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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule | Dietary Supplement | Two capsules/day (One capsule to be taken 30 minutes before breakfast & one capsule to be taken 30 minutes before dinner) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During Upper respiratory tract infection episodes throughout the study upto 7 day Treatment duration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shalini Srivastava, MBBS, MD | Contact | 9920789140 | shalini.s@vediclifesciences.com | |
| Dr Sonal Raote, BAMS | Contact | 02242172325 | sonal.raote@vediclifesciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Life care hospital | Recruiting | Nashik | Maharashtra | 422009 | India |
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A Double-blind, Randomized, Placebo-Controlled
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| MCC: 400 mg (± 10%) per Capsule | Dietary Supplement | Two capsules/day (One capsule to be taken 30 minutes before breakfast & one capsule to be taken 30 minutes before dinner) |
|
| 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 | 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 | 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 | 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 | 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) | Day 0, day 4 and day 8 |
| ENT Vertigo Clinic | Recruiting | Pune | Maharashtra | 411045 | India |
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| Jawaharlal Nehru Medical College | Recruiting | Ajmer | Rajasthan | 305001 | India |
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| Human Care Hospital | Recruiting | Lucknow | Uttar Pradesh | 226012 | India |
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| Shubham Sudbhawana Super Speciality Hospital | Recruiting | Varanasi | Uttar Pradesh | 221005 | India |
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| Janta Hospital | Not yet recruiting | Varanasi | Uttar Pradesh | 221011 | India |
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| Gastron Clinic | Recruiting | Delhi | 110015. | India |
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| Good health Clinic | Recruiting | Delhi | 110027 | India |
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| Tulsi Multispecility Hospital | Recruiting | Delhi | 110094 | India |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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