| 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 |
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Type of Study
|
Drug Ayurveda Other (Specify) [COMPARITIVE] |
| Study Design |
Non-randomized, Placebo Controlled Trial |
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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. |
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Scientific Title of Study
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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 |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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Source of Monetary or Material Support
|
| GOVT AYURVEDA COLLEGE THIRUVANATHAPURAM, WOMEN AND CHILDREN HOSPITAL POOJAPPURA
PO POOJAPPURA,PIN 695012
KERALA, INDIA |
|
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Primary Sponsor
|
| Name |
DR ANUSRI PRADEEP |
| Address |
DEPARTMENT OF KAUMARABHRITYA
GOVT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
| Type of Sponsor |
Other [GOVT AYURVEDA COLLEGE THIRUVANANTHAPURAM] |
|
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Details of Secondary Sponsor
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GOVT AYURVEDA COLLEGE THIRUVANANTHAPURAM (IEC) |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F09||Unspecified mental disorder due toknown physiological condition. Ayurveda Condition: UNMADAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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.
)
| | 2 | Comparator Arm | Procedure | - | 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.)
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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.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Participant Blinded |
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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 |
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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. |
|
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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" |
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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" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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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
|
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. |