| CTRI Number |
CTRI/2013/12/004266 [Registered on: 31/12/2013] Trial Registered Prospectively |
| Last Modified On: |
17/05/2016 |
| 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 CurQlife 500 mg and CurQlife P 500 mg (Curcumin based formulation) in Reducing Symptoms of Knee Osteoarthritis. |
|
Scientific Title of Study
|
A Randomized, Double Blinded, Placebo Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of CurQlife 500 mg and CurQlife P 500 mg in Reducing Symptoms of Knee Osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LPPL/OA/CQL/13 Version 1.0 Dated-20-Sep-2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjib Kumar Panda |
| Designation |
Manager overall trial coordinator |
| Affiliation |
Laila Pharmaceuticals Pvt Ltd |
| Address |
Laila Pharmaceuticals Pvt. Ltd. C/o Laila Nutraceuticals Research Center, Survey No.181/2, JRD Tata Industrial Estate, Kanuru,
Vijayawada,India
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
sanjib@lailapharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Somashekara |
| Designation |
Senior manager |
| Affiliation |
Laila Pharmaceuticals Pvt Ltd |
| Address |
Laila Pharmaceuticals Pvt. Ltd. C/o Laila Nutraceuticals Research Center, Survey No.181/2, JRD Tata Industrial Estate, Kanuru,
Vijayawada,India
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
somu@lailapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjib Kumar Panda |
| Designation |
Manager overall trial coordinator |
| Affiliation |
Laila Pharmaceuticals Pvt Ltd |
| Address |
Laila Pharmaceuticals Pvt. Ltd. C/o Laila Nutraceuticals Research Center, Survey No.181/2, JRD Tata Industrial Estate, Kanuru,
Vijayawada,India
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
sanjib@lailapharma.com |
|
|
Source of Monetary or Material Support
|
| Laila Pharmaceuticals Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Laila Pharmaceuticals Pvt Ltd |
| Address |
Laila Pharmaceuticals Pvt. Ltd. C/o Laila Nutraceuticals Research Center, Survey No.181/2, JRD Tata Industrial Estate, Kanuru,
Vijayawada-520007,India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Laila Pharmaceuticals Pvt Ltd |
Laila Pharmaceuticals Pvt. Ltd. C/o Laila Nutraceuticals Research Center, Survey No.181/2, JRD Tata Industrial Estate, Kanuru,
Vijayawada-520007,India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrKBalakondaiah |
Bolineni Super Speciality Hospital |
Nellore-524003.Andhra Pradesh, India
Nellore
ANDHRA PRADESH |
09440279700
bakolaxmi@rediffmail.com |
| DrPAshok kumar |
King George Hospital |
Department of orthopedics,Unit-II King George Hospital,Andhra Medical Collage,Visakhapatnam-530002
Visakhapatnam
ANDHRA PRADESH |
9849123602
ashok_ortho59@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Dr.P.Ashok Kumar |
Approved |
| Vijaya Ethics committee for Dr.Balakondaiah |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CurQlife 500mg |
One capsule twice daily
Duration-60 days |
| Intervention |
CurQlife P 500mg |
One capsule twice daily Duration-60 Days |
| Comparator Agent |
Placebo |
One capsule twice daily
Duration-60 Days |
|
|
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 to grade 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 years 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 (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 (VAS score greater than 70)
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
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Change from baseline to end of trial in WOMAC
|
Visit-1 to Visit-5
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean Change from baseline to end of trial in
VAS & LFI score and Primary knee flexion
|
Visit-1 to Visit-5 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The proposed study is to assess
the Efficacy and safety of novel formulation of curcumin I, curcumin II and III
in Reducing Symptoms of Knee Osteoarthritis by decreasing joint pain and
improvement in joint function. Several osteoarthritis trials
have been conducted to evaluate the safety and efficacy of curcumin in
alleviating the symptoms of pain and inflammation associated with
osteoarthritis and is demonstrated to be both safe and effective for long-term
use. A total of 60 ambulatory male and
female subjects with 40-75 years of age with a Body Mass Index (BMI) of
approximately 18 to 30 kg/m2,having Unilateral or bilateral OA of the knee for
greater than 3 months (ACR criteria)will be screened and randomly assigned into
any of the three treatment arms in 1:1:1 ratio (CurQlife 500 mg, CurQlife P 500
mg and Placebo). All
subjects randomized to Active group will be advised to take one capsule twice daily
There will be a total of five visits in the study [Screening
Visit/Randomization visit (Day -7 to Day 0) Visit 1 and Study Periods [Day 7,
Day 15, Day 30,and Final visit [Day 60].
The study assessment is through
Change in WOMAC,VAS,LFI and Knee flexion from baseline to day 60. |