| CTRI Number |
CTRI/2024/07/070295 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the effect of herbal product Biokesum on cognition sleep quality and mood in subjects having mild cognitive impairment |
|
Scientific Title of Study
|
A Randomized Double Blind Placebo Controlled Parallel Group Study to Investigate the Effect of Biokesum on Cognition Sleep Quality and Mood in Subjects having Mild Cognitive Impairment |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mrutyunjaya Ganiger |
| Designation |
Project Manager |
| Affiliation |
Croissance Clinical Research Pvt Ltd |
| Address |
Plot No. 37, 2nd Floor, Matrusri Nagar-Gate No.5, Miyapur, Hyderabad, 500049
Hyderabad
TELANGANA
500049
India |
| Phone |
914048523864 |
| Fax |
|
| Email |
mrutyunjaya@croissancecr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrutyunjaya Ganiger |
| Designation |
Project Manager |
| Affiliation |
Croissance Clinical Research Pvt Ltd |
| Address |
Plot No. 37, 2nd Floor, Matrusri Nagar-Gate No.5, Miyapur, Hyderabad, 500049
Hyderabad
TELANGANA
500049
India |
| Phone |
914048523864 |
| Fax |
|
| Email |
mrutyunjaya@croissancecr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrutyunjaya Ganiger |
| Designation |
Project Manager |
| Affiliation |
Croissance Clinical Research Pvt Ltd |
| Address |
Plot No. 37, 2nd Floor, Matrusri Nagar-Gate No.5, Miyapur, Hyderabad, 500049
Hyderabad
TELANGANA
500049
India |
| Phone |
914048523864 |
| Fax |
|
| Email |
mrutyunjaya@croissancecr.com |
|
|
Source of Monetary or Material Support
|
| Sponsor Biotropics Malaysia BerhadLot 21 Jalan U1 19 Section U1 Hicom Glenmarie Industrial Park 40150 Shah Alam Selangor Malaysia |
|
|
Primary Sponsor
|
| Name |
Biotropics Malaysia Berhad |
| Address |
Lot 21, Jalan U1/19, Section U1 Hicom Glenmarie Industrial Park 40150 Shah Alam, Selangor
Malaysia |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishal Akula |
Govt. Medical College and Hospital |
Room No 109, Department of Psychatry,
Jagtial 505327, Telangana, India
Karimnagar
TELANGANA |
9985075295
drvishalakula@gmail.com |
| Dr I Sharath Chandra |
Manasa Hospital |
Room No 203 Department of Clinical Research, 2nd Floor, 13-1-43, Club Road, Kothapet,
Guntur – 522001, Andhra Pradesh,
India
Guntur
ANDHRA PRADESH |
9573236486
dr.sarath25@gmail.com |
| Dr P Sai Kiran |
Nuha Hospital |
Room No 508, Clinical Research Department, 5th Floor, 12-19-61 & 62, Old Bank Road,
Guntur – 522001, Andhra Pradesh,
India
Guntur
ANDHRA PRADESH |
8919632797
drsaikiranpsychiatrist@gmail.com |
| Dr Nakul Vanjari |
Signus Hospital |
Room No 04, Clinical Research Department, 5th Floor, Atlanta Shoppers, Pathardi Road, Pathardi Phata, Nashik -
422010, Maharashtra, India.
Nashik
MAHARASHTRA |
9819625217
nakul1986@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Manasa Hospital |
Approved |
| Institutional Ethics Committee of Nuha Hospital |
Approved |
| Institutional Ethics Committee of Signus Hospital |
Approved |
| Jagital Government Medical College & Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F318||Other bipolar disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biokesum Tablet |
Participants will be given 350mg of tablet as per the randomization schedule to take orally for 84 days. |
| Comparator Agent |
Placebo Tablet |
Participants will be given 350mg of tablet as per the randomization schedule to take orally for 84 days. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Adults male and female aged between 50 to 75 years
2 Adults with mild cognitive impairment MCI based on Peterson criteria
3 Profile of mood state POMS score greater than 15 at the randomization or baseline day -1 visit 2
4 BMI between 20 to 29 kg m2
5 No plan to commence new treatment over the study period
6 Adults must have complete secondary school education
7 Must have the ability and willingness to sign an informed consent and comply with all study procedures |
|
| ExclusionCriteria |
| Details |
1 Adults with the history of alcohol tobacco dependence or any substance abuse
2 Pregnant and lactating women or suspected to be pregnant
3 Adults with any neurodegenerative diseases (that is Parkinsons disease dementia)
4 Adults who have been diagnosed with depressive disorder schizophrenia or score greater than 5 in Geriatric Depression Scale (GDS)
5 The patient may be excluded from the study at the PIs discretion if any significant abnormalities are found during the laboratory assessment on visit 1 (Screening day -3 to 0)
6 Adults with Attention Deficit Hyperactivity Disorder (ADHD) as this condition might interfere with cognitive function and psychosocial status
7 Adults who regularly consume traditional herbs vitamins and minerals supplementation for the past 6 months because it will jeopardize the effect of the supplement used in the study
8 Adults who has participated in other clinical trials during the previous 3 months
9 Adults who have any clinical condition according to the investigator who does not allow safe fulfilment of clinical trial protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change in visual memory verbal memory executive function symbol digit coding finger tapping Stroop shifting attention continuous performance
short-term memory and Continuous Performance Test- II |
Baseline, week 8 & week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in scores for the Profile of Mood States questionnaire
Mean change in Pittsburgh Sleep Quality Index questionnaire scores, Brief Pain Inventory Short Form questionnaire scores, cognitive markers Brain Derived Neurotrophic Factor & acetyl cholinesterase, hsCRP, serum cortisol, plasma glutathione, Treatment Emergent Adverse Events
Number & proportion of Treatment Emergent Serious Adverse Events, Liver parameters, Renal parameters, Complete Blood Count parameters, Lipid parameters & Urine parameters |
Baseline, week 8 & week 12 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| Date of Study Completion (India) |
19/02/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cognition and memory can decline due to aging, somatic or neurodegenerative causes; however, even healthy individuals can experience significant cognitive deterioration. Poor mood and diminished cognition are known to affect the health and quality of life significantly negatively in adults. Cognitive symptoms should therefore be regarded as a partially independent dimension of major depressive disorder (MDD), and an important target of any treatment that is initiated. A pre-clinical study conducted by George et al. (2014) indicated standardized water extract P. minor or commercially known as Biokesum possesses antioxidant and anti-cholinesterase activity and demonstrated enhanced cognition. To date, several studies have reported the ability of P. minor extract to improve learning and memory in scopolamine-induced cognitive impairment in rodents.In one of study on older adults with Mild Cognitive Impairment (MCI) investigated the effects of 6 months supplementation of P. minus on cognition, mood, biomarkers, and brain activation. The study concluded that supplementation of 500 mg of P. minus in adults is able to improve visual related learning, reduce inflammation, increase brain activity, and improve mood thus improving quality of life. The aim of the present study was to assess the effects of 12 weeks of 350 mg of Biokesum on cognition, mood, and sleep among mild cognitive impaired subjects from India. It was hypothesized that supplementation with Biokesum would improve cognitive performance as assessed by computer-based tasks and self-report questionnaires. Croissance Clinical Research Pvt Ltd. is providing Clinical Trial Management supoort to the study. |