Effect of Unani drug on thyroid disease

Phase 2

Not yet recruiting

• Conditions: Subclinical iodine-deficiency hypothyroidism,

• Registration Number: CTRI/2022/05/042682
• Lead Sponsor: NATIONAL INSTITUTE OF UNANI MEDICINE

Brief Summary

Subjects will bescreened clinically followed by laboratory investigation, whoever fulfillingthe inclusion criteria will be enrolled into study after obtaining writteninformed consent, accordingly they will be randomly allocated into two groups,Test group and Control group (n = 15 each). The patients will be blinded forthe study. Subjects in test group will be given *Jadwar* in capsule form2gm/day in two divided doses, and thecontrol group will be given identical dose of placebo. Both intervention usedorally for the duration of 56 days. The study outcome will be assessed as thedifference from the subjective and objective parameters measured at basline and56th day.

The subjectiveparameters like Fatigue, Constipation and weight gain will assessed in eachfollow up on 14th day, whilst objective parameter TSH and fT4 will be assessedon baseline and end of the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-06
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients between 20-60 years of age of either gender.
• Cases with TSH level between 5.5 and 15 mIU/L & Serum free thyroxine (fT4) level within normal range.
• Ability to provide written informed consent and understand the risks and benefits of the protocol.

Exclusion Criteria

• Pregnancy and lactation.
• Complicated cases of Hypothyroidism, Diabetes, Liver Disorders, stroke, depression, or other neurologic/psychiatric disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in TSH level	56 days

Secondary Outcome Measures

Name	Time	Method
safety assessment like •AST, ALT	•KFT (Blood Urea Serum Creatinine)

Trial Locations

Locations (1)

Department of Moalajat National Institute of Unani Medicine Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Department of Moalajat National Institute of Unani Medicine Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Sayed Mohammed Saadudheen KP

Principal investigator

9526737777

saadbinsayyid@gmail.com