To Evaluate the Efficacy and Safety of thyroid capsule in the Management of Subclinical Hypothyroidism- An Open Label Clinical Studyâ??

To evaluate the efficacy and safety of HTYR091524 capsule in the management of Subclinical Hypothyroidism- An Open Label Clinical Study

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/12/022481

Enrollment

Registered

2019-12-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E02- Subclinical iodine-deficiency hypothyroidism

Interventions

Intervention1: Thyroid Regulator: HTYR091524 is a capsule given twice daily orally to subjects for Management of Subclinical Hypothyroidism. single arm study. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Subjects of both sex aged >= 18 years to Subjects untreated with Subclinical hypothyroidism SH defined as persistently elevated TSH levels between >=4.5 - Subjects presenting with one or more of the following clinical symptoms such as anxiety weakness fatigue sleepiness cold intolerance hoarseness of voice hair loss constipation joint pains and muscle cramps depression menorrhagia infertility weight gain Subjects willing to give written informed consent. Subjects who have not participated in similar kind of study in last 2 months

Exclusion criteria

Exclusion criteria: Subjects current on levothyroxine anti thyroid drugs amiodarone or lithium Subjects with any clinically significant systemic illnesses including any chronic untreated gastrointestinal disorder Grade IV NYHA Heart failure Hospitalization for major illnesses elective surgery or acute coronary syndrome MI or unstable angina within 4 weeks Acute Myocarditis Clinical diagnosis of dementia Untreated adrenal insufficiency Pregnant & lactating women are excluded Subjects not willing to sign informed consent form

Design outcomes

Primary

Measure	Time frame
Evaluate the Efficacy and safety of Thyroid regulator in individuals suffering from Subclinical HypothyroidismTimepoint: At entry. End of 1st month End of 2nd month and end of 3rd month EOS.	—

Secondary

Measure	Time frame
Compliance of the subject to the intervention and assessment of adverse effects reported or observed during the study period.Timepoint: At entry visit. End of 1st month. End of 2nd month and End of 3rd month EOS.	—

Countries

India

Contacts

Public ContactDr Srikrishna H A

The Himalaya Drug Company

dr.palani@himalayawellness.com9686681830

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026