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Clinical Trials/CTRI/2009/091/000355
CTRI/2009/091/000355
Completed
Phase 3

An evaluation of efficacy and safety of cerebroprotein hydrolysate in the management of subjects with dementia in an open labeled, prospective, phase-III clinical trial.

upin LimitedLaxmi Towers, B wing, 4th floor,Bandra Kurla Complex, Bandra East, Mumbai-400 051, India.Telephone: 91-22-664020210 sites100 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
upin LimitedLaxmi Towers, B wing, 4th floor,Bandra Kurla Complex, Bandra East, Mumbai-400 051, India.Telephone: 91-22-66402021
Enrollment
100
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
upin LimitedLaxmi Towers, B wing, 4th floor,Bandra Kurla Complex, Bandra East, Mumbai-400 051, India.Telephone: 91-22-66402021

Eligibility Criteria

Inclusion Criteria

  • •1\.Subjects with all types of dementia.
  • •2\.Subjects of either sex of aged between 40 to 85 years.
  • •3\.Pre menopausal women with appropriate contraception.
  • •4\.Subjects with Mini Mental State Examination score 15 to 25\.
  • •5\.Subjects with Global Deterioration Scale rating of 3 to 5\.
  • •6\.Subjects with Hamilton Depression Scale rating of \&\#8804; 15\.
  • •7\.Subjects with normal vitamin\-B12 and Folate level.
  • •8\.Subjects with normal T3, T4, and TSH hormones.
  • •9\.Subjects with normal LFT and RFT.
  • •10\.All subjects with vision and hearing sufficient for compliance with testing procedure.

Exclusion Criteria

  • •1\.Subjects with evidence of other psychiatric or neurological disorders.
  • •2\.Subjects with clinically significant or active renal, hepatic, endocrine, or cardiovascular diseases.
  • •3\.Subjects with severe lung disease.
  • •4\.Subjects with major depressions.
  • •5\.Subjects with cardiac dysfunction/surgery.
  • •6\.Subjects with uncontrolled hypertension
  • •7\.Subjects with haematological or oncological disorders.
  • •8\.Subjects with Vitamin B12 or folate deficiency.
  • •9\.Subjects with a known history of hypersensitivity from any one of the said medication
  • •10\.Subject those who just experienced cardiac surgery or applied expansion cardio\-cerebrovascular treatment and Neurotrophic drugs and nootrophic drugs user (can be taken into group two weeks after drug discontinuation)

Outcomes

Primary Outcomes

Not specified

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