A Phase 4 interventional study of regular dose of JiRui® Prunella oral liquid and 2x regular dose of JiRui® Prunella oral liquid in Thyroid Nodule, sponsored by Xintian Pharmaceutical. Recruiting at 22 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Xintian Pharmaceutical · Phase 4, Interventional, and Treatment
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 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 9 months of treatment. The rate of change in thyroid nodule volume from baseline at 3 and 6 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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's planned enrollment of 234 is above the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Xintian Pharmaceutical is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: regular dose of placebo
Drug: 2x regular dose of placebo
Drug: regular dose of JiRui® Prunella oral liquid
Drug: 2x regular dose of JiRui® Prunella oral liquid
Take 10ml twice a day
Take 20ml twice a day
Take 10ml twice a day
Take 20ml twice a day
Rate of change in thyroid nodule volume from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
Rate of change in thyroid nodule volume from baseline at 3 months of treatment.
Time frame: 90 ± 7 days.
Rate of change in thyroid nodule volume from baseline at 6 months of treatment.
Time frame: 180 ± 10 days.
Rate of change in thyroid nodule volume from baseline at 12 months of treatment.
Time frame: 360 ± 14 days.
The change value of the maximum diameter of thyroid nodules from baseline at 3 months of treatment.
Time frame: 90 ± 7 days
The change value of the maximum diameter of thyroid nodules from baseline at 6 months of treatment.
Time frame: 180 ± 10 days
The change value of the maximum diameter of thyroid nodules from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
The change value of the maximum diameter of thyroid nodules from baseline at 12 months of treatment.
Time frame: 360 ± 14 days
Proportion of patients with reduced thyroid nodule volume from baseline at 3 months of treatment.
Time frame: 90 ± 7 days
Proportion of patients with reduced thyroid nodule volume from baseline at 6 months of treatment.
Time frame: 180 ± 10 days
Proportion of patients with reduced thyroid nodule volume from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
Proportion of patients with reduced thyroid nodule volume from baseline at 12 months of treatment.
Time frame: 360 ± 14 days
Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 3 months of treatment.
Time frame: 90 ± 7 days
The proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 6 months of treatment.
Time frame: 180 ± 10 days
Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 12 months of treatment.
Time frame: 360 ± 14 days
Changes in the number of thyroid nodules from baseline at the 3 months of treatment.
Time frame: 90 ± 7 days
Changes in the number of thyroid nodules from baseline at the 6 months of treatment.
Time frame: 180 ± 10 days
Changes in the number of thyroid nodules from baseline at the 9 months of treatment.
Time frame: 270 ± 14 days
Changes in the number of thyroid nodules from baseline at the 12 months of treatment.
Time frame: 360 ± 14 days
Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 3 months of treatment.
Time frame: 90 ± 7 days
Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 6 months of treatment.
Time frame: 180 ± 10 days
Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 9 months of treatment.
Time frame: 270 ± 14 days
Proportion of patients with thyroid nodule progression (greater than 50% in volume or greater than 20% in at least 2 diameters from baseline) at 12 months of treatment.
Time frame: 360 ± 14 days
Rate of change in thyroid volume from baseline at 3 months of treatment.
Time frame: 90 ± 7 days
Rate of change in thyroid volume from baseline at 6 months of treatment.
Time frame: 180 ± 10 days
Rate of change in thyroid volume from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
Rate of change in thyroid volume from baseline at 12 months of treatment.
Time frame: 360 ± 14 days
Changes in serum TSH, FT3 and FT4 from baseline at the months of treatment.
Time frame: 90 ± 7 days
Changes in serum TSH, FT3 and FT4 from baseline at the months of treatment.
Time frame: 180 ± 10 days
Changes in serum TSH, FT3 and FT4 from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
Changes in serum TSH, FT3 and FT4 from baseline at 12 months of treatment.
Time frame: 360 ± 14 days
Changes in Tg, TgAb and TPOAb levels from baseline at the 6th month of treatment.
Time frame: 180 ± 10 days
Proportion of patients with normal thyroid function at 3 months of treatment.
Time frame: 90 ± 7 days
Proportion of patients with normal thyroid function at 6 months of treatment.
Time frame: 180 ± 10 days
Proportion of patients with normal thyroid function at 9 months of treatment.
Time frame: 270 ± 14 days
Proportion of patients with normal thyroid function at 12 months of treatment.
Time frame: 360 ± 14 days
Subjects' quality of life scores (SF-36) at 3 months of treatment.
Time frame: 90 ± 7 days
Subjects' quality of life scores (SF-36) at 6 months of treatment.
Time frame: 180 ± 10 days
Subjects' quality of life scores (SF-36) at 9 months of treatment.
Time frame: 270 ± 14 days
Subjects' quality of life scores (SF-36) at 12 months of treatment.
Time frame: 360 ± 14 days
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