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
|
|
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
|
|
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 |