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CTRI Number  CTRI/2024/02/062772 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 08/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To find out the effects of Aroma oil massage on the Thyroid hormone levels in Hypothyroid Patients 
Scientific Title of Study   To evaluate the effect of Aromatherapy massage on Thyroid profile in Hypothyroid patients 
Trial Acronym  AMH 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S. Ranjit Nataesh 
Designation  PG Scholar 
Affiliation  Government Yoga and Naturopathy medical college 
Address  Department of Naturopathy, second floor, Government Yoga and Naturopathy medical college and hospital PG block, Arumbakkam,Chennai-600106

Chennai
TAMIL NADU
600106
India 
Phone  7401134686  
Fax    
Email  ranjitsak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr A Mooventhan 
Designation  Assistant medical officer cum Lecturer, Department of Research 
Affiliation  Government Yoga and Naturopathy medical college and Hospital 
Address  Department of Research, second floor, Government Yoga and Naturopathy medical college and hospital PG block, Arumbakkam,Chennai-600106

Chennai
TAMIL NADU
600106
India 
Phone  9844457496  
Fax    
Email  dr.mooventhan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr A Mooventhan 
Designation  Assistant medical officer cum Lecturer, Department of Research 
Affiliation  Government Yoga and Naturopathy medical college and Hospital 
Address  Department of Research, second floor, Government Yoga and Naturopathy medical college and hospital PG block, Arumbakkam,Chennai-600106

Chennai
TAMIL NADU
600106
India 
Phone  9844457496  
Fax    
Email  dr.mooventhan@gmail.com  
 
Source of Monetary or Material Support  
Government Yoga and Naturopathy medical college and hospital, Arumbakkam,Chennai-600106 
 
Primary Sponsor  
Name  Government Yoga and Naturopathy medical college and hospita 
Address  Government Yoga and Naturopathy medical college and hospital, Arumbakkam,Chennai-600106 
Type of Sponsor  Government medical college 
 
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 S Ranjit Nataesh  Government Yoga and Naturopathy medical college and hospital  2nd floor, Department of Naturopathy, Arumbakkam, Chennai -600106
Chennai
TAMIL NADU 
7401134686

ranjitsak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Yoga and Naturopathy Medical College and Hospital, Chennai Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aromatherapy massage  Aromatherapy massage will be done using Lavender oil with coconut oil as carrier. It will be done for 15 mins on the neck for a period of 1 month 
Comparator Agent  Massage  Massage will be done using only coconut oil. It will be done for 15 mins on the neck for a period of 1 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1) Participants with TSH levels above 5.0 mIU-L or already taking medications for hypothyroidism
2) Age between 18 to 55 years
3) Both genders
4) Participants willing to give their consent 
 
ExclusionCriteria 
Details  1) Pregnant and lactating women
2) Participants with a history of cancer
3) Participants taking immunosuppressant drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Thyroid profile
TSH – thyroid stimulating hormone, T4- thyroxine and T3 –triiodothyronin 
Thyroid profile
TSH – thyroid stimulating hormone, T4- thyroxine and T3 –triiodothyronin before and after 1 month of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Patient Health Questionnaire-9 score, Fatigue Assessment Scale score, Percceived stress scale score, Body mass index and Waist:Hip ratio  Patient Health Questionnaire-9 score, Fatigue Assessment Scale score, Percceived stress scale score, Body mass index and Waist:Hip ratio before and after 1 month of intervention 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 1 
Date of First Enrollment (India)   14/03/2024 
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="0"
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  
A randomized control study design will be adopted for this study. 40 participants will be recruited from Government Yoga and Naturopathy medical college and hospital and randomized into two groups of 20 namely study and control groups respectively. After baseline assessment of outcome variables, both the groups will undergo their respective interventions for a period of 1 month, after which post-assessments will be made. The study group will receive aromatherapy massage using Lavender oil with coconut oil as the carrier. The control group will receive massage using only coconut oil. Both groups will receive massage on the neck for 15 minutes daily in the morning for one month. The primary outcome variables measured will be Thyroid Profile including Thyroid stimulating hormone (TSH) levels, Thyroxine (T4) levels and Triiodothyronin (T3) levels. The secondary outcome variables assessed will be Patient health questionnaire (PHQ-9), Fatigue assessment scale (FAS), Perceived Stress Scale, Body mass index and waist-to-hip ratios. The values collected at baseline and after 1 month of intervention will be analyzed. 
 
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