| CTRI Number |
CTRI/2024/07/070337 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the effect of takradhara in attention deficit hyperactivity disorder-A clinical study |
|
Scientific Title of Study
|
To evaluate the efficacy of
takradhara in attention deficit hyperactivity disorder |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Doulabi M Choudhari |
| Designation |
Assistant Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur |
| Address |
Department of kaumarabhritya OPD Room No 4
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vidya nagar Bagalkot road Vijayapur
Bijapur
KARNATAKA
586109
India |
| Phone |
8197378138 |
| Fax |
|
| Email |
choudharidoulabi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Doulabi M Choudhari |
| Designation |
Assistant Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur |
| Address |
Department of kaumarabhritya OPD Room No 4
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vidya nagar Bagalkot road Vijayapur
Bijapur
KARNATAKA
586109
India |
| Phone |
8197378138 |
| Fax |
|
| Email |
choudharidoulabi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Doulabi M Choudhari |
| Designation |
Assistant Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur |
| Address |
Department of kaumarabhritya OPD Room No 4
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vidya nagar Bagalkot road Vijayapur
Bijapur
KARNATAKA
586109
India |
| Phone |
8197378138 |
| Fax |
|
| Email |
choudharidoulabi@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE Deemed To Be University Vijayapur Karnataka 586109 |
|
|
Primary Sponsor
|
| Name |
BLDE Deemed To Be University Vijayapur Karnataka 586109 |
| Address |
Bangaramma Sajjan Campus Vijayapura Karnataka 586103 |
| Type of Sponsor |
Private medical college |
|
|
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 Doulabi M Choudhari |
BLDEAs AVS AMV Hospital and Research Centre Vijayapur |
Department of kaumarabhritya OPD Room No 4
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vidya nagar Bagalkot road Vijayapur
Bijapur
KARNATAKA |
8197378138
choudharidoulabi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDEAs AVS Ayurveda Mahavidyalaya and BLDE DU Shree B M Patil Medical Collage Hospital and Research centre Vijayapur Karnataka |
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: VATAJA-UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | takradhArA, तकà¥à¤°à¤§à¤¾à¤°à¤¾ | (Procedure Reference: Dr D V Panditrav et al. translator,shahasrayogam hindi-sanskrit anuvad, CCRAS 1990, new delhi, Chapter-dharakalp 13/15,page-521, Procedure details: The patient shall be lie down on the tablewith his head resting on elevationat the head end. .
The dhara stand should be placed vertically near to the head end.dhara vessel is placed properly above the head end with a cotton wick on it the height of atleast 2 feet should maintain. The prepared takra is placed in avessal & heat contyinuosly in a medium flame.and is placed in the dhare vessel.on cooling down the medicines should be replaced simultaneously.Continously pour over the forehead. The procedure should continue for 30 min.)
(1) Medicine Name: Brahmi ghrita, Reference: Asthanga hrudaya uttarasthana adhyaaya 6/23-25, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Duration: 83 Days |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged between 6-16 years of age
2.Children fulfilling the DSM-V criteria for
diagnosis of ADHD.
3.Parents who are willing for treatment and giving
concern |
|
| ExclusionCriteria |
| Details |
1.Children under other medications or interventions
such as behavior therapy are excluded from the
study.
2.Children with mild to severe mental retardation,
conduct disorders, Pervasive disorder and other
Psychotic disorders are excluded.
3.Children with chronic ailments like tuberculosis,
malignancy etc. are excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment in reduction of symptoms of ADHD by using DSM-V criteria in 12 weeks |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of DSM-V check list within 12 weeks |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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 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
|
This single arm open label clinical trial study carries 20 ADHD children . Children who visit BLDEA’s AVS AMV Hospital OPD and IPD and Shree B M Patil Medical Collage Hospital & RC Vijayapur OPD IPD are randomly selecting who fulfill in the inclusion criteria Patient will be assessed for the subjective parameters and Takradhara will done done for 7 days and bhrahmi ghrita will be give for 83 days. Again children will be assessing on 90th day and follow up will be done on 120th day
|