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

Study Timeline

• Last Update Posted: 2022-01-04
• Study Start: 2022-11-04

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

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

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