| CTRI Number |
CTRI/2016/03/006715 [Registered on: 07/03/2016] Trial Registered Retrospectively |
| Last Modified On: |
29/02/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of Aromatherapy Oil in females suffering from stress related anxiety |
|
Scientific Title of Study
|
A Prospective, Multi-center, Clinical Study to Evaluate the Efficacy and Safety of Aromatherapy Oil in females suffering from mild to moderate stress induced anxiety |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No. AO/M/01/2015, Version 1.0, Dated 19 May 2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varsha Sadhale |
| Designation |
Assistant Professor |
| Affiliation |
Ayurved Seva Sangh, Ayurved Sanshodhan Vibhag |
| Address |
OPD NO 9, Ground floor, Ayurved Seva Sangh, Ayurved Sanshodhan Vibhag, Ganeshwadi, Panchvati, Nasik
Nashik MAHARASHTRA 422003 India |
| Phone |
9822173345 |
| Fax |
|
| Email |
shravanigirishkulkarni@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
205, B Wing, Blue Diamond Society,Nayagoan, Dahisar West, Mumbai
Mumbai (Suburban) MAHARASHTRA 400068 India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
205, B Wing, Blue Diamond Society,Nayagoan, Dahisar West, Mumbai
MAHARASHTRA 400068 India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Marico Ltd. Plot No: 23/C, Mahal Industrial Estate,
Near Ahura Centre, Paper Box Gali, Mahakali Caves Road, Andheri (E), Mumbai-400093 |
|
|
Primary Sponsor
|
| Name |
Marico Ltd |
| Address |
Plot No: 23/C, Mahal Industrial Estate,
Near Ahura Centre, Paper Box Gali, Mahakali Caves Road, Andheri (E), Mumbai-400093 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Varsha Sadhale |
Ayurved Seva Sangh, Ayurved Sanshodhan Vibhag, Ganeshwadi, Panchvati, Nasik |
OPD NO 9, Ground floor, Ayurved Seva Sangh, Ayurved Sanshodhan Vibhag, Ganeshwadi, Panchvati, Nasik-422003 Nashik MAHARASHTRA |
9822173345
shravanigirishkulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ayurved Seva Sangh, Ayurved Sanshodhan Vibhag, Ganeshwadi, Panchvati, Nasik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Stress Induced Anxiety, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aromatherapy Oil |
Contains Refined Coconut oil and Refined Sunflower oil
Dosage and Treatment Duration: Subjects will be advised to apply sufficient quantity of Study oil daily for 15 days once daily on scalp and thereafter head massage for 10-15 minutes.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
•Subjects with mild to moderate stress induced anxiety (who achieved score between 18 and 24 points on the Hamilton Scale for Anxiety) were considered eligible for recruitment in the Study
•Subjects who gave informed consent and were ready to comply with the study protocol
•Subjects who were ready to provide regular follow ups till the completion of the study
|
|
| ExclusionCriteria |
| Details |
•Subjects suffering from depression, schizophrenia, diabetes mellitus, cardiovascular disease (uncontrolled arrhythmia / acute ischemia) and kidney and liver diseases will not be recruited in the Study
•Subjects having addiction to drugs, including alcohol were not recruited in the Study
•Subjects who were using any medication that could interfere with the effect of the oil under study were not recruited in the study
•Subjects who had participated in any other clinical study in the last 3 months were not included in the study
•Subjects who reported pregnant/planning a pregnancy or lactating were not recruited in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hamilton Rating scale for Anxiety (HAM-A) score with Study oil as compared to Baseline score in mild to moderate stress induced anxiety |
Day 0, Day 7 and Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Changes in QOL in subjects suffering from mild to moderate stress induced anxiety
•Changes in Morning serum cortisol value in subjects suffering from mild to moderate stress induced anxiety.
•Changes in the level of stress measured on VAS scale
•Changes in the quality of Sleep
•Assessment of adverse events |
Day 0, Day 7 and Day 15 |
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/06/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Subjects suffering from stress induced anxiety attending Clinic/Hospital of the Investigator were screened for eligibility criteria. At the screening visit, a written informed consent was obtained from the subjects for their participation in the study. Subjects’ history was recorded and his/her physical examinations were done. Subjects were assessed for severity of Anxiety on Hamilton Anxiety Rating Scale (HAM-A). If their score was between 18 and 24 points on HAM-A, then subjects were considered eligible for recruitment in the study. At baseline visit, Subjects were recruited in the study if she met all the inclusion and exclusion criteria. Subjects’ Overall Quality Of Life was assessed on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Subjects underwent estimation of fasting (morning) serum cortisol. Subjects were asked for overall level of stress on VAS scale and quality of sleep based on questionnaire. At baseline visit and on visit 1 (7th day) subjects were given 1 bottle containing 100 ml of Study Oil. Subjects were advised to apply sufficient quantity of Study oil on scalp and thereafter head massage for 10-15 minutes. Subjects were instructed to use the study oil for head massage once daily. Subjects were asked to come to hospital for follow up after 7 days and 14 days i.e. at the completion of the study. Compliance was assessed by the study physician at every follow up visit. At every follow up visit, subjects underwent general and systemic examinations and assessment of severity of anxiety on HAM-A scale. Subjects’ Overall Quality Of Life was assessed on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) at every follow up visit. |