| CTRI Number |
CTRI/2025/06/089406 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Study to Find Out if the New Amrutanjan Headache Roll-On Gives fast Pain Relief in Migraine Patients |
|
Scientific Title of Study
|
A single arm, open label, interventional study to evaluate the safety, efficacy and tolerability of NEW AMRUTANJAN HEADACHE FASTER RELAXATION ROLL ON for pain relief in patients with migraine headache disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AFR/05/25, Version 1.0, Dated: 05-05-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sakthi Balan |
| Designation |
Principal Investigator |
| Affiliation |
Ki3 Private Limited |
| Address |
DK Elite Health Care Centre, Room no 02, Dermatologist, First Floor, No.370, Cuddalore main Road, Nainarmandapam,
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Principal Investigator |
| Affiliation |
Ki3 Private Limited |
| Address |
DK Elite Health Care Centre, Room no 02, Dermatologist, First Floor, No.370, Cuddalore main Road, Nainarmandapam,
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
Ki3 PRIVATE LIMITED |
| Address |
Room No 1, Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai
No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai- 600044
Chennai
TAMIL NADU
600032
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Amrutanjan Health Care Limited, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Amrutanjan Health Care Limited, Tamil Nadu, India |
| Address |
Mylapore Chennai 600004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 M Sakthi Balan |
DK Elite Health Care Center |
DK Elite Health Care Centre, Room no 02, Dermatologist, First Floor, No.370, Cuddalore main Road, Nainarmandapam,
Pondicherry
PONDICHERRY |
9443627722
saheerose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethique De La Nature Association |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G438||Other migraine. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: NEW AMRUTANJAN HEADACHE FASTER RELAXATION ROLL ON , Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0.2(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 2 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants of either gender, aged 18 – 65 years.
2. Participants who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
3. Participants who are diagnosed with migraine-type headache (Common Migraine, Classical Migraine, Ophthalmic Migraine and Basilar Migraine) as per The International Classification of Headache Disorders 3rd edition (ICHD-3) criteria.
4. Participants with pain score greater than or equal to 3/10 (based on numeric pain rating scale) during the past 1 week.
5. Migraine attacks present for more than 1 year.
6. Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
7. 1 to 8 migraine days per month on average across the 3 months prior to the Screening Visit
8. Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the screening visit and throughout the screening phase.
|
|
| ExclusionCriteria |
| Details |
1. Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (implants or injectable products, vaginal products, skin patches), or IUDs, barrier methods] to avoid pregnancy during the study period.
2. Pregnant or lactating participants
3. Inability to distinguish other headaches from migraine
4. History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as participants who have not responded to an adequate dose and duration of treatment
5. Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening
6. Chronic opioid therapy (greater than 3 consecutive days in the 30 days prior to screening)
7. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome
8. Known allergy to compounds of test product.
9. Participants suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments.
10. Participation in an investigational drug trial during the last 30 days.
11. Immuno-compromised (history) individuals like known HIV positive participants or participants who are on treatment with steroids or immunomodulators.
12. Participants of vulnerable group (e.g. seriously ill, mentally challenged).
13. History of drug or alcohol abuse during the last 3 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Time to onset of relief of pain [Time frame: 0-120 minutes post dose]
2. Time to achieve complete relief of pain [Time frame: 0-120 minutes post dose]
3. Reduction in pain score on numeric pain rating scale (VAS) [Time frame: 30 seconds, 1 minute, 2minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes post dose]
4. Assessment of pain relief by using McGill Pain questionnaire. [Time frame: 0-120 minutes post dose and end of 24 hours]
5. Participants overall satisfaction for pain relief on a 7- point Likert Satisfaction scale [Time Frame: on day 2 - post dose]
|
30 seconds, 1 minute, 2minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes post dose
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse events (AE) and serious adverse events (SAE) will be monitored |
0-24 hours |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/06/2025 |
| Date of Study Completion (India) |
14/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This is a single-arm, open-label clinical study designed to evaluate the safety, effectiveness, and tolerability of the NEW AMRUTANJAN HEADACHE FASTER RELAXATION ROLL ON in individuals suffering from migraine headache disorders. A total of 24 adult participants diagnosed with migraine (as per international criteria) will be enrolled. The study involves the topical application of the roll-on to areas like the temples, behind the ears, and the back of the neck within 2 hours of headache onset. If pain relief is not achieved within 2 hours, participants may use rescue medications (NSAIDs). Participants will be observed over a short period of 2 days, with follow-up assessments conducted at the clinical facility on Day 2. They will use the roll-on two to three times in a day as needed. The primary outcomes include: -
Time taken to experience pain relief and complete pain relief -
Change in pain severity (using a numeric pain scale and the McGill Pain Questionnaire) -
Overall satisfaction with the product (using a 7-point Likert scale) Secondary outcomes include monitoring for any adverse events (AEs) or serious adverse events (SAEs) within 24 hours. This study aims to assess whether the NEW AMRUTANJAN HEADACHE FASTER RELAXATION ROLL ON offers fast and effective relief for migraine sufferers in a safe and well-tolerated manner. |