Postherpetic NeuralgiaNCT04594226
Electroacupuncture Therapy for Treating Postherpetic Neuralgia
A study testing EA combined with medication and Medication in people with Postherpetic Neuralgia, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Postherpetic neuralgia (PHN) has a high incidence rate and severely impact on quality of life and health care costs, interfering with physical, emotional and social functioning of affected patients. Current therapeutic options for PHN mainly include analgetic and local anaesthesia for selective nerve blockade. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- EA combined with medication and Medication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2020to 31 Dec 2021
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have a medical history of herpes zoster;
- Skin lesion has healed in the region of herpes zoster, but the duration of postherpetic neuralgia persist for more than 30 days.
- 20 ≤ age ≤80 years, male or female
- Participants can fully understand the study protocol and written informed consent is signed.
Who cannot join
- Acute herpes zoster, herpes zoster has not disappeared;
- Herpes zoster belongs to a special type, such as ophthalmic herpes zoster, auricular herpes zoster, HZ that involves internal organs, meningeal herpes zoster, and disseminated herpes zoster.
- Pregnant or lactating women;
- Patients have severe complications in cardiovascular, cerebrovascular, liver, kidney, hematopoietic and other systems,or have malignant tumor, mental illness, immune deficiency, hemorrhagic disorders and other diseases;
- Patients have severe cognitive impairment and can not understand the study protocol;
- Patients can not receive electroacupuncture treatment due to any reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang, 310000
About this study
Official title: Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: a Multicentre Randomised Controlled Trial
Postherpetic neuralgia (PHN) has a high incidence rate and severely impact on quality of life and health care costs, interfering with physical, emotional and social functioning of affected patients. Current therapeutic options for PHN mainly include analgetic and local anaesthesia for selective nerve blockade. Nevertheless, the efficacy of analgetic is always limited by inevitable side effects, in which patients have poor compliance. Moreover, for some most suffering patients, the control of pain is often unsatisfactory despite the administration of complex combinations. As a non-pharmarceutical therapy, acupuncture is widely use for a wide range of pain conditions. Thus, it might be an alternative treatment for PHN. The aim of this multicenter randomized controlled trial is to investigate the efficacy and safety of electroacupuncture therapy in patients with postherpetic neuralgia.
Read the detailed description
This randomized controlled trial will enroll 132 patients with postherpetic neuralgia. All patients will be randomly assigned to either the EA combined with medication group or the medication group via a computerized central randomization system in a 1:1 ratio. Primary outcomes will be change in sensory thresholds and pain intensity. Secondary outcomes will be change in dosage of analgetic, quality of life, anxiety and depression severity and sleep quality.
- Conditions
- Postherpetic Neuralgia
- Being tested
- EA combined with medication, Medication
- Keywords
- Electroacupuncture, Postherpetic neuralgia, Pain, Randomized controlled trial, Protocol
- Medical subject headings
- Neuralgia, Postherpetic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA combined with medicationProcedure or surgery
Primary acupoints include Ashi points, Jiaji acupoints and Xi-cleft points. Jiaji points on the ipsilateral side will be selected according to the corresponding ganglia involved by HZ. Xi-cleft points will be selected based on the distribution regions of PHN. For pain sites that mainly distributed in the gallbladder meridian, GB36 will be selected. For pain sites that mainly distributed in the stomach meridian, ST34 will be selected. For pain sites that mainly distributed in the gallbladder meridian, BL63 will be selected. For pain sites that mainly distributed in the large intestine meridian, LI7 will be selected. Supplementary acupoints will be chosen based on TCM syndrome differentiation.
Operation: Two paired of acupoints are connected to the EA apparatus. EA parameter is selected as 2/100Hz wave. EA intensity is selected according to the patients' endurance. Needles will be retained and EA will last for 30 mins for each session.
MedicationDrug
The dosage of gabapentin starts from 100mg Tid. 100mg-300mg can be increased every 3-7 days and taken in three doses, but the total amount is not more than 1800mg/day. The dosage of gabapentin will be adjusted according to the patient's condition until his pain is effectively controlled. After maintaining the medication for two weeks, the dosage can be gradually reduced and 100mg can be reduced every 3-7 days.
| Study group | Role | What they receive |
|---|---|---|
| EA combined with medication group | Experimental | Patients in this group will receive electroacupuncture combined with gabapentin. Receives: Procedure: EA combined with medication; Drug: Medication |
| Medication group | Active comparator | Participants in this group will only receive gabapentin. Receives: Drug: Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sensory thresholds
Sensory thresholds is measured by quantitative sensory testing
Measured: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Change in pain intensity
Pain intensity is measured by Zoster Brief Pain Inventory (ZBPI)
Measured: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Secondary outcomes (5)
Change in dosage of analgetic
Dosage of analgetic
Measured: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Change in score of quality of life
Quality of life is measure by 36-item Short Form Health Survey (SF-36)
Measured: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Change in score of anxiety and depression severity
Anxiety and depression severity is measure by Hospital Anxiety and Depression Scale (HADS)
Measured: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Change in score of sleep quality
Sleep quality is measured by Pittsburgh Sleep Quality Index (PSQI)
Measured: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Adverse events
Incidence of adverse events
Measured: Up to 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start11 Nov 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Postherpetic NeuralgiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Lishui Hospital of Traditional Chinese Medicine, Zhejiang Provincial Tongde Hospital
- Responsible party
- Principal investigator, Dexiong Han, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Dexiong Han, M.D, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594226
- Sponsor's protocol ID
- 2019ZB057_
- Status last verified
- Jan 2023
- First submitted
- 11 Oct 2020
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saguil A, Kane S, Mercado M, Lauters R. Herpes Zoster and Postherpetic Neuralgia: Prevention and Management. Am Fam Physician. 2017 Nov 15;96(10):656-663.
PubMed 29431387Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33. doi: 10.1056/NEJMcp1403062. No abstract available.
PubMed 25317872Forbes HJ, Thomas SL, Smeeth L, Clayton T, Farmer R, Bhaskaran K, Langan SM. A systematic review and meta-analysis of risk factors for postherpetic neuralgia. Pain. 2016 Jan;157(1):30-54. doi: 10.1097/j.pain.0000000000000307.
PubMed 26218719Lin CS, Lin YC, Lao HC, Chen CC. Interventional Treatments for Postherpetic Neuralgia: A Systematic Review. Pain Physician. 2019 May;22(3):209-228.
PubMed 31151330Wang Y, Li W, Peng W, Zhou J, Liu Z. Acupuncture for postherpetic neuralgia: Systematic review and meta-analysis. Medicine (Baltimore). 2018 Aug;97(34):e11986. doi: 10.1097/MD.0000000000011986.
PubMed 30142834Avijgan M, Hajzargarbashi ST, Kamran A, Avijgan M. Postherpetic Neuralgia: Practical Experiences Return to Traditional Chinese Medicine. J Acupunct Meridian Stud. 2017 Jun;10(3):157-164. doi: 10.1016/j.jams.2017.02.003. Epub 2017 Feb 28.
PubMed 28712474Ruengwongroj P, Muengtaweepongsa S, Patumanond J, Phinyo P. Effectiveness of press needle treatment and electroacupuncture in patients with postherpetic neuralgia: A matched propensity score analysis. Complement Ther Clin Pract. 2020 Aug;40:101202. doi: 10.1016/j.ctcp.2020.101202. Epub 2020 May 25.
PubMed 32891279Zhang Y, Liang Z, Li S, Yang L, Guo T, Xu Y, Yang J, Xu Q, Zhang Q, Zhao J, Li C, Liu X. Fire needle plus cupping for acute herpes zoster: study protocol for a randomized controlled trial. Trials. 2020 Aug 6;21(1):701. doi: 10.1186/s13063-020-04599-2.
PubMed 32762718Wang L, Qiu L, Zheng X, Ouyang J, Zhang M, He L, Zeng S, Liu B, Peng J. Effectiveness of electroacupuncture at Jiaji acupoints (EX-B2), plus moxibustion and intermediate on postherpetic neuralgia: a randomized controlled trial. J Tradit Chin Med. 2020 Feb;40(1):121-127.
PubMed 32227773Pei W, Zeng J, Lu L, Lin G, Ruan J. Is acupuncture an effective postherpetic neuralgia treatment? A systematic review and meta-analysis. J Pain Res. 2019 Jul 16;12:2155-2165. doi: 10.2147/JPR.S199950. eCollection 2019.
PubMed 31410050Liu K, Zeng J, Pei W, Chen S, Luo Z, Lu L, Lin G. Assessing the reporting quality in randomized controlled trials of acupuncture for postherpetic neuralgia using the CONSORT statement and STRICTA guidelines. J Pain Res. 2019 Jul 29;12:2359-2370. doi: 10.2147/JPR.S210471. eCollection 2019.
PubMed 31534360Hu H, Shen Y, Li X, Tian H, Li X, Li Y, Cheng Y, Wu L, Han D. Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: Study Protocol for a Multicentre, Randomized, Controlled, Assessor-Blinded Trial. Front Med (Lausanne). 2021 May 21;8:624797. doi: 10.3389/fmed.2021.624797. eCollection 2021.
PubMed 34095161
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04594226
- Acronym / sponsor ID
- 2019ZB057_
- Conditions
- Postherpetic Neuralgia
- Keywords
- Electroacupuncture, Postherpetic neuralgia, Pain, Randomized controlled trial, Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Collaborators
- Lishui Hospital of Traditional Chinese Medicine, Zhejiang Provincial Tongde Hospital
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Oct 2020 (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.
Postherpetic neuralgia (PHN) has a high incidence rate and severely impact on quality of life and health care costs, interfering with physical, emotional and social functioning of affected patients. Current therapeutic options for PHN mainly include analgetic and local anaesthesia for selective nerve blockade. Nevertheless, the efficacy of analgetic is always limited by inevitable side effects, in which patients have poor compliance. Moreover, for some most suffering patients, the control of pain is often unsatisfactory despite the administration of complex combinations. As a non-pharmarceutical therapy, acupuncture is widely use for a wide range of pain conditions. Thus, it might be an alternative treatment for PHN. The aim of this multicenter randomized controlled trial is to investigate the efficacy and safety of electroacupuncture therapy in patients with postherpetic neuralgia.
Detailed description
This randomized controlled trial will enroll 132 patients with postherpetic neuralgia. All patients will be randomly assigned to either the EA combined with medication group or the medication group via a computerized central randomization system in a 1:1 ratio. Primary outcomes will be change in sensory thresholds and pain intensity. Secondary outcomes will be change in dosage of analgetic, quality of life, anxiety and depression severity and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA combined with medication group | Experimental | Procedure: EA combined with medication, Drug: MedicationPatients in this group will receive electroacupuncture combined with gabapentin. |
| Medication group | Active comparator | Drug: MedicationParticipants in this group will only receive gabapentin. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients have a medical history of herpes zoster;
- Skin lesion has healed in the region of herpes zoster, but the duration of postherpetic neuralgia persist for more than 30 days.
- 20 ≤ age ≤80 years, male or female
- Participants can fully understand the study protocol and written informed consent is signed.
Key exclusion criteria (6 listed)
- Acute herpes zoster, herpes zoster has not disappeared;
- Herpes zoster belongs to a special type, such as ophthalmic herpes zoster, auricular herpes zoster, HZ that involves internal organs, meningeal herpes zoster, and disseminated herpes zoster.
- Pregnant or lactating women;
- Patients have severe complications in cardiovascular, cerebrovascular, liver, kidney, hematopoietic and other systems,or have malignant tumor, mental illness, immune deficiency, hemorrhagic disorders and other diseases;
- Patients have severe cognitive impairment and can not understand the study protocol;
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 |
|---|---|---|
| EA combined with medicationPrimary acupoints include Ashi points, Jiaji acupoints and Xi-cleft points. Jiaji points on the ipsilateral side will be selected according to the corresponding ganglia involved by HZ. Xi-cleft points will be selected based on the distribution regions of PHN. For pain sites that mainly distributed in the gallbladder meridian, GB36 will be selected. For pain sites that mainly distributed in the stomach meridian, ST34 will be selected. For pain sites that mainly distributed in the gallbladder meridian, BL63 will be selected. For pain sites that mainly distributed in the large intestine meridian, LI7 will be selected. Supplementary acupoints will be chosen based on TCM syndrome differentiation. Operation: Two paired of acupoints are connected to the EA apparatus. EA parameter is selected as 2/100Hz wave. EA intensity is selected according to the patients' endurance. Needles will be retained and EA will last for 30 mins for each session. | Procedure or surgery | EA combined with medication group |
| MedicationThe dosage of gabapentin starts from 100mg Tid. 100mg-300mg can be increased every 3-7 days and taken in three doses, but the total amount is not more than 1800mg/day. The dosage of gabapentin will be adjusted according to the patient's condition until his pain is effectively controlled. After maintaining the medication for two weeks, the dosage can be gradually reduced and 100mg can be reduced every 3-7 days. | Drug | EA combined with medication group, Medication group |
Primary outcome
Change in sensory thresholds
Time frame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Sensory thresholds is measured by quantitative sensory testing
Change in pain intensity
Time frame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Pain intensity is measured by Zoster Brief Pain Inventory (ZBPI)
5 secondary outcomes
Change in dosage of analgetic
Time frame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Change in score of quality of life
Time frame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Change in score of anxiety and depression severity
Time frame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Change in score of sleep quality
Time frame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Adverse events
Time frame: Up to 6 weeks of treatment
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 27 Jan 2023.
- Background: PubMed 29431387Saguil A, Kane S, Mercado M, Lauters R. Herpes Zoster and Postherpetic Neuralgia: Prevention and Management. Am Fam Physician. 2017 Nov 15;96(10):656-663.
- Background: PubMed 25317872Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33. doi: 10.1056/NEJMcp1403062. No abstract available.
- Background: PubMed 26218719Forbes HJ, Thomas SL, Smeeth L, Clayton T, Farmer R, Bhaskaran K, Langan SM. A systematic review and meta-analysis of risk factors for postherpetic neuralgia. Pain. 2016 Jan;157(1):30-54. doi: 10.1097/j.pain.0000000000000307.
- Background: PubMed 31151330Lin CS, Lin YC, Lao HC, Chen CC. Interventional Treatments for Postherpetic Neuralgia: A Systematic Review. Pain Physician. 2019 May;22(3):209-228.
- Background: PubMed 30142834Wang Y, Li W, Peng W, Zhou J, Liu Z. Acupuncture for postherpetic neuralgia: Systematic review and meta-analysis. Medicine (Baltimore). 2018 Aug;97(34):e11986. doi: 10.1097/MD.0000000000011986.
- Background: PubMed 28712474Avijgan M, Hajzargarbashi ST, Kamran A, Avijgan M. Postherpetic Neuralgia: Practical Experiences Return to Traditional Chinese Medicine. J Acupunct Meridian Stud. 2017 Jun;10(3):157-164. doi: 10.1016/j.jams.2017.02.003. Epub 2017 Feb 28.
- Background: PubMed 32891279Ruengwongroj P, Muengtaweepongsa S, Patumanond J, Phinyo P. Effectiveness of press needle treatment and electroacupuncture in patients with postherpetic neuralgia: A matched propensity score analysis. Complement Ther Clin Pract. 2020 Aug;40:101202. doi: 10.1016/j.ctcp.2020.101202. Epub 2020 May 25.
- Background: PubMed 32762718Zhang Y, Liang Z, Li S, Yang L, Guo T, Xu Y, Yang J, Xu Q, Zhang Q, Zhao J, Li C, Liu X. Fire needle plus cupping for acute herpes zoster: study protocol for a randomized controlled trial. Trials. 2020 Aug 6;21(1):701. doi: 10.1186/s13063-020-04599-2.
- Background: PubMed 32227773Wang L, Qiu L, Zheng X, Ouyang J, Zhang M, He L, Zeng S, Liu B, Peng J. Effectiveness of electroacupuncture at Jiaji acupoints (EX-B2), plus moxibustion and intermediate on postherpetic neuralgia: a randomized controlled trial. J Tradit Chin Med. 2020 Feb;40(1):121-127.
- Background: PubMed 31410050Pei W, Zeng J, Lu L, Lin G, Ruan J. Is acupuncture an effective postherpetic neuralgia treatment? A systematic review and meta-analysis. J Pain Res. 2019 Jul 16;12:2155-2165. doi: 10.2147/JPR.S199950. eCollection 2019.
- Background: PubMed 31534360Liu K, Zeng J, Pei W, Chen S, Luo Z, Lu L, Lin G. Assessing the reporting quality in randomized controlled trials of acupuncture for postherpetic neuralgia using the CONSORT statement and STRICTA guidelines. J Pain Res. 2019 Jul 29;12:2359-2370. doi: 10.2147/JPR.S210471. eCollection 2019.
- Derived from this study: PubMed 34095161Hu H, Shen Y, Li X, Tian H, Li X, Li Y, Cheng Y, Wu L, Han D. Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: Study Protocol for a Multicentre, Randomized, Controlled, Assessor-Blinded Trial. Front Med (Lausanne). 2021 May 21;8:624797. doi: 10.3389/fmed.2021.624797. eCollection 2021.
- 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.
Dexiong Han, M.D principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EA combined with medication and Medication in people with Postherpetic Neuralgia, run by The Third Affiliated hospital of Zhejiang Chinese Medical 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 4 inclusion and 6 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 27 Jan 2023. 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.
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?
Change in sensory thresholds (time frame: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up). The study lists 2 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 NCT04594226, which also lists 12 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 27 Jan 2023; AzTrials last refreshed its copy on 30 Oct 2026.