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Allergic RhinitisITITFARNCT06523478

Intratonsillar Immunotherapy for Allergic Rhinitis

A study testing Intratonsillar immunotherapy (ITIT) and Subcutaneous immunotherapy (SCIT) in people with Allergic Rhinitis, run by Xu Yu at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, open-label, positive parallel controlled, blinded endpoint clinical study designed to compare the safety and efficacy of "Intratonsillar Immunotherapy of Standardized Dust Mite Allergen Extracts (Novo Helisen-Depot, Allergopharma, Merck, Germany)" with Subcutaneous Immunotherapy in patients with… Read more about this study

Who is it for?
Ages 5 to 65 years
Conditions the study is for
Allergic Rhinitis
What is being tested?
Intratonsillar immunotherapy (ITIT) and Subcutaneous immunotherapy (SCIT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
29 Apr 2024to 29 Apr 2028
Phase
Interventional
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 5 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Voluntarily sign informed consent.
  • Commitment to follow the research procedures and cooperate with the implementation of the entire research process.
  • Diagnosis in accordance with ARIA guidelines, based on:
  • ① Symptoms: Two or more symptoms such as paroxysmal sneezing, watery nose, nasal itching, and nasal congestion, with symptoms lasting or accumulating for more than 1 hour per day. May be accompanied by eye symptoms such as tearing, eye itching, and eye redness.
  • ② Signs: Common nasal mucosa pale, edema, nasal watery secretions.
  • Allergen test: Positive for skin prick test (SPT) and/or serum-specific IgE for at least one allergen, or positive for nasal provocation test.
Show all 13Show fewer
  • Have a history of allergic rhinitis caused by atopic allergens and one of the following:
  • ① No significant relief after drug treatment.
  • ② Do not want to continue taking medication for a long time.
  • ③ Long-term drug treatment can produce adverse side effects.
  • Allergens cannot be effectively avoided in daily life.
  • Women of childbearing age must ensure that they do not become pregnant during the treatment cycle.
  • Must be between 5 and 65 years old.

Who cannot join

  • Allergic to the excipient (aluminum hydroxide) of Allergopharma or the rescue medication epinephrine.
  • Respiratory disease other than stable asthma.
  • Pulmonary insufficiency (NYHA grade II and above or FEV1 < 80%) or irreversible changes in the responding organs such as emphysema and bronchiectasis.
  • Severe acute or chronic diseases (including malignant diseases), inflammation, and fever.
  • Multiple sclerosis.
  • Immune system diseases (autoimmune diseases, immune diseases caused by antigen and antibody complexes, immune deficiencies, etc.).
Show all 25Show fewer
  • Active tuberculosis.
  • Severe mental disorder.
  • Obvious cardiac insufficiency.
  • A history of severe recurrent acute sinusitis (defined as two episodes per year within the past 2 years, each requiring antibiotic treatment).
  • A history of chronic sinusitis, including at least two of the following symptoms (at least one of which should be nasal congestion or runny nose):
  • ① Nasal congestion, runny nose, facial pressure, or pain.
  • ② Having a diminished or lost sense of smell.
  • ③ Endoscopic or CT examination showed signs of sinusitis.
  • Severe liver and renal impairment, including but not limited to abnormal liver function (such as ALT, AST elevation more than 2 times the normal range), abnormal kidney function (such as creatinine clearance less than 60 mL/min), etc.
  • Smokers averaging more than 5 cigarettes per day in the 3 months prior to the trial or unable to give up smoking during the entire hospital stay.
  • Regular drinkers in the 3 months prior to the trial, i.e., more than 2 units of alcohol per day on average (1 unit = 360ml beer or 45ml spirits with 40% alcohol or 150ml wine).
  • Received immunotherapy within the last 3 years (subcutaneous injection or sublingual allergen-specific immunotherapy, etc.).
  • Patients who used experimental drugs or participated in other clinical studies within 30 days prior to treatment.
  • Patients treated with IgE monoclonal antibodies within the last 4 months.
  • Patients who are taking beta blockers.
  • Patients who do not have sufficient knowledge about the trial.
  • Not between the ages of 5 and 65.
  • Patients who are pregnant or nursing during the study period, or who plan to become pregnant.
  • Patients who are unable to have tonsil injections due to chronic tonsillitis, small tonsils, prior tonsillectomy, etc.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yu Xu, Doctor contact

+8615927088198

xuy@whu.edu.cn

Tian Gu, Master contact

+8615515283168

gutian@whu.edu.cn

China1 site, 1 recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

    Yu Xu, Doctor, +8615927088198, xuy@whu.edu.cn

    Tian Gu, Master, +8615515283168, gutian@whu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Study on the Efficacy and Safety of Intratonsillar Immunotherapy for Allergic Rhinitis

This is a prospective, open-label, positive parallel controlled, blinded endpoint clinical study designed to compare the safety and efficacy of "Intratonsillar Immunotherapy of Standardized Dust Mite Allergen Extracts (Novo Helisen-Depot, Allergopharma, Merck, Germany)" with Subcutaneous Immunotherapy in patients with "Dust Mite Allergic Rhinitis."

Participants will be evaluated for safety and efficacy throughout the entire three-year period.

Read the detailed description

Background:

Allergic Rhinitis (AR) presents both nasal and non-nasal symptoms. The global incidence of AR is rising, causing a significant burden. Seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) are the two related clinical divisions of AR. Allergen immunotherapy (AIT) is a treatment involving the injection of specific allergens into the body. Studies have evaluated the effectiveness and safety of subcutaneous (SCIT), sublingual (SLIT), and intra-lymphatic immunotherapy (ILIT). The mechanisms underlying AIT involve both innate and acquired immunity. AIT modulates the activity of various immune cells, including dendritic cells, innate lymphoid cells (ILCs), and regulatory T cells (Tregs).

Intra-lymphatic inoculation (ILIT) has been studied in animals for its ability to improve T cell response to antigens. Studies have found that direct injection of antigens into lymph nodes can lead to improved T cell response and more efficient delivery of the antigen to subcutaneous lymph nodes. ILIT has been effective in treating atopic dermatitis, producing targeted IgG antibodies, enhancing lymphocyte responses, and treating viral and tumor challenges. It has also been effective in treating allergies and reducing symptoms of allergic rhinitis in mice. Studies have found ILIT to be effective in treating atopic dermatitis in dogs caused by common allergens and insect bite hypersensitivity in horses caused by biting midges. In general, animal studies support the use of ILIT as a safe and effective means to induce IgG and T cell responses with fewer treatments and lower doses compared to subcutaneous injection across a range of species.

Objectives:

The primary objective is to explore the efficacy, clinical value, and possible mechanism of action of Intratonsillar Immunotherapy (ITIT) by recording and analyzing the questionnaire scores after ITIT versus SCIT, while comparing the trend of bio-indicator changes in these two treatments.

Primary Endpoint:

Combined Symptom and Medication Score (CSMS): CSMS serves as the primary efficacy endpoint, tracking changes in participant symptoms and assessing the sustainability and stability of treatment effects. It comprises:

Allergen-induced symptom score: Scored from 0 (no symptoms) to 3 (most severe symptoms) for nasal congestion, rhinorrhea, nasal itching, sneezing, eye itching, and tearing, with the average yielding the symptom score (SS).

Emergency medication use related to allergy symptoms: Assigned points based on antihistamine (1 point/day), nasal corticosteroid (2 points/day), and oral corticosteroid (3 points/day) usage, with the highest value determining the medication score (MS).

CSMS (0-6) = SS (0-3) + MS (0-3). Recorded at baseline and 1, 2, 3, 6, 12, 24, and 36 months post-dust mite extract treatment.

Adverse Reactions: Participants were observed for 30 minutes post-injection and encouraged to report any adverse events during follow-up. Adverse reactions were classified as local (LR) or systemic (SR) according to the World Allergy Organization Subcutaneous Immunotherapy Response Classification System. Detailed records included occurrence time, number of injections, clinical manifestations, and management measures.

Study Population:

A total of 120 screened participants will be required to enroll 60 subjects in each group, with an age range of 5-65 years.

Sites/Facilities Enrolling Participants:

Renmin Hospital of Wuhan University will recruit participants.

Description of Study Intervention:

In this study, participants who meet the enrollment criteria will be randomly assigned to two groups. The random assignment will be performed by an independent investigator using a computer-generated sequence of random numbers. The assignment process will be conducted before participants are enrolled to ensure fairness and randomness in the grouping. Each group will be assigned an equal number of participants to ensure the objectivity and comparability of the studies.

Due to the obvious differences between the treatment methods of the experimental group and the control group, it is difficult to blind the subjects, researchers, and evaluators. Therefore, a non-blind experimental design is adopted. To minimize bias, blind data review will be employed.

Being tested
Intratonsillar immunotherapy (ITIT), Subcutaneous immunotherapy (SCIT)
Keywords
Allergic rhinitis, Intratonsillar, Allergen immunotherapy, Standardized dust mite allergen extracts
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intratonsillar immunotherapy (ITIT)Procedure or surgery

    During injection, the operator needs to gently shake the injection bottle about 20 times, the drug must be mixed to ensure the consistency of allergen concentration, and carefully check the patient's name and concentration on the bottle. Allergy extracts should not be injected intravenously, so the syringe will be aspirated to avoid inadvertent intravascular injection. Before each injection, after inserting the needle into the selected tonsil, before injecting the dose, the investigator will slightly pull the plunger of the syringe. If blood returns from the syringe, the syringe, and its contents will be discarded. The other tonsil will be selected and a new syringe will be prepared.

  • Subcutaneous immunotherapy (SCIT)Procedure or surgery

    Injection requires shaking bottle 20x to mix drug for consistency. Verify patient name \& concentration. Use 1 ml skin test syringe for deep subcutaneous injection at 45° angle, 1 cm into outer upper arm. Lift skin folds for deeper injection, avoid subcutaneous, muscular or intravascular. Inject slowly, 1 min for 1 ml. Avoid shallow injections which may cause local side effects. Alternate between left \& right arm for 5 min after injection for compression.

Study groups in NCT06523478
Study groupRoleWhat they receive
Intratonsillar Immunotherapy (ITIT) groupExperimentalThe intervention of ITIT will be a series of 3 injections of a commercially-available standardized dust mite allergen extracts (Novo Helisen-Depot, Allergopharma, Merck, Germany) given every four weeks into tonsil through guidance using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. The specific doses are 5 TU (0.1 ml, the first injection), 50 TU (0.1 ml, the second injection), and 50 TU (0.1 ml, the third injection). Before each injection, patients will take one tablet of antihistamine.
Receives: Procedure: Intratonsillar immunotherapy (ITIT)
Subcutaneous Immunotherapy (SCIT) groupActive comparatorThe same drugs will be used in active comparator. SCIT consists of two stages: the accumulation stage and the maintenance stage. During the initial 14 weeks, patients will receive sequential subcutaneous injections as follows: (1) 1st vial: 0.1 mL, 0.2 mL, 0.4 mL, and 0.8 mL; (2) 2nd vial: 0.1 mL, 0.2 mL, 0.4 mL, and 0.8 mL; (3) 3rd vial: 0.1 mL, 0.2 mL, 0.4 mL, 0.6 mL, 0.8 mL, and 1.0 mL of allergen, achieving a maintenance dose of 5000 TU. Subsequently, maintenance therapy involves subcutaneous injections of 5000 TU (1.0 mL, 3rd vial) every 4-6 weeks. The intervention process before and after each injection is similar to that of the ITIT group.
Receives: Procedure: Subcutaneous immunotherapy (SCIT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined Symptom and Medication Score (CSMS)

    Combined Symptom and Medication Score (CSMS) serves as the primary efficacy endpoint, tracking changes in participant symptoms and assessing the sustainability and stability of treatment effects. It comprises:

    Allergen-induced symptom score: Scored from 0 (no symptoms) to 3 (most severe symptoms) for nasal congestion, rhinorrhea, nasal itching, sneezing, eye itching, and tearing, with the average yielding the symptom score (SS).

    Emergency medication use related to allergy symptoms: Assigned points based on antihistamine (1 point/day), nasal corticosteroid (2 points/day), and oral corticosteroid (3 points/day) usage, with the highest value determining the medication score (MS).

    CSMS (0-6) = SS (0-3) + MS (0-3). Recorded at baseline and 1, 2, 3, 6, 12, 24, and 36 months post-dust mite extract treatment.

    Measured: Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

  2. Number of Participants with Local or Systemic Adverse Reactions

    Participants will be observed for 30 minutes post-injection and encouraged to report any adverse events during follow-up. Adverse reactions are classified as local reaction (LR) or systemic reaction (SR) according to the World Allergy Organization Subcutaneous Immunotherapy Response Classification System. Detailed records include occurrence time, number of injections, clinical manifestations, and management measures.

    Measured: After each treatment. Up to 36 months

Secondary outcomes (7)

  1. Visual Analog Scale (VAS)

    Pain perception of allergy symptoms during treatment will be evaluated using a scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain.

    Measured: Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

  2. Absolute Value and Percentage of Blood Leukocytes

    Changes in blood eosinophil absolute value (EOS), eosinophil percentage (EOS%), basophil absolute value (BAS), and basophil percentage (BAS%) will be evaluated.

    Measured: Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

  3. Concentration of Key Serum Cytokines

    Changes in key serum cytokines, including TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10, and IL-17, will be evaluated at the same intervals as CSMS.

    Measured: Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

  4. Concentration of Serum Immune Globulins

    Changes in serum total IgE (tIgE), IgA, IgG, and specific IgE (sIgE) will be evaluated at the same intervals as CSMS.

    Measured: Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

  5. Proportion of Blood T Cell Differentiation

    Changes in the proportion of blood T cell differentiation (Th, Tfh, Tfr, Treg, Tfc, Tex, etc.) will be evaluated.

    Measured: Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

  6. RQLQ

    Administration of questionnaires, the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).

    Measured: Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

  7. Concentration of FeNO

    Change of FeNO

    Measured: Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start29 Apr 2024
  3. Primary completion29 Apr 2028 (estimated)
  4. Study completion29 Apr 2028 (estimated)

Resources

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
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06523478
Sponsor's protocol ID
WDRY2024-K097
Other IDs
2021-1-X-2
Acronym
ITITFAR
Status last verified
Jul 2024
First submitted
18 Jul 2024
Last updated
26 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Two years after the completion of the trial, data will be published on the EDC of Metz Medical (https://edc-cloud.medsci.cn/).

Publications

  • Waage J, Standl M, Curtin JA, Jessen LE, Thorsen J, Tian C, Schoettler N; 23andMe Research Team; AAGC collaborators; Flores C, Abdellaoui A, Ahluwalia TS, Alves AC, Amaral AFS, Anto JM, Arnold A, Barreto-Luis A, Baurecht H, van Beijsterveldt CEM, Bleecker ER, Bonas-Guarch S, Boomsma DI, Brix S, Bunyavanich S, Burchard EG, Chen Z, Curjuric I, Custovic A, den Dekker HT, Dharmage SC, Dmitrieva J, Duijts L, Ege MJ, Gauderman WJ, Georges M, Gieger C, Gilliland F, Granell R, Gui H, Hansen T, Heinrich J, Henderson J, Hernandez-Pacheco N, Holt P, Imboden M, Jaddoe VWV, Jarvelin MR, Jarvis DL, Jensen KK, Jonsdottir I, Kabesch M, Kaprio J, Kumar A, Lee YA, Levin AM, Li X, Lorenzo-Diaz F, Melen E, Mercader JM, Meyers DA, Myers R, Nicolae DL, Nohr EA, Palviainen T, Paternoster L, Pennell CE, Pershagen G, Pino-Yanes M, Probst-Hensch NM, Ruschendorf F, Simpson A, Stefansson K, Sunyer J, Sveinbjornsson G, Thiering E, Thompson PJ, Torrent M, Torrents D, Tung JY, Wang CA, Weidinger S, Weiss S, Willemsen G, Williams LK, Ober C, Hinds DA, Ferreira MA, Bisgaard H, Strachan DP, Bonnelykke K. Genome-wide association and HLA fine-mapping studies identify risk loci and genetic pathways underlying allergic rhinitis. Nat Genet. 2018 Aug;50(8):1072-1080. doi: 10.1038/s41588-018-0157-1. Epub 2018 Jul 16.

    PubMed 30013184

  • Skoner DP. Allergic rhinitis: definition, epidemiology, pathophysiology, detection, and diagnosis. J Allergy Clin Immunol. 2001 Jul;108(1 Suppl):S2-8. doi: 10.1067/mai.2001.115569.

    PubMed 11449200

  • Smith JM, Pizarro YA. Hyposensitization with extracts of Dermatophagoides pteronyssinus and house dust. Clin Allergy. 1972 Sep;2(3):281-3. doi: 10.1111/j.1365-2222.1972.tb01291.x. No abstract available.

    PubMed 4643787

  • James C, Bernstein DI. Allergen immunotherapy: an updated review of safety. Curr Opin Allergy Clin Immunol. 2017 Feb;17(1):55-59. doi: 10.1097/ACI.0000000000000335.

    PubMed 27906697

  • Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.

    PubMed 19001265

  • Zimmer A, Bouley J, Le Mignon M, Pliquet E, Horiot S, Turfkruyer M, Baron-Bodo V, Horak F, Nony E, Louise A, Moussu H, Mascarell L, Moingeon P. A regulatory dendritic cell signature correlates with the clinical efficacy of allergen-specific sublingual immunotherapy. J Allergy Clin Immunol. 2012 Apr;129(4):1020-30. doi: 10.1016/j.jaci.2012.02.014.

    PubMed 22464673

  • Swamy RS, Reshamwala N, Hunter T, Vissamsetti S, Santos CB, Baroody FM, Hwang PH, Hoyte EG, Garcia MA, Nadeau KC. Epigenetic modifications and improved regulatory T-cell function in subjects undergoing dual sublingual immunotherapy. J Allergy Clin Immunol. 2012 Jul;130(1):215-24.e7. doi: 10.1016/j.jaci.2012.04.021. Epub 2012 Jun 5.

    PubMed 22677046

  • Rosskopf S, Jahn-Schmid B, Schmetterer KG, Zlabinger GJ, Steinberger P. PD-1 has a unique capacity to inhibit allergen-specific human CD4+ T cell responses. Sci Rep. 2018 Sep 10;8(1):13543. doi: 10.1038/s41598-018-31757-z.

    PubMed 30201974

  • Shamji MH, Larson D, Eifan A, Scadding GW, Qin T, Lawson K, Sever ML, Macfarlane E, Layhadi JA, Wurtzen PA, Parkin RV, Sanda S, Harris KM, Nepom GT, Togias A, Durham SR. Differential induction of allergen-specific IgA responses following timothy grass subcutaneous and sublingual immunotherapy. J Allergy Clin Immunol. 2021 Oct;148(4):1061-1071.e11. doi: 10.1016/j.jaci.2021.03.030. Epub 2021 Apr 2.

    PubMed 33819508

  • JUILLARD G, BUBBERS J E. Experimental intra-lymphatic immunotherapy (ILI) of canine allergic disease[C/OL]. 1983[2023-02-12]. https://www.semanticscholar.org/paper/Experimental-intra-lymphatic-immunotherapy-(ILI)-of-Juillard-Bubbers/3d454bcc0cb13e5375ac58a9f415672a0c6b609c.

  • Sigel MB, Sinha YN, VanderLaan WP. Production of antibodies by inoculation into lymph nodes. Methods Enzymol. 1983;93:3-12. doi: 10.1016/s0076-6879(83)93031-8.

    PubMed 6346012

  • Maloy KJ, Erdmann I, Basch V, Sierro S, Kramps TA, Zinkernagel RM, Oehen S, Kundig TM. Intralymphatic immunization enhances DNA vaccination. Proc Natl Acad Sci U S A. 2001 Mar 13;98(6):3299-303. doi: 10.1073/pnas.051630798. Epub 2001 Feb 27.

    PubMed 11248073

  • Johansen P, Haffner AC, Koch F, Zepter K, Erdmann I, Maloy K, Simard JJ, Storni T, Senti G, Bot A, Wuthrich B, Kundig TM. Direct intralymphatic injection of peptide vaccines enhances immunogenicity. Eur J Immunol. 2005 Feb;35(2):568-74. doi: 10.1002/eji.200425599.

    PubMed 15682446

  • Martinez-Gomez JM, Johansen P, Erdmann I, Senti G, Crameri R, Kundig TM. Intralymphatic injections as a new administration route for allergen-specific immunotherapy. Int Arch Allergy Immunol. 2009;150(1):59-65. doi: 10.1159/000210381. Epub 2009 Apr 2.

    PubMed 19339803

  • Kreiter S, Selmi A, Diken M, Koslowski M, Britten CM, Huber C, Tureci O, Sahin U. Intranodal vaccination with naked antigen-encoding RNA elicits potent prophylactic and therapeutic antitumoral immunity. Cancer Res. 2010 Nov 15;70(22):9031-40. doi: 10.1158/0008-5472.CAN-10-0699. Epub 2010 Nov 2.

    PubMed 21045153

Questions about this trial

What is this clinical trial studying?

A study testing Intratonsillar immunotherapy (ITIT) and Subcutaneous immunotherapy (SCIT) in people with Allergic Rhinitis, run by Xu Yu 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 13 inclusion and 25 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 26 Jul 2024. 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?

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 Yu Xu, Doctor (+8615927088198, xuy@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined Symptom and Medication Score (CSMS) (time frame: Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months). 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 NCT06523478, which also lists 23 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 26 Jul 2024.

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