Upper Respiratory Tract InfectionsNCT06355661
A Study for Assessing the Efficacy and Safety ParActin® in Individuals With Upper Respiratory Tract Infections
A study testing ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule and MCC: 400 mg (± 10%) per Capsule in people with Upper Respiratory Tract Infections, run by Vedic Lifesciences Pvt. Ltd. at 9 sites in India.
Trial summary
The present study is a randomized, double-blind, placebo-controlled, comparative study. 176 individuals will be screened, and considering a screening failure rate of 15 percent approximately 150 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule and MCC: 400 mg (± 10%) per Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 9 sitesIndia
- Study dates
- 5 Apr 2024to 30 Jul 2024
- Phase
- Interventional
- 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 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male and female aged between 18 and 50 years as of the screening date.
- Individuals with symptoms of acute upper respiratory tract infection as assessed by the investigator at the time of screening.
- BMI ≤ 29.9 kg/m2.
- Upper respiratory tract infection symptoms present for at least 24 hours but not more than 48 hours prior to screening visit.
- Those having a score of ≥ 5 for at least 2 symptoms out of runny nose, plugged nose, sneezing or sore throat, on the WURSS-21.
- History of frequent common cold with past episode duration of at least 4 days.
- 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 ≥ 39ºC (≥ 102.2 ºF)
- With a history of allergy (allergic rhinitis) along with symptoms such as sneezing, runny nose and red, watery and itchy eyes.
- Individuals with history of Chronic obstructive pulmonary disease, pulmonary fibrosis or Asthma.
- Individuals with rhinitis medicamentosa, chronic cough of bacterial, fungal or other known origin.
- Individuals requiring hospitalization or likely to be hospitalised due to URTI.
- Individuals with common cold for the first time.
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- Individuals with anatomical nasal obstruction/ deformity or nasal reconstructive surgery etc.
- Individuals with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
- Individuals with history of immunocompromised state immune system with/ without organ transplant
- Individuals with known or suspected hypersensitivity or intolerance to herbal products
- Individuals diagnosed with Sickle cell disease, Thalassemia, Type I/ II Diabetes mellitus, Cystic fibrosis
- Diagnosed cases of Uncontrolled hypertension as assessed by a systolic blood pressure ≥ to 140mmHg and diastolic blood pressure ≥ to 90mmHg
- Those not willing to abstain from home based cold remedies that include but are not limited to steam inhalation, decoctions, vapour rub, ginger supplement, decoctions, or any form of dietary and/or herbal supplements during the entirety of study participation period.
- Those who have been vaccinated for influenza, swine flu 3 months prior to screening visit.
- Those who have taken within one week of the start of the study or require during study antibiotics, antivirals, steroids, nasal decongestants, antihistamines herbal remedies, Vitamin C or Zinc to alleviate cold symptoms.
- 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 study within 30 days, prior to the screening visit or plan to participate in other clinical study during the study period.
- Individuals 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.
- Individuals 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 individual's ability to successfully and safely complete the study or that may confound study outcomes.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites, 9 recruiting
- Recruiting
Jawaharlal Nehru Medical College
Ajmer, Rajasthan, 305001
Dr. Piyush Arora, MBBS, 8118877284, Doctorpiyusharora@gmail.com
- Recruiting
Gastron Clinic
Delhi, 110015.
Dr Abhinav Guliani, MBBS, 9718302294, abhinavguliani@hotmail.com
- Recruiting
Good health Clinic
Delhi, 110027
Dr Atul Gogia, MBBS, 9891003450, Atulgogia@gmail.com
- Recruiting
Tulsi Multispecility Hospital
Delhi, 110094
Dr Dipti Gupta, MBBS, 9811676049, drdipti16@gmail.com
- Recruiting
Human Care Hospital
Lucknow, Uttar Pradesh, 226012
Dr Shashi Prakash Maurya, MBBS, 9415005158, drspmauryaa@gmail.com
- Recruiting
Life care hospital
Nashik, Maharashtra, 422009
Dr Sandeep Gaidhani, MBBS, 7588606598, drsandeepgaidhani@gmail.com
- Recruiting
ENT Vertigo Clinic
Pune, Maharashtra, 411045
Dr Rupali Gulavani, MBBS, 9923108585, drrupalivg@gmail.com
- Recruiting
Shubham Sudbhawana Super Speciality Hospital
Varanasi, Uttar Pradesh, 221005
Dr siddhartha Singh, MBBS, 9415262714, dr.siddharthasinghvns@gmail.com
- Not yet recruiting
Janta Hospital
Varanasi, Uttar Pradesh, 221011
Dr.Manoj Kumar Pal, MBBS, 9198677778, manojpalvns@gmail.com
About this study
Official title: A Double-blind, Randomized, Placebo-Controlled, Comparative Study for Assessing the Efficacy and Safety of ParActin® in Individuals With Upper Respiratory Tract Infections (URTI)
The present study is a randomized, double-blind, placebo-controlled, comparative study. 176 individuals will be screened, and considering a screening failure rate of 15 percent approximately 150 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have at least 60 completed participants after accounting for a dropout/withdrawal rate of 20percent. The intervention duration for all the study participants is 7 days
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule, MCC: 400 mg (± 10%) per Capsule
- 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.
ParActin®: 300 mg + MCC: 100 mg (± 10%) per CapsuleDietary supplement
Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner)
MCC: 400 mg (± 10%) per CapsuleDietary supplement
Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner)
| Study group | Role | What they receive |
|---|---|---|
| ParActin®: 300 mg + MCC: 100 mg (± 10%) | Active comparator | Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner). Receives: Dietary Supplement: ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule |
| MCC: 400 mg (± 10%) per Capsule | Placebo comparator | Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner). Receives: Dietary Supplement: MCC: 400 mg (± 10%) per Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of investigational products on participant's severity of common cold like symptoms
evaluated by Wisconsin Upper Respiratory Symptom Survey-21 total severity score (incremental Area Under the Curve (iAUC) The WURSS-21 consists of ten symptom-specific items which includes runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion, and feeling tired.
Measured: During Upper respiratory tract infection episodes throughout the study upto 7 day Treatment duration
Secondary outcomes (6)
To evaluate the effect of investigational products on Time (in days) taken to resolution of common cold like symptoms
resolution deemed to occur when participant reports being "0 = not sick" as per Wisconsin Upper Respiratory Symptom Survey-21 for two consecutive days during the treatment period, The WURSS-21 consists of ten symptom-specific items which includes runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion, and feeling tired.
Measured: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Percentage of participants with unresolved common cold symptoms
being those who do not report being "0 = not sick" as per Wisconsin Upper Respiratory Symptom Survey-21 till the end of the treatment period.
An episode is deemed resolved when the participant marks "0 = not sick" on Q.1 of WURSS-21 for two consecutive days. If this criterion is not met, the episode is considered unresolved
Measured: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Percentage of population with minimal important difference of ≥ 10.3 as per change in Wisconsin Upper Respiratory Symptom Survey-21 total score. (daily score will be analysed in study)
The WURSS-21 consists of ten symptom-specific items which includes runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion, and feeling tired
Measured: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Number of days taken to be afebrile (temp < 100 oF/< 37.7 ºC) in the population with fever (temp ≥100oF or ≥37.7 ºC ) at baseline- as assessed by 10-point visual analogue scale.
Place the thermometer in the armpit. Press the arm against the body. Wait for 2-3 minutes before reading in case of traditional thermometer or until it beeps in case of digital thermometer. The number of days taken to be afebrile (temp < 100 oF or < 37.7 ºC) in the population with fever (temp ≥100oF or ≥37.7 ºC ) at baseline will be recorded. The participants will record their fever daily on diary
Measured: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Percentage population with fever during the study.
Place the thermometer in the armpit. Press the arm against the body. Wait for 2-3 minutes before reading in case of traditional thermometer or until it beeps in case of digital thermometer. The number of days taken to be afebrile
Measured: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Quality of life as assessed by Wisconsin Upper Respiratory Symptom Survey Quality of Life
The Wisconsin Upper Respiratory Symptom Survey-21 consists of ten symptom-specific items which includes runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion, and feeling tired.All the items will be scored on an 8-point Likert scale ranging from 0 which depicts "absent or no impairment" through 1 (very mild), 3 (mild), 5 (moderate) and 7 (severe)
Measured: Day 0, day 4 and day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start5 Apr 2024
- Primary completion15 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Double-blind, Randomized, Placebo-Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
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
- NCT06355661
- Sponsor's protocol ID
- HP/231102/PA/URTI
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jun 2024. 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 Safety of ParActin® in Individuals With Upper Respiratory Tract Infections (URTI)
- ClinicalTrials.gov ID
- NCT06355661
- Acronym / sponsor ID
- HP/231102/PA/URTI
- Conditions
- Upper Respiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 9 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.
The present study is a randomized, double-blind, placebo-controlled, comparative study. 176 individuals will be screened, and considering a screening failure rate of 15 percent approximately 150 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have at least 60 completed participants after accounting for a dropout/withdrawal rate of 20percent. The intervention duration for all the study participants is 7 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Double-blind, Randomized, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| ParActin®: 300 mg + MCC: 100 mg (± 10%) | Active comparator | Dietary Supplement: ParActin®: 300 mg + MCC: 100 mg (± 10%) per CapsuleTwo capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner). |
| MCC: 400 mg (± 10%) per Capsule | Placebo comparator | Dietary Supplement: MCC: 400 mg (± 10%) per CapsuleTwo capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner). |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male and female aged between 18 and 50 years as of the screening date.
- Individuals with symptoms of acute upper respiratory tract infection as assessed by the investigator at the time of screening.
- BMI ≤ 29.9 kg/m2.
- Upper respiratory tract infection symptoms present for at least 24 hours but not more than 48 hours prior to screening visit.
- Those having a score of ≥ 5 for at least 2 symptoms out of runny nose, plugged nose, sneezing or sore throat, on the WURSS-21.
Key exclusion criteria (27 listed)
- High grade fever defined as body temperature ≥ 39ºC (≥ 102.2 ºF)
- With a history of allergy (allergic rhinitis) along with symptoms such as sneezing, runny nose and red, watery and itchy eyes.
- Individuals with history of Chronic obstructive pulmonary disease, pulmonary fibrosis or Asthma.
- Individuals with rhinitis medicamentosa, chronic cough of bacterial, fungal or other known origin.
- Individuals requiring hospitalization or likely to be hospitalised due to URTI.
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 |
|---|---|---|
| ParActin®: 300 mg + MCC: 100 mg (± 10%) per CapsuleTwo capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner) | Dietary supplement | ParActin®: 300 mg + MCC: 100 mg (± 10%) |
| MCC: 400 mg (± 10%) per CapsuleTwo capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner) | Dietary supplement | MCC: 400 mg (± 10%) per Capsule |
Primary outcome
To evaluate the effect of investigational products on participant's severity of common cold like symptoms
Time frame: During Upper respiratory tract infection episodes throughout the study upto 7 day Treatment duration
evaluated by Wisconsin Upper Respiratory Symptom Survey-21 total severity score (incremental Area Under the Curve (iAUC) The WURSS-21 consists of ten symptom-specific items which includes runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion, and feeling tired.
6 secondary outcomes
To evaluate the effect of investigational products on Time (in days) taken to resolution of common cold like symptoms
Time frame: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Percentage of participants with unresolved common cold symptoms
Time frame: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Percentage of population with minimal important difference of ≥ 10.3 as per change in Wisconsin Upper Respiratory Symptom Survey-21 total score. (daily score will be analysed in study)
Time frame: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Number of days taken to be afebrile (temp < 100 oF/< 37.7 ºC) in the population with fever (temp ≥100oF or ≥37.7 ºC ) at baseline- as assessed by 10-point visual analogue scale.
Time frame: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Percentage population with fever during the study.
Time frame: During episodes of URTI upto 7 day Treatment duration
To evaluate the effect of investigational products on Quality of life as assessed by Wisconsin Upper Respiratory Symptom Survey Quality of Life
Time frame: Day 0, day 4 and day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule and MCC: 400 mg (± 10%) per Capsule in people with Upper Respiratory Tract Infections, run by Vedic Lifesciences Pvt. Ltd. at 9 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 7 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: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shalini Srivastava, MBBS, MD (9920789140, shalini.s@vediclifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of investigational products on participant's severity of common cold like symptoms (time frame: During Upper respiratory tract infection episodes throughout the study upto 7 day Treatment duration). 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 17 Jun 2024.