Safety and efficacy study of Menons PFPM, a nutraceutical product in diabetic and hyperlipidemia patients.

AN OPEN-LABEL RANDOMIZED SINGLE-DOSE SINGLE-PERIOD ORAL SAFETY AND EFFICACY STUDY OF MENONS RENEWABLE NUTRACEUTICAL PRODUCT WITH 30 MG and 60 MG SINGLE DOSE OF NUTRACEUTICAL TEST PRODUCT AND STANDARD CARE OF TREATMENT AS CONTROL IN PATIENTS WITH TYPE-II DIABETICS AND HYPERLIPEDEMIA PATIENTS - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/049216

Enrollment

Registered

2023-01-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Menons PFPM - A nutraceutical product 30 mg and 60 mg pellets to establish its safety and efficacy in diabetic and hyperlipidemic patients: Arm -1 Menons PFPM product 30 mg pellets Ar

Eligibility

Inclusion criteria

Inclusion criteria: Diabetic or Hyperlipidemic patients with 18 to 65 years (both years inclusive) with BMI of 18.50â??29.99 Kg/m2. Diabetic or Hyperlipidemic patients evaluated by medical history, vitals and general clinical examination. HbA1C levels greater than 8%. Normal or clinically insignificant biochemical (except blood glucose and lipid profiles) hematological, urinary, serology, Chest X Ray and ECG values/ reports. Generally Diabetic or Hyperlipidemic patients as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments. Negative urine test for drugs of abuse, alcohol breathe analysis. Diabetic or Hyperlipidemic patient, who have no evidence of suspected Covid-19 symptoms

Exclusion criteria

Exclusion criteria: History of any major surgical procedure in the past 3 months. History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematological and/or any major surgical procedure in the past three months. History of chronic alcoholism/chronic smoking/drug of abuse/ Hypersensitivity. Patient who consumed tobacco containing products within 48 hours prior to proposed time of dosing Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 7 days which potentially modify kinetics / dynamics of Menonâ??s Nutraceutical product or any other medication judged to be clinically significant by the investigator. Consumption of grapefruit and/or its products within 10 days prior to the start of study. Patient who had participated in any other clinical study or who had bled during the last 90 days. Patients who are allergic to Menonâ??s nutraceutical product or known hypersensitivity. History of difficulty in swallowing. High blood pressure and asthma Renal or liver impairment History of past and present COVID-19 infection

Design outcomes

Primary

Measure	Time frame
To assess blood glucose and HbA1C level after treatment with Menons PFPM when compared with SOCTimepoint: Day 01 and day 91 - for HbA1C level measurement.	—

Secondary

Measure	Time frame
To monitor the adverse events and safety of the patients.Timepoint: one sample - post study evaluation	—

Countries

India

Contacts

Public ContactIllavarasan

Sree Rajadeepam Hospital

dr.mahesraja@gmail.com9894851905

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026