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

Phase 2

Active, not recruiting

Lead Sponsor: Apex Laboratories Private Limited Research and Development Centre

Brief Summary: This is A Double Blind, Randomized, and Placebo Controlled Clinical Study to Evaluate Efficacy and Safety of TFN34 tablets in Individuals with subclinical & clinical hypothyroidism.

Subjects who have qualified screening and are willing to participate in the study will be called for the study.

This will be a double blind placebo controlled study.

In this study, 60 subjects randomized to two groups in 1:1 ratio, who fulfill the inclusion criteria, will be selected.

As per computer generated randomization sequence, all the subjects will be advised to take 2 tablets of TFN34 tablets or Placebo twice daily before food for a period of 6 months.

Allocations will be concealed using sealed envelopes.

Outcome assessor is not blinded as only investigators and subjects are blinded in a double blind study.

Dosage: 2 tablets of TFN34 Tablets or similar looking Placebo twice daily before food.

Recruitment & Eligibility

Inclusion Criteria

Subjects with TSH Value greater than or equal to 4.5 ï‚· 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.
ï‚· Subjects willing to sign informed consent and follow the study procedure.
ï‚· 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.
ï‚· 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.

Primary Outcome Measures

Name	Time	Method
Clinical improvement in the overall health as assessed by clinical examination of signs and	Clinical improvement in the overall health as assessed by clinical examination of signs and \| symptoms in 6 months
symptoms such as Fatigue, cold intolerance, Puffiness of face, Hoarseness, Muscle weakness,	Clinical improvement in the overall health as assessed by clinical examination of signs and \| symptoms in 6 months
Hair loss, Slowed heart rate, Depression, Irritability, Impaired memory and the points	Clinical improvement in the overall health as assessed by clinical examination of signs and \| symptoms in 6 months
mentioned in questionnaire.	Clinical improvement in the overall health as assessed by clinical examination of signs and \| symptoms in 6 months
ï‚· Blood levels of FT3 levels, FT4 levels, TSH, T3 levels, T4 levels	Clinical improvement in the overall health as assessed by clinical examination of signs and \| symptoms in 6 months

Secondary Outcome Measures

Name	Time	Method
Incidence to identify the AE and compliance to the study	Incidence to identify the AE and compliance to the study in between 6 months

Locations (1): SRM Medical College Hospital and Research Centre general medicine OPD ayurveda OPD
🇮🇳
Kancheepuram, TAMIL NADU, India
SRM Medical College Hospital and Research Centre general medicine OPD ayurveda OPD
🇮🇳Kancheepuram, TAMIL NADU, India
DR S N MEENAKSHI SUNDARI
Principal investigator
9444249933
dr.meenakshisundari@gmail.com