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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.  
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