Burning Mouth SyndromePhase 3NCT04189367
Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine
A Phase 3 study testing Traditional Chinese Medicine and Western medicine in people with Burning Mouth Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is an open-label randomized controlled trial of the efficacy of the integration of Traditional Chinese medicine (TCM) and western medicine based on TCM syndrome differentiation. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- Traditional Chinese Medicine and Western medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jun 2020to Dec 2022
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who signed the informed consent
- The clinical diagnosis was primary or secondary type BMS patient
- ≥ 20-year-old
- Female
- Willing to take Traditional Chinese Medicine
Who cannot join
- History of an angiotensin-converting enzyme inhibitor (ACEI) taking
- Autoimmune disease
- Poor kidney function
- Unwilling to take Traditional Chinese Medicine
- Male
- Participants who have been treated with TCM or Acupuncture within a month
- Participants who have been treated with medicine for burning mouth syndrome
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital
Taipei, 105
Meng Ling Chiang, +8867135211 ext. 8212, mlingchiang@gmail.com
About this study
Official title: A Prospective Study on the Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine(TCM) and Western Medicine Based on TCM Syndrome Differentiation
This study is an open-label randomized controlled trial of the efficacy of the integration of Traditional Chinese medicine (TCM) and western medicine based on TCM syndrome differentiation. The hypothesis is (1) TCM model can identify the primary and secondary type burning mouth syndrome (BMS); (2) TCM model can identify BMS after treatment with western medicine; (3) There is a positive effect of TCM in treating BMS.
Read the detailed description
BMS patients will be classified into the primary type and secondary type according to the patients' clinical histories and laboratory examinations. The secondary BMS only includes nutritional deficiency, such as Vitamin B12, folate, iron, zinc. At first, the primary BMS patients are treated with 0.5~1 mg clonazepam every day before sleep for 8 weeks. The secondary BMS patients are treated with vitamin B12, folate, iron and zinc according to the patient's nutritional deficiency status. Patients with no improvement or little improvement after the first stage of Western medicine management will be arranged to receive traditional Chinese medicine (TCM) therapy. All patients will receive the TCM model, including TCM doctor, automatic tongue diagnostic system (ATDS), and body constitutional questionnaire (BCQ), evaluations.
The results of this study are expected to understand whether adjuvant TCM treatment of BMS can improve treatment efficacy. The investigators will understand whether the constitution pattern may be a predictive indicator of efficacy for western BMS. The investigators will find a diagnostic indicator for the TCM model and apply it to the assessment of the prognosis of BMS patients.
- Conditions
- Burning Mouth Syndrome
- Being tested
- Traditional Chinese Medicine, Western medicine
- Keywords
- Burning Mouth Syndrome, Traditional Chinese Medicine, Automatic Tongue Diagnosis System, Body Constitution Questionnaire
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese MedicineDrug
Also called TCM
One bag of " Qingre Liangkou Ningxin Fang" at a time, three times a day for 12 weeks.
Western medicineDrug
Also called WM
Western medicine includes:
- clonazepam 0.5mg every day before sleep or twice a day for 12 weeks
- Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Western medicine + TCM | Experimental | 1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent.
2. Blood test and physiological assessment, and do the TCM model.
3. Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks
4. Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks.
5. TCM therapy: one bag of "Qingre Liangkou Ningxin Fang", three times a day for 12 weeks. Receives: Drug: Traditional Chinese Medicine; Drug: Western medicine |
| Western medicine | Active comparator | 1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent.
2. Blood test and physiological assessment, and do the TCM model.
3. Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks
4. Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks. Receives: Drug: Western medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global perceived effect (GPE)
GPE is defined as symptoms improvement change compared to baseline, 1=worse; 2=no difference; 3=mild improvement; 4=much improvement; 5=totally improvement.
The responder is defined to be the subject occurring at least one of the defined effective events: (1) GPE ≥2 after treatment for burning sensation; (2) GPE ≥2 after treatment for sleep; (3) GPE ≥2 after treatment for dry mouth; (4) GPE ≥2 after treatment for taste change. (5) GPE ≥2 after treatment for her other uncomfortable.
Measured: after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks
Numerical Rating Scale (NRS)
NRS is defined as 0=no pain, scale from 1 to 10 (mild to very severe).
The responder is defined to be the subject occurring at least one of the defined effective events: (1) NRS ≤ 1 after treatment; (2) NRS change from baseline ≥ 50% after treatment.
Measured: baseline, after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start20 Jun 2020 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, MENG LING CHIANG, DDS, Chang Gung Memorial Hospital
- Investigators
- Meng-Ling Chiang, DDS,MS, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189367
- Sponsor's protocol ID
- IRB201802359A3C601
- Other IDs
- NMRPG3J6101
- Status last verified
- Jun 2020
- First submitted
- 3 Dec 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grushka M, Epstein JB, Gorsky M. Burning mouth syndrome. Am Fam Physician. 2002 Feb 15;65(4):615-20.
PubMed 11871678Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
PubMed 23771276Jaaskelainen SK. Is burning mouth syndrome a neuropathic pain condition? Pain. 2018 Mar;159(3):610-613. doi: 10.1097/j.pain.0000000000001090.
PubMed 29257770Liu YF, Kim Y, Yoo T, Han P, Inman JC. Burning mouth syndrome: a systematic review of treatments. Oral Dis. 2018 Apr;24(3):325-334. doi: 10.1111/odi.12660. Epub 2017 Mar 30.
PubMed 28247977McMillan R, Forssell H, Buchanan JA, Glenny AM, Weldon JC, Zakrzewska JM. Interventions for treating burning mouth syndrome. Cochrane Database Syst Rev. 2016 Nov 18;11(11):CD002779. doi: 10.1002/14651858.CD002779.pub3.
PubMed 27855478Minguez-Sanz MP, Salort-Llorca C, Silvestre-Donat FJ. Etiology of burning mouth syndrome: a review and update. Med Oral Patol Oral Cir Bucal. 2011 Mar 1;16(2):e144-8. doi: 10.4317/medoral.16.e144.
PubMed 21217613Zakrzewska JM, Forssell H, Glenny AM. Interventions for the treatment of burning mouth syndrome. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD002779. doi: 10.1002/14651858.CD002779.pub2.
PubMed 15674897Adamo D, Sardella A, Varoni E, Lajolo C, Biasotto M, Ottaviani G, Vescovi P, Simonazzi T, Pentenero M, Ardore M, Spadari F, Bombeccari G, Montebugnoli L, Gissi DB, Campisi G, Panzarella V, Carbone M, Valpreda L, Giuliani M, Aria M, Lo Muzio L, Mignogna MD. The association between burning mouth syndrome and sleep disturbance: A case-control multicentre study. Oral Dis. 2018 May;24(4):638-649. doi: 10.1111/odi.12807. Epub 2018 Mar 13.
PubMed 29156085Cavalcanti DR, da Silveira FR. Alpha lipoic acid in burning mouth syndrome--a randomized double-blind placebo-controlled trial. J Oral Pathol Med. 2009 Mar;38(3):254-61. doi: 10.1111/j.1600-0714.2008.00735.x. Epub 2009 Jan 23.
PubMed 19175713Chang CM, Wu PC, Chiang JH, Wei YH, Chen FP, Chen TJ, Pan TL, Yen HR, Chang HH. Integrative therapy decreases the risk of lupus nephritis in patients with systemic lupus erythematosus: A population-based retrospective cohort study. J Ethnopharmacol. 2017 Jan 20;196:201-212. doi: 10.1016/j.jep.2016.12.016. Epub 2016 Dec 12.
PubMed 27974236Chang YY, Tsai YT, Lai JN, Yeh CH, Lin SK. The traditional Chinese medicine prescription patterns for migraine patients in Taiwan: a population-based study. J Ethnopharmacol. 2014 Feb 12;151(3):1209-1217. doi: 10.1016/j.jep.2013.12.040. Epub 2014 Jan 2.
PubMed 24389028Chen HY, Lin YH, Wu JC, Chen YC, Yang SH, Chen JL, Chen TJ. Prescription patterns of Chinese herbal products for menopausal syndrome: analysis of a nationwide prescription database. J Ethnopharmacol. 2011 Oct 11;137(3):1261-6. doi: 10.1016/j.jep.2011.07.053. Epub 2011 Aug 2.
PubMed 21824510Chen HY, Huang BS, Lin YH, Su IH, Yang SH, Chen JL, Huang JW, Chen YC. Identifying Chinese herbal medicine for premenstrual syndrome: implications from a nationwide database. BMC Complement Altern Med. 2014 Jun 27;14:206. doi: 10.1186/1472-6882-14-206.
PubMed 24969368Chen LL, Lin JS, Lin JD, Chang CH, Kuo HW, Liang WM, Su YC. BCQ+: a body constitution questionnaire to assess Yang-Xu. Part II: Evaluation of reliability and validity. Forsch Komplementmed. 2009 Feb;16(1):20-7. doi: 10.1159/000197770. Epub 2009 Feb 17.
PubMed 19295226Chen YL, Lee CY, Huang KH, Kuan YH, Chen M. Prescription patterns of Chinese herbal products for patients with sleep disorder and major depressive disorder in Taiwan. J Ethnopharmacol. 2015 Aug 2;171:307-16. doi: 10.1016/j.jep.2015.05.045. Epub 2015 Jun 9.
PubMed 26068429
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine(TCM) and Western Medicine Based on TCM Syndrome Differentiation
- ClinicalTrials.gov ID
- NCT04189367
- Acronym / sponsor ID
- IRB201802359A3C601
- Conditions
- Burning Mouth Syndrome
- Keywords
- Burning Mouth Syndrome, Traditional Chinese Medicine, Automatic Tongue Diagnosis System, Body Constitution Questionnaire
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 20 Jun 2020 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Dec 2019 (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.
This study is an open-label randomized controlled trial of the efficacy of the integration of Traditional Chinese medicine (TCM) and western medicine based on TCM syndrome differentiation. The hypothesis is (1) TCM model can identify the primary and secondary type burning mouth syndrome (BMS); (2) TCM model can identify BMS after treatment with western medicine; (3) There is a positive effect of TCM in treating BMS.
Detailed description
BMS patients will be classified into the primary type and secondary type according to the patients' clinical histories and laboratory examinations. The secondary BMS only includes nutritional deficiency, such as Vitamin B12, folate, iron, zinc. At first, the primary BMS patients are treated with 0.5~1 mg clonazepam every day before sleep for 8 weeks. The secondary BMS patients are treated with vitamin B12, folate, iron and zinc according to the patient's nutritional deficiency status. Patients with no improvement or little improvement after the first stage of Western medicine management will be arranged to receive traditional Chinese medicine (TCM) therapy. All patients will receive the TCM model, including TCM doctor, automatic tongue diagnostic system (ATDS), and body constitutional questionnaire (BCQ), evaluations.
The results of this study are expected to understand whether adjuvant TCM treatment of BMS can improve treatment efficacy. The investigators will understand whether the constitution pattern may be a predictive indicator of efficacy for western BMS. The investigators will find a diagnostic indicator for the TCM model and apply it to the assessment of the prognosis of BMS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Western medicine + TCM | Experimental | Drug: Traditional Chinese Medicine, Drug: Western medicine1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent. 2. Blood test and physiological assessment, and do the TCM model. 3. Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks 4. Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks. 5. TCM therapy: one bag of "Qingre Liangkou Ningxin Fang", three times a day for 12 weeks. |
| Western medicine | Active comparator | Drug: Western medicine1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent. 2. Blood test and physiological assessment, and do the TCM model. 3. Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks 4. Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who signed the informed consent
- The clinical diagnosis was primary or secondary type BMS patient
- ≥ 20-year-old
- Female
- Willing to take Traditional Chinese Medicine
Key exclusion criteria (7 listed)
- History of an angiotensin-converting enzyme inhibitor (ACEI) taking
- Autoimmune disease
- Poor kidney function
- Unwilling to take Traditional Chinese Medicine
- Male
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 |
|---|---|---|
| Traditional Chinese MedicineAlso: TCMOne bag of " Qingre Liangkou Ningxin Fang" at a time, three times a day for 12 weeks. | Drug | Western medicine + TCM |
| Western medicineAlso: WMWestern medicine includes: 1. clonazepam 0.5mg every day before sleep or twice a day for 12 weeks 2. Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks | Drug | Western medicine, Western medicine + TCM |
Primary outcome
Global perceived effect (GPE)
Time frame: after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks
GPE is defined as symptoms improvement change compared to baseline, 1=worse; 2=no difference; 3=mild improvement; 4=much improvement; 5=totally improvement. The responder is defined to be the subject occurring at least one of the defined effective events: (1) GPE ≥2 after treatment for burning sensation; (2) GPE ≥2 after treatment for sleep; (3) GPE ≥2 after treatment for dry mouth; (4) GPE ≥2 after treatment for taste change. (5) GPE ≥2 after treatment for her other uncomfortable.
Numerical Rating Scale (NRS)
Time frame: baseline, after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks
NRS is defined as 0=no pain, scale from 1 to 10 (mild to very severe). The responder is defined to be the subject occurring at least one of the defined effective events: (1) NRS ≤ 1 after treatment; (2) NRS change from baseline ≥ 50% after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 11871678Grushka M, Epstein JB, Gorsky M. Burning mouth syndrome. Am Fam Physician. 2002 Feb 15;65(4):615-20.
- Background: PubMed 23771276Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
- Background: PubMed 29257770Jaaskelainen SK. Is burning mouth syndrome a neuropathic pain condition? Pain. 2018 Mar;159(3):610-613. doi: 10.1097/j.pain.0000000000001090.
- Background: PubMed 28247977Liu YF, Kim Y, Yoo T, Han P, Inman JC. Burning mouth syndrome: a systematic review of treatments. Oral Dis. 2018 Apr;24(3):325-334. doi: 10.1111/odi.12660. Epub 2017 Mar 30.
- Background: PubMed 27855478McMillan R, Forssell H, Buchanan JA, Glenny AM, Weldon JC, Zakrzewska JM. Interventions for treating burning mouth syndrome. Cochrane Database Syst Rev. 2016 Nov 18;11(11):CD002779. doi: 10.1002/14651858.CD002779.pub3.
- Background: PubMed 21217613Minguez-Sanz MP, Salort-Llorca C, Silvestre-Donat FJ. Etiology of burning mouth syndrome: a review and update. Med Oral Patol Oral Cir Bucal. 2011 Mar 1;16(2):e144-8. doi: 10.4317/medoral.16.e144.
- Background: PubMed 15674897Zakrzewska JM, Forssell H, Glenny AM. Interventions for the treatment of burning mouth syndrome. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD002779. doi: 10.1002/14651858.CD002779.pub2.
- Results publication: PubMed 29156085Adamo D, Sardella A, Varoni E, Lajolo C, Biasotto M, Ottaviani G, Vescovi P, Simonazzi T, Pentenero M, Ardore M, Spadari F, Bombeccari G, Montebugnoli L, Gissi DB, Campisi G, Panzarella V, Carbone M, Valpreda L, Giuliani M, Aria M, Lo Muzio L, Mignogna MD. The association between burning mouth syndrome and sleep disturbance: A case-control multicentre study. Oral Dis. 2018 May;24(4):638-649. doi: 10.1111/odi.12807. Epub 2018 Mar 13.
- Results publication: PubMed 19175713Cavalcanti DR, da Silveira FR. Alpha lipoic acid in burning mouth syndrome--a randomized double-blind placebo-controlled trial. J Oral Pathol Med. 2009 Mar;38(3):254-61. doi: 10.1111/j.1600-0714.2008.00735.x. Epub 2009 Jan 23.
- Results publication: PubMed 27974236Chang CM, Wu PC, Chiang JH, Wei YH, Chen FP, Chen TJ, Pan TL, Yen HR, Chang HH. Integrative therapy decreases the risk of lupus nephritis in patients with systemic lupus erythematosus: A population-based retrospective cohort study. J Ethnopharmacol. 2017 Jan 20;196:201-212. doi: 10.1016/j.jep.2016.12.016. Epub 2016 Dec 12.
- Results publication: PubMed 24389028Chang YY, Tsai YT, Lai JN, Yeh CH, Lin SK. The traditional Chinese medicine prescription patterns for migraine patients in Taiwan: a population-based study. J Ethnopharmacol. 2014 Feb 12;151(3):1209-1217. doi: 10.1016/j.jep.2013.12.040. Epub 2014 Jan 2.
- Results publication: PubMed 21824510Chen HY, Lin YH, Wu JC, Chen YC, Yang SH, Chen JL, Chen TJ. Prescription patterns of Chinese herbal products for menopausal syndrome: analysis of a nationwide prescription database. J Ethnopharmacol. 2011 Oct 11;137(3):1261-6. doi: 10.1016/j.jep.2011.07.053. Epub 2011 Aug 2.
- 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.
Meng-Ling Chiang, DDS,MS principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Traditional Chinese Medicine and Western medicine in people with Burning Mouth Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Jun 2020. 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 Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng-Ling Chiang, DDS,MS (+8867135211 ext. 8212, mlingchiang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global perceived effect (GPE) (time frame: after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks). 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 NCT04189367, which also lists 45 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 16 Jun 2020.