| CTRI Number |
CTRI/2014/11/005205 [Registered on: 17/11/2014] Trial Registered Retrospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study to evaluate the Efficacy and Safety of EASY CLIMB CAPSULES in Patients with Painful knee Osteoarthritis’ |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo controlled, clinical Study to evaluate the Efficacy and Safety of EASY CLIMB CAPSULES in Patients with Painful knee Osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/NC/0820/40 Version 01dated 13-MAY-2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annapoorna S Bhat BAMS MD MSCP DYT |
| Designation |
Family Physician |
| Affiliation |
sampoornhealthcare |
| Address |
NO.2, 2nd Main, A.E.C.S. Layout, 3rd Stage, Sanjayanagar, Bangalore
Bangalore
KARNATAKA
560094
India |
| Phone |
9886399730 |
| Fax |
|
| Email |
sampoornhealthcare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBio Clinical research Pvt Ltd |
| Address |
ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura,Bangalore
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
08023641033 |
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBio Clinical research Pvt Ltd |
| Address |
ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura,Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
08023641033 |
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Natsyn Catalysts |
| Address |
No. 4/268, Maharishi Nagar, Mohanur road Sanyasikaradu Post, Ganeshapuram S.O, Namakkal-637002, Tamil Nadu |
| Type of Sponsor |
Other [Herbal Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajanna Muniswamappa |
Bangalore Diabetic Center |
#426,IV Cross,II Block,Kalyan Nagar,Bangalore
Bangalore
KARNATAKA |
9880367101
dr.rajanna@gmail.com |
| Dr Annapoorna S Bhat |
Sampoorn Health Care (Ayurveda Department,Clinical Division) |
NO.2, 2nd Main, A.E.C.S. Layout, 3rd Stage, Sanjayanagar, Bangalore-560094 Bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9886399730
sampoornhealthcare@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical IEC Bangalore |
Approved |
| Clinical IEC Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M15-M19||Osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EASY CLIMB Capsules 150 gm |
EASY CLIMB Capsule is to be taken 2 capsules per day. One capsule in the morning & one in the night before food for 120 days |
| Comparator Agent |
Placebo 150 gm |
To be taken 2 capsules per day. One capsule in the morning & one in the night before food for 120 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Men and women with age of 40 – 65 with a diagnosis of arthritis.
• Obtaining written Inform consent along with audio, video visual.
• Patients with mild to moderate arthritis
• Participants who are able to visit the medical institutions throughout the study period
|
|
| ExclusionCriteria |
| Details |
• Patients with Uncontrolled hypertension or diabetes.
• Patients with Hepatic or renal impairment
• Patients with Current or expected use of anticoagulant
• Candidates for imminent joint replacement
• Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
• Participation within 30 days prior to screening in another investigational study
• Conditions in the opinion of the investigator make the patient unsuitable to participate in the study.
• Any contraindication to blood sampling.
• HIV Positive serology
• Pregnant (or) Lactating
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Patients Assessment of Osteoarthritis Pain by VAS [Osteoarthritis- Pain Visual analog scale (VAS)]
• Change from Baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index-pain subscale score
• WOMAC Osteoarthritis Composite Index & QOL
• Changes in the arthritis impact measurement scale (AIMS 2)
• Change from Baseline in the CGI (Clinical Global Impression) scale score
• Changes in Comprehensive Metabolic Panel (CMP), &Synovial Fluid analysis.
|
•Screening to EOT (Day 120) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety assessed by Adverse Events |
Screening to EOT (Day 120) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2014 |
| Date of Study Completion (India) |
11/05/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
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
|
|
A
Randomized, Double Blind, Placebo controlled, clinical Study to evaluate the Efficacy and Safety of EASY CLIMB CAPSULES in Patients
with Painful knee Osteoarthritis. Primary
objectives: To show that the efficacy of EASY CLIMB CAPSULES
in Patients with Painful Knee Osteoarthritis. Secondary
objectives:To evaluate the safety of EASY CLIMB CAPSULES in Patients with Painful Knee Osteoarthritis |
Primary outcomes
- Patients Assessment
of Osteoarthritis Pain by VAS [Osteoarthritis- Pain Visual analog scale
(VAS)]
- Change from Baseline in the WOMAC OA (Western
Ontario and McMaster Universities Osteoarthritis) Index-pain subscale
score
- WOMAC
Osteoarthritis Composite Index & QOL
- Changes in the
arthritis impact measurement scale (AIMS 2)
- Change from Baseline in the CGI (Clinical
Global Impression) scale score
- Changes in Comprehensive Metabolic Panel (CMP),
&Synovial Fluid analysis.
Secondary outcomes
|
- Safety assessed by
Adverse Events
|