Thyroid NodulePhase 4ESPTTNNCT06423235
Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules
A Phase 4 study testing regular dose of JiRui® Prunella oral liquid and 2x regular dose of JiRui® Prunella oral liquid in people with Thyroid Nodule, run by Xintian Pharmaceutical at 22 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- regular dose of JiRui® Prunella oral liquid and 2x regular dose of JiRui® Prunella oral liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 22 sitesChina
- Study dates
- 30 Jul 2024to 30 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 dominant nodules in multiple nodules (the largest diameter of the second largest nodules does not exceed 50% of the largest nodules), 2) solid nodules, 3) the longest diameter of nodules ≥1cm and < 3cm, 4) C-TIRADS 3~4A nodules;
- 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 normal;
- Meet the diagnostic criteria of thyroid nodules in TCM;
- Sign the informed consent.
Who cannot join
- Exclude the patients with Deficiency of Yang syndrome, and the following two conditions can be diagnosed: Shortness of breath, abdominal pain and diarrhea, diarrhea with undigested food, Insufficiency with chills, exhaustion and lethargy, pale tongue and white fur, deep and weak pulse
- Those who have reproductive needs during pregnancy, lactation and within the last 12 months;
- Patients with high possibility of thyroid cancer indicated by ultrasonic signs and malignant confirmed by fine needle biopsy;
- Patients who meet the indications for thyroid nodule surgery, such as local compression symptoms obviously related to the nodule, the tumor is located behind the sternum or in the mediastinum, or strongly require surgery due to appearance or ideological concerns affecting normal life;
- Patients who have taken prunella preparations or other similar Chinese medicines to treat the disease within the past 1 month; Patients using glucocorticoids in the last 3 months;
- Patients who have had or plan to take thyroid hormone, iodine compound, or antithyroid drug therapy during the study period;
Show all 12Show fewer
- Patients who have previously or plan to undergo ablation, neck radiation, surgery and other non-drug treatments during the study period;
- Patients with parathyroid tumor (PTA), medullary thyroid cancer (MTC) or other malignant tumors, or patients with serious cardiovascular disease, liver and kidney disease, osteoporosis, or patients with a history of mental illness;
- Patients with a family history of thyroid cancer or thyroid cancer syndrome;
- Laboratory test index ALT, AST > 1.5 times the upper limit of reference value or blood creatinine (Scr) > the upper limit of reference value;
- Persons who are known to be allergic to the investigational drug or its ingredients;
- Other patients determined by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites, 22 recruiting
- Recruiting
Second Hospital of Army Military Medical University
Chongqing, Chongqing Municipality
Hongting Zheng
- Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning
- Recruiting
People's Hospital of Guangdong Province
Guangzhou, Guangdong
（020）83827812
Haixia Guan
- Recruiting
Zhejiang Province Hospital of Integrated Chinese and Western Medicine
Hangzhou, Zhejiang
Xin Mu
- Recruiting
First People's Hospital of Yunnan Province
Kunming, Yunnan
Heng Su
- Recruiting
The First Hospital of Kunming Medical University
Kunming, Yunnan
0871-65324888
Yushan Xu
- Recruiting
Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Nanjing, Jiangsu
Chao Liu
- Recruiting
The First Hospital of Qingdao University
Qingdao, Shandong
Jie Zhu
Yangang Wang
- Recruiting
Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
02163864050-510905
Dongjie Shen
- Recruiting
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality
Shen Qu
- Recruiting
Shanghai First People's Hospital
Shanghai, Shanghai Municipality
Yongde Peng
- Recruiting
Shanghai Pudong Zhoupu Hospital
Shanghai, Shanghai Municipality
Jin'an Zhang
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 200032
Yuqing Li, +86 15140139773
Zhongyan Shan
- Recruiting
Hospital of Liaoning University of Chinese Medicine
Shenyang, Liaoning
82961387
Tianshu Gao
- Recruiting
People's Hospital of Liaoning Province
Shenyang, Liaoning
024-24016001
Binhong Wen
- Recruiting
Shenzhen Hospital of Peking University
Shenzhen, Guangdong
Fan Zhang
- Recruiting
Shunde Hospital of Southern Medical University
Shunde, Guangdong
0757-22318000
Jie Shen
- Recruiting
Weifang People's Hospital
Weifang, Shandong
963360
Haixia Liu
- Recruiting
Weihai Hospital
Weihai, Shandong
0631-5287120
Yachao Yang
- Recruiting
Wuhan First Hospital
Wuhan, Hubei
Mingsong Gao
- Recruiting
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian
Tianchi Hu
- Recruiting
Xuzhou Medical University Hospital
Xuzhou, Jiangsu
Hongwei Lin
About this study
Official title: Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules: a Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study
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:
Read more
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.
- Conditions
- Thyroid Nodule
- Being tested
- regular dose of JiRui® Prunella oral liquid, 2x regular dose of JiRui® Prunella oral liquid, regular dose of placebo, 2x regular dose of placebo
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular dose of JiRui® Prunella oral liquidDrug
Take 10ml twice a day
2x regular dose of JiRui® Prunella oral liquidDrug
Take 20ml twice a day
regular dose of placeboDrug
Take 10ml twice a day
2x regular dose of placeboDrug
Take 20ml twice a day
| Study group | Role | What they receive |
|---|---|---|
| placebo regular dose group | Placebo comparator | Not described Receives: Drug: regular dose of placebo |
| placebo 2x regular dose group | Placebo comparator | Not described Receives: Drug: 2x regular dose of placebo |
| regular dose group of Prunella oral liquid group | Active comparator | Not described Receives: Drug: regular dose of JiRui® Prunella oral liquid |
| 2x regular dose group of Prunella oral liquid group | Active comparator | Not described Receives: Drug: 2x regular dose of JiRui® Prunella oral liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in thyroid nodule volume from baseline at 9 months of treatment.
Measured: 270 ± 14 days
Secondary outcomes (40)
Rate of change in thyroid nodule volume from baseline at 3 months of treatment.
Measured: 90 ± 7 days.
Rate of change in thyroid nodule volume from baseline at 6 months of treatment.
Measured: 180 ± 10 days.
Rate of change in thyroid nodule volume from baseline at 12 months of treatment.
Measured: 360 ± 14 days.
The change value of the maximum diameter of thyroid nodules from baseline at 3 months of treatment.
Measured: 90 ± 7 days
The change value of the maximum diameter of thyroid nodules from baseline at 6 months of treatment.
Measured: 180 ± 10 days
The change value of the maximum diameter of thyroid nodules from baseline at 9 months of treatment.
Measured: 270 ± 14 days
The change value of the maximum diameter of thyroid nodules from baseline at 12 months of treatment.
Measured: 360 ± 14 days
Proportion of patients with reduced thyroid nodule volume from baseline at 3 months of treatment.
Measured: 90 ± 7 days
Proportion of patients with reduced thyroid nodule volume from baseline at 6 months of treatment.
Measured: 180 ± 10 days
Proportion of patients with reduced thyroid nodule volume from baseline at 9 months of treatment.
Measured: 270 ± 14 days
Proportion of patients with reduced thyroid nodule volume from baseline at 12 months of treatment.
Measured: 360 ± 14 days
Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 3 months of treatment.
Measured: 90 ± 7 days
The proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 6 months of treatment.
Measured: 180 ± 10 days
Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 9 months of treatment.
Measured: 270 ± 14 days
Proportion of patients with reduced thyroid nodule volume ≥50% from baseline at 12 months of treatment.
Measured: 360 ± 14 days
Changes in the number of thyroid nodules from baseline at the 3 months of treatment.
Measured: 90 ± 7 days
Changes in the number of thyroid nodules from baseline at the 6 months of treatment.
Measured: 180 ± 10 days
Changes in the number of thyroid nodules from baseline at the 9 months of treatment.
Measured: 270 ± 14 days
Changes in the number of thyroid nodules from baseline at the 12 months of treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 360 ± 14 days
Rate of change in thyroid volume from baseline at 3 months of treatment.
Measured: 90 ± 7 days
Rate of change in thyroid volume from baseline at 6 months of treatment.
Measured: 180 ± 10 days
Rate of change in thyroid volume from baseline at 9 months of treatment.
Measured: 270 ± 14 days
Rate of change in thyroid volume from baseline at 12 months of treatment.
Measured: 360 ± 14 days
Changes in serum TSH, FT3 and FT4 from baseline at the months of treatment.
Measured: 90 ± 7 days
Changes in serum TSH, FT3 and FT4 from baseline at the months of treatment.
Measured: 180 ± 10 days
Changes in serum TSH, FT3 and FT4 from baseline at 9 months of treatment.
Measured: 270 ± 14 days
Changes in serum TSH, FT3 and FT4 from baseline at 12 months of treatment.
Measured: 360 ± 14 days
Changes in Tg, TgAb and TPOAb levels from baseline at the 6th month of treatment.
Measured: 180 ± 10 days
Proportion of patients with normal thyroid function at 3 months of treatment.
Measured: 90 ± 7 days
Proportion of patients with normal thyroid function at 6 months of treatment.
Measured: 180 ± 10 days
Proportion of patients with normal thyroid function at 9 months of treatment.
Measured: 270 ± 14 days
Proportion of patients with normal thyroid function at 12 months of treatment.
Measured: 360 ± 14 days
Subjects' quality of life scores (SF-36) at 3 months of treatment.
Measured: 90 ± 7 days
Subjects' quality of life scores (SF-36) at 6 months of treatment.
Measured: 180 ± 10 days
Subjects' quality of life scores (SF-36) at 9 months of treatment.
Measured: 270 ± 14 days
Subjects' quality of life scores (SF-36) at 12 months of treatment.
Measured: 360 ± 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start30 Jul 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xintian Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423235
- Sponsor's protocol ID
- XK-22-A-002-YJ-002
- Acronym
- ESPTTN
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules: a Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06423235
- Acronym / sponsor ID
- ESPTTN / XK-22-A-002-YJ-002
- Conditions
- Thyroid Nodule
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Xintian PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo regular dose group | Placebo comparator | Drug: regular dose of placebo |
| placebo 2x regular dose group | Placebo comparator | Drug: 2x regular dose of placebo |
| regular dose group of Prunella oral liquid group | Active comparator | Drug: regular dose of JiRui® Prunella oral liquid |
| 2x regular dose group of Prunella oral liquid group | Active comparator | Drug: 2x regular dose of JiRui® Prunella oral liquid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 dominant nodules in multiple nodules (the largest diameter of the second largest nodules does not exceed 50% of the largest nodules), 2) solid nodules, 3) the longest diameter of nodules ≥1cm and < 3cm, 4) C-TIRADS 3~4A nodules;
- 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 normal;
- Meet the diagnostic criteria of thyroid nodules in TCM;
Key exclusion criteria (12 listed)
- Exclude the patients with Deficiency of Yang syndrome, and the following two conditions can be diagnosed: Shortness of breath, abdominal pain and diarrhea, diarrhea with undigested food, Insufficiency with chills, exhaustion and lethargy, pale tongue and white fur, deep and weak pulse
- Those who have reproductive needs during pregnancy, lactation and within the last 12 months;
- Patients with high possibility of thyroid cancer indicated by ultrasonic signs and malignant confirmed by fine needle biopsy;
- Patients who meet the indications for thyroid nodule surgery, such as local compression symptoms obviously related to the nodule, the tumor is located behind the sternum or in the mediastinum, or strongly require surgery due to appearance or ideological concerns affecting normal life;
- Patients who have taken prunella preparations or other similar Chinese medicines to treat the disease within the past 1 month; Patients using glucocorticoids in the last 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regular dose of JiRui® Prunella oral liquidTake 10ml twice a day | Drug | regular dose group of Prunella oral liquid group |
| 2x regular dose of JiRui® Prunella oral liquidTake 20ml twice a day | Drug | 2x regular dose group of Prunella oral liquid group |
| regular dose of placeboTake 10ml twice a day | Drug | placebo regular dose group |
| 2x regular dose of placeboTake 20ml twice a day | Drug | placebo 2x regular dose group |
Primary outcome
Rate of change in thyroid nodule volume from baseline at 9 months of treatment.
Time frame: 270 ± 14 days
40 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
Related trials for Thyroid Nodule
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
Recruiting
Thyroid Artery Embolization for the Treatment of Compressive Goiters.
Thyroid Nodules
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
Recruiting
Radiofrequency Ablation Study in LatinX Patients
Thyroid Nodule
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing regular dose of JiRui® Prunella oral liquid and 2x regular dose of JiRui® Prunella oral liquid in people with Thyroid Nodule, run by Xintian Pharmaceutical at 22 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjing Ji (+86 18365572279, yx-jiwj@xtyyoa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in thyroid nodule volume from baseline at 9 months of treatment. (time frame: 270 ± 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.