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

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, 234 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

Trial Details

NCT ID
NCT06423235
Phase
PHASE4
Sponsor
Xintian Pharmaceutical
Status
RECRUITING
Cancer Type
Thyroid Cancer
Interventions
  • regular dose of JiRui® Prunella oral liquid
  • 2x regular dose of JiRui® Prunella oral liquid
  • regular dose of placebo
  • 2x regular dose of placebo
Locations (sample)
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Xiamen, Fujian, China|24.47979,118.08187
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Shenzhen, Guangdong, China|22.54554,114.0683
  • Shunde, Guangdong, China|22.84067,113.2503

Key Eligibility Criteria

  • 18 years old ≤65 years old;
  • Thyroid ultrasonography found thyroid nodules, may be accompanied by goiter, and the nodules meet the following conditions: 1) single nodules, or d…
  • Patients who met the puncture indications were confirmed by fine needle aspiration biopsy (FNAB) as benign nodules (Bethesda Class II);
  • Serum TSH, free thyroid hormone (FT3, FT4) levels were normal, anti-thyroglobulin (TgAb) and anti-thyroid peroxidase (TPOAb) antibody titers were n…

For full eligibility, visit ClinicalTrials.gov.

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