| CTRI Number |
CTRI/2024/04/065020 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study for Assessing the Efficacy and Safety of ParActin® in Individuals with Upper respiratory tract infections |
|
Scientific Title of Study
|
A Double-blind, Randomized, Placebo-Controlled, Comparative Study for Assessing the Efficacy and Safety of ParActin® in Individuals with Upper respiratory tract infections |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HP/231102/PA/URTI VERSION: 1.0 DATE: 14-02-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Srivastava |
| Designation |
Associate Director Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India Mumbai MAHARASHTRA 400053
Mumbai
MAHARASHTRA
400053
India |
| Phone |
9920789140 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Srivastava |
| Designation |
Associate Director Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India Mumbai MAHARASHTRA 400053
MAHARASHTRA
400053
India |
| Phone |
9920789140 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Raote |
| Designation |
Manager – Clinical Operations |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India Mumbai MAHARASHTRA 400053 India
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242172325 |
| Fax |
|
| Email |
sonal.raote@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences Pvt. Ltd.
118-B, Morya House, off New Link Road, Andheri West
Mumbai – 400053, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Vedic Lifesciences Pvt. Ltd |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhinav Guliani |
Gastron Clinic |
Gastron Clinic, I 103, First Floor, Kirti Nagar, New Delhi, Delhi 110015
New Delhi
DELHI |
9718302294
abhinavguliani@hotmail.com |
| Dr Rupali Gulavani |
ENT Vertigo Clinic |
ENT Vertigo Clinic, Pune
Flat no 2, Prachi Residency, Opp Kapil Malhar Society, Next to Vodafone Store, Main Road, Baner, Pune- 411045, Maharashtra, India
Pune
MAHARASHTRA |
9923108585
drrupalivg@gmail.com |
| Dr Atul Gogia |
Good health Clinic |
Good health Clinic , Delhi
DDA MIG Flats, Rajouri Garden, Delhi, India - 110027
West
DELHI |
9891003450
Atulgogia@gmail.com |
| Dr Shashi Prakash Maurya |
Human Care Hospital |
HUMAN CARE HOSPITAL
1 B Barigawa Road, Kanpur Rd, Sector B, Bargawan, LDA Colony, Lucknow, Uttar Pradesh 226012
Lucknow
UTTAR PRADESH |
9415005158
drspmauryaa@gmail.com |
| DrManoj Kumar Pal |
Janta Hospital & Maternity Centre |
Janta Hospital & Maternity Centre, Ground floor OPD No.1 Near Water Head Tank, Amara – Akhari Bypass Chunar Road, Varanasi – 221011, Uttar Pradesh, India
Varanasi
UTTAR PRADESH |
9198677778
manojpalvns@gmail.com |
| DrPiyush Arora |
Jawaharlal Nehru Medical College |
Jawaharlal Nehru Medical College, Kala Bagh, Ajmer, Rajasthan 305001 PI
Ajmer
RAJASTHAN |
6295446099
Doctorpiyusharora@gmail.com |
| Dr Sandeep Gaidhani |
Life care hospital |
Life care hospital , Nashik
New Nashik, Mumbai, Agra Highway, Lekha Nagar, Nashik, Maharashtra, India 422009
Nashik
MAHARASHTRA |
7588606598
drsandeepgaidhani@gmail.com |
| Dr siddhartha Singh |
Shubham Sudbhawana Super Speciality Hospital |
Shubham Sudbhawana Super Speciality Hospital
Banaras Hindu University, Naria Rd, Bhogabir, Saket Nagar Colony, Lanka, Varanasi, Uttar Pradesh, India 221005
Varanasi
UTTAR PRADESH |
9415262714
dr.siddharthasinghvns@gmail.com |
| Dr Dipti Gupta |
Tulsi Multispecility Hospital |
Tulsi Multispecility Hospital, Delhi
B-1, Loni Rd, West Jyoti Nagar, Jyoti Nagar West, Jyoti Nagar, Shahdara, Delhi, India 110094
North East
DELHI |
9811676049
drdipti16@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Good Society Ethical Research |
Approved |
| Good Society Ethical Research |
Approved |
| Good Society Ethical Research |
Approved |
| IEC Medical Care Centre and Hospital |
Approved |
| Janta Hospital Ethics Committe |
Approved |
| Jawahar Lal Nehru Medical College |
Approved |
| Muktai Hospital Institutional Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committe |
Approved |
| Shubham Sudbhawana Superspeciality Hospital Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J398||Other specified diseases of upperrespiratory tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ParActin |
Two capsules/day (One capsule to be taken 30 minutes before breakfast & one capsule to be taken 30 minutes before dinner). |
| Comparator Agent |
Placebo |
Two capsules/day (One capsule to be taken 30 minutes before breakfast & one capsule to be taken 30 minutes before dinner). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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
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:
a) For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
b) For women: More than 7 SAD/week or more than 3 SAD in a day.
c) Binge drinkers, defined as 5 or more SAD for men, in a 2-hour time frame
d) 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 per alcohol), 8.5 ounces of malt liquor (9 per alcohol), 5 ounces of wine (12 per alcohol), 3.5 ounces of fortified wine (example sherry or port), or 1.5 ounces of liquor (distilled spirits 40 per alcohol)
21. Those who have clinically significant disorder 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 individuals ability to successfully and safely complete the study or that may confound study outcomes
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of investigational products on participant’s severity of common cold like symptoms as reduction in the incremental Area Under the Curve (iAUC) of Wisconsin Upper Respiratory Symptom Survey-21 total severity score.
|
During Upper respiratory tract infection episodes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of investigational products on Time (in days) taken to resolution of common cold like symptoms with resolution deemed to occur when participant reports being 0 equal not sick as per Wisconsin Upper Respiratory Symptom Survey-21 for two consecutive days during the treatment period |
Every day Throughout the study |
| To evaluate the effect of investigational products on percentage of participants with unresolved common cold symptoms being those who do not report being 0 equal not sick as per Wisconsin Upper Respiratory Symptom Survey-21 till the end of the treatment period. |
Every day Throughout the study |
| 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). |
Every day Throughout the study |
| To evaluate the effect of investigational products On number of days taken to be afebrile (temp less than 100 F or less than 37.7 C) in the population with fever (temp ≥100 F or ≥37.7 C ) at baseline- as assessed by 10-point visual analogue scale |
Every day Throughout the study |
To evaluate the effect of investigational products on
Percentage population with fever during the study |
Every day Throughout the study |
To evaluate the effect of investigational products on
Quality of life as assessed by WURSS QoL |
Day 0, day 4 and day 8 |
To evaluate the effect of investigational products on Daily work productivity as assessed by Question no. 6, Work Productivity and Activity Impairment Questionnaire (WPAI)
|
Day 0, day 4 and day 8 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "161"
Final Enrollment numbers achieved (India)="161" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
05/04/2024 |
| Date of Study Completion (India) |
12/07/2024 |
| Date of First Enrollment (Global) |
05/04/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief 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. 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 |