| CTRI Number |
CTRI/2023/03/050257 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
26/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of New Ayurveda treatment and existing Ayurveda Treatment combined with behavioral therapy in the treatment of poor Attention and Hyperactivity in children aged 6 to 11 years. |
|
Scientific Title of Study
|
Effectiveness of a new Ayurveda treatment protocol over standard Ayurveda care when used as an adjunct to behavioral therapy in the management of Attention Deficit Hyperactivity disorder in children aged 6 to11 years. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sohini S |
| Designation |
Associate Professor |
| Affiliation |
Govt Ayurveda College , Thiruvananthapuram. |
| Address |
Dr Sohini S
Associate Professor
Department of Kaumarabhrithya
Govt Ayurveda College Hospital for Women and Children
Poojappura Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9447657471 |
| Fax |
|
| Email |
drsohini30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anilkumar MV |
| Designation |
Professor HOD |
| Affiliation |
Govt Ayurveda college , Thiruvananthapuram. |
| Address |
Dr Anilkumar MV
Professor HOD
Department of Kaumarabhrithya
Govt Ayurveda College Hospital for Women and children Poojappura Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9447657471 |
| Fax |
|
| Email |
anil8198@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anilkumar MV |
| Designation |
Professor HOD |
| Affiliation |
Govt Ayurveda college , Thiruvananthapuram. |
| Address |
Dr Anilkumar MV
Professor HOD
Department of Kaumarabhrithya
Govt Ayurveda College Hospital for Women and children Poojappura Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9447657471 |
| Fax |
|
| Email |
anil8198@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurveda College
Thiruvananthapuram
|
|
|
Primary Sponsor
|
| Name |
Govt Ayurveda College Thiruvananthapuram |
| Address |
Govt Ayurveda College
Thiruvananthapuram
Pin 695001 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kerala University of Health Sciences |
Kerala University of Health Sciences
Medical college PO Thrissur
Kerala, India
Pin: 680 596 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sohini S |
Govt Ayurveda College Hospital for Women and Children |
Department of Kaumarabhrithya
Govt Ayurveda College Hospital for Women and Children
poojappura Thiruvananthapuram. Pin 695012
Thiruvananthapuram
KERALA |
9447657471
drsohini30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt Ayurveda College, Thiruvananthapuram Kerala India |
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 | Intervention Arm | Procedure | - | sadyasnehaH , सदà¥à¤¯à¤¸à¥à¤¨à¥‡à¤¹à¤ƒ | (Procedure Reference: Ashtanga Hridayam, Procedure details: Kalyanaka ghritham will be given 5 ml for 6 to 8 yrs 10 ml for 9 – 11 yrs. Sadyasnehana will be given rice cooked with milk (palkanji) morning before food))
(1) Medicine Name: Kalyanaka ghritham , Reference: Ashtanga Hridayam, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 3 Days | | 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Ashtanga Hridayam, Procedure details: Mridu virecana-karma िवरेचन-कम. with eranda sukumaram 5-10 ml for – 6 to11 yrs at bedtime.)
(1) Medicine Name: Eranda Sukumaram, Reference: Ashtanga Hridayam, Route: Oral, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 1 Days | | 3 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtangahridayam, Procedure details: Prathimarsanasyam with ksheerabala thailam, morning after abhyanga, two drops each nostril.)
(1) Medicine Name: Ksheerabala tailam, Reference: Ashtangahridayam, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 55 Days | | 4 | Intervention Arm | Procedure | - | SiraHpicuH, शिरःपिचà¥à¤ƒ | (Procedure Reference: Ashtanga Hridayam, Procedure details: Shiropichu is a procedure in which a cloth dipped in medicated oil is applied on the scalp region. Afternoon between 4pm to 5pm ,30 ml for 30 minuts.)
(1) Medicine Name: ksheerabala tailam, Reference: Ashtanga Hridayam, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 55 Days | | 5 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: Ashtanga Hridayam, Procedure details: Abhyangam will be done morning before bath. 60ml for 30 minuts. )
(1) Medicine Name: Ksheerabala thailam, Reference: Ashtanga Hridayam, Route: Topical, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 55 Days | | 6 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kalyanaka Ghritham, Reference: Ashtanga Hridayam, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 55 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: Vicharana snehapanam,5-10ml for 6-11 years. | | 7 | Comparator Arm | Procedure | - | sadyasnehaH , सदà¥à¤¯à¤¸à¥à¤¨à¥‡à¤¹à¤ƒ | (Procedure Reference: Ashtanga Hridayam, Procedure details: Drug will be given 5 ml for 6 to 8 yrs and 10 ml for 9 – 11 yrs. sadyasnehaH will be given rice cooked with milk (palkanji) morning before food.)
(1) Medicine Name: Brahmi Ghritham , Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 3 Days | | 8 | Comparator Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: Ashtanga Hridayam, Procedure details: Pre procedure with aBya~ggaH and ushma swedanam for one day - 30 minuts)
(1) Medicine Name: Vathasini thailam , Reference: Arogyakalpadrumam, Route: Topical, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 1 Days | | 9 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Ashtanga Hridayam, Procedure details: Mridu virecana-karma िवरेचन-कम with eranda sukumaram 5-10 ml for – 6 to11 yrs at bedtime.)
(1) Medicine Name: Eranda sukumaram, Reference: Ashtanga Hridayam, Route: Oral, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 1 Days | | 10 | Comparator Arm | Procedure | - | SiraHpicuH, शिरःपिचà¥à¤ƒ | (Procedure Reference: Ashtanga Hridayam, Procedure details: Shiropichu is a procedure in which a cloth dipped in medicated oil is applied on the scalp region. Afternoon between 4pm to 5pm ,30 ml for 30 minuts.)
(1) Medicine Name: Vathasini thailam, Reference: Arogyakalpadrumam, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 55 Days | | 11 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Brahmi Ghritham , Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 55 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: Vicharana snehapanam,5-10ml for 6-11 years. | | 12 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: Ashtanga Hridayam, Procedure details: Pre procedure with Abhyangam and ushma swedanam for one day - 30 minuts duration)
(1) Medicine Name: Ksheerabala thailam, Reference: Ashtanga Hridayam, Route: Topical, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 1 Days |
|
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1.The inclusion criteria for recruitment will be based on the DSM5 diagnostic criteria for ADHD.
|
|
| ExclusionCriteria |
| Details |
1)Diagnosed cases of autism and mental retardation.
2)Severe ADHD receiving modern medicine pharmacotherapy.
3)Participants will be excluded if they have a history of or have a current heart disease, high blood pressure, diabetes mellitus, a health condition that would affect food metabolism including food allergies, kidney disease, liver disease, and gastrointestinal diseases.
4)Children who have contraindicated for snehana and have recurrent respiratory tract infections.
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improve the attention span
Reduce the Hyperactivity
Reduce the impulsivity.
(Based on the parental observation assessment scale)
|
1st day - Initial assessment
60th day - After treatment period
120th day - After follow up period.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The secondary outcome measurements are improvement in the attention span, reduce hyperactivity and impulsivity. It will be assessed by using a psychologist observation assessment scale, Attention-Deficit/Hyperactivity Disorder Test – Second edition.
2. severity of illness, Global improvement in treatment, and theraputic effect will be assessed by using Clinical Global Impression scale. |
1st day - Before treatment
60th day - After treatment
120th day- after follow up period.
|
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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 3 |
|
Date of First Enrollment (India)
|
06/03/2023 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Attention deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood and can profoundly affect the academic achievement, well-being and social interactions of the children. The clinical study will be carried out in the outpatient wing of Department of Kaumarabhrithya at Government Ayurveda College Hospital for women and children, Poojappura Thiruvananthapuram. Study population is Children with ADHD aged 6-11 years. Block Randomization will be used. Sample size calculated is 63 in each group.. The total duration of treatment period will be for 60 days and follow up period will be for 60 days. Trial group will be given a new treatment protocol including internal medication and external procedures and control group will be given a standard protocol including internal medication and external procedures. The control group and study group will be given behavioral therapy during treatment period and follow up period. Severity of Attention Deficit, Hyperactivity, impulsivity will be measured after the treatment period and after the follow up period. |