| CTRI Number |
CTRI/2024/05/067151 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of lakshadi taila shiropichu and jatamansyadi taila pratimarsha nasya in the management of attention deficit hyperactivity disorder in children. |
|
Scientific Title of Study
|
Evaluation of lakshadi taila shiropichu and jatamansyadi taila pratimarsha nasya in the management of attention deficit hyperactivity disorder in children-a randomised controlled clinical trial
|
| 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 Mithila R Nadig |
| Designation |
PG Scholar |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of Kaumarabhritya
KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003
Belgaum KARNATAKA 590003 India |
| Phone |
9011293009 |
| Fax |
|
| Email |
mitnad12@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aziz Arbar |
| Designation |
HOD & Professor |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of Kaumarabhritya
KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003
Belgaum KARNATAKA 590003 India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aziz Arbar |
| Designation |
HOD & Professor |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of Kaumarabhritya
KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003
Belgaum KARNATAKA 590003 India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Ayurveda Hospital Shahpur Belagavi 590003 |
|
|
Primary Sponsor
|
| Name |
KLE Ayurveda Hospital |
| Address |
KAHER Shri BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi 590003 |
| 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 Mithila R Nadig |
KLE SHRI B.M.KANKANWADI AYURVEDA MAHAVIDYALAYA, BELGAVI KARNATAKA |
ROOM NO 10 AND 11
DEPARTMENT OF KAUMARABHRITYA BELGAUM KARNATAKA Belgaum KARNATAKA |
09011293009
mitnad12@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee for Research on Human Subjects |
Approved |
| Institutional Ethics Commitee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F078||Other personality and behavioral disorders due to known physiological condition. Ayurveda Condition: Unmadah, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Brahmi ghruta, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | SiraHpicuH, शिरःपिचà¥à¤ƒ | (Procedure Reference: Ashtanga Hrudaya , Procedure details: • Lakshadi taila is heated in a hot water bath. The temperature of the oil should be checked. It should be lukewarm.
• Child is made to sit in a comfortable position on the chair.
• Take a piece of cotton and make a thick pad out of it
• Place the cotton bandage soaked in the medicated oil over the vertex of the head.
• The Pichu is wrapped with the bandage material and tie cotton bandage around the head.
• After the 30 minutes, remove the Shiropichu and bandage carefully.
â€)
| | 3 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtang Hrudaya , Procedure details: • The child is made to lie down in supine position
• The head is slightly extended
• The prescribed drops of medication are instilled in one nostril while the other one is closed
• Repeat the same in the other nostril
• Child is advised to be in resting position for 5 – 10 minutes
) (1) Medicine Name: Jatamansyadi taila , Reference: Sushrut Samhita, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children fulfilling the diagnostic criteria will be included for the study.
Children of either sex between the age group of 6-16 years.
|
|
| ExclusionCriteria |
| Details |
Children with an acute or chronic, local or systemic infection will be excluded.
Children who are currently using other medications will be excluded owing to the possibility of drug interaction.
Known case of cerebral palsy, mental retardation, epilepsy and hearing defect etc.
Children with obvious congenital anomalies
Children who have received any form of modern intervention for ADHD in last 1 month
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There might be an effect of Lakshadi taila Shiropichu and Jatamansyadi taila Pratimarsha Nasya in the management of ADHD in children which shall be assessed with Vanderbilt ADHD diagnostic parent rating scale |
0th day,7th day,30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There might be a significant effect of Lakshadi taila Shiropichu & Jatamansyadi taila Pratimarsha Nasya by the end of 30 days in children with ADHD which will be assessed by ADHD IMPACT MODULE-CHILD & Pediatric Quality of life Inventory |
0th day,7th day,30th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="2" Months="0" 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
|
NEED OF THE STUDY
ADHD is widely acknowledged as the most prevalent
neurobehavioral and psychiatric disorder, significantly impacting the
functional abilities of the children. The global prevalence of ADHD in
children and adolescents is estimated to be around 5.29%, with a higher
occurrence in males. In India, the prevalence varies between 2% to 17%. The
World Health Organization (WHO) refers to ADHD as Hyperkinetic Disorder, and
throughout an individual’s life, the symptoms and consequences of this
condition can vary significantly. Children with ADHD
generally struggle with inattentiveness, hyperactivity/ impulsivity which impacts on their academic skills,
interpersonal relationships and social functioning. Family functioning is also highly affected by the
child’s ADHD. Recognition and management of ADHD in children is
important so that their long-term outcomes can be improved.
In
Modern Science, The preferred treatment for ADHD involves presynaptic
dopaminergic agonists like Methylphenidate and Amphetamine ,
which are psychostimulant drugs. Adverse reactions are observed with these drug
usage such as decreased appetite, irritability, tics, sleep issues, and an
increased risk of adverse cardiovascular events. Prolonged use causes slowing
of physical growth which is transient with an unclear cause. Consequently,
there is an increasing need for an alternative treatment method.
In Ayurveda there are many drugs like Lakshadi
taila, jatamansi, vacha , guduchi, durva, ashwagandha etc that are known to be used in Manorogas and may be helpful in handling ADHD like conditions more effectively. Hence
there is a growing need for an alternative treatment modality. Administering Lakshadi
taila Shiropichu and Jatamansyadi taila Pratimarsha Nasya, by virtue of their karma may be helpful in the management of Attention
deficit hyperactivity disorder in children. |