Common ColdPhase 2NCT06497439
Efficacy and Safety of Silfamin for Common Cold
A Phase 2 study testing Silfamin in people with Common Cold and Sore-throat, run by Dexa Medica Group at 2 sites in Indonesia.
Trial summary
This is a 2-arm, prospective, randomized, double-blind, placebo-controlled, and three-days-treatment clinical study comparing the efficacy and safety of Silfamin at a dose of 2 tablets@150 mg twice daily in subjects with common cold. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold, Sore-throat
- What is being tested?
- Silfamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesIndonesia
- Study dates
- 12 Jul 2024to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Otherwise healthy (by anamnesis) men or women aged 18 to 60 years with mild or moderate common cold with or without sore throat (Common cold Score of 1 or 2)
- Willing to participate in the study by signing the informed consent
Who cannot join
- Body temperature of > 37.3˚C and/or refuse to follow health protocol for COVID-19
- Known hypersensitivity to herbal drugs containing Nigella sativa and/or Phaleria macrocarpa
- Pregnant or lactating women
- Have received any analgesic, anti-inflammatory or other common cold preparation within the past 24 hours
- Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study
- Severe illness, e.g. severe hypertension (> 160/100 mmHg)
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Makara UI Satellite Clinic
Depok, West Java, 16425
IMERI Faculty of Medicine, University of Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: Efficacy and Safety of Silfamin for Common Cold With or Without Sore Throat: Preliminary Study
This is a 2-arm, prospective, randomized, double-blind, placebo-controlled, and three-days-treatment clinical study comparing the efficacy and safety of Silfamin at a dose of 2 tablets@150 mg twice daily in subjects with common cold.
Read the detailed description
There will be 2 groups of treatment; each group will consist of 30 subjects receiving the following regimens for three days:
Treatment I : 2 tablets of Silfamin 150 mg 2 times daily Treatment II : 2 tablets of Placebo 2 times daily
Eligible subjects will be evaluated for treatment efficacy at 0 hours (just before drug administration), 1 and 2 hours after the first dose. For the next doses, subject will perform a self-assessment for treatment efficacy at 1 and 2 hours after every dosing, and record it in subject's diary.
- Conditions
- Common Cold, Sore-throat
- Being tested
- Silfamin, Placebo tablet of Silfamin
- Keywords
- Common Cold, Sore-throat, Silfamin
- Medical subject headings
- Common Cold, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilfaminDrug
Also called Herbacold
2 tablets of Silfamin 150 mg twice daily
Placebo tablet of SilfaminDrug
2 tablets of Silfamin Placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| Silfamin | Experimental | 2 tablets of Silfamin 150 mg twice daily Receives: Drug: Silfamin |
| Placebo | Placebo comparator | 2 tablets of Placebo twice daily Receives: Drug: Placebo tablet of Silfamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of common cold and sore throat
Score of common cold and sore throat measured at 0 hours (just before drug administration) for the first dose, 1 and 2 hours after every dosing
Measured: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
VAS score of sore throat
VAS score of sore throat measured at 0 hours (just before drug administration), 1 and 2 hours after every dosing
Measured: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
Secondary outcomes (1)
Adverse events
Number of adverse event, will be observed throughout the study conduct
Measured: 1, 2, 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start12 Jul 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497439
- Sponsor's protocol ID
- CRSU.P.Dexa/06/20/14.04
- Status last verified
- Feb 2025
- First submitted
- 5 Jul 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Silfamin for Common Cold With or Without Sore Throat: Preliminary Study
- ClinicalTrials.gov ID
- NCT06497439
- Acronym / sponsor ID
- CRSU.P.Dexa/06/20/14.04
- Conditions
- Common Cold, Sore-throat
- Keywords
- Common Cold, Sore-throat, Silfamin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 11 Jul 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.
This is a 2-arm, prospective, randomized, double-blind, placebo-controlled, and three-days-treatment clinical study comparing the efficacy and safety of Silfamin at a dose of 2 tablets@150 mg twice daily in subjects with common cold.
Detailed description
There will be 2 groups of treatment; each group will consist of 30 subjects receiving the following regimens for three days:
Treatment I : 2 tablets of Silfamin 150 mg 2 times daily Treatment II : 2 tablets of Placebo 2 times daily
Eligible subjects will be evaluated for treatment efficacy at 0 hours (just before drug administration), 1 and 2 hours after the first dose. For the next doses, subject will perform a self-assessment for treatment efficacy at 1 and 2 hours after every dosing, and record it in subject's diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silfamin | Experimental | Drug: Silfamin2 tablets of Silfamin 150 mg twice daily |
| Placebo | Placebo comparator | Drug: Placebo tablet of Silfamin2 tablets of Placebo twice daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Otherwise healthy (by anamnesis) men or women aged 18 to 60 years with mild or moderate common cold with or without sore throat (Common cold Score of 1 or 2)
- Willing to participate in the study by signing the informed consent
Key exclusion criteria (6 listed)
- Body temperature of > 37.3˚C and/or refuse to follow health protocol for COVID-19
- Known hypersensitivity to herbal drugs containing Nigella sativa and/or Phaleria macrocarpa
- Pregnant or lactating women
- Have received any analgesic, anti-inflammatory or other common cold preparation within the past 24 hours
- Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study
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 |
|---|---|---|
| SilfaminAlso: Herbacold2 tablets of Silfamin 150 mg twice daily | Drug | Silfamin |
| Placebo tablet of Silfamin2 tablets of Silfamin Placebo twice daily | Drug | Placebo |
Primary outcome
Score of common cold and sore throat
Time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
Score of common cold and sore throat measured at 0 hours (just before drug administration) for the first dose, 1 and 2 hours after every dosing
VAS score of sore throat
Time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
VAS score of sore throat measured at 0 hours (just before drug administration), 1 and 2 hours after every dosing
1 secondary outcome
Adverse events
Time frame: 1, 2, 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Silfamin in people with Common Cold and Sore-throat, run by Dexa Medica Group at 2 sites in Indonesia.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of common cold and sore throat (time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days). The study lists 2 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 7 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.