| CTRI Number |
CTRI/2017/02/007962 [Registered on: 27/02/2017] Trial Registered Prospectively |
| Last Modified On: |
08/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Paracetamol and haldi in arthritis of knee joints |
|
Scientific Title of Study
|
Randomized controlled study to compare the efficacy and safety of Biocurcumin and Paracetamol in patients of osteoarthritis of Knee joints |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhupinder singh |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept of Pharmacology, Maulana azad medical college delhi
Dept of Pharmacology, Maulana azad medical college delhi
Central
DELHI
110002
India |
| Phone |
9968604487 |
| Fax |
|
| Email |
drbskalra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupinder singh |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept of Pharmacology, Maulana azad medical college delhi
Dept of Pharmacology, Maulana azad medical college delhi
Central
DELHI
110002
India |
| Phone |
9968604487 |
| Fax |
|
| Email |
drbskalra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupinder singh |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dept of Pharmacology, Maulana azad medical college delhi
Dept of Pharmacology, Maulana azad medical college delhi
Central
DELHI
110002
India |
| Phone |
9968604487 |
| Fax |
|
| Email |
drbskalra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,
Lok Nayak Hospital,bahadur shah zafar marg, delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical college |
| Address |
Dept of Pharmacology, MAMC,Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Bhupinder Singh |
Dept of orthopedics, Lok Nayak Hospital |
Room no. 115,Dept of orthopedics, Maulana azad medical college and Lok Nayak Hospital, bahadur shah zafar marg, delhi
Central
DELHI |
9968604487
drbskalra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,MAMC and associated hospitals, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, Patients of osteoarthritis of knee joints, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biocurcumin |
Cap 500mg twice daily orally for 6 weeks |
| Comparator Agent |
Paracetamol |
650mg thrice daily orally for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of knee osteoarthritis(Diagnosis based on ACR Criteria) , age 40 - 80 years
2.Patient has not received any NSAIDs or any other analgesic within 24 hours
3.Patients with chronic knee pain (i.e., knee pain at least every other day during the month preceding inclusion)
4.Patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4)
5.Patients capable of comprehending the study instructions. |
|
| ExclusionCriteria |
| Details |
1.Patients with osteoarthritis linked to a metabolic arthropathy
2.Patients with Chondromatosis or villonodular synovitis of the knee
3.History of recent trauma (< 1 month) of the knee responsible for the pain
4.Patients who have Inflammatory flare (night pain, joint effusion)
5. Patients who had Corticosteroids injection in the previous month and Hyaluronic acid injection in the evaluated knee during the previous 6 months
6. Patient suffering from serious comorbid conditions(liver failure, kidney failure, uncontrolled cardiovascular diseases)
7. Pregnant patients or breastfeeding women
8. Patients allergic to Ibuprofen or turmeric |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in the WOMAC Osteoarthritis Index pain subscale score at week 6 |
week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in the WOMAC Osteoarthritis Index stiffness and physical functionscores at week 6. |
week 6 |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2017 |
| 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="2"
Months="6"
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
|
This study is designed to evaluate Biocurcumin which is an Nutritional supplement approved by Food safety and standards authority of India against Paracetamol which is a standard therapy for the treatment of patients with Knee osteoarthritis. Biocurcumin is a nutraceutic product(extract of turmeric) containing curcumin- essential oil complex mixture with Ar-turmerone, the essential oil of turmeric which makes it more bioavailable. Study design Non inferiority, randomized, controlled, intention to treat study Study duration; 6 weeks Patients will be randomly allocated in 1:1 ratio to receive Biocurcumin 1000 mg (500 mg twice a day,Group I) or Paracetamol 650mg thrice a day (Group II) over a period of 6 weeks. |