprex.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Ganu |
| Designation |
Managing Director |
| Affiliation |
Mprex Healthcare Pvt. Ltd. |
| Address |
Office 813, Sai Millenium, Mumbai Pune Bypass Rd Flyover,Kate Wasti, Punawale, Pune.
Pune
MAHARASHTRA
411033
India |
| Phone |
8554912644 |
| Fax |
- |
| Email |
drgayatri@mprex.in |
|
|
Source of Monetary or Material Support
|
| Tilman SA
Zoning industrial Sud 15 BE-5377 Baillonville, Belgium. |
|
|
Primary Sponsor
|
| Name |
Tilman SA |
| Address |
Zoning industrial Sud 15 BE-5377
Baillonville, Belgium. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramshyam Agarwal |
Health Nexus Medical Research |
2nd Floor, Health Nexus Medical Research, Near Hotel Keys, Morwadi, Pune - 411018
Pune
MAHARASHTRA |
8087282022
-
ramshyam.research@gmail.com |
| Dr Prashant Pawar |
Krishna Vishwa Vidyapeeth |
Krishna Vishwa Vidyapeeth (Deemed to be University), NH4, Pune–Bangalore Highway, Agashivnagar, Malkapur, 415539
Satara
MAHARASHTRA |
9890052696
-
drprashant80872@gmail.com |
| Dr Anuja Patil |
Omkar Multispeciality Hospital |
Survey No 94, Plot No 81, opposite to Yashada Windosong, Ravet, Pune, Pimpri-Chinchwad, Maharashtra
Pune
MAHARASHTRA |
09960789068
-
dranujap.omkarhospital@gmail.com |
| Dr Kushal Bangar |
Shivam Hospital |
Plot No.57, C.R.W. CHS,
Near M.ID.C Water tank, Kalyan Road, Dombivili (East) - 421201, Maharashtra, India.
Pune
MAHARASHTRA |
9545664884
-
drkushal.bangar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Krishna Vishwa Vidyapeeth |
Approved |
| Institutional Ethics Committee Sangvi Multispeciality Hospital |
Approved |
| Institutional Ethics Committee Sangvi Multispeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Group A (AMUA-H) |
2 capsules (AMUA-H) in a single dose once daily orally during the morning meal for 60 days. |
| Intervention |
Group B (AMUA-L) |
2 capsules (AMUA-L) in a single dose once daily orally during the morning meal for 60 days. |
| Intervention |
Group C (AMUB) |
2 capsules (AMUB) in a single dose once daily orally during the morning meal for 60 days. |
| Intervention |
Group D (CHFT) |
1 tablet (CHFT) in a single dose once daily orally during the evening meal for 60 days. |
| Intervention |
Group E (CHNG) |
2 tablets (CHNG) in a single dose once daily orally during the evening meal for 60 days. |
| Intervention |
Group F (PGUA) |
2 capsules (PGUA) in a single dose once daily orally during the morning meal for 60 days. |
| Intervention |
Group G (EPRG) |
One tablet (EPRG) twice a day, with meals orally in morning and night for 60 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and females aged 30-60 years (both inclusive);
2. Clinically diagnosed with dyslipidemia in past 3 months, must
exhibit specific fasting lipid profiles, meeting the following
thresholds:
1.Fasting total cholesterol concentration greater than or equal to 200 mg/dL
2.Fasting triglyceride concentration - 150 to 499 mg/dL
3.Fasting LDL-cholesterol concentration - greater than or equal to 130 to less than or equal to 189 mg/dL
3. Participants without concomitant statin therapy (treatment naïve)
4. Willing and able to follow dietary and lifestyle recommendations
5. Participants with BMI 18.5-30 kg/m2at screening
6. Participants providing voluntary, written informed consent to
participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Known or suspected allergy/hypersensitivity to any component of the investigational product.
2. Any other cardio-diabetic comorbidity as per investigators discretion.
3. Difficulty sleeping due to a medical condition.
4. History of a neurological disorder.
5. History of bipolar disorder, psychotic disorder, posttraumatic stress
disorder, or current psychiatric disorder that requires medication.
6. Ongoing clinical depression and anxiety disorder (showing moderate to severe diagnosis on Participants Health Questionnaire-9 (PHQ 9) and Generalized Anxiety Disorder-7 (GAD 7) scales).
7. History of substance abuse or dependence.
8. History or current evidence of a clinically significant cardiovascular disorder at pre study visit.
9. Taking certain prohibited medications.
10. Consumption of more than 15 cigarettes a day.
11. History of malignancy less than or equal to 5 years prior to signing an informed
consent.
12. Participants on medication that may interfere lipid metabolism.
13. Participants consuming nutraceuticals and health supplements for past three months.
14. Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol. |
|
|
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 including total cholesterol (TC), low-density lipoprotein cholesterol (LDL), very
low-density lipoprotein cholesterol (VLDL-C), triglycerides (TG), high-density lipoprotein cholesterol (HDL), and remnant cholesterol
(RC) |
baseline, day 30, and day 60. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Assessment of changes in subjective symptom scores (fatigue, joint pain, muscle pain, sweating, lethargy, weakness, exertional dyspnea) using a visual analog scale (VAS) scale. |
at baseline, day 30, and day 60. |
| 2. Assessment of change in Body weight, BMI, waist and hip circumference. |
at baseline, day 30, and day 60. |
| 3. Assessment of changes in metabolic state (MetS-Z score) |
at baseline, day 30, and day 60. |
Exploratory endpoint
Change in oxidized LDL (ox-LDL) levels in selected treatment groups |
at baseline and day 60 |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
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)
|
22/10/2025 |
| 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) |
Closed to Recruitment of Participants |
|
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
|
Dyslipidemia, characterized by elevated total cholesterol, LDL-C, triglycerides, or low HDLC, is a major global public health concern and a key contributor to cardiovascular disease, the leading cause of mortality worldwide. Despite the availability of pharmacotherapies such as statins, fibrates, and PCSK9 inhibitors, challenges persist due to statin intolerance, incomplete lipid control, and adverse effects, which limit optimal therapy adherence. Moreover, a significant proportion of adults with dyslipidemia remain untreated or uncontrolled, highlighting the need for alternative or complementary treatment approaches . Herbal and nutraceutical formulations, including extracts from amla, berberis, pomegranate, citrus, red yeast rice, urolithins, and flavonoids such as hesperidin, have demonstrated potential lipid-lowering, antioxidant, and anti-inflammatory effects in preclinical and clinical studies, often with favorable safety profiles. However, evidence from well-designed, controlled clinical trials evaluating their efficacy and safety in adults with newly diagnosed dyslipidemia remains limited. This study is therefore designed to evaluate the efficacy, safety, and tolerability of multiple investigational herbal and nutraceutical combinations on fasting lipid parameters, anthropometric measures, subjective symptom scores, and metabolic state over a 60-day treatment period in adults with newly diagnosed dyslipidemia. The findings aim to provide robust clinical data supporting the use of these formulations as potential adjuncts or alternatives to conventional lipid-lowering therapies. |