CTRI - Dr Himanshu Bansal Foundation

Clinical Trials Registry - India (CTRI)
National Institute of Medical Statistics, Indian Council of Medical Research),
Ansari Nagar, New Delhi -110029 - India, Telephone: 91-11-26588803 91-11-26588803 ,
91-11-26588725 91-11-26588725
Fax: 91-11-26589635, Email: ctr.nims[at]gmail.com
UTRN. WHO TEMP UTRN 121550100-1307201024093847
CTRI No.and Date CTRI/2010/091/001105, 18-08-2010
Status of Trial WHO Open to recruitment
Last Verified on WHO 18-08-2010
Last Updated on WHO 23-08-2010
Contact Details: hbansal@drhbf.org
IDENTIFIERS
UTRN. WHO * TEMP UTRN 121550100-1307201024093847
Public Title
Study WHO *
Scientific Title of
Study WHO *
Secondary IDs WHO
A clinical study to assess the benefits of Concentrace Trace Mineral Drops-
(CTMD®), a food supplement in subjects with OSTEOARTHRITIS (OA) of
knee joint
?A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE
CENTRIC AND PROSPECTIVE STUDY TO DETERMINE THE EFFECTIVENESS
AND SAFETY OF CONCENTRACE TRACE MINERAL DROPS-(CTMD®), A
FOOD SUPPLEMENT IN SUBJECTS WITH OSTEOARTHRITIS (OA) OF THE
KNEE JOINT?.
Secondary ID Registry
Protocol No: Clin/HB/CT-
IV/019/14-2010
IEC
CONTACT INFORMATION OF INVESTIGATORS & SPONSORS
Principal Investigator or overall Trial Coordinator ( multi-center study ) Details.
Principal
Investigator's
Name
Dr. Himanshu Bansal Email ID bansal.drhimanshu@gmail.com
Address line 1 Anupam Hospital Address
line2
Kashipur Road
City Rudrapur State Uttarakhand

Postal Code 263153 Country India
Telephone
No.(with STD
code)
05944-
243891 05944-
243891
Contact Person (Scientific Query). WHO
Name of the
contact
person(Scientific
query)
Fax No.
Dr. Namita Email ID drnamita@clinfoxintl.com
Address line 1 Office 14 & 15, First
Floor,Soni Business
Complex,Prashanthi Nagar
Address
line2
Kukatpally
City Hyderabad State Andhra Pradesh
Postal Code 500072 Country India
Telephone
No.(with STD
code)
Affiliation
040-
64545858 040-
64545858
Contact Person (Public Query). WHO
Name of the
contact
person(Public
query)
Fax No.
Sreedhar Singamala Email ID sreedhar@clinfoxintl.com
Address line 1 Office 14 & 15, First
Floor,Soni Business
Complex,Prashanthi Nagar
Address
line2
Kukatpally
City Hyderabad State Andhra Pradesh
Postal Code 500072 Country India
Telephone
No.(with STD
code)
Source/s of
Monetary or
Material
Support WHO
040-
64545858 040-
64545858
Fax No.
Source/(s) of Monetary or Material Support
SELF
Primary Dr. Himanshu Bansal

Sponsor WHO
Secondary
Sponsor WHO
Countries of
Recruitment WHO
Secondary Sponsor
NIL
Countries of Recruitment
India
Details Site/s of study ( details of responsible contact person at each site )
Number of Sites 1
Site/s Details Site Address Contact Person
REGULATORY APPROVALS
Anupam Hospital Dr. Himanshu Bansal , Kashipur
Road , Rudrapur , Uttarakhand -
263153 , India
Tel:05944-243891 05944-
243891
Email:bansal.drhimanshu@gmail.com
Ethics Committee* Ethics Committee Name Approval Status
Regulatory Approval
obtained from DCGI*
METHODS
Health
Condition/Problems
Studied WHO
CLINICOM-Independent Ethics
Committee
Not Applicable
Approved
A FOOD SUPPLEMENT IN OSTEOARTHRITIS (OA) OF THE KNEE JOINT
Study Type WHO Randomized, parallel group, placebo controlled trial
Intervention and Comparator/Control agent WHO
Intervention Name Intervention Other details( dose, duration, etc)
Control
Intervention Name
CONCENTRACE TRACE
MINERAL DROPS-(CTMD®)
Liquid Drops,40 drops/day
Control Intervention Other details( dose, duration, etc)
an Identical Placebo Liquid Drops, 40 Drops/Day

Key Inclusion/
Exclusion
Criteria WHO
Method of
generating
randomization
sequence
Method of
allocation
concealment
Blinding and
masking
Primary Outcome WHO
Inclusion Criteria:
1. Subjects of both sexes between 50-75 years of age 2. Subjects who are
willing to give informed consent 3. Subjects who are willing to comply with
the study procedure. 4. Symptomatic knee- The pain or discomfort should
have been experienced in the affected joint on most days for the previous 3
months 5. History of less than 30 min of morning stiffness, Western
Ontario and McMaster Universities (WOMAC) Osteoarthritis Index score ≤
75 in the target knee and using NSAIDs/ analgesics (rescue medicine) at
least once a week 6. Physical examination revealing crepitus on active
motion /bony tenderness /no palpable warmth of synovium 7. Radiological
defined, and classified as mild to moderate OA of knee joint ? Mild to
moderate osteoarthritis was determined by radiological examination ?
Kellgren Lawrence classification for knee osteoarthritis grade 0, I, II or
Grade III. 8. Laboratory findings- ESR

Outcome name Secondary Outcome Timepoints
Target sample
size WHO
Date of first
Enrollment WHO
Secondary Endpoints 1.
Change In Ultrasonography 2.
Change In Synovial Fluid
1. Change In Ultrasonography 2. Change In
Synovial Fluid
100 Phase of Trial* Phase 4
23- 08- 2010
[date-month-year]
Status of Trial WHO * Open to recruitment
Estimated duration of
trial
6 Months
Brief Summary This study is A DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED
TRIAL in 100 Patients with Osteoarthritis (OA) of the knee joint. It is a 6
month study during this period of the study the pateints are assigned
either CONCENTRACE TRACE MINERAL DROPS-(CTMD®) or an identical
placebo followed by randomization. The estimated duration of of the trial is
6 months where the patients will be followed in the 4,8,12 and 26 weeks.
The primary objective of the study is to determine the food supplement
CONCENTRACE TRACE MINERAL DROPS-(CTMD®) can act as
Chondroprotective agent by determining the Pain Score, Range of
Movement, 6min-free walking distance, Reduction in pain medication ,
Change in quality of life (WOMAC SCORE) in subjects with Osteoarthritis of
the Knee Joint in comparison with placebo. The secondary objective will be
to confirm the overall safety of (CTMD®) by Change in Ultrasonography
and Change in synovial fluid