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A Randomized, Double-Blind, Parallel Group Clinical Study To Evaluate Efficacy And Safety Of UO ABG 01 In The Management Of Borderline Cardio Vascular Risk Factors

A randomized, double-blind, parallel group clinical study to evaluate efficacy and safety of UO ABG 01 in the management of borderline cardio vascular risk factors - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058501
Enrollment
56
Registered
2023-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere

Interventions

Intervention1: UO ABG 01: UO ABG 01 is a 500 mg capsule containing Garlic extract will be given to subject for 84 days once daily Control Intervention1: Placebo: Placebo is a 500 mg capsule with no t

Sponsors

Xtractiva Life Science Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male or female subjects between 25 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 Serum triglycerides > 115mg/dL and less than If former smoker (previously smoked =10 cigarettes/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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Change from Baseline to End of the study in • Serum triglycerides • Serum HDL • Serum LDL • Total Cholesterol Timepoint: Day -7, Day 28, Day 56 and Day 84

Secondary

MeasureTime frame
Change from Baseline to End of the study in • Blood Pressure • Fasting blood glucose Timepoint: Day -7, Day 28, Day 56 and Day 84

Countries

India

Contacts

Public ContactP Sudha Rani

Chennai Meenakshi Multispeciality Hospital

clinsolve@gmail.com9566229193

Outcome results

None listed

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