| CTRI Number |
CTRI/2021/10/037126 [Registered on: 06/10/2021] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparative study of Ashwagandha for its effect on memory, attention, executive function and sleep in children. |
|
Scientific Title of Study
|
Effects of KSM-66 on memory, attention, executive function, and sleep in children: a randomized, double-blind, placebo-controlled study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RP_18_KSM_01/2021, version-1, dt- 20/09/2020 |
Protocol Number |
| ACTRN12621000656831p |
ANZCTR |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Saxena |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil Medical College, Hospital and Research Center |
| Address |
Department of Pediartrics,
D. Y. Patil Hospital and Medical College,Sector-5,
Nerul.
Thane
MAHARASHTRA
400607
India |
| Phone |
9619164465 |
| Fax |
|
| Email |
dramitsaxena1981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Langade |
| Designation |
Professor and Head, Pharmacology |
| Affiliation |
D Y Patil Medical College, Hospital and Research Center |
| Address |
Department of Pharmacology 5th floor D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA
Thane
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400607
India |
| Phone |
9930550009 |
| Fax |
|
| Email |
deepak.langade@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Langade |
| Designation |
Professor and Head, Pharmacology |
| Affiliation |
D Y Patil Medical College, Hospital and Research Center |
| Address |
Department of Pharmacology 5th floor D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA
Thane
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400607
India |
| Phone |
9930550009 |
| Fax |
|
| Email |
deepak.langade@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| Shri Kartikeya Pharma,
5-9-225, Sanali Estate, Abids, Hyderabad - 500001 |
|
|
Primary Sponsor
|
| Name |
D Y Patil Medical College Hospital and Research Center |
| Address |
D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Saxena |
D Y Patil Medical College, Hospital and Research Center |
Department of Pulmonary Medicine, D Y Patil University School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai
Thane
MAHARASHTRA
Thane
MAHARASHTRA |
9619164465
dramitsaxena1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC, D Y Patil Medical College and Hospital, Nerul, Navi Mumbai |
Approved |
| National Institute of Integrative Medicine Human Research Ethics Committee (NIIM HREC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Control Product |
Placebo capsule (150 mg), twice a day identical to KSM 66 Ashwagandha but without active ingredients for 8 weeks. |
| Intervention |
Test Product |
KSM 66 Ashwagandha Gummies (150 mg), twice a day for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Parent-reported concerns in child’s attention, concentration, or memory
2. Attendance to mainstream schooling and mainstream classing
3. Healthy males and females aged between 6 and 12 years
4. Parent/legal guardian and child willing to provide a personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial.
5. Child willing and able to swallow capsules
6. BMI between 18 and 30 kg/m2
7. No plan to commence new treatments over the study period
8. Parents and children fluent in English |
|
| ExclusionCriteria |
| Details |
1. Current or 12-month history in child of any psychiatric disorder (including ADHD)
2. Child is currently taking pharmaceutical medications expected to affect behavior and learning.
3. Current or history of clinically significant chronic medical condition including cardiovascular disease, organic brain disorder, seizure, diabetes
4. Any diagnosed learning disorders
5. Currently taking nutraceutical supplements
6. Children who are experiencing exceptional social/family stressors (e.g., serious illness in
the family, recent parental separation, etc).
7. Any significant surgeries over the last year. |
|
|
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 |
Computerized Mental Performance Assessment System (COMPASS)
|
screening week 0, and week 8
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Strengths and Difficulties Questionnaire (SDQ) – parent version |
screening week 0, week 4 and week 8 |
Behavior Rating Inventory of Executive Function, 2
nd Ed (BRIEF2) (Parent version) |
screening week 0, week 4 and week 8 |
| Sleep Disturbance Scale for Children (SDSC) |
screening week 0, week 4 and week 8
|
| PROMIS Parent Proxy Fatigue |
screening week 0, week 4 and week 8 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "85"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/10/2021 |
| Date of Study Completion (India) |
24/09/2022 |
| Date of First Enrollment (Global) |
11/10/2021 |
| Date of Study Completion (Global) |
10/11/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
This multi-center study will compare the effects of Ashwagandha extract 300 mg twice a day with placebo for its effect on the improvement of n memory, attention, executive function, and sleep in children. The study will be conducted across 2 centers in India and Australia.Enrolled patients will receive one capsule of ashwagandha (300mg) or an identical placebo capsule (starch 300 mg) two times daily with water for a period of 8 weeks.
Central randomization will be used for the random allocation of treatment. Efficacy outcomes are the Computerised Mental Performance Assessment System (COMPASS), Strengths and Difficulties Questionnaire (SDQ) – parent version, Behavior Rating Inventory of Executive Function, 2 nd Ed (BRIEF2) (Parent version), Sleep Disturbance Scale for Children (SDSC), PROMIS Parent Proxy Fatigue. Safety outcomes will be based on clinical safety assessed by the adverse events reported.
|