Effects of Bromelain and Boswellia Serrata Casperome With Centella Asiatica and Vitamins on Edema, Paresthesia and Postoperative Pain After Quadrantectomy With or Without Sentinel Lymph Node Biopsy.
NCT ID: NCT04669119
Last Updated: 2020-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2020-12-31
2022-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Methods: 120 patients will be randomized into 3 groups: A, treated with Bromelain/Boswellia Serrata Casperome and Centella Asiatica with Vitamins for 30 days; B, treated with Bromelain/Bosswellia Serrata and placebo for 30 days; C, treated with 2 placebos. Inclusion criteria: adult (\>18 years) patients with breast cancer undergoing quadrantectomy with or without sentinel lymph node biopsy. Exclusion criteria: diabetic neuropathy, previous breast/chest surgeries, allergies to studied drugs, severe kidney failure, alcohol and toxics addiction, axillary lymphadenectomy. Patients will be studied through ultrasound examination for edema and collections, VAS and DN4 for pain, during 30 postoperative days. Patients will also be studied through psychological and physiatric evaluations. Wilcoxon, T student, Chi-Squared tests will be used to evaluate the outcomes. STATA 14 (StataCorp LP, College Station, Tex, USA) will be used for the analysis. P\<0.05 will be statistically significant.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Complex Decongestıve Therapy on Oxıdatıve Stress and Antıoxıdants
NCT06572098
Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
NCT06574022
Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia
NCT05829707
What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Surgery
NCT05823467
Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block
NCT06300099
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
Bromelain/Boswellia Serrata Casperome
Dietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton
Centella Asiatica/Vitamins
Dietary supplement already commercialized based on Centella Asiatica/Vitamins (Arm B), called Kardinal V by Agaton
Bromelain/Boswellia Serrata Casperome and placebo
Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and placebo
Bromelain/Boswellia Serrata Casperome
Dietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton
Placebo
Placebo
Placebo
Patients treated post-operatively for 30 days with placebo
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bromelain/Boswellia Serrata Casperome
Dietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton
Centella Asiatica/Vitamins
Dietary supplement already commercialized based on Centella Asiatica/Vitamins (Arm B), called Kardinal V by Agaton
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Previous breast/chest surgery
* Allergies to studied drugs
* Severe kidney failure
* Alcohol and toxics addiction
* Axillary lymphadenectomy
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Bari Aldo Moro
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Angela Gurrado
Prof.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020/6422
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.