| CTRI Number |
CTRI/2024/09/074104 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Amrutanjan Pain Balm Extra Power for Headache |
|
Scientific Title of Study
|
A single arm open label interventional study to evaluate the efficacy and tolerability of Amrutanjan pain balm extra power for pain relief in patients with primary type of headache disorders |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AMRPBEP/13/24, Version 1.0, Dated 10.07.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand Babu MBBS |
| Designation |
Consultant |
| Affiliation |
Shree Lakshmi Clinic |
| Address |
Room No 1 General Medicine Dept No 41 Karunanidhi Street Nehru Nagar Velachery
Chennai
TAMIL NADU
600042
India |
| Phone |
9566086072 |
| Fax |
|
| Email |
dranandbabu4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Babu MBBS |
| Designation |
Consultant |
| Affiliation |
Shree Lakshmi Clinic |
| Address |
Room No 1 General Medicine Dept No 41 Karunanidhi Street Nehru Nagar Velachery
Chennai
TAMIL NADU
600042
India |
| Phone |
9566086072 |
| Fax |
|
| Email |
dranandbabu4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
Ki3 Private Limited |
| Address |
Room No 1 Regus Office Centre Services chennai pvt ltd Olympia technology park, level 2 Altius Block No 1 SIDCO Industrial Estate Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Amrutanjan Health Care Limited,
Mylapore, Chennai 600004
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 Anand Babu |
Shree Lakshmi Clinic |
No 41 Karunanidhi Street Nehru Nagar Velachery
Chennai
TAMIL NADU |
9566086072
dranandbabu4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KI3 Ethic Committee of Ayush |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G448||Other specified headache syndromes. Ayurveda Condition: SIROROGAH/SIRAHSULA/SIRASTAPA/SIROBITAPA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Amrutanjan Pain Balm, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1(mg), Frequency: qid, Bhaishajya Kal: Antarabhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged above 18 years.
2. Patients who can 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. Patients who had been diagnosed with primary type of headache
disorders like migraine, tension type headache and other primary
head ache disorders. |
|
| ExclusionCriteria |
| Details |
1. Women of childbearing 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. Secondary type of headache disorders.
3. Known allergy to compounds of investigational product.
4. Subjects who had a diagnosis of basilar or hemiplegic
migraine.
5. Patients suffering from medical or psychiatric conditions
that would increase the risk of adverse events or interfere
with study assessments.
6. Participation in an investigational drug trial in the 30
days prior to the screening visit.
7. Immuno-compromised (history) individuals like known
HIV positive patients or patients who are on treatment
with steroids or immunomodulators.
8. Patients of vulnerable group (children, lactating mother,
elderly greater than 80 years, handicapped, seriously ill, mentally
challenged).
9. History of drug or alcohol abuse during the last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the onset of pain reduction after treatment from
30 seconds up to 15 minutes continuously and then on hourly
basis for 24 hours using visual analog scale
To assess the duration of action ie need for second
application of the test product for pain relief time frame
0-24 hours
the severity of pain
For statistical analysis ordinal conversion of pain levels will
be assigned as 0 no pain up to 10-severe pain. |
30 seconds up to 15 minutes continuously and then on hourly
basis for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor other complications like nausea, vomiting,
photophobia, and phonophobia.
To monitor for any adverse events during the study period |
0 to 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)
|
05/08/2025 |
| Date of Study Completion (India) |
07/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
|
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
|
24 participants with primary type of headache disorders will be enrolled in this study in a single arm.Test Arm – Participants (24) with primary headache disorders will use Amrutanjan Pain balm extra Power twice or thrice daily topically for one day Subjects will be asked to visit clinical facility/institution for their follow up visits on day 2. The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 24 participants will be randomized into a single group. Test Arm – Participants (24) with primary headache disorders will use Amrutanjan Pain balm extra Power twice or thrice daily topically for one day Subjects will be asked to visit clinical facility/institution for their follow up visits on day 2. The primary outcome measures to study the efficacy are as follows: To assess the onset of pain reduction after treatment from 30 seconds up to 15 minutes continuously and then on hourly basis for 24 hours. (using visual analog scale) To assess the duration of action/ pain relief (i.e. need for second application) of the test product for pain relief. (time frame : 0-24 hours) Visual analog scale (VAS) questionnaires will be filled in by the patients and scores given, ranging from 0 to 10 (based on the severity of pain). For statistical analysis, ordinal conversion of pain levels will be assigned as 0–no pain up to 10- severe pain. To monitor other complications like nausea, vomiting, photophobia, and phonophobia. To monitor for any adverse events during the study period. |