Evaluation of the efficacy and tolerance of a throat spray based on essential oil of Cymbopogon giganteus
| ISRCTN | ISRCTN10896729 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10896729 |
| Secondary identifying numbers | phyto/essaiclin 001/22 |
- Submission date
- 03/02/2023
- Registration date
- 11/03/2023
- Last edited
- 22/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Cymbopogon giganteus essential oil has long been used in traditional medicine to treat various respiratory conditions, including sore throat. To date, no modern formulation of this essential oil is available to treat sore throat. The objective of this study is therefore to evaluate the effectiveness and safety of use of a formulation of this oil in the form of a mouth spray in order to treat sore throat.
Who can participate?
137 volunteer participants, men and women, aged 18 to 65 years, who came for consultation at the CHDZ SURULERE in Cotonou, having been diagnosed with sore throat, will be recruited.
What does the study involve?
After signing the free and informed consent, they will be given the spray and the use and treatment regimen will be explained to them. They will be followed on an outpatient basis. Every day, we will call them to find out about their state of health and the adverse effects they may have had. On the 4th day, they will be reviewed and examined at the health center to assess efficacy and tolerance. In case of signs of aggravation, they will be immediately treated according to local standards. In case of improvement, they will continue the treatment until the 7th day. We will see them again on the 8th day for a final exit exam.
What are the possible benefits and risks of participating?
The advantage of participating in this study is their contribution to the development of local herbal medicines. the potential downside is that they will be followed on an outpatient basis, but the entire research team is informed and ready to support them in the event of serious adverse effects.
Where is the study run from?
Hospital and University Center of SURU-LERE area of Cotonou (Benin)
When is the study starting and how long is it expected to run for?
May 2022 to August 2023
Who is funding the study?
Pharmacy Training and Research Unit of the Faculty of Health Sciences of the University of Abomey-Calavi (Benin)
Who is the main contact?
Prof Habib Ganfon, hganfon@yahoo.fr
Contact information
Principal Investigator
01 Bp 188 Cotonou Campus du Champ de Foire
Cotonou
494 BP
Benin
 ORCID ID |
0000-0002-1815-154X |
|---|---|
| Phone | +229 66196995 |
| hganfon@yahoo.fr |
Study information
| Study design | Prospective interventional non randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Evaluation of the efficacy and tolerance of a throat spray based on essential oil of Cymbopogon giganteus on sore throat at the Hospital and University Center of SURU-LERE area of Cotonou |
| Study objectives | Mouthwash based on Cymbopogon giganteus essential oil is effective and well tolerated for treating sore throat |
| Ethics approval(s) | Approved 22/12/2022, Research Ethics Committee of the ISBA (Institute of Applied Bio-medical Sciences, 01 B.P., COTONOU, République du Bénin; +229 21 30 55 65; isba@intnet.bj), ref: 157 |
| Health condition(s) or problem(s) studied | Sore throat |
| Intervention | Participants will be treated with the traditional plant preparation as mouthwash for 7 days |
| Intervention type | Supplement |
| Primary outcome measure | Clinical signs of sore throat at baseline and 3 days measured by the treating physician: 1. Throat pain at the level of the oropharynx 2. Fever 3. Redness of the oropharynx 4. Oropharyngeal exudate 5. Hypertrophy of the tonsil 6. Lymphoid formation on the pharyngo-posterior wall 7. Cervical adenopathy |
| Secondary outcome measures | 1. Clinical signs of sore throat at 7 days measured by the treating physician 2. Tolerance of the throat spray measured by patient report at 7 days |
| Overall study start date | 01/05/2022 |
| Completion date | 31/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | Current participant inclusion criteria as of 22/10/2024: 1. 18 to 65 years old 2. Sign the informed consent form 3. Outpatient with sore throat with the 7 clinical signs: Throat pain in the oropharynx Fever, Oropharyngeal redness, Oropharyngeal exudate, Tonsil hypertrophy, Lymphoid formation on the posterior pharyngeal wall, Cervical lymphadenopathy Previous participant inclusion criteria: 1. 18 to 50 years old 2. Sign the informed consent form 3. Outpatient with sore throat with the 7 clinical signs: Throat pain in the oropharynx Fever, Oropharyngeal redness, Oropharyngeal exudate, Tonsil hypertrophy, Lymphoid formation on the posterior pharyngeal wall, Cervical lymphadenopathy |
| Key exclusion criteria | 1. Having ongoing conventional treatment for angina 2. Having a known allergy to one of the constituents of the investigational product 3. Pregnant women 4. People with respiratory problems |
| Date of first enrolment | 06/02/2023 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- Benin
Study participating centre
Cotonou
06BP 2664
Benin
Sponsor information
University/education
01 Bp 188 Cotonou Campus du Champ de Foire
Cotonou
494
Benin
| Phone | +229 66196995 |
|---|---|
| fss_cotonou@yahoo.fr |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request hganfon@yahoo.fr |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 20/02/2023 | No | No | ||
| Other unpublished results | 22/10/2024 | No | No |
Additional files
Editorial Notes
22/10/2024: The following changes were made:
1. Results added.
2. The upper age limit was updated to 65 years and the participant inclusion criteria and plain English summary were amended to reflect that change.
3. The target number of participants was changed from 137 to 30.
4. The total final enrolment was added.
20/02/2023: Trial's existence confirmed by Research Ethics Committee of the ISBA.
