| CTRI Number |
CTRI/2017/02/007928 [Registered on: 21/02/2017] Trial Registered Prospectively |
| Last Modified On: |
13/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and safety of OLNP-08 and Placebo in treatment of Knee Osteoarthritis. |
|
Scientific Title of Study
|
A Randomized Double Blind Double Dummy Placebo Controlled Parallel Group Study to Evaluate the Safety and Efficacy of OLNP 08versus placebo in Reducing Symptoms of Knee Osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OLS/OLN08/04/16 V 01 Dated 18 April 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilima |
| Designation |
Scientist |
| Affiliation |
Olene Life Sciences Private Limited |
| Address |
325 PH Road
Aminjikarai
Chennai
TAMIL NADU
600029
India |
| Phone |
09003580729 |
| Fax |
|
| Email |
info@olenelife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nilima |
| Designation |
Scientist |
| Affiliation |
Olene Life Sciences Private Limited |
| Address |
325 PH Road
Aminjikarai
Chennai
TAMIL NADU
600029
India |
| Phone |
09003580729 |
| Fax |
|
| Email |
info@olenelife.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilima |
| Designation |
Scientist |
| Affiliation |
Olene Life Sciences Private Limited |
| Address |
325 PH Road
Aminjikarai
Chennai
TAMIL NADU
600029
India |
| Phone |
09003580729 |
| Fax |
|
| Email |
info@olenelife.com |
|
|
Source of Monetary or Material Support
|
| Olene Life Sciences Private Limited, No.325, P.H. Road, Aminjikarai, Chennai-600029 |
|
|
Primary Sponsor
|
| Name |
Olene Life sciences |
| Address |
No. 325, P.H. Road,
Amijikarai,
Chennai-600029
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 Prasad M A V V |
Vijaya Super Speciality Hospital |
Department of Orthopedics, Raghava cine complex road
Pogathota Spsr Nelore 524001
Andhra Pradesh India
Nellore
ANDHRA PRADESH |
08612316707
08612300068
projectspcr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vijaya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient with knee Osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OLNP-08 500 mg - BID for 60 days |
One capsule of 500mg Twice daily |
| Intervention |
OLNP-08 500 mg OD for 60 days |
One capsule of 500mg OLNP-08 and one placebo capsule of 500mg Placebo Twice daily |
| Comparator Agent |
Placebo - BID for 60 days
|
One capsule of 500mg Twice daily |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Ambulatory, 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. Be 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, gastrointestinal, 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 30 days 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
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Change from baseline in WOMAC Score |
Day 0, Day 7, Day 15, Day 30, day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline in
• Visual Analog Scale &
• Lequesne’s functional index (LFI)
• Primary knee flexion
|
Day 0, Day 7, Day 15, Day 30, day 60 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
27/02/2017 |
| 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="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
OLNP-08 is a unique and
novel formulation of natural active ingredient, curcuminoids, which is found to
possess significant anti-inflammatory and anti-oxidant activity. OLNP-08 uses a
unique technique for the solubilisation of curcuminoids, the major active ingredient to yield an
emulsified formulation which is found to have higher bioavailability and easy
transport across the cell membrane.
Curcuminoids belongs to a group of flavonoids which are known to exhibit significant
anti-inflammatory and anti-oxidant activity with inhibitory effect on many cytokines like TNF-α, IL-1β, IL-6 etc. Several in
vivo studies have demonstrated a
marked inhibition of inflammatory mediators in animals treated with curcumin and thereby suggesting its role in reducing the inflammatory symptoms associated with Osteo arthritis.
It is 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.
Totally 66 number of subjects planned to randomized into on of the three arm in 1:1:1 ratio. the total treatment period will be 60 days. A total 66 subjects planned to be randomized in each group only after satisfying all inclusion and exclusion criteria. Patients are requested to visit on next day after screening date (Day 0), Day 07, Day 15, Day 30, and Day 60. The efficacy will be calculated by WOMC, VAS, LFI to and Primary knee flexion from baseline to end of the study. The purpose of this study is designed to assess the clinical effectiveness and safety of OLNP-08 vs. placebo in reducing the Osteoarthritis symptoms of the knee.
|