| CTRI Number |
CTRI/2022/08/045067 [Registered on: 30/08/2022] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Evaluate the Efficacy and Safety of Berberis aristata in Adult Human Subjects who are suffering from Mild Cognitive Impairment |
|
Scientific Title of Study
|
A Prospective, Multi-Center, Randomized, Double-Blind, Parallel, Placebo- Controlled Study to Evaluate Efficacy and Safety of Berberis aristata on Memory and Cognitive Performance in Adult Human Subjects with Mild Cognitive Impairment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIAG-CSP-056 Version 1.0 Dated 08-July-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varadarajulu Reginald |
| Designation |
Principal Investigator |
| Affiliation |
Medstar Speciality Hospital |
| Address |
Medstar Speciality Hospital
#641/17/1/3, kodigehalli main road, Sahakarnagar Bangalore-560092, Karnataka, India
Bangalore
KARNATAKA
560092
India |
| Phone |
08041127524 |
| Fax |
|
| Email |
medstarclinicalresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Pvt. Ltd |
| Address |
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka
560094 India
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Pvt. Ltd |
| Address |
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka
560094 India
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Medstar Speciality Hospital
#641/17/1/3, kodigehalli main road , sahakarnagar, bangalore-500092, India |
|
|
Primary Sponsor
|
| Name |
Omniactive Health Technologies Ltd |
| Address |
T-8b, 5th Floor, Phoenix House, A wing
Phoenix Mills Compound
462 Senapati Bapat Marg
Lower Parel, Mumbai – 400013
India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varadarajulu Reginald |
Medstar Speciality Hospital |
Medstar Speciality Hospital
Neuro Department, Ground Floor,Room no 1,
kodigehalli main road , sahakarnagar, bangalore-500092
Bangalore
KARNATAKA |
08041127524
medstarclinicalresearch@gmail.com |
| Dr Keshav G C |
Sapthagiri Institute of Medical Sciences and Research Centre |
Sapthagiri Institute of Medical Sciences and Research Centre
Neuro Department, 5th floor, room no 5,
Chikkasandra, Hesaraghatta Main Road
Bangalore-560090
Bangalore
KARNATAKA |
080-28393392
kshvgsbmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Medstar Speciality Hospital Ethics Committee |
Approved |
| Sapthagiri Institute of Medical Sciences and Research Centre Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F068||Other specified mental disorders due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Berberis aristata capsule containing NLT 30 mg Berberine |
Berberis aristata is a Scarlet red colored capsules containing yellowish brown and white colored granules of roots of plant Berberis aristata. |
| Comparator Agent |
Placebo granules capsule |
Placebo granules capsule containing Microcrystalline cellulose granules 358 mg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult male/female human participants of ≥ 18 and ≤55 years of age.
2.Participants with BMI ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2.
3.Participants with Mini-Mental State Examination (MMSE) score 19 to 26 indicating mild cognitive impairment.
4.Participants who agree to maintain their usual dietary habits throughout the trial period.
5.Participants who agree to maintain their usual level of activity, i.e., maintain their usual lifestyle throughout the trial period.
|
|
| ExclusionCriteria |
| Details |
1.Participants ˂ 18 or ˃ 55 years of age.
2.Participants having hypersensitivity or history of allergy to the study product or any of its ingredients.
3.Participants suffering from moderate to severe fatigue or having chronic fatigue syndrome.
4.Participants suffering from malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
5.Participants suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in memory functions as assessed by Working memory - Monkey Ladder task, Episodic memory - Paired Associates task, Short-term spatial memory - Spatial Span task and Short-term verbal memory - Digit Span task of Cambridge Brain Sciences from Baseline to Visit 5, End of Study Visit (Day 84 + 3 days) |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean change in planning as assessed by Spatial Planning task of Cambridge Brain Sciences from Baseline to Visit 5, End of Study Visit (Day 84 plus 3 days)
2.Mean change in reasoning and decision making as assessed by Odd One Out task of Cambridge Brain Sciences from Baseline to Visit 5, End of Study Visit (Day 84 plus 3 days) |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/09/2022 |
| Date of Study Completion (India) |
06/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
Berberine is a natural product with a definite structure and a wide range of pharmacological effects. Berberine displays many biological functions and potential therapeutic applications in neurological diseases. Animal research is an essential early step toward evaluating and developing an intervention for clinical trials in humans. The neuroprotective activity of Berberis aristata DC. against 6-hydroxydopamine (6-OHDA) Parkinson’s disease in a rat model was evaluated. The methanol extract of Berberis aristata DC. showed potent neuroprotective activity against 6-OHDA-induced Parkinson’s disease in a rat model.
It would be interesting to see if herbal supplementation could help various cognitive parameters in adults with cognitive impairment. |