| CTRI Number |
CTRI/2026/02/104058 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Kashmir Lavender (Lavandula angustifolia) oil (Aroma Therapy)] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to see the efficacy and safety of Kashmir Lavender (Lavandula angustifolia) oil in healthy adult human subjects having impaired sleep patterns and self reported sleep issues. |
|
Scientific Title of Study
|
A Principal Investigator blind, Single Center, Prospective, Randomized Clinical Study to Evaluate the efficacy and safety of Kashmir Lavender (Lavandula angustifolia) oil in participants with impaired sleep patterns and self-reported sleep issues. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 25-AGCR-002 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mangesh Shende |
| Designation |
Chief Executive Officer |
| Affiliation |
Akshar Global Clinical Research Private Limited |
| Address |
Akshar Global Clinical Research Private Limited, 322, Shreeya Amalga, Avalon Hotel Cross Road, Thaltej, Ahmedabad-380054, Gujarat, India.
Ahmadabad
GUJARAT
380054
India |
| Phone |
09978078056 |
| Fax |
|
| Email |
mangesh.shende@agcro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh Shende |
| Designation |
Chief Executive Officer |
| Affiliation |
Akshar Global Clinical Research Private Limited |
| Address |
Akshar Global Clinical Research Private Limited, 322, Shreeya Amalga, Avalon Hotel Cross Road, Thaltej, Ahmedabad-380054, Gujarat, India.
Ahmadabad
GUJARAT
380054
India |
| Phone |
09978078056 |
| Fax |
|
| Email |
mangesh.shende@agcro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh Shende |
| Designation |
Chief Executive Officer |
| Affiliation |
Akshar Global Clinical Research Private Limited |
| Address |
Akshar Global Clinical Research Private Limited, 322, Shreeya Amalga, Avalon Hotel Cross Road, Thaltej, Ahmedabad-380054, Gujarat, India.
Ahmadabad
GUJARAT
380054
India |
| Phone |
09978078056 |
| Fax |
|
| Email |
mangesh.shende@agcro.com |
|
|
Source of Monetary or Material Support
|
| Department of Natural Products & Medicinal Chemistry, CSIR-Indian Institute of Chemical Technology, Uppal Road, Tarnaka, Hyderabad-500007, Telangana, India |
|
|
Primary Sponsor
|
| Name |
CSIR-Indian Institute of Chemical Technology, Hyderabad & Integrative Medicine, Jammu |
| Address |
Council of Scientific and Industrial Research (CSIR)- - Indian Institute of Chemical Technology, Hyderabad-500007, Telangana, India. |
| Type of Sponsor |
Other [Drug Research Laboratory ] |
|
|
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 Alpesh Gediya |
Navneet Memorial Hospital Sushrusha |
OPD room, Ground Floor, Navneet Memorial Hospital ‘Sushrusha’, Opp. Sardar Patel Seva Samaj Hall, Navrangpura, Ahmedabad, Gujarat-380009
Ahmadabad
GUJARAT |
9909919369
alpeshgediyacr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Navneet Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants with impaired sleep patterns and self-reported sleep issues. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kashmir Lavender Lavandula angustifolia oil |
Spray the lavender oil twice, approximately 200 microliters in total, each night before sleep for 14 days. |
| Comparator Agent |
Placebo
Distilled water |
Spray the distilled water twice, approximately 200 microliters in total, each night before sleep for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female participants aged 18 to 65 years.
2. Participant has self reported sleep issues such as difficulty falling asleep, frequent awakenings during the night, or daytime sleepiness.
3. Participant has total PSQI score greater than 5.
4. Weight not less than 50 kg for male and 45 kg for female and BMI between 18.50 and 30.00 kg per square meter inclusive.
5. Participants with screening vital signs within normal limits, or with values outside the normal range that are deemed clinically insignificant by the physician or principal investigator.
6. Participant able to read, understand and sign informed consent form.
7. Participant willing not to use spray or any type of fragrance before sleeping at night in the room.
8. Ready to follow study protocol until study completion. |
|
| ExclusionCriteria |
| Details |
1. Participants who have night shift work or use prescription sleep medications.
2. Participants with PHQ 9 score greater than or equal to 10 and GAD 7 score greater than or equal to 10 during the screening visit.
3. Hypersensitivity to active ingredients of investigational product or any related chemical substances or excipients in the formulation.
4. Nasal allergy, nasal pathology such as history of bleeding or active bleeding, and nasal infections.
5. Refusal to undergo the procedure.
6. Known history or presence of the following:
a. Cardiovascular, pulmonary, metabolic, hepatic, renal, hematological, gastrointestinal, ocular, endocrine including diabetes, immunologic, dermatologic, venereal, neurological, musculoskeletal or psychiatric disorders.
b. Asthma, urticaria or other allergic reactions after taking any medication.
c. Alcohol dependence, alcohol abuse or drug or chemical abuse such as marijuana THC, cocaine, morphine, benzodiazepines, barbiturates and amphetamine within the past one year.
7. Participants taking any prescription or non prescription medication, herbal, nutraceutical, ayurvedic products or special diet that might interfere with the study outcome.
8. Respiratory system dysfunction such as rhinorrhea or nasal polyps, or respiratory tract infection.
9. Participants with difficult airway or obstructive sleep apnea syndrome.
10. Pregnant women and breastfeeding mothers.
11. Females of childbearing potential refusing to use contraceptive methods.
12. Any other condition that prevents adequate understanding, cooperation and compliance with study procedures or any condition that could pose a risk to participant safety as per the investigator’s judgment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Kashmir Lavender (Lavandula angustifolia) oil in healthy adult human subjects having Inadequate sleep hygiene |
Visit 1 to Visit 2 (Day 1 to Day 14 + 2 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety of Kashmir Lavender (Lavandula angustifolia) oil in healthy adult human subjects having Inadequate sleep hygiene |
Spray the lavender oil twice, approximately 200 microliters in total, each night before sleep for 14 days |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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)
|
28/02/2026 |
| 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="9"
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
|
The objective of this study is to evaluate efficacy and safety of Kashmir Lavender Lavandula angustifolia oil in participants with impaired sleep patterns and self-reported sleep issues. -
Primary Objective: To evaluate the efficacy of Kashmir Lavender Lavandula angustifolia oil in participants with impaired sleep patterns and self-reported sleep issues. -
Secondary Objective: To assess the safety of Kashmir Lavender Lavandula angustifolia oil in participants with impaired sleep patterns and self-reported sleep issues.
The overall study will include 111 participants, and the additional sleep tracking will provide deeper insights into how Kashmir Lavender oil may impact sleep patterns. |