NCT07323706

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
45mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Oct 2024Dec 2029

Study Start

First participant enrolled

October 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

2.2 years

First QC Date

December 15, 2025

Last Update Submit

December 31, 2025

Conditions

Hypothyroidism Primary

Keywords

hypothyroidismVegetarian dietAyurveda

Outcome Measures

Primary Outcomes (1)

  • digestion

    change in digestion measured by self-reported questionnaire

    8 weeks

Secondary Outcomes (1)

  • symptoms of hypothyroidis

    8 weeks

Study Arms (2)

habitual diet

OTHER

continuation of habitual diet

Other: habitual diet

ayurvedic diet

EXPERIMENTAL

plant based ayurvedic diet

Behavioral: Ayurvedic diet

Interventions

Ayurvedic dietBEHAVIORAL

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

ayurvedic diet
habitual dietOTHER

instruction on continuation of the habitual diet

habitual diet

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with primary hypothyroidism
  • primary digestive type Vishamagni
  • under medical treatment for hypothyroidism
  • unchanged medication for the past 6 months

You may not qualify if:

  • previous Ayurvedic treatment
  • prescription drugs other than medication for hypothyroidism
  • pregnancy
  • lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, 1954, Denmark

RECRUITING

Ayuvedic Clinic, Sorø

Sorø, 4180, Denmark

RECRUITING

Related Links

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • Jens Rikardt Andersen, MD, MPA

    University of Copenhagen

    STUDY CHAIR

  • Mette Westerholt, MSc

    AYUS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Rikardt Andersen, MD, MPA

CONTACT

0045 35332504jra@nexs.ku.dk

Mette Westerholt, MSc

CONTACT

0045 81444180kontakt@ayus.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2025

First Posted

January 7, 2026

Study Start

October 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2029

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)