Health Condition 1: E02- Subclinical iodine-deficiency hypothyroidism
Conditions
Interventions
Intervention1: TNF34 TABLETS: 2 tablets should be taken in the morning and night before food orally for 6 months duration.
tablet contains polyherbal formulations
Control Intervention1: ELTROXIN: ELTR
Sponsors
Apex Laboratories Private Limited Research and Development Centre
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with TSH Value greater than or equal to 4.5 ïâ??· 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. ïâ??· Subjects willing to sign informed consent and follow the study procedure. ïâ??· Has not participated in a similar investigation in the past four weeks.
Exclusion criteria
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. ïâ??· 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement in the overall health as assessed by clinical examination of signs and symptoms such as Fatigue, cold intolerance, Puffiness of face, Hoarseness, Muscle weakness, Hair loss, Slowed heart rate, Depression, Irritability, Impaired memory and the points mentioned in questionnaire. ïâ??· Blood levels of FT3 levels, FT4 levels, TSH, T3 levels, T4 levelsTimepoint: Clinical improvement in the overall health as assessed by clinical examination of signs and symptoms in 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence to identify the AE and compliance to the studyTimepoint: Incidence to identify the AE and compliance to the study in between 6 months | — |
Countries
India
Contacts
Public ContactBMothishwaran
SRM Medical College Hospital and Research Centre
Outcome results
None listed