| CTRI Number |
CTRI/2024/08/071963 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Combined effect of chandanadi sirodhara and dhatryadi ghritha internally in ADHD of age group 3 -12 years |
|
Scientific Title of Study
|
A non-randomised controlled trial to evaluate the combined effect of sirodhara with chandanadi ksheera and dhatryadi ghritha internally as compared to behavioral therapy in children with Attention-Deficit/ Hyperactivity Disorder in the age group 3-12 years |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muhsina Javad |
| Designation |
PG scholar |
| Affiliation |
Government ayurveda college TVM |
| Address |
Department of kaumarabrthya
Government Ayurveda college
Thiruvanathapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
8281504470 |
| Fax |
|
| Email |
muhsinajavad123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ROSHNI ANIRUDHAN |
| Designation |
HOD Department of kaumarabrthya |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
HOD Department of kaumarabhrtya
Government Ayurveda college for women and child poojappura
Thiruvanathapuram
Department of kaumarabrthya
Government Ayurveda tvm
kerala India
pin code 695001
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9447006585 |
| Fax |
|
| Email |
doctoroshni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muhsina Javad |
| Designation |
pg scholar |
| Affiliation |
Government ayurveda college Thiruvanathapuram |
| Address |
Department of Kaumarabrthya
Government Ayurveda college
Thiruvanathapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
8281504470 |
| Fax |
|
| Email |
muhsinajavad123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College for women and child poojappura Thiruvananthapuram
kerala India
pin code 695012 |
|
|
Primary Sponsor
|
| Name |
Muhsina Javad |
| Address |
PG Scholar
Department OF Kaumarabrthya
Government Ayurveda College
Thiruvananthapuram
Kerala India
Pin code 695001 |
| 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 Muhsina Javad |
OPD Government Ayurveda college Thiruvananthapuram |
Department of kaumrabrthya
Government Ayurveda College for women and child poojappura
Thiruvananthapuram
KERALA |
8281504470
muhsinajavad123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Government Ayurveda College TVM |
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: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | behavioral therapy | behavioral therapy including the principles of CBT given for 5 days in a week for one month for 15 participants(control group) | | 2 | Intervention Arm | Procedure | - | sirodhara | (Procedure Reference: sahasrayoga, Procedure details: Sirodhara with chanadanadi ksheera for 30 minutes for 21days, Datryadi gritha orally 2.5 to 10 gm twice daily for one month (reference sahasrayogam) ,behavioral therapy including the principles of CBT for 5 days in a week for one month. Total study period one month.
)
(1) Medicine Name: chandanadi ksheera, Reference: sahasrayoga, Route: Topical, Dosage Form: Ksheerpaka, Dose: 2000(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children who are fulfilling the DSM 5 criteria for ADHD within the age group of 3-12 years |
|
| ExclusionCriteria |
| Details |
presence of any other psychiatric co-morbities
history of recurrent lower respiratory tract infection
children having intractable epilepsy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the combined effect of sirodhara with chandanadi ksheeram, datryadi ghritha internally and behavioral therapy and it is compared with behavioral therapy alone in inattention hyperactivity and impulsivity among children with ADHD in age group 3-12 years assessed by ADHD T2 and VADPRS |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evalute the overall changes in ADHD |
30 days |
|
|
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)
|
19/08/2024 |
| 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="0"
Months="0"
Days="30" |
|
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
|
Children in age group of 3-12 years, satisfying DSM 5 criteria for ADHD will be selected for the study from OPD of Government Ayurveda Hospital for women and child poojappura. The participants satisfying the DSM5 criteria for ADHD will be allocated into two groups, study group (15 participants) and control group (15 participants). The participants in the study group will receive proper preparatory measures like digestive correctives to make fit for internal snehapana and external sirodhara. The study group will receive datryadi ghritha 2.5 gm to 10 gm twice daily (empty stomach in morning and one hour before food in evening )for one month depending upon the age and weight of child, Sirodhara with chandanadi ksheera for 30 minutes for 21 days within a period of one month, modified behavioral therapy including the principles of CBT will be given for 5 days in a week for one month (study period one month). Control group will receive behavioral therapy including the principles of CBT 5 days in a week for one month. Both group participants will be assessed before, after and follow up period using ADHD T2 and VADPRS. Follow up peroid one month. |