| CTRI Number |
CTRI/2024/07/070482 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Medha-Plus to Improve Cognitive Function in Adolescence |
|
Scientific Title of Study
|
A 3-month, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Medha-Plus®, an Ayurvedic Formulation to Improve Cognitive Function in Adolescence |
| 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 Srikanta Pandit |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor, Dept. of Kayachikitsha J. B. Roy State Ayurvedic Medical College and Hospital |
| Address |
Research Unit
Dept. of Kayachikitsha
J. B. Roy State Ayurvedic Medical College and Hospital
Raja Dinendra Street
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831723650 |
| Fax |
|
| Email |
srikantapandit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srikanta Pandit |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor, Dept. of Kayachikitsha J. B. Roy State Ayurvedic Medical College and Hospital |
| Address |
Research Unit
Dept. of Kayachikitsha
J. B. Roy State Ayurvedic Medical College and Hospital
Raja Dinendra Street
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831723650 |
| Fax |
|
| Email |
srikantapandit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srikanta Pandit |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor, Dept. of Kayachikitsha J. B. Roy State Ayurvedic Medical College and Hospital |
| Address |
Research Unit
Dept. of Kayachikitsha
J. B. Roy State Ayurvedic Medical College and Hospital
Raja Dinendra Street
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831723650 |
| Fax |
|
| Email |
srikantapandit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parker Robinson Pvt. Ltd.
1 Nimak Mahal Road, Kolkata 700043 |
|
|
Primary Sponsor
|
| Name |
Parker Robinson Pvt Ltd |
| Address |
Parker Robinson Pvt. Ltd.
1 Nimak Mahal Road, Kolkata, India
PIN-700043 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Srikanta Pandit |
Research Unit, J. B. Roy State Ayurvedic Medical College and Hospital |
Research Unit,
J. B. Roy State Ayurvedic Medical College and Hospital
170-172 Raja Dinendra Street, Kolkata 700004
Kolkata
WEST BENGAL |
9831723650
srikantapandit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JB Roy State Ayurvedic Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F09||Unspecified mental disorder due toknown physiological condition. Ayurveda Condition: BUDDHISAMMOHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Medha Plus, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Vitamin B Complex, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Vitamin B Complex syrup
5 ml syrup OD for 3 months
Each 5 ml syrup contains Thiamine HCl 2 mg, Riboflavin 1.2 mg, Nicotinamide 10 mg, Pyridoxine HCl 1 mg, Vitamin B12 2µg, Calcium D-pantothenate 10 mg
|
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Healthy school age children in the cohort, Education level grades 5 to12 in high school, ChAMP score less than 100 for 12-13 yrs and less than 85 for 14 to15 yrs and less than 75 for 16-18 years, PHQ9 score less than 10 for all, WISC score more than70 for all, Do not use any vitamins or herbal remedies on a regular basis for at least six months |
|
| ExclusionCriteria |
| Details |
History of any neurological disorders like epilepsy, ADHD, dyslexia etc., History of congenital deformity, Thyroid dysfunction TSH less than 0.5 or more than 5.0 mIU per L, Severe anemia Hb more than 8 g percent, Unwillingness to participate, Use of any medications or supplements which, in the opinion of the investigators, may influence the results of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall Cognitive function assessed by Child and Adolescent Memory Profile (ChAMP) at 3 month |
Overall Cognitive function assessed by Child and Adolescent Memory Profile (ChAMP) at at baseline, 1 month, 2 month, 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Patient Health Questionnaire (PHQ-9) at 3 months and Changes in IQ by WISC-V (Wechsler’s Intelligence Scales for Children) at 3 months. |
3 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized, double blind, placebo control group, single centre trial comparing the safety and efficacy of Medha Plus Syrup 5 ml daily and Vitamin B Complex syrup 5 ml daily for 3 months in 70 adolescent participants (12-18 years) to improve cognitive function. The primary outcome measures are Child and Adolescent Memory Profile (ChAMP) at 3 months. The secondary outcomes are IQ by WISC-V Scales for Children at 3 months. The subjects are divided following the prefixed blinding and masking rule into two arms: Test group: 5 ml Medha Plus (p.o), and Placebo: Identical color Vitamin syrup (p.o), preferably 30 min before bedtime for 3 months. The treatment duration are consist of 4 visits, including the screening visit or baseline visit (V1), Follow-up I (V2), Follow-up II (V3) and final visit or Follow-up III (V4). Reliable instruments (ChAMP, PHQ-9, WISC-V) are used to evaluate overall cognitive functions and health condition. Laboratory safety parameters (CBC, TSH, renal function, and liver function) are evaluated at the screening visit and at the final visit. The occurrence of all AE data are monitored. After unmasking, all variables will be presented in groups and statistically compared according to their nature. The performance of efficacy and safety of Medha Plus will be compared with baseline and placebo. A value of P < 0.05 will be considered statistically significant. |