To develop a unani medicine for the treatment of subclinical hypothyroidism

Phase 2

Not yet recruiting

Conditions: Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: DHATUVAISHAMYAM,

Registration Number: CTRI/2021/06/034158

Lead Sponsor: Ayurvedic and Unani Tibbia College and Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TSH, cold intolerance, tiredness, constipation will be assessed	6 weeks

Secondary Outcome Measures

Name	Time	Method
To assess lipid profile	6 weeks

Trial Locations

Locations (1): Ayurvedic and unani Tibbia college and Hospital
🇮🇳
Central, DELHI, India
Ayurvedic and unani Tibbia college and Hospital
🇮🇳Central, DELHI, India
Dr Irshad
Principal investigator
7011724763
Irshadfaiz23@gmail.com