CTRI/2017/02/007764Active, not recruitingPhase 4
An Open Label, Multicentre, Phase IV Study to Evaluate the Safety and Treatment Effects of Tebokan® forte (Ginkgo Biloba EGb 761®) One Tablet of 120 mg Twice Daily in Adult Patients with Dementia
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Pms
Eligibility Criteria
Inclusion Criteria
- •1 Subjects with at least 50 years of age
- •2 Subjects diagnosed with dementia specifically Major Neurocognitive Disorder due to Alzheimers disease Major Vascular Neurocognitive Disorder or mixed form of both in accordance with DSM 5 criteria cf section 4 1 1
- •3 MMSE between 12 and 24 inclusive 12 to 18 moderate dementia and 19 to 24 mild dementia
- •4 Presence of a caregiver
- •5 Subject LAR ready to give written consent to participate in the trial and ready to follow all study related procedures
- •6 Post menopausal female subjects or non menopausal female subjects with negative serum pregnancy test and willing to use a reliable means of contraception other than or in addition to hormonal contraceptives eg double barrier method diaphragm plus spermicide condom plus spermicide, etc surgical sterilization or abstinence for the duration of the study.
- •7 Subjects not participating in any other clinical trial since last 6 months
Exclusion Criteria
- •Subjects diagnosed with dementia except AD VD or mixed dementia
- •Subjects currently undergoing treatment for depression
- •Subjects with major depression or other psychiatric disorder hospitalized for depression within one year prior to baseline visit
- •Use of Ginkgo biloba within 8 weeks prior to baseline visit
- •Use of cholinesterase inhibitor within 6 months of baseline visit
- •History of any bleeding abnormalities other than in the context of anti platelet or anti coagulant drugs
- •Any other type of neurological disorder as per investigator s discretion
- •Active malignant disease HIV or serious infection as per investigators discretion
- •Subjects currently on cognitive enhancers cholinergic anti cholinergic or haemorheologically active drugs
- •Severe or insufficiently controlled cardiovascular renal or hepatic disorder diabetes anaemia or thyroid dysfunction as per investigator s discretion
Investigators
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