| CTRI Number |
CTRI/2017/06/008874 [Registered on: 20/06/2017] Trial Registered Prospectively |
| Last Modified On: |
19/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
OLNP-08 for the Treatment 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-08 versus placebo in Reducing Symptoms of
Knee Osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OLS/OLN08/04/17-02, Version: 01, Date: 31 Mar 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Sanjib panda |
| Designation |
Head Operation |
| Affiliation |
Ocius Life Sciences Private Limited |
| Address |
Department of clinical research, No.325, P.H road, Aminjikarai
Chennai
TAMIL NADU
600029
India |
| Phone |
9003580729 |
| Fax |
|
| Email |
sanjib@ociuslife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Miss Nilima Mohanty |
| Designation |
Senior Research Associate |
| Affiliation |
Olene Life Sciences Private Limited |
| Address |
Department of Research and Development, No.325, P.H road, Aminjikarai
Chennai
TAMIL NADU
600029
India |
| Phone |
9791021271 |
| Fax |
|
| Email |
nilima@olenelife.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sanjib panda |
| Designation |
Head Operation |
| Affiliation |
Ocius Life Sciences Private Limited |
| Address |
Department of Clinical Research, No.325, P.H road, Aminjikarai
Chennai
TAMIL NADU
600029
India |
| Phone |
9003580729 |
| Fax |
|
| Email |
sanjib@ociuslife.com |
|
|
Source of Monetary or Material Support
|
| Olene Life Sciences, No. 325, P.H. Road, Aminjikarai, Chennai-600029, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Olene Life Sciences Private Limited |
| Address |
No. 325, P.H Road, Aminjikarai, Chennai- 600 029, Tamil Nadu,
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 |
| Dr Alok Kalyani |
Maharaja Agrasen Hospital |
Department of Orthopedics, West Punjabi Bagh, New Delhi-110026
New Delhi
DELHI |
954094955
alokkalyani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Symptoms of
Knee Osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OLNP-08 |
One Capsule of 500 mg twice daily orally for a period of 60 days |
| Comparator Agent |
Placebo Capsule |
One capsule of 500 mg twice daily orally for a period of 60 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects 40 – 75 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2.
2. Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria)
3. Subjects with radio graphic evidence by Kellgren - Lawrence grade 2 or 3
4. 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
5. VAS score during the most painful knee movement between 40-70 mm
6. Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs
7. Results of screening are within normal range or considered not clinically significant by the Principal Investigator
8. Drug naive subjects 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.
9. Willing to sign the informed consent and comply with study procedure |
|
| ExclusionCriteria |
| Details |
1. Female subjects, who are pregnant, breast feeding or planning to become pregnant.
2. 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
3. History of underlying inflammatory arthropathy or severe RA or OA
4. Subjects scheduled for any surgery within 3 months of completing the study
5. Recent injury in the area affected by OA of the knee (past 4 months)
6. History of Gout
7. History of congestive heart failure
8. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, ngastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies
9. History of Systemic Lupus Erythematosus (SLE)
10. High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc)
11. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent
12. Participation in any other trials involving investigational or marketed products within 30days prior to the Screening Visit
13. 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
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Change from baseline in WOMAC score |
Screening visit (Day 07 to 0), Randomization
visit (Day 1), Visit 2 (Day 7), Visit 3 (day 15),
Visit 4 (Day 30) and Visit 5 (Day 60) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline in Visual Analog Scale
(VAS) |
Screening visit (Day 07 to 0), Randomization
visit (Day 1), Visit 2 (Day 7), Visit 3 (day 15),
Visit 4 (Day 30) and Visit 5 (Day 60) |
Change from baseline in WOMAC subscale
score (pain, stiffness and physical function) |
Screening visit (Day 07 to 0), Randomization
visit (Day 1), Visit 2 (Day 7), Visit 3 (day 15),
Visit 4 (Day 30) and Visit 5 (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)
|
26/06/2017 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis is a common, chronic, progressive, skeletal, degenerative disorder, which commonly affects the knee joint. Osteoarthritis disables about 10% of people who are older than 60 years, compromises the quality of life of more than 20 million Americans, and costs the United States economy more than $60 billion per year.
OLNP-08 is a unique and novel formulation of natural active ingredient, which is found to possess significant anti-inflammatory and anti-oxidant activity. So this randomized, double blind, placebo control, parallel group study is designed to access the efficacy and safety of OLNP-08 capsule versus placebo for the treatment of Osteoarthritis. A total 50 subjects will be randomized with 1:1 allocation for test group (OLNP-08) and for control group (Placebo) for a period of approximately 60 days. During the study, subjects will visit the study site at screening visit (Day -7 to 0) randomization visit (Day 1), visit 2 (Day 7), visit 3 (Day 15), visit 5 (Day 30) and at final visit (Day 60).
The efficacy will be accessed on the basis of WOMAC score and VAS score. Safety parameters will be evaluated on basis of change in vitals, Laboratory parameters and adverse events. |