RecruitingNCT06423235ESPTTNUpdated Mar 24, 2026

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

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

Phase: Phase 4
Study type: Interventional
Enrollment: 234
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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, 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.

Conditions studied

Thyroid Nodule

Browse trials for

Thyroid Nodule 199

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion 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 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.

Exclusion criteria

Exclusion Criteria:

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;
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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 234 participants (estimated)

Study arms

Placebo comparator
placebo regular dose group
Drug: regular dose of placebo
Placebo comparator
placebo 2x regular dose group
Drug: 2x regular dose of placebo
Active comparator
regular dose group of Prunella oral liquid group
Drug: regular dose of JiRui® Prunella oral liquid
Active comparator
2x regular dose group of Prunella oral liquid group
Drug: 2x regular dose of JiRui® Prunella oral liquid

Interventions

Drugregular dose of JiRui® Prunella oral liquid
Take 10ml twice a day
Drug2x regular dose of JiRui® Prunella oral liquid
Take 20ml twice a day
Drugregular dose of placebo
Take 10ml twice a day
Drug2x regular dose of placebo
Take 20ml twice a day

What researchers measure

Primary outcomes

Rate of change in thyroid nodule volume from baseline at 9 months of treatment.
Time frame: 270 ± 14 days

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

Study locations

22 of 22 sites recruiting

Second Hospital of Army Military Medical University
Chongqing, Chongqing Municipality, China
- Hongting Zheng · Sub investigator
Recruiting
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
- Tianchi Hu · Sub investigator
Recruiting
People's Hospital of Guangdong Province
Guangzhou, Guangdong, China
- · Contact · （020）83827812
- Haixia Guan · Sub investigator
Recruiting
Shenzhen Hospital of Peking University
Shenzhen, Guangdong, China
- Fan Zhang · Sub investigator
Recruiting
Shunde Hospital of Southern Medical University
Shunde, Guangdong, China
- · Contact · 0757-22318000
- Jie Shen · Sub investigator
Recruiting
Wuhan First Hospital
Wuhan, Hubei, China
- Mingsong Gao · Sub investigator
Recruiting
Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Nanjing, Jiangsu, China
- Chao Liu · Sub investigator
Recruiting
Xuzhou Medical University Hospital
Xuzhou, Jiangsu, China
- Hongwei Lin · Sub investigator
Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning 200032, China
- Yuqing Li · Contact · +86 15140139773
- Zhongyan Shan · Principal investigator
Recruiting
Hospital of Liaoning University of Chinese Medicine
Shenyang, Liaoning, China
- · Contact · 82961387
- Tianshu Gao · Sub investigator
Recruiting
People's Hospital of Liaoning Province
Shenyang, Liaoning, China
- · Contact · 024-24016001
- Binhong Wen · Sub investigator
Recruiting
The First Hospital of Qingdao University
Qingdao, Shandong, China
- Jie Zhu · Contact
- Yangang Wang · Principal investigator
Recruiting
Weifang People's Hospital
Weifang, Shandong, China
- · Contact · 963360
- Haixia Liu · Sub investigator
Recruiting
Weihai Hospital
Weihai, Shandong, China
- · Contact · 0631-5287120
- Yachao Yang · Sub investigator
Recruiting
Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
- · Contact · 02163864050-510905
- Dongjie Shen · Sub investigator
Recruiting
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China
- Shen Qu · Sub investigator
Recruiting
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
- Yongde Peng · Sub investigator
Recruiting
Shanghai Pudong Zhoupu Hospital
Shanghai, Shanghai Municipality, China
- Jin'an Zhang · Sub investigator
Recruiting
First People's Hospital of Yunnan Province
Kunming, Yunnan, China
- Heng Su · Sub investigator
Recruiting
The First Hospital of Kunming Medical University
Kunming, Yunnan, China
- · Contact · 0871-65324888
- Yushan Xu · Sub investigator
Recruiting
Zhejiang Province Hospital of Integrated Chinese and Western Medicine
Hangzhou, Zhejiang, China
- Xin Mu · Sub investigator
Recruiting

Registry details

Key details

Study ID: NCT06423235
Lead sponsor: Xintian Pharmaceutical
Responsible party: Sponsor
First posted: May 21, 2024
Start date: Jul 30, 2024
Primary completion: Jul 30, 2025
Completion: Jul 30, 2028 (estimated)
Last update: Mar 24, 2026

Study contacts

Wenjing Ji

Contact

yx-jiwj@xtyyoa.com

+86 18365572279

Biao Chen

Contact

ht-cb@xtyyoa.com

+86 13915637727

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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