Clinical toxicology of Melagrião® syrup in healthy volunteers
| ISRCTN | ISRCTN15486061 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15486061 |
| Protocol serial number | Protocol 255/07 |
| Sponsor | Federal University of Ceará |
| Funder | Investigator initiated and funded |
- Submission date
- 19/10/2017
- Registration date
- 13/03/2018
- Last edited
- 09/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Melagrião® is a medicine made from six medicinal plants with known action in the respiratory tract (breathing system): Mikania glomerata, Cephaelis ipecacuanha, Aconitum napellus, Polygala senega, Myroxylon balsamum and Nasturtium officinale. The aim of this study is to evaluate the safety and the genotoxic (DNA-damaging) potential of Melagrião® syrup in healthy volunteers.
Who can participate?
Healthy volunteers aged 18-50
What does the study involve?
Participants are randomly allocated to take either Melagrião® syrup or a placebo (dummy medicine) as four daily doses for 28 uninterrupted days. Blood samples are taken and clinical and laboratory tests are performed at the start of the study, during the treatment period and at the end of the study.
What are the possible benefits and risks of participating?
If it is found to be safe this medication will be of great value for the treatment of respiratory (lung) diseases. Melagrião® can cause some gastric (stomach) disorders, vomiting and diarrhoea. Blood sampling is a safe procedure and may cause mild discomfort as well as a small purple spot that often resolves without major problems.
Where is the study run from?
Federal University of Ceara (Brazil)
When is the study starting and how long is it expected to run for?
May 2007 to October 2007
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Sérgio Pereira
luiss@unifor.br
Contact information
Public
Av. Washington Soares, 1321 - Course of Dentistry - University of Fortaleza
Fortaleza
60811905
Brazil
| Phone | +55 (85) 34773200 |
|---|---|
| luiss@unifor.br |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind single-centre placebo-controlled randomized parallel trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Clinical toxicology of Melagrião® syrup in healthy volunteers: a randomized parallel trial |
| Study objectives | Melagrião® syrup is safe to use in healthy volunteers. |
| Ethics approval(s) | Research Ethics Committee of the Federal University of Ceará, accredited by the National Health Council / MS (Protocol 255/07), 11/08/2007 |
| Health condition(s) or problem(s) studied | Respiratory diseases |
| Intervention | 48 adult subjects were randomly divided into two groups: Placebo (n=24) and Melagrião® (n=24). In order to have a uniformity of the groups the volunteers were randomized by means of lottery, using sealed envelopes. The subjects were treated for 28 uninterrupted days with 120 mL of Melagrião® or Placebo, divided into four daily doses. Clinical and laboratory evaluations were performed in the pre-study, during the treatment period and after the end of the study. The genotoxicity of Melagrião® was investigated through the comet assay. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Melagrião® |
| Primary outcome measure(s) |
1. The genotoxicity of Melagrião® investigated through the comet assay at baseline and after 28 days |
| Key secondary outcome measure(s) |
Adverse effects assessed by questionnaire every 7 days over the 28 days |
| Completion date | 30/10/2007 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 48 |
| Key inclusion criteria | 1. Men and women aged 18-50 years 2. Body mass index (BMI) greater than or equal to 19 and less than or equal to 30 3. Good health conditions or without significant diseases, to medical judgment, according to the rules defined in the Protocol, and evaluations to which it was submitted: clinical history, pressure and pulse measurements, physical examination, ECG and complementary laboratory tests |
| Key exclusion criteria | Positive response to any of the following criteria excluded the study volunteer: 1. Hypersensitivity to components of the formulation under study or history of serious adverse reactions history or presence of liver or gastrointestinal diseases or another condition that interferes with the absorption, distribution, excretion or metabolism of the drug 2. Use of maintenance therapy with any drug except oral contraceptive; history of liver, kidney, lung, gastrointestinal, epileptic, haematological or psychiatric disease 3. Hypo or hypertension of any etiology that needs pharmacological treatment 4. Have a history or had myocardial infarction, angina and/or heart failure 5. Smokers (more than 10 cigarettes per day) 6. Ingestion of more than 5 cups of coffee or tea per day 7. Use of alcohol or illicit drugs; use of regular medication within 4 weeks prior to initiation of treatment of this study 8. Use of any medication within one week before starting treatment of this study 9. Hospitalization for any reason during the eight weeks prior to the start of treatment of this study 10. Pregnant or breastfeeding 11. Treatment within three months prior to the study with any drug known to have a well-defined toxic potential in large organs 12. Participation in any experimental study 13. Ingestion of any experimental drug within the three months preceding the start of this study 14. Donation or loss of 450 mL or more of blood within three months prior to initiation of treatment of this study or donation of more than 1500 mL within 12 months prior to initiation of treatment in this study |
| Date of first enrolment | 12/08/2007 |
| Date of final enrolment | 30/08/2007 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Sérgio Luís da Silva Pereira (luiss@unifor.br). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
