Acute Herpes ZosterPhase 4NCT06985589
Efficacy and Safety of Fire Needle Therapy Combined With Cortex Phellodendri Compound Fluid Wet Compress for Acute Herpes Zoster: a Randomized Controlled Trial.
A Phase 4 study testing Fire needle, Cortex Phellodendri compound fluid wet compress and basic treatment in people with Acute Herpes Zoster, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
Herpes zoster (HZ) results from a reactivation of varicella-zoster virus (VZV), which causes primary infection leading to chickenpox and remains latent in the ganglia. Fire needle therapy is a non-pharmacological treatment that combines heat therapy with traditional acupuncture. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Herpes Zoster
- What is being tested?
- Fire needle, Cortex Phellodendri compound fluid wet compress and basic treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females, aged 18-80 years old;
- diagnosed as acute HZ with the course of disease within 7 days;
- without history of other treatment before enrollment.
Who cannot join
- specific types of HZ, including Ramsay Hunt Syndrom, ophthalmic, disseminated, deep, purpuric and central nervous system HZ;
- pregnancy and lactation;
- allergic to the related Chinese herbals;
- patients with contraindications to penciclovir, mecobalamin and pregabalin; (e) history of hypertrophic scar or keloid;
- severe cardiovascular, cerebrovascular, digestive, urinary or hematopoietic disease; (g) mental disease; (h) coagulation disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
About this study
Herpes zoster (HZ) results from a reactivation of varicella-zoster virus (VZV), which causes primary infection leading to chickenpox and remains latent in the ganglia. Fire needle therapy is a non-pharmacological treatment that combines heat therapy with traditional acupuncture. This technique involves heating sterilized needles and swiftly inserting them into specific points or areas of the skin. Chinese herbal wet compress therapy is directly delivering medications to the lesion site, facilitating rapid transdermal absorption. This method ensures stable local drug concentrations and effectively alleviates pain, swelling, and other clinical symptoms. In this study, we conducted a randomized controlled trial to evaluate the clinical efficacy and safety of fire needle therapy combined with CPCF wet compress for the treatment of acute HZ. 32 acute HZ patients were randomized into control (standard antiviral and analgesic therapy) and treated groups (standard therapy plus fire needle [5 sessions, every other day] and CPCF wet compress [3 times/day, 10 days]). After 10 days of treatment, fire needle combined with CPCF wet compress significantly enhances symptom relief, pain reduction, and quality of life in acute HZ, with favorable safety.
Read the detailed description
Herpes zoster (HZ) results from a reactivation of varicella-zoster virus (VZV), which causes primary infection leading to chickenpox and remains latent in the ganglia. Fire needle therapy is a non-pharmacological treatment that combines heat therapy with traditional acupuncture. This technique involves heating sterilized needles and swiftly inserting them into specific points or areas of the skin. Chinese herbal wet compress therapy is directly delivering medications to the lesion site, facilitating rapid transdermal absorption. This method ensures stable local drug concentrations and effectively alleviates pain, swelling, and other clinical symptoms. In this study, we conducted a randomized controlled trial to evaluate the clinical efficacy and safety of fire needle therapy combined with CPCF wet compress for the treatment of acute HZ. 32 acute HZ patients were randomized into control (standard antiviral and analgesic therapy) and treated groups (standard therapy plus fire needle [5 sessions, every other day] and CPCF wet compress [3 times/day, 10 days]). After 10 days of treatment, fire needle combined with CPCF wet compress significantly enhances symptom relief, pain reduction, and quality of life in acute HZ, with favorable safety.
- Conditions
- Acute Herpes Zoster
- Being tested
- Fire needle, Cortex Phellodendri compound fluid wet compress, basic treatment
- Keywords
- acute Herpes zoster, fire needle therapy, Cortex Phellodendri compound fluid, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fire needleProcedure or surgery
At the beginning of the fire needle therapy, the patient was instructed to exposure the lesion in a comfortable position. And the Ashi point (lesion area) was disinfected with iodophor. The 95% alcohol lamp was lit and held by the left hand. Then the needle was held by the right hand in the outer flame of the alcohol lamp to heat the needle body, making the tip of the needle whiten. Subsequently, the needle was quickly and accurately puncted into the base of the herpes at a depth of about 2-5 mm, straight in and out. According to the number of herpes, the early-onset herpes was puncted first, and about 5 to 10 blisters were selected for each puncture. The acupuncture was performed 1-5 times according to the size of the herpes. The treatment was performed once every other day for total 5 sessions.
Cortex Phellodendri compound fluid wet compressDrug
For the Chinese herbal wet compress treatment, CPCF (Shandong Hanfang Pharmaceutical Co., LTD.) was decocted using forsythia, honeysuckle, phellodendron, dandelion, and centipede. Appropriate amount of liquid was diluted with 5 times the volume of water. Then according to the area of skin lesions, several pieces of medical fat-free cotton gauze with thickness of 8 layers were put into the liquid completely wet. After wringing out to a semi-dry state, the gauze was applied to the lesion for 15 minutes/time, 3 times a day, for 10 days.
basic treatmentDrug
The basic treatment consisted of penciclovir 0.5g/time per day intravenously, mecobalamin 0.5mg/time three times a day orally and pregabalin 75mg/time twice a day orally for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| treated group | Experimental | The patients received fire needle (5 sessions, every other day) combined with CPCF wet compress treatment (3 times/day, 10 days) in addition to the basic treatment of the control group. Receives: Procedure: Fire needle; Drug: Cortex Phellodendri compound fluid wet compress; Drug: basic treatment |
| control group | Experimental | The control group received basic treatment, which consisted of penciclovir 0.5g/time per day intravenously, mecobalamin 0.5mg/time three times a day orally and pregabalin 75mg/time twice a day orally for 10 days. Receives: Drug: basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
herpes zoster symptom and sign quantitative scoring scale
The degree of the clinical symptoms and signs of HZ (including local pain, local itching, burning sensation, papular erythema, number of blisters, number of blister clusters, herpes character, ulcer, fever, local lymph node enlargement, and skin lesion area change) were divided into four grades: 0 (none), 1 (mild), 2 (moderate), and 3 (severe).
Measured: From enrollment to day 10
lesion improvement index n
The lesion improvement index n was calculated by the formula: n (%) = (symptom and sign quantitative score at baseline - symptom and sign quantitative score at 10 days)/symptom and sign quantitative score at baselin ×100%.
Measured: From enrollment to day 10
the total improved rate
The clinical improvement was graded as follows: clinical cure (n≥90%), significant improvement (70%≤n<90%), moderate improvement (30%≤n<70%), no improvement (n < 30%). The total improved rate was calculated as cases of (clinical cure + significant improvement + moderate improvement)/total cases×100%.
Measured: From enrollment to day 10
Secondary outcomes (5)
questionnaire of Dermatology Life Quality Index
Measured: From enrollment to day 10
Pittsburgh sleep quality index
Measured: From enrollment to day 10
Hamilton Anxiety Scale
Measured: From enrollment to day 10
Visual analog scale
The pain intensity due to HZ was evaluated by a visual analog scale (VAS) ranging from 0 to 10 (0: no pain, 1-3: mild, 4-6: moderate, 7-10: severe) at day 0 and day 10.
Measured: From enrollment to day 10
incidence of postherpetic neuralgia
The incidence of postherpetic neuralgia was analysed at day 90.
Measured: From enrollment to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Jan 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Herpes ZosterStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihui Zeng, Second Affiliated Hospital of Xi'an Jiaotong University
- Investigators
- Weihui Zeng, Study chair, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985589
- Sponsor's protocol ID
- 2025514
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng JC, Liao YZ, Li JJ, Lu LH, Li HZ, Lu LM, Li QJ, Li LX, Wang SX, Lin GH. [Clinical efficacy of fire needling combined with cupping therapy on herpes zoster of acute stage and the effect on Th17/Treg cellular immune balance]. Zhongguo Zhen Jiu. 2023 Oct 12;43(10):1128-33. doi: 10.13703/j.0255-2930.20221005-k0004. Chinese.
PubMed 37802518Zhang Y, Li SH, Yang L, Xu QN, Pei WY, Liang ZH, Liu XH, Yang JJ, Lin GH. [Shallow Fire-needle Acupuncture Stimulation Plus Cupping Relieves Neuralgia and Down-regulates Serum Substance P Level in Patients with Acute Herpes Zoster]. Zhen Ci Yan Jiu. 2018 Aug 25;43(8):492-4. doi: 10.13702/j.1000-0607.170923. Chinese.
PubMed 30232851Huang SX, Mao M, Pu JJ, Chen YH, Deng L, Zhao H, Geng MJ, Zhong RF, Guo YJ, Liu ZS, Wang YH, Ye YM, Liu J, Yang T, Zhao AM, Chen XH, Zhu HY, Du YC. [Clinical research on fire filiform needle combined with mild moxibustion for postherpetic neuralgia]. Zhongguo Zhen Jiu. 2014 Mar;34(3):225-9. Chinese.
PubMed 24843959Chen J, Luo C, Ju P, Tu S, Shi S, Wang Z, Wu H. A bibliometric analysis and visualization of acupuncture and moxibustion therapy for herpes zoster and postherpetic neuralgia. Skin Res Technol. 2024 Jun;30(6):e13815. doi: 10.1111/srt.13815.
PubMed 38924142Dai YX, Yeh FY, Shen YJ, Tai YH, Huang N, Chang YT, Chen TJ, Li CP, Wu CY. Cigarette smoking and risk of herpes zoster: a population-based cohort study in Taiwan. Clin Exp Dermatol. 2021 Oct;46(7):1293-1298. doi: 10.1111/ced.14650. Epub 2021 May 11.
PubMed 33763912Patil A, Goldust M, Wollina U. Herpes zoster: A Review of Clinical Manifestations and Management. Viruses. 2022 Jan 19;14(2):192. doi: 10.3390/v14020192.
PubMed 35215786
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fire Needle Therapy Combined With Cortex Phellodendri Compound Fluid Wet Compress for Acute Herpes Zoster: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06985589
- Acronym / sponsor ID
- 2025514
- Conditions
- Acute Herpes Zoster
- Keywords
- acute Herpes zoster, fire needle therapy, Cortex Phellodendri compound fluid, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 22 May 2025 (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.
Herpes zoster (HZ) results from a reactivation of varicella-zoster virus (VZV), which causes primary infection leading to chickenpox and remains latent in the ganglia. Fire needle therapy is a non-pharmacological treatment that combines heat therapy with traditional acupuncture. This technique involves heating sterilized needles and swiftly inserting them into specific points or areas of the skin. Chinese herbal wet compress therapy is directly delivering medications to the lesion site, facilitating rapid transdermal absorption. This method ensures stable local drug concentrations and effectively alleviates pain, swelling, and other clinical symptoms. In this study, we conducted a randomized controlled trial to evaluate the clinical efficacy and safety of fire needle therapy combined with CPCF wet compress for the treatment of acute HZ. 32 acute HZ patients were randomized into control (standard antiviral and analgesic therapy) and treated groups (standard therapy plus fire needle [5 sessions, every other day] and CPCF wet compress [3 times/day, 10 days]). After 10 days of treatment, fire needle combined with CPCF wet compress significantly enhances symptom relief, pain reduction, and quality of life in acute HZ, with favorable safety.
Detailed description
Herpes zoster (HZ) results from a reactivation of varicella-zoster virus (VZV), which causes primary infection leading to chickenpox and remains latent in the ganglia. Fire needle therapy is a non-pharmacological treatment that combines heat therapy with traditional acupuncture. This technique involves heating sterilized needles and swiftly inserting them into specific points or areas of the skin. Chinese herbal wet compress therapy is directly delivering medications to the lesion site, facilitating rapid transdermal absorption. This method ensures stable local drug concentrations and effectively alleviates pain, swelling, and other clinical symptoms. In this study, we conducted a randomized controlled trial to evaluate the clinical efficacy and safety of fire needle therapy combined with CPCF wet compress for the treatment of acute HZ. 32 acute HZ patients were randomized into control (standard antiviral and analgesic therapy) and treated groups (standard therapy plus fire needle [5 sessions, every other day] and CPCF wet compress [3 times/day, 10 days]). After 10 days of treatment, fire needle combined with CPCF wet compress significantly enhances symptom relief, pain reduction, and quality of life in acute HZ, with favorable safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treated group | Experimental | Procedure: Fire needle, Drug: Cortex Phellodendri compound fluid wet compress, Drug: basic treatmentThe patients received fire needle (5 sessions, every other day) combined with CPCF wet compress treatment (3 times/day, 10 days) in addition to the basic treatment of the control group. |
| control group | Experimental | Drug: basic treatmentThe control group received basic treatment, which consisted of penciclovir 0.5g/time per day intravenously, mecobalamin 0.5mg/time three times a day orally and pregabalin 75mg/time twice a day orally for 10 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- males and females, aged 18-80 years old;
- diagnosed as acute HZ with the course of disease within 7 days;
- without history of other treatment before enrollment.
Key exclusion criteria (5 listed)
- specific types of HZ, including Ramsay Hunt Syndrom, ophthalmic, disseminated, deep, purpuric and central nervous system HZ;
- pregnancy and lactation;
- allergic to the related Chinese herbals;
- patients with contraindications to penciclovir, mecobalamin and pregabalin; (e) history of hypertrophic scar or keloid;
- severe cardiovascular, cerebrovascular, digestive, urinary or hematopoietic disease; (g) mental disease; (h) coagulation disorders.
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 |
|---|---|---|
| Fire needleAt the beginning of the fire needle therapy, the patient was instructed to exposure the lesion in a comfortable position. And the Ashi point (lesion area) was disinfected with iodophor. The 95% alcohol lamp was lit and held by the left hand. Then the needle was held by the right hand in the outer flame of the alcohol lamp to heat the needle body, making the tip of the needle whiten. Subsequently, the needle was quickly and accurately puncted into the base of the herpes at a depth of about 2-5 mm, straight in and out. According to the number of herpes, the early-onset herpes was puncted first, and about 5 to 10 blisters were selected for each puncture. The acupuncture was performed 1-5 times according to the size of the herpes. The treatment was performed once every other day for total 5 sessions. | Procedure or surgery | treated group |
| Cortex Phellodendri compound fluid wet compressFor the Chinese herbal wet compress treatment, CPCF (Shandong Hanfang Pharmaceutical Co., LTD.) was decocted using forsythia, honeysuckle, phellodendron, dandelion, and centipede. Appropriate amount of liquid was diluted with 5 times the volume of water. Then according to the area of skin lesions, several pieces of medical fat-free cotton gauze with thickness of 8 layers were put into the liquid completely wet. After wringing out to a semi-dry state, the gauze was applied to the lesion for 15 minutes/time, 3 times a day, for 10 days. | Drug | treated group |
| basic treatmentThe basic treatment consisted of penciclovir 0.5g/time per day intravenously, mecobalamin 0.5mg/time three times a day orally and pregabalin 75mg/time twice a day orally for 10 days. | Drug | control group, treated group |
Primary outcome
herpes zoster symptom and sign quantitative scoring scale
Time frame: From enrollment to day 10
The degree of the clinical symptoms and signs of HZ (including local pain, local itching, burning sensation, papular erythema, number of blisters, number of blister clusters, herpes character, ulcer, fever, local lymph node enlargement, and skin lesion area change) were divided into four grades: 0 (none), 1 (mild), 2 (moderate), and 3 (severe).
lesion improvement index n
Time frame: From enrollment to day 10
The lesion improvement index n was calculated by the formula: n (%) = (symptom and sign quantitative score at baseline - symptom and sign quantitative score at 10 days)/symptom and sign quantitative score at baselin ×100%.
the total improved rate
Time frame: From enrollment to day 10
The clinical improvement was graded as follows: clinical cure (n≥90%), significant improvement (70%≤n<90%), moderate improvement (30%≤n<70%), no improvement (n < 30%). The total improved rate was calculated as cases of (clinical cure + significant improvement + moderate improvement)/total cases×100%.
5 secondary outcomes
questionnaire of Dermatology Life Quality Index
Time frame: From enrollment to day 10
Pittsburgh sleep quality index
Time frame: From enrollment to day 10
Hamilton Anxiety Scale
Time frame: From enrollment to day 10
Visual analog scale
Time frame: From enrollment to day 10
incidence of postherpetic neuralgia
Time frame: From enrollment to day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Results publication: PubMed 37802518Zeng JC, Liao YZ, Li JJ, Lu LH, Li HZ, Lu LM, Li QJ, Li LX, Wang SX, Lin GH. [Clinical efficacy of fire needling combined with cupping therapy on herpes zoster of acute stage and the effect on Th17/Treg cellular immune balance]. Zhongguo Zhen Jiu. 2023 Oct 12;43(10):1128-33. doi: 10.13703/j.0255-2930.20221005-k0004. Chinese.
- Results publication: PubMed 30232851Zhang Y, Li SH, Yang L, Xu QN, Pei WY, Liang ZH, Liu XH, Yang JJ, Lin GH. [Shallow Fire-needle Acupuncture Stimulation Plus Cupping Relieves Neuralgia and Down-regulates Serum Substance P Level in Patients with Acute Herpes Zoster]. Zhen Ci Yan Jiu. 2018 Aug 25;43(8):492-4. doi: 10.13702/j.1000-0607.170923. Chinese.
- Results publication: PubMed 24843959Huang SX, Mao M, Pu JJ, Chen YH, Deng L, Zhao H, Geng MJ, Zhong RF, Guo YJ, Liu ZS, Wang YH, Ye YM, Liu J, Yang T, Zhao AM, Chen XH, Zhu HY, Du YC. [Clinical research on fire filiform needle combined with mild moxibustion for postherpetic neuralgia]. Zhongguo Zhen Jiu. 2014 Mar;34(3):225-9. Chinese.
- Results publication: PubMed 38924142Chen J, Luo C, Ju P, Tu S, Shi S, Wang Z, Wu H. A bibliometric analysis and visualization of acupuncture and moxibustion therapy for herpes zoster and postherpetic neuralgia. Skin Res Technol. 2024 Jun;30(6):e13815. doi: 10.1111/srt.13815.
- Results publication: PubMed 33763912Dai YX, Yeh FY, Shen YJ, Tai YH, Huang N, Chang YT, Chen TJ, Li CP, Wu CY. Cigarette smoking and risk of herpes zoster: a population-based cohort study in Taiwan. Clin Exp Dermatol. 2021 Oct;46(7):1293-1298. doi: 10.1111/ced.14650. Epub 2021 May 11.
- Results publication: PubMed 35215786Patil A, Goldust M, Wollina U. Herpes zoster: A Review of Clinical Manifestations and Management. Viruses. 2022 Jan 19;14(2):192. doi: 10.3390/v14020192.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Weihui Zeng study chair
Second Affiliated Hospital of Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fire needle, Cortex Phellodendri compound fluid wet compress and basic treatment in people with Acute Herpes Zoster, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
herpes zoster symptom and sign quantitative scoring scale (time frame: From enrollment to day 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06985589, which also lists 6 linked publications.
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 22 May 2025.