Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-04-07
Brief Title:
Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules
Sponsor:
Xintian Pharmaceutical
Organization:
Xintian Pharmaceutical
Study Overview
Official Title:
Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules a Multicenter Prospective Randomized Double-blind Placebo-controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESPTTN
Brief 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 34A 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 1122 scale to Group A placebo conventional dose group 10 mLtimes 2 timesday group B placebo 2x dose group 10mltimes 2 timesday 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 AESAE leading to discontinuation Changes in safety laboratory test values from baseline
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 34A 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 1122 scale to Group A placebo conventional dose group 10 mLtimes 2 timesday group B placebo 2x dose group 10mltimes 2 timesday 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 AESAE leading to discontinuation Changes in safety laboratory test values from baseline
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None