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A clinical study on primary hypothyroidism and its treatment with a Unani drug.

Phase 2
Not yet recruiting
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
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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
NameTimeMethod
TSH, Free T3 & T46 Week
Tiredness6 Week
Loss of appetite6 Week
Cold intolerance6 Week
Constipation6 Week
Sleep6 Week
will be assessed.6 Week
Secondary Outcome Measures
NameTimeMethod
Lipid Profile and Quality of Life will be assessed6 Week

Trial Locations

Locations (1)

Ayurvedic and Unani Tibbia College and Hospital

🇮🇳

Delhi, DELHI, India

Ayurvedic and Unani Tibbia College and Hospital
🇮🇳Delhi, DELHI, India
Dr Saema Khanam
Principal investigator
9625973500
drsaemakhanam@gmail.com

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