Upper Respiratory Tract InfectionPhase 3A PaniculataNCT04955327
To Compare the Efficacy and Tolerability of A. Paniculata/A. Chilensis in Individuals With URTI
A Phase 3 study testing A. Paniculata, A. Chilensis and A. Paniculata and A. Chilensis in people with Upper Respiratory Tract Infection, run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
Trial summary
Conventional therapy of upper respiratory tract infection (URTI) is not always effective and sometimes leads to side effects and also to inappropriate use of antibiotic. Hence, a search for safe and effective further treatment options is justified and would be a welcome addition to available conventional treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- A. Paniculata, A. Chilensis and A. Paniculata and A. Chilensis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 5 sitesIndia
- Study dates
- 20 Mar 2021to 25 Feb 2022
- Phase
- Phase 3
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females aged between 18 and 50 years, complete as of the screening date.
- Participants with symptoms of acute upper respiratory tract infection as assessed by the investigator at the time of screening.
- Participants with BMI ≤ 29.9 kg/m2.
- Upper respiratory tract infection symptoms present for at least 24 hours but not more than 72 hours prior to screening visit.
- Those having a score of ≥ 5 for at least 2 symptoms out of runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough or head congestion on the Wisconsin Upper Respiratory Symptom Survey-21.
- Participants not requiring hospitalization.
Show all 11Show fewer
- Participants with COVID +ve/ COVID -ve RT-PCR report.
- SPO2 level ≥ 90%
- Systolic blood pressure < 130 mm Hg and/or diastolic blood pressure < 90.
- Those who demonstrate an understanding of the study details and have a willingness to participate, as evidenced by voluntary written informed consent.
- Must be literate and have the ability to complete the study-based questionnaires and requirements.
Who cannot join
- High grade fever defined as body temperature ≥ 40°C.
- With a history of allergy (allergic rhinitis) along with symptoms such as sneezing, runny nose and red, watery and itchy eyes.
- Chest X-ray showing signs of pneumonia.
- Participants with history of chronic obstructive pulmonary disease, pulmonary fibrosis or asthma
- Participants with rhinitis medicamentosa, chronic cough of bacterial, fungal or other known origin.
- Participants with anatomical nasal obstruction/ deformity or nasal reconstructive surgery etc.
Show all 27Show fewer
- Participants with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies.
- Participants with history of immunocompromised state immune system with/ without organ transplant.
- Participants with known or suspected hypersensitivity or intolerance to herbal products.
- Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2.0 times the upper limit of normal.
- Participants diagnosed with Sickle cell disease, Thalassemia, Type I/ II diabetes mellitus, cystic fibrosis.
- Diagnosed cases of hypertension.
- Those not willing to abstain from home based cold remedies that include but are not limited to steam inhalation, decoctions, vapour rub, ginger tea, honey tea, decoctions, or any form of dietary supplements during the entirety of study participation period.
- Those who have been vaccinated for influenza, swine flu or COVID three months prior to screening visit.
- Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines or other medications that are expected to alleviate cold symptoms within one week of the start of the study.
- Those who have severe mental illnesses, such as dementia, Parkinson's disease, Alzheimer's Disease, depression or anxiety disorders, or those who are currently taking psychoneurological drugs, such as antidepressants.
- Those who have participated in other clinical trials within 30 days, prior to the screening visit or plan to participate in other clinical trials during the trial period.
- Participants with substance abuse as per last two year history that includes the use of but is not limited to drugs such as cocaine, amphetamine, marijuana etc.
- Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco.
- Participants with heavy alcohol consumption, defined as:
- For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
- For women: More than 7 SAD/week or more than 3 SAD in a day.
- Binge drinkers, defined as 5 or more SAD for men, in a 2-hour time frame.
- Binge drinkers, defined as 4 or more SAD for Women, in a 2-hour time frame. (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9% alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol)
- Those who have clinically significant disorder/s of cardiovascular, endocrine, lymphatic, respiratory, hepatobiliary, urinary, reproductive, central nervous system, musculoskeletal and digestive systems.
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Apollo Spectra Hospitals
Kanpur, Uttar Pradesh, 208001
St . George Hospital
Mumbai, Maharashtra, 400001
Gillurkar Multispecialty Hospital
Nagpur, Maharashtra, 440009
Shree Hospital & Critical Care Center
Nagpur, Maharashtra, 440009
Shubham Sudbhawana Super Specialty Hospital
Varanasi, Uttar Pradesh, 221005
About this study
Official title: A Double-blind, Randomized, Placebo-Controlled, Comparative Study for Assessing the Efficacy and Tolerability of A. Paniculata/A. Chilensis in Individuals With Upper Respiratory Tract Infections
Conventional therapy of upper respiratory tract infection (URTI) is not always effective and sometimes leads to side effects and also to inappropriate use of antibiotic. Hence, a search for safe and effective further treatment options is justified and would be a welcome addition to available conventional treatment. Use of plant based dietary supplements has become increasingly popular over the last few decades or so. Research based on some plants is more than centuries old and its main therapeutic objective is to stimulate the self-healing power of the body. Andrographolide was docked successfully in the binding site of SARS-CoV-2 Mpro. Computational approaches also predicts this molecule to have good solubility, pharmacodynamics property and target accuracy. This molecule also obeys Lipinski's rule, which makes it a promising compound to pursue further biochemical and cell based assays to explore its potential for use against COVID-19. A. Paniculata is a patented extract, standardized to Andrographolide, 14-deoxyandrographolide, and Neo-andrographolide. Maqui contains Maqui Berry Extract of Aristotelia Chilensis (10% Anthocyanidin, 8% Delphinidin) belonging to the family of Elaeocarpaceae, which has been known for its use in several conditions such as sore throat, fever and several other ailments. In the present study, the therapeutic potential of Andrographis Paniculata and Aristotelia chilensis as single ingredients as well as in combination will be evaluated in participants with common cold and COVID related symptoms. The products to be evaluated have been rigorously standardized and are available under the brand names of A. Paniculata and A. Chilensis. Literature indicates that both A. Paniculata and A.Chilensis are effective and safe in the treatment of typical cold-related symptoms in adults.
Read the detailed description
The common cold is one of the most frequent minor illnesses in the world. A large US-American survey showed that over 70% of the population annually was suffering from at least one viral respiratory tract infection. Also the economic burden in the USA was almost USD 40 billion annually causing considerable direct and indirect healthcare costs. Caused by 200 identified types of viruses, the common cold is primarily associated with rhinoviruses. Common cold symptoms may include sore throat, runny nose, general malaise, and low-grade fever at onset, followed by nasal congestion and cough. While benign, they last for several days and cause 40% of all missed work days. Complications also include sinusitis, otitis media and pneumonia, exacerbations of asthma and chronic obstructive pulmonary disease, and serious illness in immunocompromised patients.
Colds typically afflict most adults and adolescents 2-4 times a year and symptoms usually peak around day 3 or 4 and last 1-2 weeks with a median of 7 days. There is no approved specific therapy for URTI, treatment is therefore mainly symptomatic. The most common pharmacological treatments are antipyretics, anti-inflammatory drugs, expectorants, decongestants, and cough suppressants, either alone or in combination. Supportive measures can include bed rest, hot baths, and inhalations, gargling, and drinking plenty of fluids. Antibiotics are widely prescribed, but often is inappropriate because URTI are mostly caused by viruses and are only indicated in the case of bacterial infection. Its overuse can also lead to the development of community acquired resistant pathogens which are an increasing and serious health burden.
- Conditions
- Upper Respiratory Tract Infection
- Being tested
- A. Paniculata, A. Chilensis, A. Paniculata and A. Chilensis, Microcrystalline cellulose
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A. PaniculataDrug
Extract from A. Paniculata
A. ChilensisDrug
Extract from A. Chilensis
A. Paniculata and A. ChilensisDrug
Combination of A. Paniculata and A. Chilensis
Microcrystalline celluloseDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| A. Paniculata150 mg | Experimental | Extract from Andrographis Paniculata Receives: Drug: A. Paniculata |
| A. Chilensis 300 mg | Experimental | Extract from A. Chilensis Receives: Drug: A. Chilensis |
| A. Panicluata 150 mg + A. Chilensis 300 mg. | Experimental | combination of extract of A. Paniculata and A. Chilensis Receives: Drug: A. Paniculata and A. Chilensis |
| Microcrystalline Cellulose +/-450 mg | Placebo comparator | Comparator Receives: Drug: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity Outcome
Change in total symptom severity scores from 0 to 7 (where 0 means not sick to 7 means severe) as assessed by Wisconsin Upper Respiratory Symptom Survey-21 on day 7 from baseline and in comparison to placebo.
Measured: Day 0, 1, 2, 3, 4, 5, 6, and 7
Secondary outcomes (5)
Time to resolve symptoms
Time to resolution of common cold like symptoms as assessed by participant reporting '0 = not sick' out of 7, for any one day during treatment period as per Wisconsin Upper Respiratory Symptom Survey-21
Measured: Day 0, 1, 2, 3, 4, 5, 6, and 7
percentage wise severity resolution
Percentage of participants with resolved common cold like complaints at the end of day 7 in comparison to placebo (unresolved participants being those who do not report "0 = not sick" out of 7, as per Wisconsin Upper Respiratory Symptom Survey-21, till the end of treatment period.
Measured: 7 days
Minimal Important Difference
Percentage of participants achieving minimal important difference of ≥ 10.3 Wisconsin Upper Respiratory Symptom Survey-21 total scores at day 5 and 7 from baseline and in comparison to placebo. Therefore, in the study Minimal important difference will be calculated as the difference of Wisconsin Upper Respiratory Symptom Survey-21 total scores from baseline to day 5 and day 7 and if it is ≥ 10.3, it will be deemed as clinically significant treatment effect.
Measured: Day 0, 5, and 7
Visual Analogue Scale based severity outcomes
Change in participant's fever and burning eyes sensation severity scores (from 0 to 7 where 0 means not at all severe to 100 means very severe) as assessed by visual analogue scale on day 7 from baseline and in comparison to placebo.
Measured: Day 0, 1, 2, 3, 4, 5, 6, and 7
Change in symptom resolution
Change in severity of COVID related symptoms (from 0 to 7 where 0 means no symptom to 7 means severe) as assessed by total scores of COVID diary at day 7 and day 15 from baseline and in comparison to placebo.
Measured: Day 0 to day 7 (for all COVID +ve participants) and Day 8 to day 15 (For COVID participants who didn't turn negative on day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start20 Mar 2021
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955327
- Sponsor's protocol ID
- HP/200802/PARACTIN/CC
- Acronym
- A Paniculata
- Status last verified
- May 2022
- First submitted
- 5 May 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-Controlled, Comparative Study for Assessing the Efficacy and Tolerability of A. Paniculata/A. Chilensis in Individuals With Upper Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT04955327
- Acronym / sponsor ID
- A Paniculata / HP/200802/PARACTIN/CC
- Conditions
- Upper Respiratory Tract Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 8 Jul 2021 (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.
Conventional therapy of upper respiratory tract infection (URTI) is not always effective and sometimes leads to side effects and also to inappropriate use of antibiotic. Hence, a search for safe and effective further treatment options is justified and would be a welcome addition to available conventional treatment. Use of plant based dietary supplements has become increasingly popular over the last few decades or so. Research based on some plants is more than centuries old and its main therapeutic objective is to stimulate the self-healing power of the body. Andrographolide was docked successfully in the binding site of SARS-CoV-2 Mpro. Computational approaches also predicts this molecule to have good solubility, pharmacodynamics property and target accuracy. This molecule also obeys Lipinski's rule, which makes it a promising compound to pursue further biochemical and cell based assays to explore its potential for use against COVID-19. A. Paniculata is a patented extract, standardized to Andrographolide, 14-deoxyandrographolide, and Neo-andrographolide. Maqui contains Maqui Berry Extract of Aristotelia Chilensis (10% Anthocyanidin, 8% Delphinidin) belonging to the family of Elaeocarpaceae, which has been known for its use in several conditions such as sore throat, fever and several other ailments. In the present study, the therapeutic potential of Andrographis Paniculata and Aristotelia chilensis as single ingredients as well as in combination will be evaluated in participants with common cold and COVID related symptoms. The products to be evaluated have been rigorously standardized and are available under the brand names of A. Paniculata and A. Chilensis. Literature indicates that both A. Paniculata and A.Chilensis are effective and safe in the treatment of typical cold-related symptoms in adults.
Detailed description
The common cold is one of the most frequent minor illnesses in the world. A large US-American survey showed that over 70% of the population annually was suffering from at least one viral respiratory tract infection. Also the economic burden in the USA was almost USD 40 billion annually causing considerable direct and indirect healthcare costs. Caused by 200 identified types of viruses, the common cold is primarily associated with rhinoviruses. Common cold symptoms may include sore throat, runny nose, general malaise, and low-grade fever at onset, followed by nasal congestion and cough. While benign, they last for several days and cause 40% of all missed work days. Complications also include sinusitis, otitis media and pneumonia, exacerbations of asthma and chronic obstructive pulmonary disease, and serious illness in immunocompromised patients.
Colds typically afflict most adults and adolescents 2-4 times a year and symptoms usually peak around day 3 or 4 and last 1-2 weeks with a median of 7 days. There is no approved specific therapy for URTI, treatment is therefore mainly symptomatic. The most common pharmacological treatments are antipyretics, anti-inflammatory drugs, expectorants, decongestants, and cough suppressants, either alone or in combination. Supportive measures can include bed rest, hot baths, and inhalations, gargling, and drinking plenty of fluids. Antibiotics are widely prescribed, but often is inappropriate because URTI are mostly caused by viruses and are only indicated in the case of bacterial infection. Its overuse can also lead to the development of community acquired resistant pathogens which are an increasing and serious health burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A. Paniculata150 mg | Experimental | Drug: A. PaniculataExtract from Andrographis Paniculata |
| A. Chilensis 300 mg | Experimental | Drug: A. ChilensisExtract from A. Chilensis |
| A. Panicluata 150 mg + A. Chilensis 300 mg. | Experimental | Drug: A. Paniculata and A. Chilensiscombination of extract of A. Paniculata and A. Chilensis |
| Microcrystalline Cellulose +/-450 mg | Placebo comparator | Drug: Microcrystalline celluloseComparator |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Males and females aged between 18 and 50 years, complete as of the screening date.
- Participants with symptoms of acute upper respiratory tract infection as assessed by the investigator at the time of screening.
- Participants with BMI ≤ 29.9 kg/m2.
- Upper respiratory tract infection symptoms present for at least 24 hours but not more than 72 hours prior to screening visit.
- Those having a score of ≥ 5 for at least 2 symptoms out of runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough or head congestion on the Wisconsin Upper Respiratory Symptom Survey-21.
Key exclusion criteria (27 listed)
- High grade fever defined as body temperature ≥ 40°C.
- With a history of allergy (allergic rhinitis) along with symptoms such as sneezing, runny nose and red, watery and itchy eyes.
- Chest X-ray showing signs of pneumonia.
- Participants with history of chronic obstructive pulmonary disease, pulmonary fibrosis or asthma
- Participants with rhinitis medicamentosa, chronic cough of bacterial, fungal or other known origin.
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 |
|---|---|---|
| A. PaniculataExtract from A. Paniculata | Drug | A. Paniculata150 mg |
| A. ChilensisExtract from A. Chilensis | Drug | A. Chilensis 300 mg |
| A. Paniculata and A. ChilensisCombination of A. Paniculata and A. Chilensis | Drug | A. Panicluata 150 mg + A. Chilensis 300 mg. |
| Microcrystalline cellulosePlacebo comparator | Drug | Microcrystalline Cellulose +/-450 mg |
Primary outcome
Severity Outcome
Time frame: Day 0, 1, 2, 3, 4, 5, 6, and 7
Change in total symptom severity scores from 0 to 7 (where 0 means not sick to 7 means severe) as assessed by Wisconsin Upper Respiratory Symptom Survey-21 on day 7 from baseline and in comparison to placebo.
5 secondary outcomes
Time to resolve symptoms
Time frame: Day 0, 1, 2, 3, 4, 5, 6, and 7
percentage wise severity resolution
Time frame: 7 days
Minimal Important Difference
Time frame: Day 0, 5, and 7
Visual Analogue Scale based severity outcomes
Time frame: Day 0, 1, 2, 3, 4, 5, 6, and 7
Change in symptom resolution
Time frame: Day 0 to day 7 (for all COVID +ve participants) and Day 8 to day 15 (For COVID participants who didn't turn negative on day 8)
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 10 May 2022.
- Individual participant dataSharing planned: No
Related trials for Upper Respiratory Tract Infection
RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Recruiting
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
Acute Respiratory Illness, Viral Respiratory Infection
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing A. Paniculata, A. Chilensis and A. Paniculata and A. Chilensis in people with Upper Respiratory Tract Infection, run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
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 11 inclusion and 27 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Severity Outcome (time frame: Day 0, 1, 2, 3, 4, 5, 6, and 7). 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 10 May 2022.