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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)  
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  
Nil 
 
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] 
 
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 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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee Goverment 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-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
2Comparator 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.
 
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.
 
 
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.
 
 
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  
 
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
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.

 
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