A randomised, placebo-controlled study of the effect of three herbal extracts (Condothymus capitatis, Origanum dictamnus and Salvia fruticosa/promifera) on the inflammatory reaction during infection of the upper respiratory tract

A randomised, placebo-controlled study of the effect of three herbal extracts (Condothymus capitatis, Origanum dictamnus and Salvia fruticosa/promifera) on the inflammatory reaction during infection of the upper respiratory tract: an interventional, randomised, double-blind, parallel groups comparative study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN09700238

Enrollment

100

Registered

2014-06-27

Start date

2013-10-10

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections and Infestations, Upper Respiratory Tract Infections Respiratory Upper Respiratory Tract Infection

Interventions

1. Test product: dosage: 1 ml extract from Coridothymus capitatus + Origanum dictamnus + Salvia fruticosa/promifera dissolved in olive oil prepared in soft gel capsules. Mode of administration: Oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults >18 years 2. Signed and dated informed consent form 3. Capability and availability to visit one of the study centers within 24 hours of onset of URTI symptoms (common cold)

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation 2. Antibiotics use (any type and route of administration) up to 14 days prior to inclusion in the study 3. Use of antiretroviral pharmaceutical medications or herbs from Crete 4. Participation in interventional clinical study during the period of the study conduct 5. Requirement for long-term administration of aspirin, non-steroid anti-inflammatory agents or other antipyretic/analgesic medicines (such as paracetamol). Use of low dosage aspirin for the prevention of cardiovascular events is excluded 6. Use of immunosuppressive medication including the systemic administration of steroids or other cancer therapy, and/or the presence of neoplastic disease or AIDS 7. Planned surgery or other invasive procedure requiring systemic anesthesia during the period of the study conduct

Design outcomes

Primary

Measure	Time frame
1. Recording of the severity of symptoms of upper respiratory infection in the test and in the control group with the aid of the WURSS-21 questionnaire 2. The average duration of the symptoms of URTI in the test and control groups	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 09/07/2014 Mean change in C-reactive protein (CRP) levels from the start of administration and day 7, between the test and the control group Previous secondary outcome measures 1. Mean change in C-reactive protein (CRP) levels from the start of administration and day 7, between the test and the control group 2. Mean change in viral load from the start of administration and day 7 between the test and the control group Safety: the percentage of the participants that experienced an adverse event (AE) during the treatment administration period of the investigational product (7 days) will be recorded. Incidence, relatedness, severity, intensity and action taken regarding the investigational product will also be recorded.	—

Measure

Time frame

Current secondary outcome measures as of 09/07/2014 Mean change in C-reactive protein (CRP) levels from the start of administration and day 7, between the test and the control group Previous secondary outcome measures 1. Mean change in C-reactive protein (CRP) levels from the start of administration and day 7, between the test and the control group 2. Mean change in viral load from the start of administration and day 7 between the test and the control group Safety: the percentage of the participants that experienced an adverse event (AE) during the treatment administration period of the investigational product (7 days) will be recorded. Incidence, relatedness, severity, intensity and action taken regarding the investigational product will also be recorded.

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Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026