| CTRI Number |
CTRI/2025/01/078848 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Attention Deficit Hyperactivity Disorder |
|
Scientific Title of Study
|
Evaluation of Shiroabhyanga with Panchgavya Ghrita Matra Basti in the Management of Attention Deficit Hyperactivity Disorder |
| 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 Puja CN Pathak |
| Designation |
PhD Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Cuttack, Odisha |
| Address |
Department of Kaumarabhritya,
Sri Sri College of Ayurvedic Science and Research Hospital,
Sri Sri University, Sri Sri Vihar, Bidyadharpur, Ward No 3, PO-Godisahi,
Cuttack,
Odisha.
Cuttack
ORISSA
754006
India |
| Phone |
7353823216 |
| Fax |
|
| Email |
dr.pujapathak19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puja CN Pathak |
| Designation |
PhD Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Cuttack, Odisha |
| Address |
Department of Kaumarabhritya,
Sri Sri College of Ayurvedic Science and Research Hospital,
Sri Sri University,Sri Sri Vihar, Bidyadharpur, PO-Godisahi,
Cuttack,
Odisha.
Cuttack
ORISSA
754006
India |
| Phone |
7353823216 |
| Fax |
|
| Email |
dr.pujapathak19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Durgaprasad Dash |
| Designation |
Professor and Head |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Department of Kaumarabhritya
Sri Sri College of Ayurvedic Science and Research Hospital,
Sri Sri University,Sri Sri Vihar, Bidyadharpur, PO-Godisahi,
Cuttack,
Odisha.
Cuttack
ORISSA
754006
India |
| Phone |
9853435916 |
| Fax |
|
| Email |
durga.d@srisriuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University,Sri Sri Vihar, Bidyadharpur, Ward No.3, PO-Godisahi, Cuttack,
PIN-754006, Odisha, India |
|
|
Primary Sponsor
|
| Name |
Dr Puja CN Pathak |
| Address |
Sri Sri College of Ayurvedic Science And Research Hospital,
Sri Sri University, Sri Sri Vihar, Bidyadharpur,PO-Godisahi,
Cuttack-754006
Odisha |
| Type of Sponsor |
Other [Self] |
|
|
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 Puja CN Pathak |
Shri Ramchandra Vaidya Ayurvedic Hospital |
Department of Kaumarabhritya,Yamuna Vihar, Eldeco Tiraha, Chinhat, Lucknow-226028
Lucknow
UTTAR PRADESH |
7353823216
dr.pujapathak19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee for Biomedical Research of Faculty of Health and Wellness Sri Sri College of Ayurvedic Science and Research Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F90||Attention-deficit hyperactivity disorders. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchagavya Ghrita, Reference: Charak Chikitsa Sthana 10th Chapter and Ashtanga Hrudaya Chikitsa Sthana 12th chapter, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: Dose shall vary fro 5ml-7.5ml depending on age of child | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchagavya Ghrita, Reference: Charak Chikitsa Sthana 10th Chapter and Ashtanga Hrudaya Chikitsa Sthana 12th chapter, Route: Rectal, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: dose shall be 30-40ml depending on age of child |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants in between age group of 6-12 years.
2. All participants will be included irrespective of Sex, religion, and socioeconomic status.
3. Children without any acute illness and brain trauma.
4. Children in whom parents are willing to sign the written consent form to participate
|
|
| ExclusionCriteria |
| Details |
1. Children with an acute or chronic, local or systemic infection will be excluded.
2. Known case of cerebral palsy, mental retardation and epilepsy, hearing defect etc.
3. Children who have received any form of modern intervention for ADHD in last 1 year.
4. Children in whom parents are hesitant to sign the written consent form to participate
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Panchgavya Ghrita Matrabasti alongwith Brahmi Taila Shiro Abhyanga is effective in the management of ADHD in children. |
30 days of intervention and
frequency of assessment- 0th , 30th , 60th , 90th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Panchgavya Ghrita Matrabasti alongwith Brahmi Taila Shiro Abhyanga is effective when compared with oral administration of Panchgavya Ghrita with Brahmi Taila Shiro Abhyanga in the management of ADHD in children. |
30 days of intervention and
frequency of assessment- 0th , 30th , 60th , 90th day. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/01/2025 |
| 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
|
The global prevalence of ADHD in children and adolescents is estimated to be around 8.0 %, with a higher occurrence in males. In India, the prevalence varies between 2% to 17%.3,4 The immediate and long-term consequences of untreated or under-treated ADHD can be quite severe for children, their families, and society .5 Covid -19 pandemic have shown significant adverse impacts on a child with neurodevelopmental conditions such as ADHD In Modern Science, the treatment of ADHD involves Methylphenidate and Amphetamine, which are psychostimulant drugs. Adverse reactions of the drug includes decreased appetite, irritability, tics, sleep issues, with an increased risk of cardiovascular events. Prolonged use, causes slowing of physical growth which is transient with an unclear cause6 ADHD is comparable to Unmada which is described as a disorder of the manovaha srotas. Ghrita is mentioned as a remedy for Unmada in Caraka Samhita Sutrasthana Annapanvidhi Adhyaya.7 In Ayurveda there are many drugs like Kalyanaka Ghrita, Panchgavya Ghrita, Brahmi Churna, Vachadi churna etc. that are known to be used in Manovaha srotas vikaras as aushadhi and may be helpful in handling ADHD like conditions more effectively. |