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CTRI Number  CTRI/2025/09/094786 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Bay Leaf Decoction on Sleep Quality in Adults with Primary Insomnia 
Scientific Title of Study   EFFECT OF BAY LEAF ON QUALITY OF SLEEP IN PATIENTS WITH PRIMARY INSOMNIA: A RANDOMIZED CONTROL STUDY. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyadharshini D 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences 
Address  Department of diet and nutrition, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire,574240 D.K, Karnataka

Dakshina Kannada
KARNATAKA
574240
India 
Phone  7358846160  
Fax    
Email  priyadharshinidamodaran@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyadharshini D 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences 
Address  Department of diet and nutrition Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire,574240 D.K, Karnataka

Dakshina Kannada
KARNATAKA
574240
India 
Phone  7358846160  
Fax    
Email  priyadharshinidamodaran@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prashanth Shetty 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences 
Address  Department of diet and nutrition, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire,574240 D.K, Karnataka

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9448252696  
Fax    
Email  drprashanth9@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital, Shantivana, Dharmasthala, Belthangadi, Dakshina Kannada, Karnataka, India-574216 
 
Primary Sponsor  
Name  Dr Priyadharshini D 
Address  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire, Belthangadi, D.K., Karnataka-574240 
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 Priyadharshini D  Government Taluk Hospital Panruti  DEPARTMENT OF GENERAL MEDICINE,KUMBAKONAM ROAD, PANRUTI, CUDDALORE, TAMIL NADU-607106
Cuddalore
TAMIL NADU 
7358846160

priyadharshinidamodaran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Institutional Ethical Comimittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bay leaf decoction  3 grams (1 teaspoon) of bay leaf powder is added to 100ml of water and bought to a boil and is given to the subject to sip it warm. 
Comparator Agent  warm water  100ml of warm water given to the subject to sip it warm. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  Subjects who are diagnosed as primary insomnia by DSM 5 criteria.
 
 
ExclusionCriteria 
Details  1. Individuals with psychotic conditions.
2. Individuals under any medications.
3. Individuals with other serious illness. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Insomnia Severity Index (ISI)
 
Pre, Post 
 
Secondary Outcome  
Outcome  TimePoints 
Serum cortisol level  Pre, Post 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2 
Date of First Enrollment (India)   01/10/2025 
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="8"
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  

Primary insomnia is a type of sleep disturbance characterized by a subjective complaint of difficulty falling or staying asleep, or of having an unrefreshing sensation when sleeping, that not attributable to a coexisting mental or physiological condition. About 30% of the general population suffers from insomnia. The perennial shrub known as bay leaf (Laurus nobilis) is a member of the Laurel family. A study discovered that the chemical linalool, found in bay leaves, lengthened people’s sleep duration. The drop in blood cortisol levels in healthy volunteers drinking Laurus nobilis tea, suggesting a potential benefit in lowering the risk of stress-related disorders. Criteria for Diagnosis: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) will be applied during screening. Bay leaf decoction – 3 grams (1 teaspoon) of bay leaf powder is added to 100ml of water and bought to a boil and is given to the subject to sip it warm. The data from insomnia severity index( ISI) and serum cortisol levels will be collected at baseline and post intervention [post 90 Days]. The aim is to study the effect of bay leaf decoction on quality of sleep in patients with primary insomnia.

 
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