A clinical trial to study the effects of cerebroprotien hydrolysate in patients with all type of dementia.
- Registration Number
- CTRI/2009/091/000355
- Lead Sponsor
- upin LimitedLaxmi Towers, B wing, 4th floor,Bandra Kurla Complex, Bandra East, Mumbai-400 051, India.Telephone: 91-22-66402021
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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 ≤ 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.
11.Willing to give written informed consent.
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)
11.The patient has a history of stroke or after examination some stroke evidence can be found, or there are signs of stroke in Quiet Zone of MRI cerebral cortex.
12.Subjects have used the investigational drug within 4 months before entering the trial.
13.Subjects using psychotropic drugs, drug influencing cerebral blood flow, or stimulants.
14.Pregnant women or lactating woman.
15.Subjects with history of alcohol and drug of abuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Activities of daily living rated by physicianTimepoint: baseline, 10th day, 20th day;Clinical Global ImpressionTimepoint: baseline, 10th day, 20th day;MMSETimepoint: baseline, 10th day, 20th day;Sandoz clinical assessment-GeriatricTimepoint: baseline, 10th day, 20th day;Trial making testTimepoint: baseline, 10th day, 20th day
- Secondary Outcome Measures
Name Time Method Incidence of all adverse events<br>?Common ?Solicited local and systemic reactions<br>?Unsolicited AEs (including abnormal laboratory value)<br>?SAEs during the study period<br>Timepoint: 20 days