A clinical trial to study the effects of LycoRed on cardiovascular protection and bone health in menopausal women

Effect of LycoRed on biochemical markers for cardiovascular-protection and osteo-protection at menopause: a parallel group placebo controlled double-blind superiority randomized control trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2010/091/000089

Enrollment

100

Registered

2010-02-26

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

None listed

Interventions

Intervention1: 8 mg lycopene: 2 BD orally for 6 months Control Intervention1: Placebo: 2 BD orally for 6 months

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Healthy normotensive (as defined by 120/80mmHg) 2. Age 40-55years 3. Natural and surgical menopause 4. Natural menopause: amenorrhea for >1 year 5. If surgical menopause: confirm by Follicular Stimulating Hormone levels >40U/L

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. History of smoking 2. History of Hormone Replacement Therapy in last six months 3. History of intake of Antioxidant in last six months 4. Drug therapy for hyper-lipidemia 5. Drug therapy for osteoporosis 6. Antihypertensive medication

Design outcomes

Primary

Measure	Time frame
Primary outcome measures: 1. Rise in serum levels of lycopene 2. Changes in serum levels of lipid profile, hsCRP 3. Changes in bone resorption marker (C-Telopeptide) 4. Changes in bone formation marker (P1NP)Timepoint: after 6 months	—

Secondary

Measure	Time frame
Secondary outcome measures: 1. Symptomatic relief in menopausal symptoms i.e. hot/cold flushes, mood swings, urinary & vaginal symptoms 2. Any unforeseen complication 3. Patient acceptance and experience of the study 4. Blood pressure control with LycoRed Timepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Deepika Chhabra

Jagsonpal Pharma Ltd.

deepika@jagsonpal.com011-26494519

Outcome results