| 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
|
|
|
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
|
|
|
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. |