A clinical study on primary hypothyroidism and its treatment with a Unani drug.
- Conditions
- Hypothyroidism, unspecified,
- Registration Number
- CTRI/2022/04/041632
- Lead Sponsor
- Ayurvedic and Unani Tibbia College and Hospital
- Brief Summary
Diagnosed cases of Primary Hypothyroidism, whofulfill the inclusion criteria, will be enrolled in the trial after making themunderstand about the study & taking their informed written consent.Patients will be given the test drug, prepared in the extract formof Unani Polyherbal formulation, 2 capsules (500 mg each) twice a day orallyand would be followed up on 10th,20th, 30thand 42nd day and will be clinically evaluated on assessment parameters. The data will be statistically analyzed using appropriatestatistical tests. The safety of the test drug will be ensured bymonitoring the Hemogram and biochemical indicators for kidney and liverfunctions. Any adverse effects of the drug during study will be noticedcarefully.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
- Diagnosed cases of Primary Hypothyroidism with TSH level >20mIU/L.
- Patient willing to participate and sign the consent form.
- Patient willing to discontinue the drugs taking for the treatment of Primary Hypothyroidism.
- Patient unwilling to sign the consent form.
- Patient taking hormonal therapy.
- Pregnant and lactating women.
- Renal and hepatic insufficiency and malignancy.
- Patient with tachyarrhythmia.
- Patient with increased bowel movements.
- Patient with menorrhagia, metrorrhagia and polymenorrhea.
- Patient with parkinsonism and tremors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TSH, Free T3 & T4 6 Week Tiredness 6 Week Loss of appetite 6 Week Cold intolerance 6 Week Constipation 6 Week Sleep 6 Week will be assessed. 6 Week
- Secondary Outcome Measures
Name Time Method Lipid Profile and Quality of Life will be assessed 6 Week
Related Research Topics
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Trial Locations
- Locations (1)
Ayurvedic and Unani Tibbia College and Hospital
🇮🇳Delhi, DELHI, India
Ayurvedic and Unani Tibbia College and Hospital🇮🇳Delhi, DELHI, IndiaDr Saema KhanamPrincipal investigator9625973500drsaemakhanam@gmail.com