| CTRI Number |
CTRI/2023/03/050974 [Registered on: 22/03/2023] Trial Registered Prospectively |
| Last Modified On: |
21/06/2023 |
| 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 study the effect of Ashwagandha extract on Memory |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled Pilot Study to Evaluate the Effect of Ashwagandha (Withania somnifera) Extract in improving memory in adults with mild cognitive impairment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-01-BND0223H1-WES13, Version 1 dated 01 Feb 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Arjuna Innovation Centre,
Clinical Trial Department,
Door No. 187/D, Behind ISRO,
Erumathala P.O.
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Arjuna Innovation Centre,
Clinical Trial Department,
Door No. 187/D, Behind ISRO,
Erumathala P.O.
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Giby Abraham |
| Designation |
Research Associate |
| Affiliation |
Arjuna Natural Pvt. Ltd |
| Address |
Arjuna Innovation Centre,
Clinical Trial Department,
Door No. 187/D, Behind ISRO,
Erumathala P.O.
Ernakulam
KERALA
683112
India |
| Phone |
09288004381 |
| Fax |
|
| Email |
giby.a@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Pvt. Ltd., Bank Road, Aluva, Kerala, India - 683 101 |
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Private Limited, |
| Address |
Bank Road, Aluva, Kerala, India - 683 101 |
| Type of Sponsor |
Other [Neutraceutical company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hari Prakash Rai |
Hitech Hospital and Trauma Center |
Ground floor, OPD Room number -01,
Opposite MLB Medical College, Gate no. 4, Kanpur Road, Jhansi 284128
Jhansi
UTTAR PRADESH |
9839684036
drhprai.neuro@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Nirmal Hospital Institutional Ethics Committee |
Approved |
| Nirmal Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mild cognitive impairment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandha extract |
one capsule of 250 mg, once daily for 60 days |
| Comparator Agent |
Placebo |
One capsule of 250 mg, once daily for 60 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 25 to 65 years
2. Participants with mild, subjective symptoms of memory impairment
3. Participants with no impairment in Social and Occupational Functioning
4. Instrumental Activities of Daily Life (IADL) score > 6
5. Montreal Cognitive Assessment (MoCA) Score 18-25
6. Clinical Dementia Rating (CDR) Global score < 0.5
7. Mini-Mental State Examination (MMSE) score 20-23
8. Vitamin B12 (Serum) 200-900pg/mL
|
|
| ExclusionCriteria |
| Details |
1. Known neuropsychiatric conditions including depression
2. Persistent endocrine disorders
3. Uncontrolled hypertension
4. Diabetes mellitus
5. Drug dependence or addiction
6. Use of alcohol
7. Psychotropic drugs or drugs or alternative medicines for memory enhancement, or any severe comorbid medical condition.
8. Pregnant or lactating women and
9. Subjects with known hypersensitivity to ashwagandha
10. Other than ashwagandha in the treatment group, the use of nootropic agents or anticholinesterase drugs will be prohibited during the study.
11. History of significant brain disorders (e.g., stroke or epilepsy);
12. Use of any type of dementia-delaying medication;
13. Head trauma with post-traumatic loss of consciousness for at least 30 min during the lifespan
14. Brain damaged patients (brain tumour; penetrating head injury; closed head injury; cerebral vascular accident; cerebral abscess; cerebral atrophy; subdural hematoma; temporal lobectomy for epilepsy; dementia paralytica; congenital anomaly of brain)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Wechsler Memory Scale –III (WMS-III) Score
Shepard Mental Rotation Task Score
|
Baseline, Day 30, Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Montreal Cognitive Assessment (MoCA)
Mini-mental state examination (MMSE) |
Baseline, Day 30, Day 60 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
04/04/2023 |
| 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
|
The study is designed to evaluate the effect of ashwagandha extract ti omprove memory. Participants meeting inclusion/exclusion criteria are enrolled into the study and randomized to receive either test product or placebo. Participants will be assessed using memory scales at Baseline. The participants will be given investigational products for 60 days at a dose of 250mg/day. Memory assessment will be done after 30 and 60 days after intake of investigational products. |