UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051957 |
|---|---|
| Receipt number | R000059300 |
| Scientific Title | Homeopathy for chronic nonspecific low back pain: randomized, double-blind, crossover, placebo-controlled clinical trial investigating the efficacy of a lumbar vertebra biotherapic (BIOVERT trial) |
| Date of disclosure of the study information | 2023/08/30 |
| Last modified on | 2025/02/20 18:45:14 |
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Basic information
Public title
Homeopathy for chronic nonspecific low back pain
Acronym
BIOVERT (Bioactive Vertebra)
Scientific Title
Homeopathy for chronic nonspecific low back pain: randomized, double-blind, crossover, placebo-controlled clinical trial investigating the efficacy of a lumbar vertebra biotherapic (BIOVERT trial)
Scientific Title:Acronym
BIOVERT (Bioactive Vertebra)
Region
| South America |
Condition
Condition
Chronic nonspecific low back pain
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of biotherapic lumbar vertebra LM2 in the short-term management of nonspecific chronic low back pain and to estimate its therapeutic duration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Assessment of changes in self-reported pain levels using the Numeric Rating Scale (NRS) score, analysed with a random effects model across both treatment periods.
Key secondary outcomes
Assessment of changes in self-reported disability levels using the Oswestry Disability Index, analysed with a random effects model across both treatment periods. Pain and disability variations, evaluated by the NRS score and Oswestry Disability Index, respectively, after the first and second treatment periods. Adverse events assessed at weeks 2 and 8. Concomitant use of pain medications. Adherence, evaluated by the weight of medication returned/standard weight.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Homeopathy
Lumbar Vertebra LM2 oral solution: the participant must perform 10 succussions to the vial before each dose and administer 1 drop orally in the morning, afternoon, and evening of the solution derived from a globule of the dynamized biotherapic.
Lumbar Vertebra LM2 cream (30 g of base cream containing 10% of the same solution as above): the participant must apply and gently massage a thin layer of the cream onto the lumbar region before bedtime.
The clinical investigator can make dosage adjustments without unmasking, such as escalating the daily dosage to four times if initial response is not observed.
Interventions/Control_2
Placebo
30% hydroalcoholic solution: the participant must perform 10 succussions to the vial before each dose and administer 1 drop orally in the morning, afternoon, and evening.
Inert cream: the participant must apply and gently massage a thin layer of the cream (same base) onto the lumbar region before bedtime.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Women and men aged 20 to 60 years, clinically diagnosed with chronic non-specific low back pain by the study's physiotherapist, meeting all the following criteria:
Low back pain lasting at least three months and/or pain in at least half of the days in the past six months.
Pain localized between T12 and gluteal folds.
Pain intensity equal to or greater than three on a 10-unit Numeric Rating Scale (NRS); Oswestry Disability Index score higher than 14%.
Key exclusion criteria
Radicular pain or signs of radiculopathy and/or alerting clinical features indicating specific disorders of the lumbar spine, such as trauma, fever, malaise, night sweats, weight loss, history of cancer, HIV, chronic steroid use, injectable drug use, immunosuppression, relentless pain, urinary or fecal incontinence, saddle anesthesia, bilateral neurological symptoms, lower limb weakness; comorbidities that render the participant incapable of complying with study procedures; pregnancy, or puerperium (up to 60 days after delivery).
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ubiratan |
| Middle name | Cardinalli |
| Last name | Adler |
Organization
Universidade Federal de Sao Carlos (Sao Carlos Federal University) - Sao Carlos/SP/Brazil
Division name
Department of Medicine
Zip code
13565905
Address
Rodovia Washington Luiz, Km 235, Sao Carlos, SP, Brazil
TEL
00551633518340
ubiratanadler@ufscar.br
Public contact
Name of contact person
| 1st name | Ubiratan |
| Middle name | Cardinalli |
| Last name | Adler |
Organization
Sao Carlos Federal University
Division name
Department of Medicine
Zip code
13565905
Address
Rodovia Washington Luiz, Km 235, Sao Carlos, SP, Brazil
TEL
00551633518340
Homepage URL
https://www.ufscar.br/a-ufscar
ubiratanadler@ufscar.br
Sponsor or person
Institute
Center for Biological and Health Sciences/Sao Carlos Federal University
Institute
Department
Personal name
Funding Source
Organization
The researchers will fund the BIOVERT study. The Pharmacy HN-Cristiano of Sao Paulo kindly provided study medications and placebos.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Brazilian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Universidade Federal de Sao Carlos (UFSCar) Human Research Ethics Committee
Address
Rodovia Washington Luis km 235 Sao Carlos/SP 13.565-905
Tel
00551633519685
cephumanos@ufscar.br
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
February 26, 2024: we have included 59/60 participants, and the study protocol has been accepted for publication.
April 05, 2024: study protocol publication: https://pubmed.ncbi.nlm.nih.gov/38508222/
September 03, 2024: The last follow-up date has been anticipated to be September 30th.
February 20, 2025: all participants ended the study. Data analysis in progress.
Management information
Registered date
| 2023 | Year | 08 | Month | 21 | Day |
Last modified on
| 2025 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059300
