| CTRI Number |
CTRI/2024/04/065680 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of kushmanda ghrita with pratimarsha nasya in ADHD children |
|
Scientific Title of Study
|
A Randomied Controlled Clinical Study To Evaluate The Efficacy Of Kushmanda Ghrita As Internal Medication With Pratimarsha Nasya In The Management Of Core symptoms Of ADHD In Children |
| Trial Acronym |
attention deficit hyperactivity disorder (ADHD) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Trupti Anilbhai Gamit |
| Designation |
Pg Scholar |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
OPD NO 103 Department Of Kaumarbhritya Parul Ayurveda Hospital,Parul University Ap Limbda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
6354293822 |
| Fax |
|
| Email |
truptigamit3293@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharati Changle |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
OPD NO 103 Department Of Kaumarbhritya Parul Ayurveda Hospital,Parul University Ap Limbda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
6354293822 |
| Fax |
|
| Email |
brpatil04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharati Changle |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
OPD NO 103 Department Of Kaumarbhritya Parul Ayurveda Hospital,Parul University Ap Limbda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
6354293822 |
| Fax |
|
| Email |
brpatil04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurveda Parul University, Post Limba Waghodia Vadodara Gujarat 391760 India |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurveda |
| Address |
Parul Institute Of Ayurveda Parul University, Po limbda, Tal waghodia, vadodara 391760 gujarat, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Trupti Anilbhai Gamit |
Parul Institute Of Ayurveda |
OPD NO 103 Department Of Kaumarbhritya Parul Ayurveda Hospital Parul University AP Limbda Tal Waghodia
Vadodara
GUJARAT |
6354293822
truptigamit3293@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Parul Institute Of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F902||Attention-deficit hyperactivity disorder, combined type. Ayurveda Condition: NOT SPECIFIC, (2) ICD-10 Condition:F902||Attention-deficit hyperactivity disorder, combined type. Ayurveda Condition: NOT SPECIFIC, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KUSHMANDA GHRITA, Reference: ASTANGA HRIDAYA, Route: Oral, Dosage Form: Ghrita, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: DOSE IS ACCORDING TO AGE GROUP | | 2 | Intervention Arm | Procedure | - | PRATIMARSHA NASYA | (Procedure Reference: SUSHRUTA SAMHITA, Procedure details: PRATIMARSHA NASYA 2 DROPS IN EACH NOSTRIL)
(1) Medicine Name: KUSHMANDA GHRITA, Reference: SUSHRUTA SAMHITA, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 3 Months | | 3 | Comparator Arm (Non Ayurveda) | | - | CONTROL GROUP | OCCUPATIONAL THERAPHY |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Parents/Guardian Willing To Give Informed Written Consent To Participate In The Study.
2. Known Cases Of ADHD With Core Symptoms |
|
| ExclusionCriteria |
| Details |
1. Children With Acute And Chronic Systemic Disorder, Inborn Error Of Metabolism
2. Children With Seizures
3. Surgical Procedures
4. Children With Other Genetic Disorder And Congnital Disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Enhance Mental Performance |
One Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Improve Quality Of Life Of Children Diadnosed With ADHD |
One Month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
21/04/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 Hyperactivity Disorder (ADHD) Is The Most Common Neurobehavioral Disorder Of Childhood, Among The Most Prevalent Chronic Health Conditions Affecting School-Aged Children And The Most Extensively Studied Mental Disorder Of Childhood. ADHD Is Characterized By Inattention, Including Increased Distractibility And Difficulty Sustaining Attention, Poor Impulse Control And Decreased Self-Inhibitory Capacity, And Motor Over Activity And Motor Restlessness, Affected Children Commonly Experience academic Underachievement, Problems With Interpersonal Relationship With Family Members And Peers, And Low Self Esteem. ADHD Often Occurs With Other Emotional, Behavioral, Language And Learning Disorders.
ADHD Is Characterized By Inattention And Distractibility, Restlessness, Inability To Sit Still, And Difficulty Concentrating On One Thing For Any Period Of Time. It Is Not The Child Merely Being "Naughty" But An Inability To Focus, Stay Still Or Concentrate That They Cannot Help And That Imparts Their Daily Life, Particularly Their Education.
Though There Are Number Of Researches Previously Done On ADHD Here Is One More Sincere Effort With Help Of Kushmanda Ghrita With Pratimarsha Nasya In Management Of Core Symptoms Of ADHD.
Kushmanda ghrita Is Described In Ashtanga Hridaya In Apasamara Pratisheda Adhyaya. Kushmandaz Ghrita Contains Kushmanda (Benincasa Hispida) And Yastimadhu (Glycyrrhizza glabra) . The Present Study Is Planned To Evaluate The Efficacy Of Kushmada Ghrita With Pratimarsha Nasya In Management of Core Symptoms Of ADHD Children.
|