Efficacy & Safety of Prunella Oral Liquid in the Treatment of Thyroid

Status Not yet recruiting

Clinical Trial Summary

A multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of Prunella oral liquid in patients with benign thyroid nodules, which belongs to the post-marketing reevaluation clinical study. In this study, 426 subjects will be enrolled by competitive enrollment at several research centers across China. The main inclusion criteria are: ① Thyroid ultrasound examination found thyroid nodules, can be accompanied by goiter, and the nodules meet the following conditions: 1) There were dominant nodules in single or multiple nodules (the largest diameter of the second largest nodules was not more than 50% of the largest nodules), 2) solid nodules, 3) the longest diameter of nodules was ≥1cm and < 3cm, 4) C-TIRADS 3~4A nodules. ② Patients who met the puncture indication were confirmed by fine needle aspiration biopsy (FNAB) as benign nodules (Bethesda II). ③ Levels of TSH, FT3 and FT4 were normal, and the antibody titers of TgAb and TPOAb were normal. Eligible subjects will be randomly assigned on a 1:1:2:2 scale to: Group A (placebo conventional dose group, 10 mL/times, 2 times/day), group B (placebo 2x dose group, 10ml/times, 2 times/day), group C (conventional dose group of Prunella oral liquid), group D (Prunella oral liquid 2x dose group). All subjects will receive the treatment for 9 months and follow up at 3rd, 6th, 9th and 12th month. The primary efficacy endpoint of this study was the rate of change in thyroid nodule volume from baseline at 6 months of treatment. The rate of change in thyroid nodule volume from baseline at 3 and 9 months of treatment was a secondary efficacy endpoint. Other secondary efficacy endpoints included maximum thyroid nodule diameter, number of thyroid nodules, proportion of patients with reduced thyroid nodule volume or ≥50% from baseline, thyroid volume, thyroid function (serum TSH, FT3, FT4, thyroid egg levels (Tg), thyroid antibody levels (TgAb, TPOAb), quality of life evaluation (SF-36), etc. Safety endpoints included incidence of AE/ serious adverse events (SAE), causality, and outcomes. Incidence of AE/SAE leading to discontinuation. Changes in safety laboratory test values from baseline.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06423235
Study type	Interventional
Source	Xintian Pharmaceutical
Contact	Wenjing Ji
Phone	+86 18365572279
Email	yx-jiwj@xtyyoa.com
Status	Not yet recruiting
Phase	Phase 4
Start date	July 30, 2024
Completion date	July 30, 2028

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules — ESPTTN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms