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临床试验/CTRI/2024/02/062772
CTRI/2024/02/062772尚未招募1 期

To evaluate the effect of Aromatherapy massage on Thyroid profile in Hypothyroid patients

Government Yoga and Naturopathy medical college and hospita1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月14日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Thyroid profile

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Pregnant and lactating women 2) Participants with a history of cancer 3) Participants taking immunosuppressant drugs.

结局指标

主要结局

Thyroid profile

时间窗: Thyroid profile | TSH – thyroid stimulating hormone, T4- thyroxine and T3 –triiodothyronin before and after 1 month of intervention

TSH – thyroid stimulating hormone, T4- thyroxine and T3 –triiodothyronin

时间窗: Thyroid profile | TSH – thyroid stimulating hormone, T4- thyroxine and T3 –triiodothyronin before and after 1 month of intervention

次要结局

  • 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)

研究者

发起方
Government Yoga and Naturopathy medical college and hospita
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

S. Ranjit Nataesh

Government Yoga and Naturopathy medical college

研究点 (1)

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