| CTRI Number |
CTRI/2025/02/081118 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Behavioral Other (Specify) [CURATIVE] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Himasagara thaila with behavioral therapy on sleep problems in children with Autism (ages 3-12yrs) |
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Scientific Title of Study
|
Non randomized controlled trial to compare the effect of Himasagara thaila as siropichu with an add on to behavioral therapy in sleep disturbances in children of Autism Spectrum Disorder among the age group 3-12yrs |
| Trial Acronym |
NARCOHAS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KEERTHI |
| Designation |
PG SCHOLAR |
| Affiliation |
Govt ayurveda college thiruvananthapuram |
| Address |
Department of kaumarabhritya
Govt ayurveda college women and children hospital poojappura thiruvananthapuram
Department of kaumarabhritya
Govt ayurveda college women and children hospital poojappura thiruvananthapuram
Thiruvananthapuram KERALA 695012 India |
| Phone |
9526532577 |
| Fax |
|
| Email |
keerthi7otp@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SOHINI S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Govt ayurveda college Thiruvananthapuram |
| Address |
Department of Kaumarabhritya,
Govt ayurveda college For Women and Children Hospital, Poojappura ,Thiruvananthapuram
Department of Kaumarabhritya,
Govt ayurveda college For women and children hospital, Poojappura ,Thiruvananthapuram
Thiruvananthapuram KERALA 695012 India |
| Phone |
9447657471 |
| Fax |
|
| Email |
drsohini30@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR KEERTHI |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
| Address |
Department of Kaumarabhritya,
Govt Ayurveda college For Women and Children Hospital, Poojappura, Thiruvananthapuram
Department of Kaumarabhritya
Govt ayurveda College For Women and Children Hospital, Poojappura ,Thiruvananthapuram
Thiruvananthapuram KERALA 695012 India |
| Phone |
9526532577 |
| Fax |
|
| Email |
keerthi7otp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR KEERTHI |
| Address |
Department of Kaumarabrithya
Government Ayurveda College
For Women and Children, poojapura , Thiruvananthapuram,KERALA ,INDIA , PIN-695012 |
| Type of Sponsor |
Other [Self] |
|
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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 KEERTHI |
Goverment Ayurveda college Thiruvananthapuram For women and children Hospital Poojappura |
Goverment Ayurveda College For
Women and Children Hospital
Poojappura ,Thiruvananthapuram,KERALA,INDIA PIN-695012 Thiruvananthapuram KERALA |
9526532577
keerthi7otp@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Goverment 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 | - | SiraHpicuH, शिरःपिचुः | (Procedure Reference: Ashtanga Hridayam -Soothrastahnam, Procedure details: The process of siropichu involves placing cotton dipped in oil over bregma for an hour and then wiping it off.) (1) Medicine Name: Himasagara thaila, Reference: bhaishajya ratnaveli , Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 30 Months | | 2 | Comparator Arm (Non Ayurveda) | | - | behavioral therapy | Behavioral therapy aims to regulate the sleep-wake cycle, thereby improving the quality of sleep. Parents of the participants will attend the behavioral therapy consisting of 4 sessions in a week for a period of one month each lasting for 50 minutes. |
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Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Children of the age group 3- 12years.
2)Children with autism and sleep disturbances diagnosed by CARS score-30 and above, PSQ-33% of questions answered positively.
|
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| ExclusionCriteria |
| Details |
a.)Other forms of Autism Spectrum Disorder(ASD) and Pervasive Developmental Disorder (PDD) like Rett Syndrome, Asperger’s Syndrome, Childhood Disintegrative Disorder, PDD-NOS (not
otherwise specified).
b.)Children with intractable epilepsy seizure.
c.)Children with Autism spectrum disorder with recurrent respiratory infections.
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| “To compare the effect of Himasagara thaila as siropichu with an add on to Behavioral Therapy in sleep disturbances in children of Autism Spectrum Disorder among the age group 3-12 years assessed with SDSC”. |
Period of intervention will be 30 days. Assessment will be done before and after intervention and after follow up period of 1 month.
0th,30th and 60th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the changes in behavioral symptoms of autism spectrum disorders assessed with CARS. |
The period of intervention will be 30 days. Assessment will be done before & after.
Intervention & after a follow-up period of 1 month.
0th & 60th day |
|
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Target Sample Size
|
Total Sample Size="26" Sample Size from India="26"
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)
|
10/03/2025 |
| 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
|
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Brief Summary
|
Autism (or autism spectrum disorders, ASD) is a neurodevelopmental disorder characterized by deficits in social communication and the presence of restricted interests and repetitive behaviors.A diagnosis of autism spectrum disorders can be made as early as 18–24 months of age, and is well established by 3yrs of age. Autism spectrum disorder are neuro developmental conditions having a high prevalence of 1in 36 children .Sleep disturbance particularly insomnia is very common in ASD and used to be the very first symptom noticed by parents.This occurs in 50-80% in children diagnosed with ASD[3]. Sleep is critical for typical synaptic development and brain maturation, and poor sleep can have detrimental effects on children’s cognition in the domains of attention, memory, mood regulation, and behavior. Sleep disturbances accounts abnormalities of the sleep-wake rhythm, primarily sleep-onset, maintenance, and awakenings at night (with difficulty falling back to sleep), resulting in reduced sleep hours. Disturbed sleep increases ASD symptoms such as social skill deficits, communication impairments, higher rate of stereotypic behaviours and thus badly effecting the quality of life. Conventional treatments include behavioral therapy, intervention to circardian regulation such as melatonin. Although the medicines are effective, their long-term use are having side effects such as morning drowsiness, increased enuresis, headache, dizziness, hypothermia, and some studies have reported the suppression of hypothalamic pituatory axis (HPA axis) and potential for precocious puberty on discontinuation.Medicines that are sometimes used to treat behaviors related to autism include selective serotonin reuptake inhibitors (SSRIs) and antipsychotic medicines. SSRIs have side effects, such as weight gain, insomnia, and increased agitation.Hence earlier identification of sleep disturbances in ASD children could potentially prevent the development of neurobehaviour difficulties in their later life.In Ayurvedic classics psychiatric disorders are explained under the disease balaunmade (psychosis/mania).Autism spectrum disorders can also be included under this umbrella term. Hence management of balaunmade (psychosis/mania) can effectively be used in autism too. In Ayurveda sleep disorders can be correlated to Nidranasa. Nidra, which means sleep, is described as one of the trayobasthamba [basic pillars of life].Nidra is a special state of mind in which the mind is not associated with any type of indrya[senses]. Proper sleep provides sukha [happiness], pushti [nourishment], bala [strength], vrushatha [virility], jnana [knowledge], and jivana [life].Nidranasa is defined as loss of sleep or derangement in quality of sleep.Improper sleep causes dukha [misery], karshya [emaciation], abala [weakness], ajnana [ignorance], and marana [death]. It is said that nidra is caused by tamo avarana[occultion] to Hridaya[heart].[4]Sleep disorder causes increase of autism symptoms and wise versa, autism symptoms like stereotypic movements , hyperactivity cause difficulties in sleep patterns ,both these accounts to aggravate vata and pitha.so here is a need to use safe , effective and simple formulation ,one such formulation is Himasagara thaila which is explained in Vatavyadhi Chikitsa of Bhaishajya Ratnavali [5]. It contains 37 drug, highly effective in improving sleep impairment due to increase of vata-pitha. This preparation is widely practiced in the management of sleep and clinical experiences have shown positive results. |