| CTRI Number |
CTRI/2024/03/064400 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurveda Treatment Protocol in management of Autism in children |
|
Scientific Title of Study
|
Evaluation of Ayurveda Treatment Protocol in management of Autism in children – A Randomised Clinical Trial |
| 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 Kaveri Hulyalkar |
| Designation |
Asst Prof |
| Affiliation |
KAHER shri BMK Ayurveda Hospital , Belagavi |
| Address |
KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi
Department of kaumarbhritya - OPD Num 10 / 11 KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi
Department of kaumarbhritya - OPD Num 10 / 11 Belgaum KARNATAKA 590003 India |
| Phone |
09538900603 |
| Fax |
|
| Email |
kaverihulyalkar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kaveri Hulyalkar |
| Designation |
Asst Prof |
| Affiliation |
KAHER shri BMK Ayurveda Hospital , Belagavi |
| Address |
KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi
Department of kaumarbhritya
Room num 10 /11 KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi
Department of kaumarbhritya
Room num 10 /11 Belgaum KARNATAKA 590003 India |
| Phone |
09538900603 |
| Fax |
|
| Email |
kaverihulyalkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aziz arbar |
| Designation |
Prof HOD Dept OF Kaumarabhritya |
| Affiliation |
kaher shri BMKAM shahapur belagavi |
| Address |
KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi
Department of kaumarbhritya
Room num 10 / 11 KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi
Department of kaumarbhritya
Room num 10 / 11 Belgaum KARNATAKA 590003 India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Shri BMK Ayurveda mahavidyalaya , shahapur , belagavi |
|
|
Primary Sponsor
|
| Name |
KLE Ayurveda Hospital |
| Address |
KAHER shri BMK Ayurveda mahavidyalaya shahapur , belagavi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kaveri Hulyalkar |
KLE ayurveda hospital shahapur belagavi |
KAHER shri BMKAM , department of Kaumarabhritrya Room num 10 /11 sHAHAPUR bELAGAVI Belgaum KARNATAKA |
9538900603
kaverihulyalkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE University Shri BMK Ayurved mahavidyalaya & KLE Ayurved Hospital, shahapur, Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: charaka chikitsa unmaad chikitsa, Procedure details: Materials required for smooth conduction of abhyanga followed by nadi swedana has to be collected, they
include oil, vessel, water, gas stove and pressure cooker, nadi yantra attached over its nozzel cotton.
• The child is allowed to stay in comfortable position.
• Smear oil and massage the luke warm oil over head, ear, neck, face, upper extrimities, trunk, lower
extremities for a duration of 35 to 40 mins with 7 distinct position.
• Steam is applied to affected part using nadi yantra) (1) Medicine Name: ksheerabala taila , Reference: charka chikitsa unmaad , Route: Topical, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Duration: 38 Days |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children of either sex between the age group of 3yrs-16 yrs
Children satisfying DSM5 diagnostic criteria for autism will be included for the study
|
|
| ExclusionCriteria |
| Details |
At the time of enrollment, if the child is found to be non-inclusive due to underlying health condition or medication will be excluded
Children with any acute or chronic,local or systemic infection will be excluded.
Children with any Congenital malformations will be excluded
Children who are currently under any other medications will be excluded
At the time of enrollment,if the child is found to be no n inclusive due to underlying health condition or medication will be excluded
Children with any acute or chronic,local or systemic infection will be excluded.
Children with any Congenital malformations will be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of ayurveda treatment protocol
and to improve the quality of life |
To evaluate the effect of ayurveda treatment protocol
and to improve the quality of
life
Time points - 7 th day , 38 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There might be effect of ayurveda treatment protocol |
0th day - enrollment
7 th day - assesment , follow up
38 th day - assesment , follow up |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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="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
|
Autism is a heterogeneous neurodevelopmental condition manifesting in early childhood. [1]The abilities and needs of people with autism vary. While some can live independently , most of the them will have severe disabilities and require lifelong care and support. According to WHO, It is an emerging global concern with 1 in 160 children diagnosed with autism[1] . In India, 01 in every 88 children is diagnosed with Autism[2]. It is approximately four times more common in males than females. At present no medications are established to treat its core symptoms. Risperidone and Aripiprazole are the only FDA approved medication targeting the irritability seen with this diagnosis. Moreover, Children and adolescents with autism appear to be more susceptible to adverse effects with these medications[3]. The line of treatment commonly used is speech therapy, psychotherapy, occupational therapy, behaviour training and dietary modification. These treatments are time consuming and need of much manpower. Because of all the above reasons, there is a need to find a new approach and modality for Autism. In Ayurveda, the autism can be understood under the concept of Unmada. In this study, we are planning the Ayurveda Panchakarma treatment protocol which includes sarvanaga Abhyanga, Nasya, matrabasti and shrotalam which will be beneficial in autistic children. Hence an effort is made to evaluate the effect of Ayurveda treatment protocol in autism in specified number of samples. |