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CTRI Number  CTRI/2021/02/031040 [Registered on: 05/02/2021] Trial Registered Prospectively
Last Modified On: 27/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy and tolerability of Amrutanjan Pain Balm  
Scientific Title of Study   A Randomized, Multicentric,Open label,Interventional study to evaluate the Efficacy and tolerability of two 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  Principal Investigator/Medical Consultant 
Affiliation  KI3, CRO 
Address  PM Medical centre, 38, thesai street, Walajapet, Vellore.

Vellore
TAMIL NADU
632513
India 
Phone  9677786447  
Fax    
Email  srkguruvarshan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Kannan 
Designation  Principal Investigator/Medical Consultant 
Affiliation  KI3, CRO 
Address  PM Medical centre, 38, thesai street, Walajapet, Vellore.

Vellore
TAMIL NADU
632513
India 
Phone  9677786447  
Fax    
Email  srkguruvarshan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Kannan 
Designation  Principal Investigator/Medical Consultant 
Affiliation  KI3, CRO 
Address  PM Medical centre, 38, thesai street, Walajapet, Vellore.

Vellore
TAMIL NADU
632513
India 
Phone  9677786447  
Fax    
Email  srkguruvarshan@gmail.com  
 
Source of Monetary or Material Support  
Amrutanjan Health Care Limited 
 
Primary Sponsor  
Name  Amrutanjan Health Care Limited 
Address  103, (Old No. 42-45), Luz Church Road. Mylapore, Chennai- 600 004. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 and Taj Clinic  38, thesai street, Walajapet, Tamil Nadu
Vellore
TAMIL NADU 		 9677786447

srkguruvarshan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ki3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R51||Headache. Ayurveda Condition: VATAJA-SIROROGAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amrutanjan Pain Balm Extra Power   apply pea-sized amount of approximately 0.25 g of the pain balm in thin layer to the pain area,once/twice over 24 hours for 1 day.  
Intervention  Amrutanjan Strong Pain Balm Double Power  apply pea-sized amount of approximately 0.25 g of the pain balm in thin layer to the pain area,once/twice over 24 hours for 1 day. 
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, known spinal disc herniation and osteoporosis.
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   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary efficacy endpoints 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)
2. To assess the duration of action (i.e need for second application) of the test product for pain relief.
 		 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor for any adverse events during the study period and assess the quality of life  30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min. 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/02/2021 
Date of Study Completion (India) 27/02/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="30" 
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)?  

Response - NO
Brief Summary  

The selected study participants will receive treatment as follows.

 Test arm 1: Amrutanjan Pain Balm Extra Power (APBEP): 36 subjects

Test arm 2: Amrutanjan Strong Pain Balm Double Power (ASPBDP): 36 subjects

 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

 If they have no relief after 2 h of product application, they will be permitted to use their own rescue Medication. The participant will be requested to visit for only one follow up  on the subsequent day.

 
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