| CTRI Number |
CTRI/2024/07/070527 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate combined effect of polyherbal ghee and polyherbal oilapplication over head in children with ADHD |
|
Scientific Title of Study
|
A clinical study to evaluate the combined efficacy of Mahapaishachika ghrita orally and Balaswagandhalakshadi taila shiropichu in children with ADHD(Unmada) |
| 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 Rakshitha C N |
| Designation |
PG scholar |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
Department of PG studies in Kaumarabhritya ,JSS Ayurveda Medical college and Hospital,OPD no 11 41/E Lalithadripura Road Alanahalli Mysuru 570028
Department of PG studies in Kaumarabhritya JSS Ayurveda Medical college and Hospital,OPD no 11, 41/E Lalithadripura Road Alanahalli Mysuru 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9535611674 |
| Fax |
|
| Email |
rakshithanagaraj303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srihari S |
| Designation |
Professor And Head Of The Department |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
Department of PG studies in Kaumarabhritya ,JSS Ayurveda Medical college and Hospital,OPD no 11 41/E Lalithadripura Road Alanahalli Mysuru 570028
Department of PG studies in Kaumarabhritya ,JSS Ayurveda Medical college and Hospital,OPD no 11 41/E Lalithadripura Road Alanahalli Mysuru 570028
Mysore
KARNATAKA
570028
India |
| Phone |
7776077626 |
| Fax |
|
| Email |
dr.srihari@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakshitha C N |
| Designation |
PG scholar |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
Department of PG studies in Kaumarabhritya ,JSS Ayurveda Medical college and Hospital,OPD no 11 41/E Lalithadripura Road Alanahalli Mysuru 570028
Department of PG studies in Kaumarabhritya ,JSS Ayurveda Medical college and Hospital,OPD no 11 41/E Lalithadripura Road Alanahalli Mysuru 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9535611674 |
| Fax |
|
| Email |
rakshithanagaraj303@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rakshitha C N |
| Address |
Department of PG studies in Kaumarabhritya ,JSS Ayurveda Medical college and Hospital,OPD no 11 41/E Lalithadripura Road Alanahalli Mysuru 570028 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JSS Ayurveda Medical college and hospital |
41/E Lalithadripura Road Alanahalli Mysuru 570028 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakshitha C N |
JSS Ayurveda medical college and hospital |
Kaumarabhritya OPD 11
41E Lalitadripura road Alanahalli Mysuru
Mysore
KARNATAKA |
9535611674
rakshithanagaraj303@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance 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: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahapaishachika Ghrita, Reference: Charaka Samhitha,Chikitsasthana,Unmada chikitsa ,9/48, Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: luke warm watert), Additional Information: - | | 2 | Intervention Arm | Procedure | - | Shiropichu | (Procedure Reference: Ashtanga samgraha ,sutrasthana,31/10, Procedure details: every day shiropichu is applied before bath )
(1) Medicine Name: Balaswagandhalakshadi Taila, Reference: Sahasrayogam, Route: Topical, Dosage Form: Not Applicable, Dose: 30(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1) Children in between the age group of 3-15 years irrespective of gender, religion and socioeconomic
status.
2) Already diagnosed cases of ADHD (ICD-10-CM F90.0)
3) New cases of ADHD fulfilling the Diagnostic criteria as per DSM 5. |
|
| ExclusionCriteria |
| Details |
1) Know cases of Systemic and other Developmental disorders.
2) Know cases of any genetic disorders.
3) Diagnosed cases of psychological illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the combined efficacy of Mahapaisachika Ghrita and Balaswagandhalaksadi
Taila Shiropichu on the clinical features of Unmada (ADHD) and on the scores of SWAN Rating scale of ADHD. |
Base line
29th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reversal symptoms of Unmada (ADHD) |
42th 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 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="6"
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 neurobehavioral disorder 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. The Current treatment modalities available are behavioural therapies with or without psycho-stimulant drugs to control the symptoms.In Ayurveda, ADHD can be correlated with “Unmada†based on similarity in clinical features or
presentation. The clinical features explained in Kashyapa Samhita are Pralapa (Delerium),
Vaichitya (Instability of mind) and Arati (Restlessness) which is applicable in children. Acharya
Charaka explains Vibhrama of Manas, Budhi, Samjna, Jnana, Sheela, Cheshta and Achara in
Unmada. Mahapaishachika Ghrita polyherbal ghee based formulation mentioned in Charaka Chikitsa mainly indicated in all types of Unmada which improves Buddhi, Smrithi and Medha when used internally in age dependant divided dosage twice a day, before food with luke warm water for the duration of 28 days. Along with that a modality of Murdhini taila i.e. Shiropichu with Balashwagandalakshadi Taila pacifies Vata and also indicated in Unmada. External application of Shiropichu daily once Morning before bath,30 minutes/day for 14 days in 2 courses. |