| CTRI Number |
CTRI/2025/10/095792 [Registered on: 09/10/2025] 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 Zandu Ultra Power Balm in cold symptoms, muscle and joint pain |
|
Scientific Title of Study
|
Clinical Study to Evaluate Efficacy and Safety of Zandu ultra power balm in subjects suffering from headache, cold, body ache, muscle pain and joint pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZUPB/ZANDU/2025/, Version 1.0, 18th Sept 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 = 1 |
| 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 |
|
|
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 |
Headache, cold, body ache, muscle pain and joint pain |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Zandu Ultra Power Balm , Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Samudga, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Cohort-1:
Subjects will be asked to apply Zandu Ultra Power balm on forehead, nose, paranasal sinuses area, throat and chest three times daily for 7 days.
Cohort 2
Subject will be asked to apply sufficient quantity of assigned product on the affected part two times daily for 30 days
| | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Cohort 1:
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
Cohort 2-
1. Participants suffering from neck and shoulder pain, sprains, strong knee pain,
muscle pain, and joint pain
2. Subjects with pain on VAS scale greater than 40 mm
3. Subjects who willing to sign the written informed consent and ready to
comply with the protocol requirement
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cohort 1
1. Change in cold symptoms i.e. nasal block, cough, headache, sore throat,
runny nose, body ache
2. Number and percentage of participants who report complete relief in
headache, cold and body ache
Cohort 2
Change in joint and muscle pain on VAS scale
|
Baseline Visit, Visit1 (24hrs), Visit 2 (48hrs), Visit 3 Day 3, Visit4 Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cohort 1
1. Satisfaction of the quality of sleep
2. Requirement of rescue medications
3. Assessment of skin patch test.
4. Global assessment for overall change by participants and by physician
5. Assessment of adverse events adverse drug reactions including vitals
Cohort 2
1. Requirement of rescue medications
2. Assessment of onset of action of Zandu ultra power balm as pain relief
3. Assessment of skin patch test
4. Assessment of duration of action of the Zandu ultra power balm as pain reliever
5. Global assessment for overall change as assessed by participants and investigator
6. Tolerability of study medications as assessed by participants and investigator
|
Baseline Visit, Visit1 (24hrs), Visit 2 (48hrs), Visit 3 Day 3, Visit4 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 Zandu ultra power balm
in subjects suffering from headache, cold, body ache, muscle pain and joint
pain. The study will be carried out at 1-2 centres in India. There will be two
cohorts. In cohort 1, subjects suffering from cold symptoms, headache and body
ache will be recruited. In cohort 2, subjects suffering from muscle and joint
pain will be recruited. In Cohort 1, subjects will be asked to apply Zandu
Ultra Power balm on forehead, nose, paranasal sinuses area, throat and chest
three times daily for 7 days. and in Cohort 2, subject will be asked to apply
sufficient quantity of assigned product on the affected part two times daily
for 30 days.
Cohort 1: In Primary objectives of the study will be to assess change
in cold symptoms i.e. nasal block, cough, headache, sore throat, runny nose,
body ache and number and percentage of participants who report complete relief
in headache, cold and body ache. Secondary objectives of the study will be to
assess satisfaction of the quality of sleep, requirement of rescue medications,
skin patch test, global assessment for overall change by participants and by
physician and adverse events, adverse drug reactions including vitals
Cohort 2: Primary objective of the study will be
to assess change in joint and muscle pain on VAS scale. Secondary objectives of
the study will be to assess requirement of rescue medications, skin patch test,
onset of action of Zandu ultra power balm as pain relief, duration of action of
the Zandu ultra power balm as pain reliever, global assessment for overall
change as assessed by participants and investigator and tolerability of study
medications as assessed by participants and investigator on Baseline Visit,
Visit1 (24hrs), Visit 2 (48hrs), Visit 3 (Day 3), Visit 4 (Day 7) |