| CTRI Number |
CTRI/2025/02/080248 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of the investigational product,
Cognitus/Bacomind, in comparison to placebo, in the treatment
of ADHD disorder in children and
adolescents |
|
Scientific Title of Study
|
Efficacy & safety of a standardized extract from Bacopa
monnieri in children & adolescents with attention deficit
hyperactivity disorder (ADHD): A Randomized, Double-blind,
Placebo-controlled with an extended open label clinical trial. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR0018-008 (2.0) 1st April 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Gupta |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Pratyasha Mind Clinic |
| Address |
Pratyasha Mind Clinic,
Department of Psychiatry room no 1 , ground floor G-2, Motherland Apartment, 6th Cross, Kaggadasapura, C. V. Raman Nagar
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560093
India |
| Phone |
9880051351 |
| Fax |
|
| Email |
drruchibrise@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arabinda Patnaik |
| Designation |
Associate Director, Project Operations |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
Syncorp Health,No 6 ,3rd Floor, second Main Road
sarvobhaogam Nagar , Arekere ,
Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
9014308214 |
| Fax |
|
| Email |
arvind.p@syncorphealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Arabinda Patnaik |
| Designation |
Associate Director, Project Operations |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
Syncorp Health, No 6 , 3rd Floor second Main Road sarvobhaogam Nagar Arekere
Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
9014308214 |
| Fax |
|
| Email |
arvind.p@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Pratyasha G-2, Motherland Apartment, 6th Cross, Kaggadasapura, C. V. Raman Nagar,
Bangalore
|
|
|
Primary Sponsor
|
| Name |
Natural Remedies |
| Address |
Plot No. 5B, Veerasandra Industrial. Area,
19th K.M. Stone, Hosur Road,
Electronic City Post, |
| 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 Ruchi Gupta |
Pratyasha Mind Clinic |
Department of Psychiatry room no 1 ground floor G-2, Motherland Apartment, 6th Cross, Kaggadasapura, C. V. Raman Nagar
Bangalore
KARNATAKA |
9880051351
drruchibrise@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Durgamba Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F900||Attention-deficit hyperactivity disorder, predominantly inattentive type. Ayurveda Condition: Anava, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Cognitus/ Bacomind, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 225(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 28 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | The placebo product contains 225 mg of pharmaceutical grade excipients per capsule
Frequency: Once (morning after breakfast)
Route of administration: Oral |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children or adolescents of both sexes between 6 and 16 years old both inclusive who exhibit mild to moderate ADHD with predominantly inattentive or combined presentation according to DSM V criteria assessed via the MINI KID
Inattentive subset and hyperactivity subset of not greater than 22 on SNAP IV scale
Voluntary Assent to participate in the study from all those who are more than 7 years of age
Informed Consent Form signed by legal guardians research participant when possible
Results of laboratory tests chemistry blood count and urine physical examination and vital parameters with no clinically significant changes clinically significant changes are defined as laboratory results requiring acute drug intervention indicating severe illness or requiring further medical evaluation according to the discretion of the investigator |
|
| ExclusionCriteria |
| Details |
Wechsler Intelligence Scale for Children Fourth Edition Short Form WISC IV SF score subjects whose scores are less than 80 To be administered by a psychiatrist or a clinical psychologist
Patients diagnosed with previous cognitive development delay
Research participants with known hypersensitivity to the other medications History of alcohol or drug abuse by the research participant
Where the immediate concern is around another Primary psychiatric diagnoses other than ADHD
Diagnosis of psychiatric comorbidities except for simple phobia adjustment disorders learning disorders oppositional defiant disorder sleep disorders mild anxiety and or mild depressions
History of seizures except for mild febrile seizures within 2 years from the time of recruitment
Diagnosis of Tourette Syndrome and chronic tics
Research participants who are making use of drugs for the treatment of ADHD in the last three months
Research participants who are making use of anticonvulsants antidepressants and antipsychotics up to 6 weeks prior to study entry or during the same
Positive beta HCG test for girls who have attained menarche
Patients at identified risk of suicide through clinical interview
Children or adolescents with ADHD predominantly hyperactive or impulsive
Other conditions considered by the investigator as reasonable for disqualification of the subjects participation in 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 |
ADHD symptoms as measured by the SNAP IV
CGI I Scale scores |
Timeframe on week 0 6 14 and 28
Timeframe on week 0 6 14 and 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Computer based Continuous Performance Test scores
Rey Auditory Verbal Learning Test RAVLT scores |
Timeframe on week 0 14 & 28
Timeframe on week 0 14 & 28 |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
19/02/2025 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Attention deficit and hyperactivity disorder ADHD is a common childhood disorder characterized by persistent symptoms of lack of attention hyperactivity and impulsivity being associated to decreased school performance and academic success and social rejection and in adults it is related to worst performance and success in professional field Children with ADHD have a significantly greater probability than their peers to develop conduct disorders during adolescence and personality disorders in adulthood Ample number of resources are available in the public domain on the positive effectiveness of Bacopa monnieri in improving attention Also many literature suggest this plant extract may be effective in treating young patients with Attention deficit and hyperactivity disorder |