| CTRI Number |
CTRI/2022/01/039859 [Registered on: 31/01/2022] Trial Registered Prospectively |
| Last Modified On: |
28/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Safety and Efficacy of OLNP-27 versus placebo in Reducing Symptoms of Knee Osteoarthritis |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of OLNP-27 versus placebo in Reducing Symptoms of Knee Osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sanjib Panda |
| Designation |
COO |
| Affiliation |
Olene Life Scineces Private Limited |
| Address |
ABlock4th FloorPrinceInfoPark 2nd Main Road
Ambattur
Chennai
Chennai
TAMIL NADU
600101
India |
| Phone |
4440074444 |
| Fax |
|
| Email |
sanjib@olenelife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sanjib Panda |
| Designation |
COO |
| Affiliation |
Olene Life Scineces Private Limited |
| Address |
ABlock 4th FloorPrince Info Park 2nd Main Road
Ambattur
Chennai
Chennai
TAMIL NADU
600101
India |
| Phone |
4440074444 |
| Fax |
|
| Email |
sanjib@olenelife.com |
|
Details of Contact Person
Public Query
|
| Name |
sanjib Panda |
| Designation |
COO |
| Affiliation |
Olene Life Scineces Private Limited |
| Address |
ABlock 4th FloorPrince Info Park 2nd Main Road
Ambattur
Chennai
Chennai
TAMIL NADU
600101
India |
| Phone |
4440074444 |
| Fax |
|
| Email |
sanjib@olenelife.com |
|
|
Source of Monetary or Material Support
|
| Olene Life Sciences Pvt.Ltd
A Block 4th Floor Prince Info Park 81B 2nd Main Road
Ambattur Chennai 600 058 India
|
|
|
Primary Sponsor
|
| Name |
Olene Life Sciences Private Limited |
| Address |
Olene Life Sciences Pvt.Ltd
A Block 4th Floor Prince Info Park 81B 2nd Main Road
Ambattur Chennai 600 058 India
|
| 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 |
| DrV Krishnamurthy |
Chennai Meenakshi Multispeciality Hospital |
Department: Orthopedic
New No. 70, Old No. 149, Luz Church Road
Mylapore Chennai 600004
Chennai
TAMIL NADU |
04442938902
researchchennaimeenakshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHENNAI MEENAKSHI MUTTISPTCIATITY HOSPTTAT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Boswellia serrata extract |
one capsule once daily for 8 weeks |
| Comparator Agent |
Placebo capsile |
one capsule once daily for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Male and female subjects 40 to 75 years of age
Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria)
Subjects with radio graphic evidence by Kellgren - Lawrence grade 2 or 3
Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy
VAS score during the most painful knee movement between 40-70 mm
Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs
Results of screening are within normal range or considered not clinically significant by the Principal Investigator
Drug naive subjects for OA treatment or subjects willing to refrain from using ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue) or any other pain reliever including topical application (OTC or prescription) and Omega 3 fatty acids during the entire trial
Willing to sign the informed consent and comply with study procedure
|
|
| ExclusionCriteria |
| Details |
Female subjects, who are pregnant, breast feeding or planning to become pregnant
Subject has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication
History of underlying inflammatory arthropathy or severe RA or OA
Subjects scheduled for any surgery within 3 months of completing the study
Recent injury in the area affected by OA of the knee (past 4 months)
History of Gout
History of congestive heart failure
Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies
History of Systemic Lupus Erythematosus (SLE)
High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc)
History of psychiatric disorder that may impair the ability of subjects to provide written informed consent
Participation in any other trials involving investigational or marketed products within 30days prior to the Screening Visit
Have taken any corticosteroid, indomethacin, glucosamine + chondroitin, within 3 months prior to the Treatment Period, Day 0 (Visit 1) or intra-articular treatment / injections with corticosteroid or hyaluronic acid or Omega-3 Fatty acids dietary supplements within 6 months preceding the treatment period
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Change from baseline to end of trial in
WOMAC score
|
Day 0, Day 7, Day 15, Day 30, Day 60
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean Change from baseline to end of trial in
VAS
WOMAC subscale score (pain, stiffness and physical function)
hs CRP
|
Day 0, Day 7, Day 15, Day 30, Day 60
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/02/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
OLNP-27 is a natural, water dispersible and highly
concentrated boswellia extract standardized to >40% Acetyl keto- β-Boswellic
acid (AKBA). It is a highly absorbable formulation produced using patent
pending and clinically validated technology.
OLNP-27
comprehensively resolves all the limitations of existing standard Boswellia
extracts such as lower concentration of AKBA (1 to 3%), non-dispersible, poor
bioavailability, intense resinous smell (not suitable for food and beverage
formats), limited applications (suitable only for capsule and tablets) and high
levels of contaminants (residual solvents, heavy metals, aflatoxins and
pesticides). This study will evaluate efficiacy of the product in OA patients |