Evaluate the Effect of Haridradighanvati in Combination with Standard Care Protocol for Managing Hypothyroidism

An open-label randomized prospective active-controlled clinical study to evaluate the add-on effect of Haridradighanvati along with standard care protocol in the management of hypothyroidism - nill

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086117

Enrollment

Registered

2025-05-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Eligibility

Inclusion criteria

Inclusion criteria: Patients already diagnosed as hypothyroidism with or without medication as well as newly diagnosed. Patients fulfilling the criteria of diagnosis according to Billewicz diagnostic index of hypothyroidism.

Exclusion criteria

Exclusion criteria: Patients who have undergone any type of thyroid surgery. Patients suffering from systemic diseases like IHD, PCOD, Diabetes Mellitus, and uncontrolled HTN. Immune-compromised diseases like HIV etc. Patients suffering from congenital and secondary Hypothyroidism. Pregnant and lactating women.

Design outcomes

Primary

Measure	Time frame
Improvement in Serum Thyroid Profile Parameters: TSH (Thyroid Stimulating Hormone) T3 (Triiodothyronine) T4 (Thyroxine) Measured at baseline, mid-point (optional), and end of study. Reduction in Clinical Symptoms of Hypothyroidism: Assessed using the Billewicz Diagnostic Index This includes symptoms like weight gain, fatigue, dry skin, cold intolerance, etc. Timepoint: BT- 0th Day (Baseline) DT- 4th and 8th week AT- 12th week (End)	—

Measure

Time frame

Improvement in Serum Thyroid Profile Parameters: TSH (Thyroid Stimulating Hormone) T3 (Triiodothyronine) T4 (Thyroxine) Measured at baseline, mid-point (optional), and end of study. Reduction in Clinical Symptoms of Hypothyroidism: Assessed using the Billewicz Diagnostic Index This includes symptoms like weight gain, fatigue, dry skin, cold intolerance, etc. Timepoint: BT- 0th Day (Baseline) DT- 4th and 8th week AT- 12th week (End)

—

Secondary

Measure	Time frame
Improvement in Lipid Profile Parameters: Total Cholesterol LDL HDL TriglyceridesTimepoint: BT- 0th Day (Baseline) DT- 4th & 8th week AT- 12th week (End)	—

Countries

India

Contacts

Public ContactDr Palak Parmar

Parul Institute of Ayurved and Research, Parul University, Vadodara, Gujrat

drnareshkore46@gmail.com9096082950

Outcome results