Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000561482
Ethics application status
Approved
Date submitted
24/04/2025
Date registered
2/06/2025
Date last updated
2/06/2025
Date data sharing statement initially provided
2/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects on thyroid function of a supplement containing: Ashwagandha, Guggul, Magnesium, L-Tyrosine, L-Glutamine, Zinc, Resveratrol, Manganese, Copper, Folic acid, Selenium, Iodine, and Vitamin B12.
Scientific title
Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of a Novel Nutraceutical based on Ashwagandha and Guggul, in subjects with Subclinical Hypothyroidism.
Secondary ID [1] 312538 0
Nil known
Universal Trial Number (UTN)
U1111-1310-7126
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subclinical Hypothyroidism 334411 0
Condition category
Condition code
Metabolic and Endocrine 331048 331048 0 0
Thyroid disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomsied, placebo controlled trial. One interventional arm and one placebo/comparator arm. Participants are randomised to treatment arm or placebo.The study is parallel in design.
Arm 1: Nutraceutical containing: Ashwagandha, Guggul, Magnesium, L-Tyrosine, L-Glutamine, Zinc, Resveratrol, Manganese, Copper, Folic acid, Selenium, Iodine, and Vitamin B12,taken once daily for 12 weeks via two oral tablets.
Arm 2: Nutraceutical Placebo once daily for 12 weeks via two oral tablets
Adherence to therapy : tablet return at the end of the study.
For additional notes on placebo tablets, please see section below.
Intervention code [1] 329051 0
Treatment: Drugs
Comparator / control treatment
The placebo tablets will be identical in appearance to their active counterparts and contain microcrystalline cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 338817 0
Investigation of the efficacy of the examined supplements to restore thyroid function (indicated by achieving Thyrotropin, (TSH) levels lower than 4mU/ml at the end of the study).
Timepoint [1] 338817 0
Baseline, and 12 weeks after intervention commencement.
Secondary outcome [1] 437566 0
Composite secondary Outcome: Comparison of blood levels of TSH, FT4, anti-TPO, and anti-Tg before and after 3 months of intervention with supplement therapy.
Timepoint [1] 437566 0
Basal and 12 weeks after treatment initiation
Secondary outcome [2] 437567 0
Adverse effects related to the specifically used supplement ( eg: nausea, gastrointestinal symptoms, taste, kidney problems, allergic reactions).
Timepoint [2] 437567 0
During the study period ( 12 weeks).

Eligibility
Key inclusion criteria
Patients with TSH levels between 4 and 8 mU/I, Free- T4 levels within normal rang (0.9 – 1.7 ng/dL) and increased titers of antithyroid antibodies: Thyroid peroxidase antibodies (TPOAb) and/or Thyroglobulin antibodies (Tg Ab).
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. individuals who have been taking thyroxin before the study.
2. Medications affecting thyroid function: individuals who are taking medications known to interfere with thyroid function or can alter thyroid function tests, such as anticonvulsants, non-steroidal anti-inflammatory drugs, beta-adrenoceptor antagonists, steroid hormones, amiodarone, and heparin.
3. Individuals taking supplements containing iodine or biotin.
4. Other metabolic disorders: individuals with specific metabolic disorders that could impact thyroid function metabolism or lead to altered thyroid tests, such as chronic renal and liver disease.
5. Pregnancy and breastfeeding
7. Severe illnesses or comorbidities: terminal cancer, uncontrolled diabetes, or autoimmune disorders.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation via numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table generated by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary outcome is a reduction in TSH levels . This will be assessed by intergroup comparison and by comparison of the two groups in the end of the study. All analysis will be performed at the completion of the trial. Participants who withdraw from the study will not be replaced. Sample size calculations are based on assumptions made on the primary outcome, reduction in TSH levels. The level of significance is p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
30/07/2025
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 26427 0
Greece
State/province [1] 26427 0

Funding & Sponsors
Funding source category [1] 316965 0
Self funded/Unfunded
Name [1] 316965 0
Country [1] 316965 0
Primary sponsor type
Charities/Societies/Foundations
Name
Hellenic Endocrine Network
Address
Country
Greece
Secondary sponsor category [1] 319210 0
None
Name [1] 319210 0
Address [1] 319210 0
Country [1] 319210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315717 0
Hellenic Endocrine Network Ethics Committee
Ethics committee address [1] 315717 0
Ethics committee country [1] 315717 0
Greece
Date submitted for ethics approval [1] 315717 0
15/07/2024
Approval date [1] 315717 0
23/04/2025
Ethics approval number [1] 315717 0
?2025/0121321

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135590 0
Dr Nikolaos George Angelopoulos
Address 135590 0
Endocrine Clinic, Veniselou 26G, Kavala,65302
Country 135590 0
Greece
Phone 135590 0
+302510225200
Fax 135590 0
Email 135590 0
[email protected]
Contact person for public queries
Name 135591 0
Nikolaos George Angelopoulos
Address 135591 0
Endocrine Clinic, Veniselou 26G, Kavala,65302
Country 135591 0
Greece
Phone 135591 0
+302510225200
Fax 135591 0
Email 135591 0
[email protected]
Contact person for scientific queries
Name 135592 0
Nikolaos George Angelopoulos
Address 135592 0
Endocrine Clinic, Veniselou 26G, Kavala,65302,Greece
Country 135592 0
Greece
Phone 135592 0
+302510225200
Fax 135592 0
Email 135592 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• researchers who provide a methodologically sound proposal

Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• individual participant data underlying published results

What types of analyses could be done with individual participant data?
• uppon request for sientific purposes ( e.g. meta-analyses)

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• approval by the principal investigator by e-mail: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Clinical study report  [email protected]
Ethical approval  [email protected]
Informed consent form  [email protected]
Study protocol  [email protected]
Statistical analysis plan  [email protected]


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.