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CLINICAL TRIAL TO EVALUATE THE EFFECT OF TRIKATU IN SUBCLINICAL HYPOTHYROIDISM

RANDOMISED, PLACEBO CONTROLED, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE THE EFFECT OF TRIKATU IN SUBCLINICAL HYPOTHYROIDISM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040430
Enrollment
270
Registered
2022-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: E039- Hypothyroidism, unspecified

Interventions

None listed

Sponsors

Central Council for Research in AYurvedic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Patients of either sex with age between 18 and 60 years. b. Freshly diagnosed Patients of subclinical Hypothyroidism with elevated TSH levels between 5.5-10uIU/ml with normal T4 value. c. Patients, willing to give written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: a. TSH levels >10uIU/ml b. Patients who have undergone any type of thyroid surgery. c. Patients with uncontrolled Diabetes mellitus (HbA1C >8%). d. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.4 mg/dl) e. Patients suffering from congenital hypothyroidism and secondary hypothyroidism. f. Patients with poorly controlled hypertension ( >= 160/100 mmHg) g. Patients who are under treatment for any thyroid disorder h. Hypertensive patients who are on β blockers. i. Symptomatic patients with clinical evidence of Heart failure. j. Alcoholics and/or drug abusers. k. H/o hypersensitivity to any of the trial drugs or their ingredients. l. Pregnant/lactating woman. m. Patients who are currently enrolled in any other clinical trial. n. Any other condition which the Investigator thinks may jeopardize the study.

Design outcomes

Primary

MeasureTime frame
â?¢Change in Signs and symptoms. â?¢Reduction in TSH Timepoint: 84 days

Secondary

MeasureTime frame
LFT, RFT and adverse drug reaction for safety assessmentTimepoint: 84 days

Countries

India

Contacts

Public ContactSHASHIDHAR DODDAMANI

Central Ayurveda Research Institute

shd_ayu@yahoo.co.in

Outcome results

None listed

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