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CTRI Number  CTRI/2017/03/008132 [Registered on: 17/03/2017] Trial Registered Prospectively
Last Modified On: 24/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effects of an ointment made of Indian frankincense extract in patients with acute inflammatory conditions. 
Scientific Title of Study   A Multicentric Randomized, Double Blind, Placebo Controlled Comparative Pilot Human Clinical Study to Assess the Efficacy and Tolerability of a Boswellia Serrata Extract Ointment in Patients with acute inflammatory conditions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AN-01BSO 0615H4-CRF02; Version 01 dated 30/06/2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Binu T Kuruvilla  
Designation  Overall Trial Co-ordinator 
Affiliation  Arjuna Natural Extracts Limited 
Address  AGM R&D, Arjuna Natural Extracts Limited P.B.No.126, Bank Road, Alwaye

Ernakulam
KERALA
683 101
India 
Phone  04842542480  
Fax  04842532404  
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Binu T Kuruvilla  
Designation  Overall Trial Co-ordinator 
Affiliation  Arjuna Natural Extracts Limited 
Address  AGM R&D, Arjuna Natural Extracts Limited P.B.No.126, Bank Road, Alwaye

Ernakulam
KERALA
683 101
India 
Phone  04842542480  
Fax  04842532404  
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sreejith Sreekumar 
Designation  Chief Executive Officer 
Affiliation  Clinfound Clinical Research Services Pvt Ltd 
Address  Clinfound Clinical Research Services Pvt. Ltd Chennal Buildings, Kumaramangalam P O Thodupuzha, Kerala

Idukki
KERALA
685597
India 
Phone  04846007955  
Fax    
Email  drsreejith@clinfound.com  
 
Source of Monetary or Material Support  
Arjuna Natural Extracts Limited P.B.No.126, Bank Road, Alwaye – 683 101 Tel: 0484-2542480, 2551648 Fax: 0484 2622612; 2532404 Email: lab@arjunanatural.com  
 
Primary Sponsor  
Name  Clinfound Clinical Research Services PvtLtd 
Address  Chennal Buildings Kumaramangalam PO Thodupuzha Idukki Kerala-685597 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr KBalakondaiah MSOrtho  Bollineni Superspeciality Hospital  Department of Orthopedics Bollineni Superspeciality Hospital, Krishna Institute of Medical Sciences, Dargamitta, Nellore - 524003 Andhra Pradesh
Nellore
ANDHRA PRADESH 
9440279700

bakolaxmi@rediffmail.com 
Dr Ram S Kaulgue  Karnataka Institute of Medical Sciences(KIMS)  Ward 304,Third Floor Dept of Medicine Karnataka Institute of Medical Sciences(KIMS) Hubli,Karnataka-580022
Dharwad
KARNATAKA 
9844426887

ramk72@yahoo.com 
DrPrasad MAVV  Vijaya Superspeciality Hospital  Room No 1 Department of Orthopaedics and Traumatology Vijaya Superspeciality Hospital, Ragahava Cini-complex,Pogathotta SPSR,Nellore- 524 001 Andhra Pradesh,India
Nellore
ANDHRA PRADESH 
8612321828

mavvprasad@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Kims Ethics Committee Situated at Office of Principal, Karnataka Institute of Medical Sciences , Hubli-580021, Karnataka, India,ECR/486/Inst/KA/2013  Approved 
Vijaya Ethics Committee, Nellore, Andhra Pradesh Reg No ECR/453/Inst/AP/2013  Approved 
Vijaya Ethics Committee, Nellore, Andhra Pradesh Reg No ECR/453/Inst/AP/2013  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Acute inflammatory conditions like sprain, strain, or contusion , (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Boswellia serrata extract ointment  Topical application applied three times daily to cover the affected area 
Comparator Agent  Placebo Ointment  Topical application applied three times daily to cover the affected area 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or female outpatients aged 18 to 65 years
2.Patients with acute inflammatory condition (within 72 hours of entry in the study) like sprain, strain, or contusion
3.Patients with a pain score > 5 on visual analog scale (VAS)
4.Patients ready to give written informed consent and willing to comply the study protocol
 
 
ExclusionCriteria 
Details  1.Patients with an injury to the same body region within the prior 3 months or a lifetime history of 3 or more injuries to the injured body region
2.Use of NSAIDs (including acetaminophen) within 24 hours, opioids within 7 days, long acting NSAIDs like piroxicam or naproxem since the injury, any topical medication since injury or corticosteroid drugs by any route of administration within 60 days of entry in the study
3.Patients with an open lesion or serious injury, including a fracture, nerve injury, and a tear of ligament, muscle, or cartilage
4.Known hypersensitivity or intolerance or allergic type reactions to curcumin, boswellia or acetaminophen.
5.History of known alcohol, analgesic or narcotic abuse within 2 years.
6.Sensitive skin and loss of skin at the application site.
7.Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential.
8.Presence of any severe medical or psychological condition or chronic condition/inflammation/infection that in the opinion of the investigator would compromise the patient’s safety or successful participation in the study.
9.Participation in any other clinical study within 30 days of screening.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in VAS score of pain   experienced during normal activity in the preceding 24 hours at end of study as compared to baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Pain relief score   “spontaneous pain relief” and “pain relief during activity and movement” at the end of study  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   N/A 
Date of First Enrollment (India)   20/03/2017 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a randomized, double blind, parallel group, placebo controlled multi-centre Pilot trial comparing the efficacy and Tolerability of a Boswellia Serrata Extract Ointment in Patients with Acute Inflammatory Conditions in comparison with placebo ointment daily on three times daily dosage for 07 days in 150 patients with chronic low back ache that will be conducted in five centers in India. The primary outcome measures will be Change in Visual Analogue Scale score of pain experienced at end of study as compared to baseline. The secondary outcomes will be Change in Pain relief score at end of study, Change in VAS score of pain experienced during normal activity in the preceding 24 hours at end of Day 3 as compared to baseline, Total requirement of rescue analgesia and Patient’s and investigators overall assessment 
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