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A study of Herbal product on Hyperlipidemia and Prediabetes patients

Efficacy and safety study of Phyto Formulation I (PF I) in the management of mild to moderate hyperlipidemia and prediabetes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/07/003812
Enrollment
20
Registered
2013-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- subjects with newly diagnosed mild to moderate hyperlipidemia and prediabetes

Interventions

Intervention1: PHYTO FORMULATION: Herbal supplement containing mixture of plant extracts Intervention2: PF I (Phytoformulation): Total expected duration of subject participation is 8 weeks. Its a Herb

Sponsors

T Stanes Co Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) As per ATP III guidelines: Baseline LDL ranging 160-189 mg/dL, TC >200 mg/dL and with no or one of the below risk factors • Current cigarette smoking • Family history of premature CHD (CHD in male first degree relative • Hypertension (BP >140/90 mmHg or on antihypertensive medication) • Low HDL-C ( • Age (men > 40 years; women > 40 years) 2) Impaired fasting sugar (FBS levels in the range of >= 100 to 3) Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with severe liver, renal, cardiac or brain diseases. 2) Pregnant or lactating women or women of childbearing potential whom are not practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives). 3) Unable to complete follow up. 4) Subjects on any medication like Statins. 5) Allergic to any medication. 6) With a history of alcohol and/or drug abuse.

Design outcomes

Primary

MeasureTime frame
To examine the effect of the test substance on Fasting Blood Sugar (FBS) and Postprandial blood sugar (PPBS)& Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL), High Density Lipoprotein (HDL) and Total Cholesterol (TC)Timepoint: Assessment of efficacy will be done on Day 0, 20, 40 and 60—

Secondary

MeasureTime frame
Safety and tolerability [Physical examination and Clinical laboratory evaluations will be performed during initial and final visits (day 0 and day 60): ECG, haematology (CBP), biochemical tests (blood urea, and serum creatinine), liver function tests and urine analysis].Timepoint: Assessment of efficacy and safety will be done on Day 0 and 60.—

Countries

India

Contacts

Public ContactDr K Venkateshwarlu

ANASUYA AYURVEDA CLINIC

drvenkatesh64@gmail.com9945232107

Outcome results

None listed

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