| CTRI Number |
CTRI/2010/091/001092 [Registered on: 09/09/2010] |
| Last Modified On: |
05/02/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, Glucosamine 750 mg +Diacerine 50mg + Aceclofenac 100 mg Tablet in patients with osteoarthritis of knee joints. |
|
Scientific Title of Study
|
Multicentric, Open label, Randomized, Parallel-group, Active-controlled Clinical trial of the Fixed Dose Combination of Glucosamine 750 mg , Diacerein 50 mg and Aceclofenac
100 mg In patients with osteoarthritis of knee joint. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JENBURKT/GDA-02/10A |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
Consulting Physician,Dr R N Cooper Hospital,Ville Parle (West)
Mumbai
MAHARASHTRA
400 056
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
Consulting Physician,Dr R N Cooper Hospital,Ville Parle (West)
Mumbai
MAHARASHTRA
400 056
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
Consulting Physician,Dr R N Cooper Hospital,Ville Parle (West)
Mumbai
MAHARASHTRA
400 056
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Jenburkt Pharmaceuticals Ltd.Nirmala Apartments,
93, Jayprakash Road,
Andheri (West),
Mumbai - 400 058. India.
|
|
|
Primary Sponsor
|
| Name |
M/S Jenburkt Pharmaceuticals Ltd.Nirmala Apartments,
93, Jayprakash Road,
Andheri (West),
Mumbai - 400 058. India.
|
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajiv Oza |
Clinic, Bhavnagar, Rajivoza59@hotmail.com |
Clinic, Bhavnagar,-
Bhavnagar
GUJARAT |
Rajivoza59@hotmail.com |
| Dr Kirti C Patel |
KEM Hospital, Mumbai, pkirtic@yahoo.in |
KEM Hospital, Mumbai,-
Mumbai
MAHARASHTRA |
pkirtic@yahoo.in |
| Dr Nitin M Rathod |
RN Cooper Hospital, Mumbai, nitinmr@yahoo.in |
RN Cooper Hospital, Mumbai,-
Mumbai
MAHARASHTRA |
nitinmr@yahoo.in |
| Dr. Ra G Bhagat |
Smt.N.H.L.Muni.Medical College & Hospital,Ahmedabad, Rajpurvi@yahoo.com |
Smt.N.H.L.Muni.Medical College & Hospital,Ahmedabad,-
Ahmadabad
GUJARAT |
Rajpurvi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Osteoarthritis of knee joints, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diacerine 50mg, Aceclofenac 100 mg Tab |
One tab two times a day for 30 days. |
| Intervention |
Glucosamine 750mg ,Diacerine 50mg ,Aceclofenac 100mg Tab |
One Tab two times a dayfor 30 days. |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
All the patients with dully filled Informed Consent Forms ( ICF).
Age : 35 to 40 years.
Sex : Both male and female.
The patients with radiologically defined symptoms of osetoarthritis established diagnosis of osteoarthritis already on analgesic treatment with NSAID ( diclofenac sodium, , Aceclofenac, nimesulide, Naproxen ) not having significant pain relief in terms of pain and disability. |
|
| ExclusionCriteria |
| Details |
Patients with advance disease such as :
* Patients with secondary arthritis such as infective, tubercular or psoriatic arthritis.
* Patients who had arthroplasty.
* Patients having undergone arthroscopic washout of knee joint.
* Patients with concomittant diseases such as malignancy, HIV.
* Pregnancy nd lactation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary parameters:
1) Pain relief by Visual Analogue scale of 100 millimeters ( VAS)
2. Macgill Questionaire for Pain.
3. Clinical examination for joint pain, stiffness,tenderness and swellings.
4. The range of movement extension by Long-arm Goniometer. |
30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondery parameters :
1. Quality of Life ( European Q5D)
2. Physician's Global Assessment - 1 to 5 ( Very poor, Poor, Fair, Good and excellent.) |
30 days. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/07/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years=""
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 a randomised, open label, multicentric trial to compare the efficacy, tolerability and safety of fixed dose combination of " Glucosamine 750 mg, Diacerine 50mg, Aceclofenac 100 mg Vs Diacerine 50 mg and Aceclofenac 100 mg in patients with Osteoarthritis of knee joint that will be conducted in four centres in India. |