| CTRI Number |
CTRI/2024/08/072759 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| 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 that Ashwagandha Extract is good for people with memory loss |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled Study to Evaluate the
Effect of Ashwagandha (Withania somnifera) Extract in improving memory in
adults with mild cognitive impairment. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-02BND0624H3-WES22, Version 1.0 dated 01 July 2024 |
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
683112
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.
KERALA
683112
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Giby Abraham |
| Designation |
Senior Scientist Clinical Research |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D, Behind ISRO, Erumathala P.O.
Ernakulam
KERALA
683112
India |
| Phone |
9995215790 |
| Fax |
|
| Email |
giby.a@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Pvt. Ltd., Desom P.O, Aluva, Kerala, India - 683 102 |
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Private Limited |
| Address |
Desom P.O, Aluva, Kerala, India - 683 102 |
| Type of Sponsor |
Other [Neutraceutical company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aneepu Ashok |
Abhaya Hospital |
Room No. 07, Ground floor, Department of General Medicine,
St. Josephs High School,
Convent Road, Day &
Night Junction - 532001
Srikakulam
ANDHRA PRADESH |
9949587162
draashok@yahoo.com |
| Dr A Gopal Rao |
Akshaya Hospital |
Door.No.43-9-
201, Sy No. 321-323,Ground Floor, Department of General Medicine,
Railway New Colony -530016
Visakhapatnam
ANDHRA PRADESH |
9440122790
drgopalraoa@gmail.com |
| Dr S S V V Narasinga Rao |
Government Medical College & Government General Hospital |
Room No. 009, Ground floor, Department of General Medicine
Shanti Nagar Colony,
Balaga - 532001
Srikakulam
ANDHRA PRADESH |
9908611119
drnarasingaraossvv@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Medigene Multispeciality Hospital Private Limited |
Approved |
| Institutional Ethics Committee, Govt. Medical College Govt.General Hospital, Srikakulam |
Approved |
| Institutional Ethics Committee, Govt. Medical College Govt.General Hospital, Srikakulam |
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 125 mg |
One capsule daily in the morning for 90 days |
| Intervention |
Ashwagandha extract 250 mg |
One capsule daily in the morning for 90 days |
| Comparator Agent |
Placebo |
One capsule daily in the morning for 90 days |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female ≥ 50 years of age with 1:1 ratio
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 greater than 6
5. Montreal Cognitive Assessment (MoCA) Score 18-25
6. Clinical Dementia Rating (CDR) Global score less than 0.5
7. Mini-Mental State Examination (MMSE) score 20-23
8. Vitamin B12 (Serum) 200-900pg/mL
9. Ability to follow all instructions in the study protocol and be willing to give written informed
consent. |
|
| ExclusionCriteria |
| Details |
1.Known neuropsychiatric conditions including depression
2.Persistent endocrine disorders
3.Uncontrolled hypertension
4.Uncontrolled Diabetes mellitus
5.Hypothyroidism
6.Drug dependence or addiction
7.Alcohol dependence
8.Psychotropic drugs or drugs or alternative medicines for memory enhancement, or any severe
comorbid medical condition.
9.Pregnant or lactating women
10.Subjects with known hypersensitivity to ashwagandha
11.Other than ashwagandha in the treatment group, the use of nootropic agents or anticholinesterase
drugs will be prohibited during the study.
12.History of significant brain disorders (e.g., stroke or epilepsy)
13.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)
14.Participant with a medical disorder, condition, or history such that could impair the participant’s
ability to participate or complete this study in the opinion of the investigator.
15.Subjects who participated in a clinical trial for the past 3 months.
16.Unwilling to provide written informed consent. |
|
|
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 |
| Mean change in MOCA |
Baseline, Day 30, Day 60, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in MMSE, MSQ, WHO-5 |
Baseline, Day 30, Day 60, Day 90
|
| Mean change in computerized cognitive tests assessed |
Baseline, Day 30, Day 60, Day 90 |
| Mean change in Safety profile and Biomarkers |
Baseline, Day 90 |
| Adverse event evaluation |
Throughout the study duration |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The study is designed to evaluate the effect of ashwagandha extract to improve memory. Participants meeting inclusion/exclusion criteria are enrolled into the study and randomized to receive either test products or placebo. Participants will be assessed using memory scales at Baseline. The participants will be given investigational products for 90 days at a dose of Ashwagandha extract 125 mg/day or Ashwagandha extract 250mg/day. Memory assessment will be done after 30 days, 60 days and 90 days after intake of investigational products. |