| CTRI Number |
CTRI/2020/06/026013 [Registered on: 22/06/2020] Trial Registered Prospectively |
| Last Modified On: |
11/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Pain balm on Headache |
|
Scientific Title of Study
|
A Randomized, Multicentric,Open label,Interventional study to evaluate the Efficacy and Tolerability of four types of AMRUTANJAN PAIN BALM for pain relief in patients with primary type of HEADACHE and BODY PAIN disorders. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh kannan |
| Designation |
Assistant Professor |
| Affiliation |
KI3, CRO |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU
Dr Ramesh kannan
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh kannan |
| Designation |
Assistant Professor |
| Affiliation |
KI3, CRO |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU
Dr Ramesh kannan
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh kannan |
| Designation |
Assistant Professor |
| Affiliation |
KI3, CRO |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU
Dr Ramesh kannan
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrutanjan Health Care Limited |
|
|
Primary Sponsor
|
| Name |
Amrutanjan Health Care Limited |
| Address |
42, 103, Luz Church Rd, Kapali Thottam, Mylapore, Chennai, Tamil Nadu 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 Ramesh Kannan |
PM Medical Centre (Hospital) |
Room no:10, General Medicine OPD, PM Medical Centre Hospital, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU |
7708925866
srkguruvarshan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ki3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G448||Other specified headache syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amrutanjan New Maha Strong Pain Balm (ANMSPB) |
Apply pea ball-sized amount (equivalent to 0.25g) of the pain balm in thin layer to the pain area. |
| Intervention |
Amrutanjan Strong Pain Balm(ASPB) |
Apply pea ball-sized amount (equivalent to 0.25g) of the pain balm in thin layer to the pain area. |
| Intervention |
New Amrutanjan Headache Faster Relaxation Roll-on (NAFRR) |
gently apply 4 rolls (equivalent to 0.25g) on the pain area as mentioned above. |
| Intervention |
New Amrutanjan Pain Balm Extra Power (NAPBEP) |
Apply pea ball-sized amount (equivalent to 0.25g) of the pain balm in thin layer to the pain area. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged above 18 years.
2. Patients 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. Patients who had been diagnosed with body pain disorders like knee pain, low back pain and primary type of headache disorders like migraine, tension type headache and other primary head ache disorders.
|
|
| 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. 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 >80 years, handicapped, seriously ill, mentally challenged).
9. History of drug or alcohol abuse during the last 6 months. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
 To assess the onset of pain reduction after treatment at 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min.(using visual analog scale)
 To assess the duration of action (i.e need for second application) of the test product for pain relief.(time frame : 0-24 hours)
|
30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
|  To monitor other complications like skin rashes, redness, photophobia, and phonophobia. |
0-24 hours |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "144"
Final Enrollment numbers achieved (India)="144" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/06/2020 |
| Date of Study Completion (India) |
02/08/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We will screen and enroll 144 study participants with knee pain, low
back pain and primary headache disorders as per the inclusion criteria.Each arm will comprise 12 study
participants with knee pain, 12 study participants with low back pain and 12
study participants with primary head ache disorders. The study participants will be
requested to apply pea-sized amount of approximately 0.25g of the pain balm in
thin layer to the pain area. In case of roll-on, gently apply 4
rolls (equivalent to 0.25g) on the pain area as mentioned above. The primary efficacy
end points are: 1.To assess the onset of pain reduction after treatment at 30 seconds,
1 min, 2 min, 5 min, 10 min, 30 min and 60 min. (using visual analog scale) and To assess the duration
of action (i.e. monitor the need for second application) of the test product
for pain relief.(time frame : 0-24 hours)
|