| CTRI Number |
CTRI/2026/01/100601 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on Menthoplus Soft balm in symptoms of cold |
|
Scientific Title of Study
|
Clinical Study to Evaluate Efficacy and Safety of Menthoplus Soft balm in subjects suffering symptoms of cold. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EMAMI/MENTHOSOFTBALM/2025/, Version 1.0, 08th Dec 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Patil |
| Designation |
Ayurveda Consultant Physician |
| Affiliation |
Target Institute of Medical Education and Research Pvt Ltd |
| Address |
Department of Clinical Research, OPD No. 1, Second Floor, Target Institute of Medical Education and Research Pvt Ltd. Office E-203, Jaymala Business Court, Takle Nagar
Manjri BK. Hadapsar Pune.
Pune
MAHARASHTRA
412307
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 Clinical Research Department, Room No, 402 A, B, C, A wing, 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 Clinical Research Department, Room No, 402 A, B, C, A wing, 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Patil |
Target Institute of Medical Education and Research Pvt Ltd. |
Department of Clinical Research, OPD No. 1, Second Floor, Office E-203, Jaymala Business Court, Takle Nagar
Manjri BK. Hadapsar Pune-412307.
Pune
MAHARASHTRA |
8329623407
drpriyaspatil9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kusum Independent Ethics Committee, Hadapsar, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Symptoms of Cold |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Menthoplus Soft Balm, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: tds, Bhaishajya Kal: Samudga, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to apply Menthoplus Soft balm 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 Menthoplus Soft balm thrice daily for 7 days | | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed with common cold defined by clinical evaluation and
presence of at least two or more of the following symptoms nasal block, cough, headache, sore throat, runny nose, body-ache, chills classified as moderate to severe category
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in cold symptoms i.e. nasal block, cough, headache, sore throat, runny nose, body-ache, chills
|
Day 0, Day 3 and Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of subjects relieved completely from symptoms of cold
2. Assessment of headache on VAS
3. Assessment of onset of action, duration of action, and relief period of cold symptoms and headache
4. Assessment of onset of action, duration of action of counter-irritancy and
cooling effects
5. Satisfaction of the quality of sleep
6. Requirement of rescue medications
7. Skin patch test using Dermal Response Score.
8. Global assessment for overall change by participants and by physician
9. Adverse events, adverse drug reactions including vitals
|
Day 0, Day 3 and 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 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="3"
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 Menthoplus Soft balm in subjects suffering symptoms of cold. The study will be carried out at one center in India. Subjects will be asked to apply Menthoplus Soft balm 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 Menthoplus Soft balm thrice daily for 7 days. The primary objective of the study will be to assess change in cold symptoms nasal block, cough, headache, sore throat, runny nose, body ache, chills. The secondary objectives of the study will be to assess number of subjects relieved completely from symptoms of cold, headache on VAS, onset of action, duration of action, and relief period of cold symptoms and headache, onset of action, duration of action of counter-irritancy and cooling effects, satisfaction of the quality of sleep, requirement of rescue medications, skin patch test using Dermal Response Score, global assessment for overall change by participants and by physician and adverse events, adverse drug reactions including vitals on Day 0, Day 3 and Day 7. |