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CTRI Number  CTRI/2025/11/096903 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Does rubbing a special herbal paste, made with Karuthavattu Gutika and Ksheerabala (101), on the top-center spot of the head (the Bregma) helps in people falling asleep better in persons having sleeplessness  
Scientific Title of Study   A pilot clinical trial to evaluate the effect of Thalam with Karuthavattu and Ksheerabala (101) in insomnia disorders w.s.r to EEG and sleep indices 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sudheesh P N 
Designation  P G Scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda College Panchakarma Hospital Poojappura Government Ayurveda College Thiruvananthapuram

Thiruvananthapuram
KERALA
695012
India 
Phone  9495204216  
Fax    
Email  sudheesh.pn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sudheesh P N 
Designation  P G Scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda College Panchakarma Hospital Poojappura Government Ayurveda College Thiruvananthapuram

Thiruvananthapuram
KERALA
695012
India 
Phone  9495204216  
Fax    
Email  sudheesh.pn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Simi Ravindran 
Designation  Assosiate Professor 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Panchakarma Government Ayurveda College Panchakarma Hospital Poojappura Government Ayurveda College Thiruvananthapuram

Thiruvananthapuram
KERALA
695012
India 
Phone  9496370179  
Fax    
Email  simisreehari@gmail.com  
 
Source of Monetary or Material Support  
Department of Panchakarma Govt ayurveda college Panchakarma Hospital Poojappura Thiruvananthapuram 
 
Primary Sponsor  
Name  Sudheesh P N 
Address  Department of Panchakarma Govt: Ayurveda College Panchakarma Hospital Government Ayurveda College Thiruvananthapuram 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 Sudheesh P N  Government Ayurveda College Panchakarma Hospital  OP No1 Government Ayrveda College Panchakarma Hospital Poojappura
Thiruvananthapuram
KERALA 		 9495204216

sudheesh.pn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-talam, तलम् (Procedure Reference: Sirassekadi vidhi, Procedure details: . Procedure will be done as per SOP for Thalam STANDARD OPERATIVE PROCEDURE FOR THALAM PREPARATION OF THE PATIENT; 1. Educate the patient 2. Obtain informed consent 3. Ask to satisfy natural urges 4. Check vitals 5. Remove hair over the bregma in a circle of 2-3 cm PROCEDURE 1. Prepare the medicine into a thick paste. 2. Ask the patient to sit comfortably in a straight arm chair 3. Apply paste over the bregma covering 2-3 cm area in circumference 4. The thickness of paste should be 1-2 cm 5. Maintain the position for 15-30 minutes 6. Remove the paste 7. Clean the head with clean and dry towel 8. Apply rasnadi choorna on bregma 9. Explain pathya-apathya )
(1) Medicine Name: Karutta vattu. Ksheerabala(101), Reference: Sahasrayogam, Ashtanga Hridayam chi23/46, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 15(g), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants fulfilling diagnostic criteria
2. Aged in between 20 and 60
3. Participants willing to go for EEG study pre and post intervention.
4. Participants who are fit for application of thalam with Karuthavattu and kshirabala (101) 
 
ExclusionCriteria 
Details  1. All insomniacs Due to any systemic illness
2. All insomniacs due to any space occupying lesion
3. Insomnia due to substance abuse or psychiatric
illness
4. Taking any medication causing sedation
5. Taking any medication hindering sleep 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the following variables will be noted.
1. Insomnia severity index ,0 th and 15th day
2. Pittsburgh sleep quality index ,0 th and 15th day
3. Event evaluation scale accessed daily
4. Polysomnography 0th and 15th day 		 0th day, and 15th day in case of sleep indices and polysomnography 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   17/11/2025 
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="0"
Months="11"
Days="0" 
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  
Insomnia is defined as difficulty in initiating or maintaining sleep or early
morning awakening associated with impaired daytime time functioning viz reduced
cognitive performance fatigue or mood disorders. As Age increases, the prevalence of
insomnia also increases. As insomnia can lead to a lot of systemic disorders and
psychological disorders, management is crucial.
Thalam is a unique method of drug delivery developed by Vridha Vaidyas of Kerala
and is practiced widely. It is an integral part of Ayurvedic treatment showing deep knowledge
and precision in medicinal application. Thalam with karutha vattu and ksheerabala (101)Is
widely practiced in Kerala for sleeplessness.
There are numerous studies claiming effectiveness in insomnia with ayurvedic
intervention. But the realm of scientific validation with electrical changes the intervention
brings about remains unscathed, the main reason being difficulty in accessing affordable
technology. . The objective of the study is to evaluate whether thalam with Karuthavattu
and Ksheerabala (101) Is effective in inducing EEG changes in Insomnia disorders. As this
is A pilot clinical trial , a total number of 12 patients having Insomnia disorder is
administered Thalam and pre and post treatment Polysomnography ( PSG)  will be evaluated along with sleep
quality indices
.For sleep indices, parameters taken will be Sleep latency, total sleep time (TST), Sleep
efficiency, percentages of REM and NREM sleep. and its sub-stages Nl, N2 and N3.

The PSG parameters for objective assessment of sleep during pre and post treatrnent will
be done using basic EEG, EMG and EOG required sensors as per AASM (American
Association of Sleep Medicine): EEGs including O1, 02, F3, F4, C3, C4 channels along
with mastoid references Ml, M2; EOG (left and right) and chin EMG lbr insomnia and
ECG.

Keywords: - Insomnia disorders, Thalam ,Karuthavattu, Ksheerabala(101) ,EEG, PSG
 
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