A Study for Assessing the Efficacy and Safety ParActin® in Individuals With Upper Respiratory Tract Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-05

Study Completion Date

2024-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections

NCT00827502

Upper Respiratory Tract Infections

COMPLETED

Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects

NCT01026545

Respiratory Tract Infections

COMPLETED PHASE1

AMS VS MOXI Ketek vs Avelox in AMS

NCT00537563

Maxillary Sinusitis

COMPLETED PHASE3

Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox

NCT00668304

Maxillary Sinusitis

COMPLETED PHASE4

A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia

NCT00717561

Pneumonia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Upper Respiratory Tract Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Double-blind, Randomized, Placebo-Controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ParActin®: 300 mg + MCC: 100 mg (± 10%)

Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner).

Group Type ACTIVE_COMPARATOR

ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule

Intervention Type DIETARY_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 Capsule

Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner).

Group Type PLACEBO_COMPARATOR

MCC: 400 mg (± 10%) per Capsule

Intervention Type DIETARY_SUPPLEMENT

Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule

Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner)

Intervention Type DIETARY_SUPPLEMENT

MCC: 400 mg (± 10%) per Capsule

Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male and female aged between 18 and 50 years as of the screening date.
2. Individuals with symptoms of acute upper respiratory tract infection as assessed by the investigator at the time of screening.
3. BMI ≤ 29.9 kg/m2.
4. Upper respiratory tract infection symptoms present for at least 24 hours but not more than 48 hours prior to screening visit.
5. 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.
6. History of frequent common cold with past episode duration of at least 4 days.
7. Must be literate and have the ability to complete the study-based questionnaires and requirements.

Exclusion Criteria

1. High grade fever defined as body temperature ≥ 39ºC (≥ 102.2 ºF)
2. With a history of allergy (allergic rhinitis) along with symptoms such as sneezing, runny nose and red, watery and itchy eyes.
3. Individuals with history of Chronic obstructive pulmonary disease, pulmonary fibrosis or Asthma.
4. Individuals with rhinitis medicamentosa, chronic cough of bacterial, fungal or other known origin.
5. Individuals requiring hospitalization or likely to be hospitalised due to URTI.
6. Individuals with common cold for the first time.
7. Individuals with anatomical nasal obstruction/ deformity or nasal reconstructive surgery etc.
8. Individuals with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
9. Individuals with history of immunocompromised state immune system with/ without organ transplant
10. Individuals with known or suspected hypersensitivity or intolerance to herbal products
11. Individuals diagnosed with Sickle cell disease, Thalassemia, Type I/ II Diabetes mellitus, Cystic fibrosis
12. Diagnosed cases of Uncontrolled hypertension as assessed by a systolic blood pressure ≥ to 140mmHg and diastolic blood pressure ≥ to 90mmHg
13. 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.
14. Those who have been vaccinated for influenza, swine flu 3 months prior to screening visit.
15. 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.
16. 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.
17. 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.
18. 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.
19. Individuals having a history of smoking or currently smoking or using any form of smokeless tobacco.
20. Individuals with heavy alcohol consumption, defined as:

1. For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
2. For women: More than 7 SAD/week or more than 3 SAD in a day.
3. Binge drinkers, defined as 5 or more SAD for men, in a 2-hour time frame.
4. 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)
21. Those who have clinically significant disorder/s of cardiovascular, endocrine, lymphatic, respiratory, hepatobiliary, urinary, reproductive, central nervous system, musculoskeletal and digestive systems.
22. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
23. 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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes