| CTRI Number |
CTRI/2024/12/078431 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Acupressure for children with autism spectrum disorder |
|
Scientific Title of Study
|
Efficacy of acupressure at ghost points and yin tang for children with autism spectrum disorder A randomized controlled study |
| 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 Steffi Krishnamurthy |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block, Ground Floor, Department of Acupuncture
and Energy Medicine, Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9003014361 |
| Fax |
|
| Email |
steffibnys14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S T Venkateshwaran |
| Designation |
Director |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (first floor), Director Office, Kamarajar
Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9444227007 |
| Fax |
|
| Email |
stvspeech@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S T Venkateshwaran |
| Designation |
Director |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (first floor), Director Office, Kamarajar
Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9444227007 |
| Fax |
|
| Email |
stvspeech@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu-603001, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Dr Steffi Krishnamurthy |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block, Ground Floor, Department of Acupuncture
and Energy Medicine, Kamarajar Nagar, Chengalpattu- 603001 ,
Tamil Nadu, India |
| 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 N Prabu |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
184/4, International
Institute of Yoga and Naturopathy Medical Sciences, Kamarajar Nagar,
Chengalpattu-603001
Kancheepuram
TAMIL NADU |
9566351891
drprabubnys91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Science, Chengalpattu Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupressure |
Acupressure will be given on following points, it will be in unilaterally left for man and right side for women: Shuigou (GV 26), Shaoshang (LU 11), Yinbai (SP 1), Daling (PC 7), Shenmai (BL 62),Fengfu (GV 16), Jiache(ST 6), Chengjiang (CV 24), Laogong (PC 8), Shangxing(GV 23), Quchi (LI 11) and Yin tang ( M-HN-3). slight pressure is given using a finger in clockwise rotation three times and anticlockwise rotation three times, then again clockwise rotation three times, and ending with a slight press. proceed for three alternate days per week for 12weeks. |
| Comparator Agent |
waitlisted |
patient will be wait listed for the period of 12weeks |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to participate in study with informed consent.
|
|
| ExclusionCriteria |
| Details |
Uncooperative patients. Critically ill patients
Patients under anti-depressants and tranquilizers Any other psychiatric illness. Participants with skin lesions, open wounds, scalds, burns on ghost points areas, yin tang. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Childhood Autism Rating Scale (CARS) |
Base line and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Indian Scale for Assessment of Autism (ISAA) |
Base line and 12th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
|
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
|
Autism spectrum
disorder (ASD) is a psychological development disorder that causes difficulties with social communication and
interaction, as well as restricted and repetitive patterns of behaviour, interests, and activities. It often affects
children between the ages of one and three, exhibiting unique symptoms. It
has been identified as the primary risk factor for childhood mental
disabilities, with a growing
occurrence in recent years. The World Health
Organization estimated that one in 160 children globally has ASD, with a male-to-female ratio of 4:1. The number of
reported ASD cases has increased approximately
20-fold over the past 30 years. Previous studies
observed that ghost point bring benefits in ASD and cognitive
impairment. this study is unique has ghost point and yin tang used as
therapeutic point for ASD. A Randomized controlled trial will be adopted for this study. The simple randomization method with 1:1 ratio will be done for 60 subjects get a sample size of (n=30) in each group. After obtaining informed consent, participants who fit the inclusion criteria will be randomly allocated into GROUP A (study group) GROUP B (control group). GROUP A Acupressure will be given on following points, it will be in
unilaterally left for man
and right side for women: Shuigou
(GV 26), Shaoshang (LU 11), Yinbai
(SP 1), Daling (PC 7), Shenmai (BL 62), Fengfu (GV 16), Jiache(ST 6), Chengjiang (CV 24),
Laogong (PC 8), Shangxing(GV
23), Quchi (LI 11) and Yin
tang ( M-HN-3). Slight pressure is given using a finger in clockwise
rotation three times and
anticlockwise rotation three times, then again clockwise rotation three times,
and ending with a slight press. proceed for three alternate
days per week for 12weeks. While the GROUP B (control group) will be in waiting list. As a primary assessment The Childhood Autism
Rating Scale (CARS) is used to measure the behavior and autism diagnosis of the patients at baseline and 12th week. As a Secondary outcome Assessment The Indian Scale for Assessment of Autism (ISAA) is used to measure the Indian standard behavior and autism diagnosis of the patients on baseline and at 12th week. |