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A clinical trial to study the effect of ayurvedic drug TNF34 tablets in patients with clinical and subclinical hypothyroidism

Phase 2
Conditions
Health Condition 1: E02- Subclinical iodine-deficiency hypothyroidism
Registration Number
CTRI/2022/10/046836
Lead Sponsor
Apex Laboratories Private Limited Research and Development Centre
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Subjects with TSH Value greater than or equal to 4.5

? Individual presenting with at least four of the symptoms like Fatigue, cold

intolerance, Constipation, Dry rough & pale skin, Weight gain, Puffiness of face,

Hoarseness, Muscle weakness, Muscle cramps and frequent muscle aches, Abnormal

menstrual cycle, Dry, coarse thinning of hair, Hair loss, Slowed heart rate,

Depression, Irritability, Impaired memory, Decreased libido.

? Subjects willing to sign informed consent and follow the study procedure.

? Has not participated in a similar investigation in the past four weeks.

Exclusion Criteria

Subjects currently on levothyroxine, anti-thyroid drugs, amiodarone or lithium.

Subjects with any clinically significant and uncontrolled systemic illnesses

(including Gastrointestinal, Cardiac, Neurological, Respiratory, Immunological or

endocrinological disorder) as judged by the investigator, which can hamper the

participation of subjects in clinical study.

? Hospitalization for major illnesses/ elective surgery within 4 weeks

Clinical diagnosis of any psychiatric or psychological disorders rendering the subject

not to follow the study procedures.

Pregnant or lactating women or women of child bearing potential not willing to use

the established measures of of contraception.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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