| 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
|
|
|
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
|
|
|
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. |