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Safety and efficacy of herbal supplements in prediabetic and mild to moderate hyperlipidemic subjects.

Efficacy and safety study of herbal supplements (SR-L-01, SR-B-01 and SI-S-01) in the management of prediabetes and mild to moderate hyperlipidemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/05/002678
Enrollment
40
Registered
2012-05-21
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- Prediabetes and mild to moderate hyperlipidemia

Interventions

Intervention1: Placebo: Microcrystalline cellulose Intervention2: SR-L-01: 2 capsules BID orally,for 6 weeks Intervention3: SR-B-01: 2 capsules BID orally, for 6 weeks Intervention4: SI-S-01: 2 capsul

Sponsors

Olive Lifesciences Pvt 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 glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of >=140 to 3.Impaired fasting sugar (FBS levels in the range of >= 100 to 4.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 that would affect evaluation like Statins 5.Allergic to any medication 6.With a history of alcohol and/or drug abuse

Design outcomes

Primary

MeasureTime frame
Change in FBS,OGTT, and PPBS levels Change in LDL, VLDL, HDL and TC levelsTimepoint: 3 and 6 weeks 3 and 6 weeks—

Secondary

MeasureTime frame
Safety and tolerabilityTimepoint: 6 weeks—

Countries

India

Contacts

Public ContactDr H N Shivaprasad PhD Pharma

Olive Lifesciences Pvt. Ltd.

shiv@olivelifesciences.com8971489704

Outcome results

None listed

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