| CTRI Number |
CTRI/2025/10/095917 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on Vaporizing Cold Rub in common Cold symptoms |
|
Scientific Title of Study
|
Clinical Evaluation of efficacy and safety of Vaporizing Cold Rub in symptoms of cold |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VCR/EMAMI/2025/1, Version 1.0, 08th Aug 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Patil |
| Designation |
Ayurveda Consultant Physician |
| Affiliation |
Shree Sai Clinic |
| Address |
Clinical Research Department, OPD no.1, Ground Floor
Shree Sai Clinic, Shop No 3, Kamalai Apt, Nandini Takle Nagar, Manjari Bk Pune
Pune
MAHARASHTRA
4123307
India |
| Phone |
8329623407 |
| Fax |
|
| Email |
drpriyaspatil9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt Ltd |
| Address |
Target Institute of Medical Education and Research Pvt Ltd
A wing 402 A/B/C, Jaswanti Allied Business Center,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt Ltd |
| Address |
Target Institute of Medical Education and Research Pvt Ltd
A wing 402 A/B/C, Jaswanti Allied Business Center,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Emami Ltd.
Tower 687, Anandpur, E. M. Bypass,
Kolkata 700107
|
|
|
Primary Sponsor
|
| Name |
Emami Ltd. |
| Address |
Tower 687, Anandpur, E. M. Bypass,
Kolkata 700107
|
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Patil |
Shree Sai Clinic |
Clinical Research Department, OPD no.1, Ground Floor
Shree Sai Clinic, Shop No 3, Kamalai Apt, Nandini Takle Nagar, Shewalwadi Phata, Manjari Bk -4123307
Pune
MAHARASHTRA |
8329623407
drpriyaspatil9@gmail.com |
| Dr Chirag Chand |
Spandan Hospital |
Clinical Research Department, OPD no.1, Ground Floor
Spandan Hospital, Kandoba Mal, Fursungi- Wadki road, Fursungi, Pune, MH 412308.
Pune
MAHARASHTRA |
9767822626
ccchand30101993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kusum Independent Ethics Committee, Hadapsar, Pune |
Approved |
| Kusum Independent Ethics Committee, Hadapsar, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cold Symptoms |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Vaporizing Cold Rub , Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Samudga, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to apply Vaporizing Cold Rub on forehead, nose, paranasal sinuses area, throat and chest three times daily for 7 days. Also, subjects will be asked to take steam inhalation using Vaporizing Cold Rub thrice daily for 7 days. | | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed with common cold
2. Beginning of the symptoms of common cold in a minimum period of 24 hours
and a maximum of 72 hours prior to baseline visit;
3. Willing to comply with all requirements of the study
|
|
| ExclusionCriteria |
| Details |
1. Presence of significant septum deviation, compatible with impaired nasal
ventilatory function, at the investigators discretion.
2. Presence of nasal polyposis to previous rhinoscopy.
3. Required antibiotic therapy for upper airway infection treatment
4. Subjects on any other investigational products within 1 month prior to
randomization
5. Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer,
kidney failure, liver failure
6. Any medical conditions which may interfere with efficacy and or safety of the
treatment with the investigational product
7. Pregnant and lactating women
8. Known hypersensitivity to any of the ingredients of Vaporizing Cold Rub
9. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his or her participation in, and completion of the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in cold symptoms |
Baseline Visit, Visit1 (24hrs), Visit 2 (48hrs), Visit 3 (Day 3), Visit 4 (Day 7) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of subjects relieved completely from symptoms of cold
2. Satisfaction of the quality of sleep
3. Requirement of rescue medications
4. Skin patch test
5. Global assessment for overall change by participants and by physician
6. Adverse events, adverse drug reactions including vitals
|
Baseline Visit, Visit1 (24hrs), Visit 2 (48hrs), Visit 3 (Day 3), Visit 4 (Day 7) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/10/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is a clinical study to evaluate efficacy and
safety of Vaporizing Cold Rub in symptoms of cold. The study will be carried
out at 1-2 center in India. Subjects will be asked to apply Vaporizing Cold Rub
on the forehead, nose, sinuses, throat, and chest and take steam inhalation three
times daily for 7 Days. The primary objective of the study will be to assess cold
symptoms. Secondary objectives of the study will be to assess number of
subjects completely relieved from cold symptoms, sleep quality satisfaction
requirement for rescue medications, skin patch tests global assessments of
overall change as assessed participant and physician, adverse events and drug
reactions including vital signs on Baseline Visit, Visit1 (24hrs), Visit 2
(48hrs), Visit 3 (Day 3), Visit 4 (Day 7) |