Role Of Individualized Homoeopathic Medicines In The Treatment Of Subclinical Hypothyroidism Using Synthesis Repertory An Open Label Prospective Clinical Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To assess Serum TSH Level & Thyroid Symptom Rating Questionnaire (Thy-SRQ)
Study Overview
Brief Summary
Subclinical Hypothyroidism is a clinical condition in which serum TSH is raised, and serum T3 and T4 concentrations are at the lower end of the reference range.
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Samples will be selected following preliminary and detailed screening using specified selection criteria.
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Inclusion and exclusion criteria are strictly followed.
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After consideration of dropout cases, a minimum 40 patients will be enrolled for the study.
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Case-taking will be done as per the strict homoeopathic principle.
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Baseline scoring will be taken using Thy-SRQ & and Serum TSH levels will be assessed.
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Analysis and evaluation of each case will be done.
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Miasmatic analysis will be done.
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Repertorization will be done in Synthesis Repertory.
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Final selection of the remedy will be done after consultation with Materia Medica.
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Potency, dose and repetition of the indicated remedies will be guided strictly as per homoeopathic principles.
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General (non-medicinal) management including appropriate diet and regimen will be advised.
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Subsequent prescriptions (follow-ups) will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets.
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The baseline data will be compared with the data obtained after 6 months.
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The score obtained by the patients will be compared and result will be analyzed as per appropriate statistical methods and interference will be done thereafter.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of both sexes from any religion or socio-demographic background and aged between 18-65 years with high Serum TSH level but less than 20 mIU/ml (5-20 mIU/ml), and T3, T4 within normal range.
- •Patients agreeing to undergo T3, T4, TSH investigation, if required.
- •Patients willing to give written consent to participate in the study.
Exclusion Criteria
- •Patients with serum TSH level more than 20 mIU/ml.
- •Pregnant or lactating women.
- •Patients taking any other treatment for subclinical hypothyroidism from other system of medicine.
- •Patients having the habits of substance abuse and/or dependence.
- •Patients having any uncontrolled systemic illness or any life-threatening disease.
- •Patients not willing to participate in the study, not willing to undergo any investigation, if so advised.
Outcomes
Primary Outcomes
To assess Serum TSH Level & Thyroid Symptom Rating Questionnaire (Thy-SRQ)
Time Frame: Baseline & 6 months
Secondary Outcomes
- Socio-demographic data(After 6 months)
Investigators
Dr Vaka Ashok Kumar
National Institute Of Homoeopathy