| CTRI Number |
CTRI/2025/07/091301 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Assess How Well Karvol Plus Capsules Relieve Nasal Congestion and Related Symptoms in People with Common Cold, Allergies, or Sinusitis |
|
Scientific Title of Study
|
A Prospective, Single-Arm, Real-World Study to Evaluate of the Efficacy and Safety of Karvol Plus Capsules in the Management of Nasal Congestion and Associated Symptoms in Patients with Common Cold, Allergic Rhinitis or Sinusitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IN-25-01 Version 01 Dated 17 Jun 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297/301, SoBo Center, South Bopal, ahmedabad.
Ahmadabad
GUJARAT
380058
India |
| Phone |
07600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit Anil Trailokya |
| Designation |
Sr. GM Medical Services |
| Affiliation |
Indoco Remedies Limited |
| Address |
Indoco House, 166 CST Road,
Santacruz (E)
Mumbai
MAHARASHTRA
400098
India |
| Phone |
8080042460 |
| Fax |
|
| Email |
abhijit.trailokya@indoco.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijit Anil Trailokya |
| Designation |
Sr. GM Medical Services |
| Affiliation |
Indoco Remedies Limited |
| Address |
Indoco House, 166 CST Road,
Santacruz (E)
Mumbai
MAHARASHTRA
400098
India |
| Phone |
8080042460 |
| Fax |
|
| Email |
abhijit.trailokya@indoco.com |
|
|
Source of Monetary or Material Support
|
| Indoco Remedies Limited, Indoco House, 166 CST Road, Santacruz (E), Mumbai 400 098, INDIA |
|
|
Primary Sponsor
|
| Name |
Indoco Remedies Limited |
| Address |
Indoco House, 166 CST Road,
Santacruz (E), Mumbai 400 098, INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chintan Patel |
Aatman Hospital |
Basement, Clinical Research Department,5, Anveshan Row House, Opp Umiya Mata Mandir Bopal-Ghuma Main Road, Bopal - 380058 India
Ahmadabad
GUJARAT |
9825182251
drchintan.cr@gmail.com |
| Dr Bakulesh A Madhu |
Harshil Medical Nursing Home |
Room no 05, 1st floor Clinical Research Department, 19, Asha Society, Near Verai Mata Temple, near Isanpur bus stop,Isanpur-bhairavnath road, Isanpur,382443
Ahmadabad
GUJARAT |
9824045708
drbakuleshmadhucr@gmail.com |
| Dr Dhiraj Kumar Panda |
Maxfort Hospital |
Room Number 106. 1st floor, Clinical Research Department, Infront of, police station, 37, Gayatri Vihar, Kanan Vihar, Chandrasekharpur, Bhubaneswar, Odisha 751024
Khordha
ORISSA |
9090775555
drpandadhiraj88@myyahoo. com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| EC UNCE |
Submittted/Under Review |
| Institutional Ethics Committee Aatman Hospital Aatman Hospital |
Approved |
| Institutional Ethics Committee Aatman Hospital Aatman Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], (2) ICD-10 Condition: J01||Acute sinusitis, (3) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Karvol® Plus Capsule |
Take one capsule thrice daily of Karvol® Plus for 5 days, or as often as needed depending on the severity of symptoms. For morning use, snip off the tip of the capsule, squeeze the contents into hot water, and inhale the vapours deeply for 5–10 minutes. During the daytime, snip the capsule and apply the contents to a tissue or handkerchief, then inhale the vapours as needed. At night, snip the capsule and apply it to the pillow or nightdress to allow inhalation of vapours during sleep. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 to 65 years.
2. Onset of nasal congestion and associated symptoms due to common cold, allergic rhinitis, or sinusitis within the past 48 hours prior to enrolment.
3. Willing and able to provide written informed consent.
4. Willing and able to comply with study procedures, including follow-up assessments as required by the study protocol.
|
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity or allergy to any of the components of Karvol Plus capsules (e.g., menthol, camphor, eucalyptol).
2. Patients with known history of severe respiratory comorbidities, such as uncontrolled asthma or chronic obstructive pulmonary disease (COPD).
3. Patients currently receiving other nasal decongestants (topical or systemic) within the last 48 hours that may interfere with the assessment of Karvol Plus effectiveness.
4. Any other condition or therapy that, in the investigator’s opinion, may interfere with the study outcomes or pose a safety risk. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Total Nasal Symptom Score (TNSS). |
Day 0 to Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in individual symptoms, including nasal congestion, runny nose, nasal itching, sneezing, and sleep disturbance. |
Day 0 to Day 5 |
| Time to first noticeable relief after using Karvol Plus. |
Day 0 to Day 5 |
| Patient-reported satisfaction with treatment effectiveness. |
Day 5 |
| Change in cough severity and impact |
Day 0 to Day 5 |
| Change from baseline in the severity of “heaviness in head”, as measured by the subject using an 11-point Numeric Rating Scale (NRS). |
Day 0 to Day 5 |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
29/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a prospective,
single-arm, real-world study designed to evaluate the efficacy and safety of
Karvol® Plus Capsules in patients suffering from nasal congestion and
associated symptoms due to the common cold, allergic rhinitis, or sinusitis.
Approximately 250 eligible subjects will be enrolled at baseline (Day 0) and
receive Karvol® Plus Capsules. Participants will either visit the site or
receive telephonic follow-up daily until Day 5. The primary endpoint is the
change in Total Nasal Symptom Score (TNSS) from baseline to end of treatment.
Safety will be assessed through monitoring of adverse events. Data collection
includes demographics, medical history, clinical symptoms, treatment
compliance, and safety outcomes. |