| CTRI Number |
CTRI/2026/01/100458 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Head massage with Clary Sage oil to reduce stress among Office going individuals |
|
Scientific Title of Study
|
The Effect of Aromatherapy Head Massage with Clary Sage Oil on Heart rate variability and Stress among Working Professionals - A Randomized Controlled Trial” |
| 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 Devarajan A |
| Designation |
Post Graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block first floor, Dept. of Naturopathy, Kamaraj nagar, Ammanambakkam, Chengalpattu. 603001.
Kancheepuram TAMIL NADU 603001 India |
| Phone |
8300334972 |
| Fax |
|
| Email |
adevarajan11@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pandiaraja M |
| Designation |
Head of the Department - Naturopathy (incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block first floor, Dept. of Naturopathy, Kamaraj nagar, Ammanambakkam, Chengalpattu. 603001.
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pandiaraja M |
| Designation |
Head of the Department - Naturopathy (incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block first floor, Dept. of Naturopathy, Kamaraj nagar, Ammanambakkam, Chengalpattu. 603001.
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Tamilnadu. 603001 |
|
|
Primary Sponsor
|
| Name |
Dr Devarajan .A |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block first floor, Dept. of Naturopathy, Kamaraj nagar, Ammanambakkam, Chengalpattu. 603001. |
| 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 Devarajan A |
International Institute of Yoga and Naturopathy Medical Sciences |
184/4, Faculty block first floor, Dept. of Naturopathy, Kamaraj nagar, Ammanambakkam, Chengalpattu. 603001. Kancheepuram TAMIL NADU |
8300334972
adevarajan11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, International Institute of Yoga and Naturopathy Medical Sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F439||Reaction to severe stress, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Head massage with Clary Sage oil |
The subjects will be given head massage with clary sage oil. Dilution of 4 drops of Clary sage oil with 20 ml of carrier oil (cold press coconut oil) 1% dilution is used for a total of 12 session with each session carried out 3 times a week on alternate days for a month, with each massage session lasting 15 minutes in duration in a sitting position. |
| Comparator Agent |
Yoga and Naturopathy intervention |
Yoga and Naturopathy intervention for weekly 3 days alternatively for 1 month |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants who are currently employed as a working professional with at least 1 year of continuous work experience.
2.Participants who have work-related stress for a minimum of 3 months (present history).
3.Participants with a score of 14 or above on the Perceived Stress Scale – 10 item version (PSS-10), indicating moderate to high stress levels.
4.Participants who are able to read, understand, and respond to the questionnaire in English or the regional language.
5.Participants who are willing to provide informed consent and participate fully in the study.
|
|
| ExclusionCriteria |
| Details |
1. Participants with inflammatory scalp conditions (e.g., scalp psoriasis, seborrheic dermatitis).
2. Pregnant or lactating women.
3. Participants with known allergies or adverse reactions to any aromatic oils (if applicable, such as oils or massage).
4. Participants who are not willing or unable to give informed consent or comply with the study intervention.
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability |
Heart Rate Variability will be checked before the start of the intervention at baseline (before 1st session) and at the end of intervention after 4 weeks.(end of 12th session) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perceived Stress Scale – 10 item version (PSS-10), Depression Anxiety Stress Scales – 21 items (DASS-21). |
Values of the questionnaires will be obtained before the start of the intervention at baseline (before 1st session) & at the end of intervention after 4 weeks.(end of 12th session) |
|
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
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)
|
18/01/2026 |
| 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="1" Months="11" Days="28" |
|
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
|
Stress is a multifaceted physiological and psychological response that occurs when individuals perceive an imbalance between external demands and their ability to cope. This response primarily activates the hypothalamic pituitary adrenal (HPA) axis and the sympathetic nervous system, resulting in hormonal and autonomic changes that influence both physical and mental health. Although acute stress can be adaptive, prolonged or chronic stress is detrimental and has been linked to cardiovascular diseases, immune dysfunction, anxiety, depression, and sleep disturbances. Occupational stress is particularly prevalent among working professionals worldwide, with recent meta-analytic evidence suggesting that nearly 30–40 percentage of working adults experience moderate to high levels of stress, especially in urban and highly competitive work environments. Factors such as extended working hours, excessive workload, role conflict, job insecurity, and poor work–life balance significantly contribute to occupational stress. Persistent exposure to such stress negatively impacts productivity, increases absenteeism, and reduces overall quality of life. The adverse physiological effects of stress are largely mediated through sustained activation of the HPA axis and dysregulation of the autonomic nervous system, leading to elevated cortisol levels, reduced heart rate variability, fatigue, and impaired emotional regulation. Considering the limitations and potential side effects associated with long-term pharmacological management, increasing attention is being directed toward non-pharmacological and complementary approaches for stress reduction. Naturopathy is a holistic system of healthcare that emphasizes the body’s innate capacity for self-healing, guided by the principle of Vis Medicatrix Naturae, or the healing power of nature. Naturopathic interventions—including mud therapy, hydrotherapy, massage, and other natural modalities aim to restore physiological balance in accordance with the Panchamahabhuta theory. Massage therapy, which involves the systematic manipulation of soft tissues, exerts beneficial effects on the musculoskeletal, vascular, and nervous systems. Aromatherapy is a complementary modality that employs essential oils derived from plant sources to enhance physical and psychological well-being. Aromatherapy massage integrates massage techniques with essential oils diluted in carrier oils to augment therapeutic effects. Head massage, in particular, is a well-established intervention for stress management, as it stimulates pressure points on the scalp and neck, enhances local circulation, and promotes muscular relaxation. When combined with aromatherapy oils such as clary sage, head massage may further activate the parasympathetic nervous system, regulate heart rate, and facilitate the release of neurotransmitters including endorphins and serotonin. Clary sage (Salvia sclarea) essential oil, extracted through steam distillation of the flowering tops and leaves, has traditionally been recognized for its calming, antispasmodic, and antidepressant properties. Its major bioactive constituents, linalyl acetate and linalool, are known to influence gamma-aminobutyric acid (GABA) receptor pathways, thereby promoting relaxation and emotional stability. Emerging evidence suggests that clary sage oil may reduce cortisol levels, alleviate anxiety, and induce a sense of calm when administered via inhalation or topical application in conjunction with massage. The integration of clary sage essential oil with head massage may therefore exert a synergistic effect by combining the mechanical relaxation of massage with the neurochemical and olfactory benefits of aromatherapy. This intervention is particularly suitable for working professionals, as it is simple, non-invasive, and cost-effective. However, despite its potential benefits, there is a scarcity of controlled clinical trials evaluating the effectiveness of clary sage oil based head massage for reducing occupational stress. Hence, the present study aims to assess the effectiveness of head massage using clary sage essential oil in reducing stress among working professionals through a randomized controlled trial design. |