A Clinical Study On Subclinical Hypothyroidism and its Management with An Extract of Jawarish e Bisbasa Formulation- A Randomized Double-Blind Placebo Controlled Clinical Trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- TSH, cold intolerance, tiredness, constipation will be assessed
Study Overview
Brief Summary
Diagnosed cases of subclinical hypothyroidism who fulfill the inclusion criteria, will be enrolled in the study after making them understand about the study and taking their informed written consent. Patients will be allocated into two groups, 20 in test group & in control group respectively by using "block randomization" method. Test group will be subjected to 1 capsule (500 mg each) of extract of jawarish e bisbasa formulation twice a day orally. Blinding would be done by the pharmacist and distribution of drug will be as per the block randomization method. Patients would be followed up on 7th, 15th, 30th and 42nd day and clinically evaluated on assessment parameters. The data for both the groups will be statistically analyzed and compared with each other using appropriate statistical tests. The safety of the test drug will be ensured by monitoring the Haemogram with ESR and serological indicators for kidney and liver. Any unwanted effect of the drug during study will be noticed carefully.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified block randomization
- Masking
- Double Blind Double Dummy
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed cases of subclinical hypothyroidism, patients willing to participate and sign the understood and informed consent form.
Exclusion Criteria
- •Pregnant and lactating women, renal and hepatic sufficiency, malignancy, patient unwilling to sign the informed consent form, patient taking hormonal therapy.
Outcomes
Primary Outcomes
TSH, cold intolerance, tiredness, constipation will be assessed
Time Frame: 6 weeks
Secondary Outcomes
- To assess lipid profile(6 weeks)