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CTRI Number  CTRI/2025/02/081394 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [COMPARITIVE]  
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   A CLINICAL TRIAL ON THE EFFECTIVENESS OF SIROUTSADANA OVER SIROLEPA WITH BALASOHALADI YOGA IN HYPERACTIVITY ASSOCIATED WITH AUTISM SPECTRUM DISORDER IN CHILDREN AGED 3-12 YEARS IN A LIMITED SAMPLE OF 14 INDIVIDUALS. 
Scientific Title of Study   A NON RANDOMIZED CONTROL TRIAL ON THE EFFECTIVENESS OF SIROUTSADANA OVER SIROLEPA WITH BALASOHALADI IN HYPERACTIVITY ASSOCIATED WITH AUTISM SPECTRUM DISORDER IN CHILDREN AGED 3- 12 YEARS. 
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 ANUSRI PRADEEP 
Designation  MD SCHOLAR 
Affiliation  MD SCHOLAR 
Address  DEPARTMENT OF KAUMARABHRITYA GOVT AYURVEDA COLLEGE WOMEN AND CHILDREN HOSPITAL POOJAPPURA THIRUVANANTHAPURAM
GOVT AYURVEDA COLLEGE WOMEN AND CHILDREN HOSPITAL POOJAPPURA THIRUVANANTHAPURAM
Thiruvananthapuram
KERALA
695012
India 
Phone  8281866048  
Fax    
Email  anusripradeep@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ROSHNI ANIRUDHAN 
Designation  PROFESSOR AND HOD 
Affiliation  GOVT AYURVEDA COLLEGE THIRUVANANTHAPURAM 
Address  DEPARTMENT OF KAUMARABHRITYA GOVT AYURVEDA COLLEGE WOMEN AND CHILDREN HOSPITAL POOJAPPURA THIRUVANANTHAPURAM

Thiruvananthapuram
KERALA
695012
India 
Phone  9447006585  
Fax    
Email  doctoroshni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ANUSRI PRADEEP 
Designation  MD SCHOLAR 
Affiliation  GOVT AYURVEDA COLLEGE THIRUVANANTHAPURAM 
Address  DEPARTMENT OF KAUMARABHRITYA GOVT AYURVEDA COLLEGE WOMEN AND CHILDREN HOSPITAL POOJAPPURA THIRUVANANTHAPURAM
GOVT AYURVEDA COLLEGE WOMEN AND CHILDREN HOSPITAL POOJAPPURA THIRUVANANTHAPURAM
Thiruvananthapuram
KERALA
695012
India 
Phone  08281866048  
Fax    
Email  anusripradeep@gmail.com  
 
Source of Monetary or Material Support  
GOVT AYURVEDA COLLEGE THIRUVANATHAPURAM, WOMEN AND CHILDREN HOSPITAL POOJAPPURA PO POOJAPPURA,PIN 695012 KERALA, INDIA 
 
Primary Sponsor  
Name  DR ANUSRI PRADEEP 
Address  DEPARTMENT OF KAUMARABHRITYA GOVT AYURVEDA COLLEGE THIRUVANANTHAPURAM 
Type of Sponsor  Other [GOVT AYURVEDA COLLEGE THIRUVANANTHAPURAM] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ANUSRI PRADEEP  GOVT AYURVEDA COLLEGE THIRUVANANTHAPURAM WOMEN AND CHILDREN HOSPITAL POOJAPPURA  DEPARTMENT OF KAUMARABHRITYA GOVT AYURVEDA COLLEGE WOMEN AND CHILDREN HOSPITAL POOJAPPURA THIRUVANANTHAPURAM
Thiruvananthapuram
KERALA 
8281866048

anusripradeep@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE GOVT AYURVEDA COLLEGE THIRUVANANTHAPURAM (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F09||Unspecified mental disorder due toknown physiological condition. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-UTSADANAM (Procedure Reference: SUSRUTHA SAMHITHA CHIKITSA, Procedure details: SIROUTSADANAM: Siroutsadanam is a mode of application of paste on the scalp externally. The prepared medicated paste is tied in a cloth like a kizhi. Then it can be applied to the head after dipping in lukewarm balaksheerakashayam. This will be continued for a period for 48 minutes (1muhurtam) after the procedure for a prescribed time, it will be wiped with clean cloth. Water boiled with bala and panchagandha will be used for head bath and amalaka powder will be dusted over bregma after bath. )
2Comparator ArmProcedure-SIROLEPAM (Procedure Reference: AROGYAKALPADRUMAM, Procedure details: Sirolepa is the external application of medicated paste all over the scalp. Thickness of sirolepa will be ¼ Angula (about 0.5 cm). Scalp will be covered by lotus leaf to avoid spillage & to have a cooling effect. This will be retained for a period of 48 minutes (1 muhurtam) & after the prescribed time, it will be removed & these scalp will be wiped with clean cloth. Water boiled with Bala & Panchagandha will be used for head bath & amalaka powder will be dusted over bregma after bath.)
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Subject of both sex of age group 3 to 12 years satisfying DSM 5 criteria for ASD and having a CARS score above 30 and ADHD T2 score above 60 
 
ExclusionCriteria 
Details  1. Clinically diagnosed cases of PDD (Pervasive developmental disorder) like Rett syndrome, Asperger’s syndrome, Childhood Disintegrative disorder, PDD - NOS (Pervasive developmental disorder- Not otherwise specified)
2. Clinically diagnosed cases of other developmental disorders and neurological disorders.
3. Children with recurrent respiratory tract infections, and intractable epilepsy.
The exclusion is based on clinical features, history of illness along with available investigation report.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
PRIMARY: Amount of Change in the hyperactivity domain of ASD with siroutsadanam as compared to sirolepam.

 
Changes in the pre and post assessment scores of CARS, ATEC, ADHD T2 in Hyperactivity in children with Autism.
ASSESSMENT AFTER 4 WEEKS,8 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
To study the changes in the Behavioral & Social domain also the severity of Autism spectrum disorders (ASD).  Changes in the pre & post assessment scores of CARS, ATEC, ADHD T2 in Hyperactivity in children with Autism.
AFTER 4 WEEKS, 8 WEEKS.  
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
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)   03/03/2025 
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="1"
Months="6"
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 spectrum disorder (ASD) is a neurodevelopmental condition with heterogeneous etiologies, which have in common clinically significant, persistent deficits in social communication, and restricted, repetitive patterns of behavior and or interest. Prevalence grown to one in 36 children effected with Autism. One of the most prevalent symptoms in children with ASD is hyperactivity. Children that exhibit hyperactivity are considered to be abnormally or exceptionally active. People who are hyperactive typically find it impossible to delay the experiences and desires they have. When a kid with ASD exhibits a combination of these symptoms, such as difficulty initiating or ending a conversation, interacting with peers, or joining them, it can be very challenging to manage their hyperactivity. Compared to other parent groups, parents of hyperactive ASD children report higher levels of stress. Atypical antipsychotics, behavioral therapy, and psychostimulants have all been used with some degree of success in the management of hyperactivity. However, the clinical response to the stimulants varies, and neither medication group is entirely satisfying. A significant gap in the current situation is the adverse effects and disadvantages of these medications, as well as the shortage of professionals qualified to provide intense therapy. According to Ayurveda Hyperactivity with ASD can be considered under Balaunmada and it impair all the three dosas specifically with vata- pitta predominance. It imparts impairment in Budhi, Sanja, Jnana, Smriti, Seela, Cheshta, Acharam. Thereby resulted in Avarana of Manovahasrotas. In order to evaluate the effect of Siroutsadana (rubbing of scalp with medicated paste) over Sirolepa (covering the scalp with medicated paste) present in ayurvedic textbooks using Balasohaladi yogam in Hyperactivity with ASD, A nonrandomized controlled trial with 16 participants each in study and control group of age group 3–12 years and patient satisfying DSM-5 criteria having CARS score above 30, ADHD T2 score above 60 recruited into the study. The samples will be selected following the inclusion criteria, from the OPD of Dept. of Kaumarabhritya, Govt. Ayurveda College Hospital for Women and Children, Poojappura. For both study group and control group, the total period of intervention is 28 days. The study group will be given Siroutsadana and sirolepam using Balasohaladi yogam for 48min (1muhurtham) and the control group will be given with Sirolepam with Balasohaladi yogam for 48Min (1muhurtam) for a period of 28 days. Assessment will be done with internationally accepted tools like ADHD T2, Childhood Autism Rating Scale [CARS] and Autism Treatment Evaluation checklist [ATEC] before and after the intervention and also after 14 days of follow up. Data will be finally analyzed using appropriate statistical tests.

 
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