CTRI/2024/02/063267 [Registered on: 28/02/2024] Trial Registered Prospectively
Last Modified On:
30/11/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Clinical Study on Topical Head Oil Application
Scientific Title of Study
A Randomized, Double Blind, Comparative, Multi-centric, Interventional, Prospective, Clinical study to Evaluate Efficacy & Safety of Topical head application Oil in participants with Stress & Insomnia
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
DCO-STRESINSO/2024/01, Version 1.0, Dated 10th Feb 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Narendra B Mundhe
Designation
Assistant Professor
Affiliation
KVTR Ayurvedic College and Hospital Boradi
Address
KVTR Ayurvedic College and Hospital Boradi
Department of Kayachikitsa, OPD No 5, Ground Floor, KVTR
Ayurvedic College and Hospital, Boradi, Tal. Shirpur, Dist. Dhule
Maharashtra 425428 India
Dhule MAHARASHTRA 425428 India
Phone
9850378206
Fax
Email
drnbmundhe@gmail.com
Details of Contact Person Scientific Query
Name
Dr Ruchi Srivastava
Designation
Principal Scientist
Affiliation
Dabur India Ltd.
Address
Department of Medical Services,
Dabur India Ltd
Plot No.22, First Floor, Site IV, Sahibabad,
Ghaziabad, UP, India
Ghaziabad UTTAR PRADESH 201010 India
Phone
9650535899
Fax
Email
ruchi.srivastava@dabur.com
Details of Contact Person Public Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research Pvt. Ltd.
Address
Target Institute of Medical Education and Research Pvt. Ltd. Fourth Floor,
A Wing 402 A,B,C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai
Mumbai (Suburban) MAHARASHTRA 400064 India
Phone
009322522252
Fax
Email
targetinstitute@yahoo.com
Source of Monetary or Material Support
Dabur India Ltd
Plot No.22, Site IV, Sahibabad,
Ghaziabad – 201 010, UP, India
Primary Sponsor
Name
Dabur India Ltd
Address
Plot No.22, Site IV, Sahibabad,
Ghaziabad – 201010, UP, India
Type of Sponsor
Other [Healthcare Industry]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 3
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Shishir P Pande
Ayurved Seva Sangh’s, Ayurved Mahavidyalaya & Rugnalaya
Ayurved Sanshodhan Vibhag, OPD No 9, Ground Floor, Ayurved Seva Sangh’s Ayurved Mahavidyalaya and Rugnalaya, Ganeshwadi, Panchvati, Nashik, Maharashtra
Nashik MAHARASHTRA
09146030818
shishir.nsk@gmail.com
Dr Narendra B Mundhe
KVTR Ayurvedic College and Hospital Boradi
Department of Kayachikitsa, OPD No 5, Ground Floor, KVTR
Ayurvedic College and Hospital, Boradi, Tal. Shirpur, Dist. Dhule
Maharashtra 425428 India Dhule MAHARASHTRA
09850378206
drnbmundhe@gmail.com
Dr Nilesh Londhe
Nirvikar Ayurveda Hospital,
Department of General OPD, OPD No. 1, First Floor, B Wing, Jay Ganesh Samrajya, Pune - Nashik Hwy, Sector No. 3, Bhosari, Pune, Pimpri-Chinchwad, Maharashtra 411039
Pune MAHARASHTRA
Independent Ethics Committee, Nirvikar Ayurveda Hospital Pune
Approved
Institutional Ethics Committee Ayurveda Seva Sangh, Ayurveda Mahavidyalaya, Nashik.
Approved
Institutional Ethics Committee, KVTR Ayurved College and Hospital, Boradi
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Stress and Insomnia
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Comparator Arm
Drug
Other than Classical
(1) Medicine Name: Market Preparation, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Samudga, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Sufficient quantity (5 ml) of given oil on scalp in evening and thereafter head massage for 5 minutes for 14 days
2
Intervention Arm
Drug
Other than Classical
(1) Medicine Name: Topical Head Application Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Samudga, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Sufficient quantity (5 ml) of given oil on scalp in evening and thereafter head massage for 5 minutes for 14 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1. Participants who perceive themselves to be under stress and having a score of between 14 - 24 on the Perceived Stress Scale (PSS)
2. Participants with insomnia severity more than 7 and less than or equal to 21 on insomnia severity index
3. Participants willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
ExclusionCriteria
Details
1. Participants currently suffering from any known chronic physical, hormonal or psychiatric illness
2. Participants with uncontrolled diabetes and hypertension
3. Participants with substance dependence e.g. taking prohibited medications such as opium, cannabis (marijuana) and methamphetamines etc.
4. Chronic alcoholics and Habitual Tobacco chewers.
6. Known cases of severe/chronic hepatic or renal disease.
7. Known case of any active malignancy.
8. Participants with history of cardiovascular event less than 12 weeks prior to recruitment.
9. Participants having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
10. Participants using any other investigational drug within 1 month prior to recruitment or participants currently participating in any other Clinical study
11. Known hypersensitivity to any of the ingredients used in study products
12. Participants with any current skin or scalp related medical or surgical condition
13. Pregnant and Lactating females.
14. Other conditions, which in the opinion of the investigators, make participant unsuitable for enrolment or could interfere with his/her participation and completion of the study
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1. Change in stress level using perceived stress scale (PSS)
2. Change in patient-reported total sleep time (as per Participant diary)
Day 0, Day 7 and Day 14
Secondary Outcome
Outcome
TimePoints
1. Assessment of relaxation, cooling, refreshing, soothing on VAS and time duration of relaxation, cooling, refreshing, soothing post application
2. Change in sleep efficiency, Time to sleep onset. Number of awakenings, Wake time after sleep onset
3. Change in fatigue using Fatigue Severity Scale
4. Change in headache mood, ability to function at work, and concentration on a graded scale
5. Change in severity of insomnia using Insomnia Severity Index
6. Change in quality of sleep using Pittsburgh Sleep Quality Index
7. Change in hair fall through running finger test, comb test pull test and Dandruff test
8. Change in quality of life using Q LES Q SF
9. Changes in morning serum cortisol level
10. Assessment of adverse events and vitals
11. Global assessment for overall change
12. Assessment of post study tolerability of study product
Day 0, Day 7 and Day 14
Target Sample Size
Total Sample Size="144" Sample Size from India="144" Final Enrollment numbers achieved (Total)= "138" Final Enrollment numbers achieved (India)="138"
It is a randomized, double blind, comparative, multi-centric, interventional, prospective, clinical study to evaluate efficacy & safety of Topical head application Oil in participants with Stress and Insomnia. Study will be carried out in 3 to 4 centers in India. As per computer generated randomization list, participants will be randomized to one of the two study groups in 1:1 ratio. Participants will be asked to apply sufficient quantity of given oil on scalp in evening and thereafter head massage for 5 minutes for 14 days. Primary objectives of the study will be to assess change in stress level using perceived stress scale (PSS) and change in patient-reported total sleep time (as per Participant diary). Secondary objectives of the study will be to assess relaxation, cooling, refreshing, soothing (VAS) and time duration of relaxation, cooling, refreshing, soothing post application, change in sleep efficiency, Time to sleep onset. Number of awakenings, Wake time after sleep onset based on participant diary, change in fatigue using Fatigue Severity Scale (FSS), change in headache mood, ability to function at work, and concentration on a graded scale, change in severity of insomnia using Insomnia Severity Index (ISI), change in quality of sleep using Pittsburgh Sleep Quality Index (PSQI), change in hair fall through running finger test, comb test pull test and Dandruff test, change in quality of life (QOL) using Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF), changes in morning serum cortisol level, assessment of adverse events and vitals, global assessment for overall change by participants and by physician and post study tolerability of study product by participants and physician on day 0, day 7 and day 14.
Summary of Results:
The study concludes that topical use of DCO (DRDC/2024/009) for head message for a period of 14 days helps to reduce stress and fatigue and improve sleep onset, duration of sleep and sleep efficiency. DCO helped to impart relaxing, cooling (calming), refreshing and soothing effects, which was observed to be significantly better than control. The cooling (calming) refreshing and relaxation experience lasted for more than 8 hours. DCO also helped to reduce symptoms like headache and improve daytime mood, ability to function and concentration. Topical use of DCO to relieve the above symptoms was assessed to be safe.