Community Pharmacy ServicesNCT06378099
Evaluation of the Effect of Consensus-based Protocols for the Treatment of Minor Ailments
A study testing Patient guided and followed by the pharmacist in people with Community Pharmacy Services, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Minor ailments are common, self-limited conditions unrelated to the patient's underlying health problems or adverse effects of their current medications. Minor ailment services are pharmacist-led interventions that provide patients with the most appropriate recommendation when unsure about the medication for a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Community Pharmacy Services
- What is being tested?
- Patient guided and followed by the pharmacist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteColombia
- Study dates
- 4 Dec 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Drugstores and drugstores/pharmacies:
- Establishments located in Medellin and Metropolitan area
- Establishments that have a Pharmacy Technician serving as the technical director.
- Establishments with electronic point-of-sale system for data collection.
- Commitment to participate for the full 10-month study period.
- Participants (patients):
Show all 10Show fewer
- Explicit consent to participate in the study.
- Are the direct consumers requesting the nonprescription drug (i.e., not requesting them on behalf of someone else).
- Present one of the five predefined potential MA that will be included in the study: influenza-like syndrome and catarrh, headache, common cold, sore throat, and menstrual pain or cramps.
- Have access to mobile phone for follow-upThe person requesting the OTC medication must be the end consumer of it.
Who cannot join
- Subjects who refuse to sign the informed consent
- Subjects with an evident incapacity to complete the data questionnaire
- Pregnant or breastfeeding women
- Patients whose MA result from an ADR
- Patients with symptoms lasting more than seven days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Farmacias Pasteur S.A.
Medellín, Antioquia, 050001
Olga Henao, +573103895657, ohenao@pasteur.com.co
About this study
Official title: Evaluation of the Effect of Consensus-based Protocols for the Treatment of Minor Ailments in Drugstores and Pharmacies in Medellin and the Metropolitan Area, Colombia: A Randomized Clinical Trial.
Minor ailments are common, self-limited conditions unrelated to the patient's underlying health problems or adverse effects of their current medications. Minor ailment services are pharmacist-led interventions that provide patients with the most appropriate recommendation when unsure about the medication for a specific minor ailment. It involves advice on nonprescription drugs, non-pharmacological measures, or referral to another health care practitioner. In Colombia, evaluating and implementing this service could optimize nonprescription drugs use and improve minor ailment management in primary health care settings.
Read the detailed description
A 10-month parallel-group clinical trial will be conducted in drugstores and pharmacies (ambulatory retail establishments) in Medellín and the Metropolitan Area. Patients requesting nonprescription drugs for one of five predefined minor ailments (influenza-like syndrome, common cold, headache, dysmenorrhea, or sore throat) will be eligible. Establishments, randomized by cluster sampling, will be allocated to either the intervention (management using CBPs) or control (standard management + education on responsible self-medication) group. Pharmacy staff will receive training in appropriate CBP use. Eligible patients will be consecutively enrolled and followed-up by the research team on days 3, 5, 7, and 10 after the consultation in both groups. Analyses will be performed using Python, including descriptive statistics, bivariate comparisons (p < 0.05), and multivariate Cox regression for significant variables. An intention-to-treat approach will address missing data and dropouts.
The aim of this study is to evaluate the effect of Consensus-based Protocols (CBPs) on the management and duration of some MA, and on the referral rate to General medical Practitioner (GPs) in drugstores and pharmacies. Secondary outcomes include: 1) To clinically and socio-demographically characterize the population that visits a drugstore or pharmacy requesting a nonprescription drug to manage a MA, and 2) To assess the management, duration, rate and causes of GP referrals in drugstores and pharmacies with the use of CBPs among patients requesting nonprescription drugs for the management of a potential MA.
- Conditions
- Community Pharmacy Services
- Being tested
- Patient guided and followed by the pharmacist
- Keywords
- Minor ailments, Minor Ailment Services, Pharmacies, Nonprescription drugs, Pharmacy Technicians, Health education, Self care, Ambulatory care, Community Health Services
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient guided and followed by the pharmacistOther
Also called Use of consensus-based protocols
The Study Coordinating Group will train the pharmacy Staff regarding these protocols.
This training will cover both pharmacological and non-pharmacological aspects of MA management. The pharmacological component will emphasize the appropriate selection and safe use of nonprescription drugs, with a focus on identifying potential drug interactions, contraindications, and moderate and serious ADRs. Pharmacy staff will also be equipped with tools to apply proper criteria for referral to a GP when necessary.
The staff will be divided into three groups, and every group will have a minimum of two sessions, each one of 4 hours. Additionally, there will be a practical component where simulations of real situations will be conducted.
Throughout the 12-month follow-up and intervention period, one of the researchers will be available to receive phone calls to address doubts and concerns about the Consensus-based Protocols.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (standard management + education on responsible self-medication) | No intervention | Patients will receive standard management + education on responsible self-medication. This group will have three activities: 1. Voluntary selection of OTC medication, 2. Health education on what responsible self-medication entails, 3. Monitoring for moderate and serious ADRs related to the use of selected nonprescription drugs or worsening symptoms of the MA, with referral to a GP if necessary. For each MA, the Pharmacist will request the patient's signature on Annex 1, proceed with Activity 1, fill in the instrument included in Annex 4, and continue with Activity 2. On days 3, 5, 7, and 10 after the consultation, patients will be contacted via a chatbot or a phone call to answer Annex 5. On days 5 to 6, and 10 to 12, a pharmacist of the research team will review patient responses to evaluate the need for medical referral (Activity 3), if the presence of a moderate or serious ADR or worsening of the symptom is identified (T5-T6, T10-T12). |
| Intervention Group (management using CBPs) | Experimental | Patients will receive management using CBPs. This group will have four activities: 1. Identification and classification of the MA, 2.Referral to a GP if the patient's condition is not classified as an MA, 3. Patient guidance on appropriate pharmacological measures in case an OTC medication is required 4. Monitoring for moderate or serious ADRs related to the use of selected nonprescription drugs or worsening symptoms of the MA, with referral to a GP if necessary.
For each MA, the Pharmacist will request the patient's Informed Consent, apply what is described in Activities 1, 2, and 3, and fill in the instrument included in Annex 4.
Days 3, 5, 6, 7, 10, and 12 will be followed as described for control group. Receives: Other: Patient guided and followed by the pharmacist |
What is being measured
The primary outcome is the main question the study is designed to answer.
MA resolution
MA resolution will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation.
MA resolution will be recorded as a binary outcome (yes/no). This outcome is clinically relevant as it will reflect the effectiveness of the intervention with CBPs.
Measured: 12 months
MA duration
The duration of the MA will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation.
MA duration will be measured in days from the intervention at the drugstore or pharmacy to complete symptom resolution or if a referral to a GP is needed. This outcome is clinically relevant as it will reflect the effectiveness of the intervention with CBPs.
Measured: 12 months
Referral rate to GP
Referral rate to GP, both due to symptoms worsening or occurrence of moderate or serious ADRs, will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation.
Based on patients' responses to follow-up questionnaires, referral to a GP will be recorded as a binary outcome (yes/no), indicating whether a referral occurred due to symptom worsening or suspected moderate or serious ADRs. This measure is relevant for evaluating patient safety and the effectiveness of the intervention with CBPs.
Measured: 12 months
Secondary outcomes (3)
Characterization of the patient population visiting the drugstores and pharmacies to request nonprescription drugs for the management of a MA
Sociodemographic and clinical data (e.g., age, sex, education level, prior use of nonprescription drugs) will be collected only at baseline (T0), before the intervention. This data will help contextualize the findings and identify population-specific factors influencing outcomes.
Measured: 3 months
Identification and classification of the MA
In both the intervention and control groups, the presence and type of MA will be recorded at baseline (T0). In the control group (standard management + education on responsible self-medication), the patient will self-identify and classify the MA, whereas in the intervention group (management using CBPs), this will be done by the pharmacy staff following protocolized classification criteria. The outcome is relevant to verify the presence of a MA within drugstores and pharmacies.
Measured: 12 months
Need for a nonprescription drug to treat the MA
This binary variable (yes/no) will be assessed in both groups at baseline (T0) and will indicate whether the patient obtained a nonprescription drug for MA management. In the control group (standard management + education on responsible self-medication), medication selection will be driven by the patient's decision. In the intervention group (management using CBPs), this decision will be guided by the pharmacy staff in accordance with the CBPs. Clinically, this informs the appropriateness and potential rationalization of nonprescription drug use under protocol-based pharmaceutical guidance.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start4 Dec 2024
- Primary completion3 Jun 2025
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Pharmacy ServicesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An exploratory, clustered randomized controlled clinical trial with a baseline period will be conducted over a 10-month period. During this time, five MA will be analyzed: influenza-like syndrome and catarrh, headache, common cold, sore throat, and menstrual pain or cramps. Drugstores and pharmacies (clusters) will be randomized in a 1:1 ratio to either the intervention group (management using CBPs) or the control group (standard management + education on responsible self-medication).
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- Farmacias Pasteur
- Responsible party
- Principal investigator, Pedro Amariles, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378099
- Sponsor's protocol ID
- CBP Colombia
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality of information will be assured, ensuring that the collected data remains anonymous and will not be disclosed at any phase of the trial (results, publications, or result presentations).
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Consensus-based Protocols for the Treatment of Minor Ailments in Drugstores and Pharmacies in Medellin and the Metropolitan Area, Colombia: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06378099
- Acronym / sponsor ID
- CBP Colombia
- Conditions
- Community Pharmacy Services
- Keywords
- Minor ailments, Minor Ailment Services, Pharmacies, Nonprescription drugs, Pharmacy Technicians, Health education, Self care, Ambulatory care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- Farmacias Pasteur
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 22 Apr 2024 (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.
Minor ailments are common, self-limited conditions unrelated to the patient's underlying health problems or adverse effects of their current medications. Minor ailment services are pharmacist-led interventions that provide patients with the most appropriate recommendation when unsure about the medication for a specific minor ailment. It involves advice on nonprescription drugs, non-pharmacological measures, or referral to another health care practitioner. In Colombia, evaluating and implementing this service could optimize nonprescription drugs use and improve minor ailment management in primary health care settings.
Detailed description
A 10-month parallel-group clinical trial will be conducted in drugstores and pharmacies (ambulatory retail establishments) in Medellín and the Metropolitan Area. Patients requesting nonprescription drugs for one of five predefined minor ailments (influenza-like syndrome, common cold, headache, dysmenorrhea, or sore throat) will be eligible. Establishments, randomized by cluster sampling, will be allocated to either the intervention (management using CBPs) or control (standard management + education on responsible self-medication) group. Pharmacy staff will receive training in appropriate CBP use. Eligible patients will be consecutively enrolled and followed-up by the research team on days 3, 5, 7, and 10 after the consultation in both groups. Analyses will be performed using Python, including descriptive statistics, bivariate comparisons (p < 0.05), and multivariate Cox regression for significant variables. An intention-to-treat approach will address missing data and dropouts.
The aim of this study is to evaluate the effect of Consensus-based Protocols (CBPs) on the management and duration of some MA, and on the referral rate to General medical Practitioner (GPs) in drugstores and pharmacies. Secondary outcomes include: 1) To clinically and socio-demographically characterize the population that visits a drugstore or pharmacy requesting a nonprescription drug to manage a MA, and 2) To assess the management, duration, rate and causes of GP referrals in drugstores and pharmacies with the use of CBPs among patients requesting nonprescription drugs for the management of a potential MA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An exploratory, clustered randomized controlled clinical trial with a baseline period will be conducted over a 10-month period. During this time, five MA will be analyzed: influenza-like syndrome and catarrh, headache, common cold, sore throat, and menstrual pain or cramps. Drugstores and pharmacies (clusters) will be randomized in a 1:1 ratio to either the intervention group (management using CBPs) or the control group (standard management + education on responsible self-medication).
| Arm | Type | Receives |
|---|---|---|
| Control Group (standard management + education on responsible self-medication) | No intervention | –Patients will receive standard management + education on responsible self-medication. This group will have three activities: 1. Voluntary selection of OTC medication, 2. Health education on what responsible self-medication entails, 3. Monitoring for moderate and serious ADRs related to the use of selected nonprescription drugs or worsening symptoms of the MA, with referral to a GP if necessary. For each MA, the Pharmacist will request the patient's signature on Annex 1, proceed with Activity 1, fill in the instrument included in Annex 4, and continue with Activity 2. On days 3, 5, 7, and 10 after the consultation, patients will be contacted via a chatbot or a phone call to answer Annex 5. On days 5 to 6, and 10 to 12, a pharmacist of the research team will review patient responses to evaluate the need for medical referral (Activity 3), if the presence of a moderate or serious ADR or worsening of the symptom is identified (T5-T6, T10-T12). |
| Intervention Group (management using CBPs) | Experimental | Other: Patient guided and followed by the pharmacistPatients will receive management using CBPs. This group will have four activities: 1. Identification and classification of the MA, 2.Referral to a GP if the patient's condition is not classified as an MA, 3. Patient guidance on appropriate pharmacological measures in case an OTC medication is required 4. Monitoring for moderate or serious ADRs related to the use of selected nonprescription drugs or worsening symptoms of the MA, with referral to a GP if necessary. For each MA, the Pharmacist will request the patient's Informed Consent, apply what is described in Activities 1, 2, and 3, and fill in the instrument included in Annex 4. Days 3, 5, 6, 7, 10, and 12 will be followed as described for control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Establishments located in Medellin and Metropolitan area
- Establishments that have a Pharmacy Technician serving as the technical director.
- Establishments with electronic point-of-sale system for data collection.
- Commitment to participate for the full 10-month study period.
- Explicit consent to participate in the study.
Key exclusion criteria (5 listed)
- Subjects who refuse to sign the informed consent
- Subjects with an evident incapacity to complete the data questionnaire
- Pregnant or breastfeeding women
- Patients whose MA result from an ADR
- Patients with symptoms lasting more than seven days
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 |
|---|---|---|
| Patient guided and followed by the pharmacistAlso: Use of consensus-based protocolsThe Study Coordinating Group will train the pharmacy Staff regarding these protocols. This training will cover both pharmacological and non-pharmacological aspects of MA management. The pharmacological component will emphasize the appropriate selection and safe use of nonprescription drugs, with a focus on identifying potential drug interactions, contraindications, and moderate and serious ADRs. Pharmacy staff will also be equipped with tools to apply proper criteria for referral to a GP when necessary. The staff will be divided into three groups, and every group will have a minimum of two sessions, each one of 4 hours. Additionally, there will be a practical component where simulations of real situations will be conducted. Throughout the 12-month follow-up and intervention period, one of the researchers will be available to receive phone calls to address doubts and concerns about the Consensus-based Protocols. | Other | Intervention Group (management using CBPs) |
Primary outcome
MA resolution
Time frame: 12 months
MA resolution will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation. MA resolution will be recorded as a binary outcome (yes/no). This outcome is clinically relevant as it will reflect the effectiveness of the intervention with CBPs.
MA duration
Time frame: 12 months
The duration of the MA will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation. MA duration will be measured in days from the intervention at the drugstore or pharmacy to complete symptom resolution or if a referral to a GP is needed. This outcome is clinically relevant as it will reflect the effectiveness of the intervention with CBPs.
Referral rate to GP
Time frame: 12 months
Referral rate to GP, both due to symptoms worsening or occurrence of moderate or serious ADRs, will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation. Based on patients' responses to follow-up questionnaires, referral to a GP will be recorded as a binary outcome (yes/no), indicating whether a referral occurred due to symptom worsening or suspected moderate or serious ADRs. This measure is relevant for evaluating patient safety and the effectiveness of the intervention with CBPs.
3 secondary outcomes
Characterization of the patient population visiting the drugstores and pharmacies to request nonprescription drugs for the management of a MA
Time frame: 3 months
Identification and classification of the MA
Time frame: 12 months
Need for a nonprescription drug to treat the MA
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No. Confidentiality of information will be assured, ensuring that the collected data remains anonymous and will not be disclosed at any phase of the trial (results, publications, or result presentations).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient guided and followed by the pharmacist in people with Community Pharmacy Services, run by Universidad de Antioquia at 1 site in Colombia.
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 10 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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 Colombia. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Salazar (+573017971909, asalazarospina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MA resolution (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2025.