| CTRI Number |
CTRI/2025/10/095733 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| 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 Balm Headache caused due to tension |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Menthoplus Balm in Subjects Suffering from Tension Type Headache |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MPB/EMAMI/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
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 |
| Patients |
(1) ICD-10 Condition:G442||Tension-type headache. Ayurveda Condition: SIRASPURTIH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Menthoplus Balm, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Samudga, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to use Menthoplus balm as and when headache occurs for 15 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 |
1. Subjects diagnosed to have Tension Type Headache as per the ICHD II criteria.
2. Headache without any serious medical or surgical condition requiring the continuous use of NSAIDs for pain relief.
3. Willing to comply with all requirements of the study.
|
|
| ExclusionCriteria |
| Details |
1. Headache due to conditions like migraine, sinusitis, headache, fever or any other underlying disease
2. History of surgery of the Head, Neck, Eyes, Ear, and Nose at least one year prior to recruitment in the study
3. Subjects who use regular analgesics for headache relief
4. Use of any other investigational drug within 1 month prior to randomization
5. Any medical conditions which may interfere with efficacy and or safety of the
treatment with the investigational product
6. Known other active and serious medical or surgical disease
7. Pregnancy and Lactation
8. Known hypersensitivity to any ingredients of the trial drug.
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 |
1. Percentage of subjects with total or meaningful headache relief
2. Change in pain (Headache) intensity
|
Baseline Visit, visit 1 (Day 7), Visit 2 (Day 15) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain free period after 1 hour and 2 hours
2. Use of rescue medications
3. Onset and duration of action as pain (headache) reliever of Menthoplus Balm
4. Satisfaction of the quality of sleep
5. Quality of pain relief (ability to get back to normal) action of Menthoplus balm
6. Global assessment of overall change as assessed by physician and subjects
7. Global assessment of tolerability of study product
8. Assessment of adverse events including vitals
|
Baseline Visit, visit 1 (Day 7), Visit 2 (Day 15) |
|
|
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)
|
28/10/2025 |
| 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 the Menthoplus Balm in Subjects
Suffering from Tension Type Headache. The study will be carried out at 1-2
center in India. Subjects will be asked to use Menthoplus balm as and when
headache occurs for 15 days. The primary objectives of the study will be to
assess percentage of subjects with total or meaningful headache relief and change
in pain (Headache) intensity. Secondary objectives of the study will be to
assess pain free period after 1 hour and 2 hours, use of rescue medications,
onset and duration of action as pain (headache) reliever of Menthoplus Balm,
satisfaction of the quality of sleep, quality of pain relief (ability to get
back to normal) action of Menthoplus balm, global assessment of overall change
as assessed by physician and subjects, global assessment of tolerability of
study product and adverse events including vitals on baseline Visit, visit 1
(Day 7), Visit 2 (Day 15) |