| CTRI Number |
CTRI/2019/08/020711 [Registered on: 14/08/2019] Trial Registered Prospectively |
| Last Modified On: |
04/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to test the safety and effectiveness of Neuralzhein in management of memory loss related to age. |
|
Scientific Title of Study
|
A Prospective, Open label, multi-center Clinical Study to evaluate the efficacy and safety of Neuralzhein in management of Mild to Moderate age onset Dementia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreedhara KC |
| Designation |
Managing Director |
| Affiliation |
Deepashri Hospital |
| Address |
DNo.86, 2nd Main, 16th D Cross, Nagarbhavi, Bangalore - Near Malagala Inner Ring Road Under Pass
Bangalore
KARNATAKA
560072
India |
| Phone |
9481574797 |
| Fax |
|
| Email |
deepashrihospitalcr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasanth Samaga |
| Designation |
Director |
| Affiliation |
BioMylz Pvt.Ltd |
| Address |
#21-D, 2nd Phase, Peenya Industrial Area.
Bangalore
KARNATAKA
560058
India |
| Phone |
9686204660 |
| Fax |
|
| Email |
vasanthsamaga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Subham Dutta |
| Designation |
Director |
| Affiliation |
Syncorp Clincare Technologies Pvt.Ltd |
| Address |
187/2,Tapaswiji Arcade,2nd Floor. BTM Layout,1st Stage. Hosur Main Road.
Bangalore
KARNATAKA
560068
India |
| Phone |
8050072226 |
| Fax |
|
| Email |
subham@syncorp.in |
|
|
Source of Monetary or Material Support
|
| BioMylz Pvt. Ltd
Building NO:1, #21-D, 2ndPhase, Peenya Industrial Area, Bengaluru, Karnataka 560058 |
|
|
Primary Sponsor
|
| Name |
Lexxus Laboratories DBA OPUS PHARMA |
| Address |
225 Lincoln Highway, Suite 187,
Fairless Hills, PA 19030, USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| BioMylz Pvt Ltd |
#21-D, 2nd Phase, Peenya Industrial Area |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sreedhara KC |
Deepashri Hospital(Rehab/ Deaddiction/ Old age) |
No.86, 2nd Main, 16th D Cross, Nagarbhavi, Bangalore - 560072, Near Malagala Inner Ring Road Under Pass
Bangalore
KARNATAKA |
9481574797
deepashrihospitalcr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashraya Medinova Private Limited Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Neuralzein |
Neuralzein(powder form)is a herbal product developed using combination of several natural ingredients and have been proved to be effective in cognitive functions (memory loss , short and long term loss, visual perception and auditory recognition capacity ,etc and symptoms associated with dementia having multifactorial therapeutic benefits like helps in healthy functions , improves cardiovascular health by maintaining cholesterol level and helps in condition of insulin resistance of Type II Diabetes condition.
5 gms of Neuralzhein sachet (powder form of peach color) to be taken orally before breakfast and before dinner by dissolving the Neuralzhein in 50 ml of water / 20 ml of virgin coconut oil. |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject should be able to give written consent for participation on their own or through their legally acceptable representative/Caregiver.
2.Adult males or females aged between 55 years to 75 years with the diagnosis of any type of age onset Mixed Dementia Insulin resistance associated Diabetes Mellitus, Thyroid disorders, Vitamin B12 deficiency, Vitamin D deficiency.
3.Subjects with following conditions will be recruited:
4.Memory impairment (short term and long term), particularly recent events.
5.Spatial arrangement recalls skills
6. Mood swings
7.Irritability, Inattentiveness, difficulty in focusing and apathy
8.Speech impairment
9. Reading and learning inability
10. Sleep cycle changes
11.Personality changes
12.Inability to perform daily activities
13. Disorientation and reduced eye movement.
14. Visual perception & auditory recognition capacity.
15. Subjects with Mini-Mental State Examination (MMSE) score of 13 to 24
16. Subjects with Modified Hachinski Ischemic Scale (MHIS) score of ¬¬¬¬ 4 or less.
17. The subjects having an identified, reliable, study partner (care giver) who is able to read, write and understand the study procedures and can attend study appointments. The caregiver should have the ability to answer questions about the subject’s behavior, activity of daily living, quality of life, and their own level of stress. The compliance card has to be filled by the caregiver.
18. Subjects newly diagnosed with dementia who are willing to participate into the study, subjects who have not shown any improvement with other medications or subjects who are ready to quit the ongoing treatment and ready to start IP.
19. Subjects must have gradual and progressive change in memory function for >6 months.
20. Subjects who are willing to undergo MRI if required.
21. Subjects should have adequate visual and auditory acuity to allow neuropsychological testing.
22.Subjects who will be able to travel to the research site without being non-compliant with the visits and procedures.
|
|
| ExclusionCriteria |
| Details |
1. Presence of non-neurological medical conditions interfering with cognition.
2. Subject having any contraindications or inability to tolerate brain magnetic resonance imaging (MRI) and Positron emission tomography (PET scans)
3. Subject with history of myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.
4. Subject having history of seizures.
5. Subjects having significant neurological disease affecting the nervous system, other than dementia, that affects cognition or may affect completion of the study.
6. Subjects having history of cancer within the last 5 years
7. Subjects having serious risk for suicide.
8. Subjects having history of drug or alcohol use disorder within the last 2 years.
9. Subjects mustn’t be immunocompromised, or have Hepatitis B or C.
Clinically significant uncontrolled medical or psychiatric illness Renal or liver impairment.
10. Terminal illness (i.e., life expectancy < 1 year)
11. Participation in another research study that could potentially confound current study (e.g., medication or behavioral intervention)
12. History of head trauma associated with injury-onset cognitive complaints or loss of consciousness for 10 minutes or longer.
13. Women with Child bearing capabilities.
14. Subjects taking sedative, antidepressants or antipsychotics
15. Any surgical procedure in the recent time.
16. Any autoimmune disorders.
17. Febrile patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in the scores of ACE (R) from baseline to last visit.
2. Change in the scores of MHIS from baseline to last visit.
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To know the occurrence of the safety part in case of Adverse Drug Reactions,Adverse Events or Serious Adverse Events.
2. To measure the quality of life of patients with the help of QOL questionnaire from the baseline till the last visit. |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/08/2019 |
| Date of Study Completion (India) |
06/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The
study is indicated for the management of symptoms in patients with age-onset
dementia induced disease progression involving Mixed Dementia impairing
cognitive traits like Memory loss, short term & long term loss, visual
perception & auditory recognition capacity, mood swing, speech impairment,
reading and learning inability, sleep cycle changes, irritability,
inattentiveness and difficulty in focusing, spatial arrangement recall skill
and reduced eye movement. |