Actively Recruiting
Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules: a Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study
Led by Xintian Pharmaceutical · Updated on 2026-03-24
234
Participants Needed
22
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Prunella oral liquid in adults with benign thyroid nodules. This phase 4, multicenter, randomized, double-blind, placebo-controlled trial aims to provide post-marketing reevaluation data on this treatment. Eligible participants have thyroid nodules confirmed benign by biopsy and normal thyroid hormone and antibody levels. The study includes 234 subjects recruited across multiple centers in China and focuses on changes in nodule volume and related health measures over time. Participants are randomly assigned to one of four groups receiving either a regular or double dose of Prunella oral liquid or a matching placebo at the same doses. Treatment lasts for 9 months, with follow-up visits scheduled at 3, 6, 9, and 12 months. Dosing is oral, twice daily, and the study includes monitoring for treatment effects and safety measures. During the study, participants undergo thyroid ultrasound examinations and blood tests to assess nodule size, thyroid function, antibody levels, and quality of life through questionnaires. Researchers track changes in nodule volume and diameter as primary and secondary outcomes, along with safety assessments such as adverse event monitoring and laboratory tests. The total participation duration spans up to 12 months, with thorough evaluations at specified intervals to understand treatment impact and safety.
CONDITIONS
Brief Title
Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old
- Thyroid ultrasound shows single or dominant solid nodules between 1 cm and less than 3 cm
- Nodules classified as C-TIRADS 3 to 4A
- Benign nodules confirmed by fine needle aspiration biopsy (Bethesda Class II)
- Normal serum TSH, free thyroid hormones (FT3, FT4), and normal thyroid antibody levels (TgAb, TPOAb)
- Meet traditional Chinese medicine diagnostic criteria for thyroid nodules
- Signed informed consent
You will not qualify if you...
- Diagnosis of Yang deficiency syndrome with symptoms like shortness of breath, abdominal pain, diarrhea, chills, exhaustion, pale tongue, and weak pulse
- Pregnant, lactating, or planning pregnancy within the next 12 months
- Signs of suspected thyroid cancer or confirmed malignancy by biopsy
- Indications for thyroid nodule surgery such as significant local symptoms or tumor location
- Use of prunella or similar Chinese medicines within the past month
- Use of glucocorticoids within the last 3 months
- Planned or previous thyroid hormone, iodine, antithyroid drug, ablation, neck radiation, or surgery treatments during the study period
- History of parathyroid tumor, medullary thyroid cancer, other malignancies, serious cardiovascular, liver, kidney disease, osteoporosis, or mental illness
- Family history of thyroid cancer or thyroid cancer syndrome
- Elevated liver enzymes or blood creatinine beyond specified limits
- Known allergy to the investigational drug or its ingredients
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants take Prunella oral liquid or placebo twice daily to treat thyroid nodules.
Visits at approximately 3, 6, 9, and 12 months during treatment
Trial Site Locations
Total: 22 locations
1
Second Hospital of Army Military Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
2
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
Actively Recruiting
3
People's Hospital of Guangdong Province
Guangzhou, Guangdong, China
Actively Recruiting
4
Shenzhen Hospital of Peking University
Shenzhen, Guangdong, China
Actively Recruiting
5
Shunde Hospital of Southern Medical University
Shunde, Guangdong, China
Actively Recruiting
6
Wuhan First Hospital
Wuhan, Hubei, China
Actively Recruiting
7
Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Nanjing, Jiangsu, China
Actively Recruiting
8
Xuzhou Medical University Hospital
Xuzhou, Jiangsu, China
Actively Recruiting
9
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Actively Recruiting
10
The First Hospital of China Medical University
Shenyang, Liaoning, China, 200032
Actively Recruiting
11
Hospital of Liaoning University of Chinese Medicine
Shenyang, Liaoning, China
Actively Recruiting
12
People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Actively Recruiting
13
The First Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
14
Weifang People's Hospital
Weifang, Shandong, China
Actively Recruiting
15
Weihai Hospital
Weihai, Shandong, China
Actively Recruiting
16
Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
17
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
18
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
19
Shanghai Pudong Zhoupu Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
20
First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Actively Recruiting
21
The First Hospital of Kunming Medical University
Kunming, Yunnan, China
Actively Recruiting
22
Zhejiang Province Hospital of Integrated Chinese and Western Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
W
Wenjing Ji
B
Biao Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here