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CTRI Number  CTRI/2022/11/047368 [Registered on: 16/11/2022] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Oroxylin-A, as a neuroprotector in improving memory in patients with MCI and early dementia. 
Scientific Title of Study   A double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of Oroxylin-A, as a neuroprotective agent in improving memory in patients with mild cognitive impairment or early dementia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CW/110/OXN_DEME/I/JUL/22 Ver-1.0, Dated : 27 Jul 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vikhram Ramasubramanian 
Designation  M.D (Psychiatrist) 
Affiliation  Ahana Hospitals LLP 
Address  No.7,Subburaman Street,Gandhi Nagar, Mudurai-625020,Tamil Nadu, India.

Madurai
TAMIL NADU
625020
India 
Phone  9443772233  
Fax    
Email  vikhram@ahanahospitals.in  
 
Details of Contact Person
Scientific Query  
Name  Shaji Paulose 
Designation  General Manager 
Affiliation  Sami-Sabinsa Group Ltd 
Address  Sami-Sabinsa Group Limited # 19/1 &19/2, I Main, II Phase, Peenya Industrial Area, Bangalore -560058 Tel: 91-80-28397973-75

Bangalore
KARNATAKA
560058
India 
Phone  080-68527777  
Fax  91-80-28373035  
Email  shaji@clinworld.net  
 
Details of Contact Person
Public Query  
Name  Shaji Paulose 
Designation  General Manager 
Affiliation  Sami-Sabinsa Group Ltd 
Address  Sami-Sabinsa Group Limited # 19/1 &19/2, I Main, II Phase, Peenya Industrial Area, Bangalore -560058 Tel: 91-80-28397973-75

Bangalore
KARNATAKA
560058
India 
Phone  080-68527777  
Fax  91-80-28373035  
Email  shaji@clinworld.net  
 
Source of Monetary or Material Support  
Sami-Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area,Bangalore, Karnataka. 560058. 
 
Primary Sponsor  
Name  Sami Sabinsa Group Limited 
Address  Sami-Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya IndustrialArea, Bangalore, Karnataka. 560058. 
Type of Sponsor  Other [Manufactures and markets phytonutrients, standardized herbalextracts and nutritional supplements] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikhram Ramasubramanian  Ahana Hospital  No.7,Subburaman Street, Gandhi Nagar,Madurai - 625020
Madurai
TAMIL NADU 		 9443772233

vikhram@ahanahospitals.in 
Dr TV Devarajan  Apollo First Med Hospitals  Apollo First Med Hospitals, No.154, [Poonamalle High Road, Chennai-600 010, Tamil Nadu, India
Madurai
TAMIL NADU 		 984003737
28294449
drtv1994@gmail.com 
Dr Sam P J  Elite Mission Hospital  Elite Mission Hospital Koorkenchery, Thrissur, Kerala- 680007, India
Thrissur
KERALA 		 9645276743

info@elitemissionhospital.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee, Radianz Healthcare and Research  Approved 
Institutional Ethics Committe  Approved 
Institutional Ethics Committe-Bio medical Research Apollo hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F99-F99||Unspecified mental disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  10 % Oroxylin -A 250 mg and Bioperine 5 mg  One capsule twice a day for 90 days  
Comparator Agent  Microcrystalline cellulose ( MCC) 250 mg  One capsule twice a day for 90 days 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Aged 50 to 80 years ( male & female) both inclusive.
2. Mild cognitive impairment or early dementia patients with:
- Complaints of memory which is reflected in everyday activities like difficulty in remembering names of individuals, misplacing objects, difficulty in remembering in multiple items to be purchased, difficulty in performing multiple tasks, difficulty in remembering telephone numbers, difficulty in recalling information.
- Mini-Mental State Examination (MMSE) score greater than or equal to 18 and less than or equal to 23.
- Montgomery – Asberg Depression Rating Scale (MADRS)score of less than or equal to 8
3. Patients whose functional performance and cognitive abilities are sufficiently preserved.
4. Stable general health with no additional diseases expected to interfere with the outcome of the study
5. Able to give written informed consent and comply with requirements of the trial.
6. Ability to swallow & retain the oral medications. 
 
ExclusionCriteria 
Details  1. Psychiatric with known neuropsychiatric conditions like Schizophrenia, Parkinsonism, Huntington’s disease, Picks disease etc.
2. History of alcoholism (inability to control drinking due to both physical and emotional dependence on alcohol characterized by uncontrolled drinking and preoccupation with alcohol) and drug addiction.
3. Patients taking any other drugs or alternative medicines for enhancement of memory
4. Patients with Vitamin B12 deficiency.
5. Patients with uncontrolled hypertension and diabetes mellitus
6. Pregnant and lactating women
7. History of major surgery within the past 6 months or any acute medical/surgical complications which require hospitalization.
8. Patients with a diagnostic history of clinically significant thyroid disorder (hypo or hyper), cardiovascular (congenital heart disease, cardiomyopathy, heart failure, valvular heart disease) haematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases or any clinical condition, according to the investigator which does not allow safe fulfilment of the study protocol.
9. A history of significant multiple and/or severe allergies or anaphylactic reactions.
10. Patients with known history of hypersensitivity to the investigational product.
11. Subject has participated in any clinical trial within last 3 months.
12. Any other condition which the Principal Investigator thinks may jeopardize the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess the efficacy of 10% Oroxylin – A, on memory improvement in the patients with, mild cognitive impairment or early dementia.
a. Mean change in memory from visit 2 (Enrolment/Randomization) to Visit 5 (day 90) as assessed by Montreal Cognitive Assessment (MoCA). 
a. Dat 0 to day 90  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the safety of 10% Oroxylin - A, in patients with mild cognitive impairment or early dementia.
1. Mean change in other cognitive abilities (at least by 20%) from visit 2 (Enrolment/Randomization) to Visit 5 (day 90) by MoCA assessment.
2. Mean change in MMSE
3. Mean change in Montgomery – Asberg Depression Rating Scale (MADRS)
4. To assess the safety of 10% Oroxylin – A, by occurrence of adverse event throughout the study period.
5. Biomarker results: BDNF levels in serum 		 1. Day 0 to Day 90
2. Screening to Day 90
3. screening to Visit 5 (Day 90)
4. screening to Visit 5 (Day 90).
5. Day 0 to Day 90 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   21/12/2022 
Date of Study Completion (India) Date Missing 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   a) Male and female patients who meet all the Inclusion and none of the Exclusion criteria will be enrolled/randomised in the study.
b) Patients will be randomized and will be administered and advised to take either 10% Oroxylin-A 250 mg and Bioperine 5 mg or Placebo capsules, b.i.d. for a period of 90 days.
c) Patients will have to visit the study site on Screening (Day -5), Enrolment/Randomization Visit (Day 0), Visit 3 (Day 30) +/- 5 days, Visit 4 visit (Day 60) +/- 5 days, Visit 5/ final visit (Day 90) +/- 5 days.
d) Telephonic follow-up after 7th day till a maximum of 15th day of the last visit to know the overall wellbeing of the patients.
e) This study will provide an insight about 10% Oroxylin-A and its efficacy on memory enhancement and improvement in other cognitive abilities.
 
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