Ayurvedic Diet in Myxedema

ConditionHypothyroidism Primary

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-90

SponsorUniversity of Copenhagen

About this trial

Primary hypothyroidism is diagnosed by elevated thyroid stimulating hormone (TSH) level and a reduced thyroxine (T4) level in plasma. Some of the most common symptoms of hypothyroidism are fatigue, weight gain and reduced cognition and is associated with reduced quality of life and increased days of sick leave. Levothyroxine, a synthetic form of T4, is clinically recommended as first-line treatment for hypothyroidism. When normalizing TSH/T4 with levothyroxine, the prevalence of persistent symptoms is present in 15% of patients. The composition of our gut bacteria, the microbiome, plays a significant role for a healthy thyroid gland and metabolism and is influenced by our diet. The Indian medical system, Ayurveda, is based on generations of experience and knowledge in disease prevention and treatment, including various diet plans, exercise and lifestyles that are put into context for physical and mental health. Ayurveda works with four different types of digestion and is based on a vegetarian diet. The purpose of this study is to investigate the effect of an Ayurvedic diet plan, as a supplement to medical treatment, among people with hypothyroidism.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosed with primary hypothyroidism

primary digestive type Vishamagni

under medical treatment for hypothyroidism

unchanged medication for the past 6 months

Disqualifiers

previous Ayurvedic treatment

prescription drugs other than medication for hypothyroidism

pregnancy

lactating women.

Trial design

Design model

Parallel

Treatments tested in this trial

Ayurvedic diet
Behavioral
Guidance in implementation of a diet adapted to Vishamagni; which foods and flavors are appropriate to consume, intake of oils, eating patterns, herbal supplements and guidance on which foods and flavors are inappropriate to consume. General Ayurvedic dietary advice for vishamagni: Regular meals; 3 main meals daily at approximately the same time. Consume foods with the Ayurvedic taste nuances: sweet, sour and salty. Primarily consume hot and prepared meals. Eat lactovegetarian. Avoid spicy, bitter and astringent foods. Avoid meat, raw vegetables (all vegetables must be cooked), dry and crunchy foods such as crackers, dried fruit, rice crackers and muesli, and avoid ice cold foods and drinks. One Ayurvedic herbal supplement MA505 (Triphala), with fruits and spices intended to balance the digestive type Vishamagni
habitual diet
Other intervention
instruction on continuation of the habitual diet

Treatment groups

88 Participants

are divided into 2 treatment groups

Group A: habitual dietOther 1 intervention

Group B: ayurvedic dietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

digestion

change in digestion measured by self-reported questionnaire

Time frame

8 weeks

Secondary outcomes

symptoms of hypothyroidis

symptoms of hypothyroidism measured by self-reported questionnaire

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Copenhagen

Lead sponsor

Source ClinicalTrials.gov

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