| CTRI Number |
CTRI/2017/12/010899 [Registered on: 18/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and safety of KAL-13 in Osteoarthritis |
|
Scientific Title of Study
|
A prospective clinical, double-blind, placebo controlled, randomized, phase 2 study-to compare the efficacy and safety of KAL-13 in treating the signs and symptoms of osteoarthritis in the knee and/or hip. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Rastogi |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Orthopedics Faculty of Medicine Institute of Medical Sciences Banaras Hindu University varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9369192077 |
| Fax |
|
| Email |
amitrastogibhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayashree M |
| Designation |
Manager - Technical Marketing and Research |
| Affiliation |
|
| Address |
No. 1134, 1st floor, 100 feet road, HAL 2nd Stage, Indiranagar, Bengaluru
Bangalore
KARNATAKA
560008
India |
| Phone |
9880677814 |
| Fax |
08041808043 |
| Email |
jayashree@katraphyto.com |
|
Details of Contact Person
Public Query
|
| Name |
Jayashree M |
| Designation |
Manager - Technical Marketing and Research |
| Affiliation |
|
| Address |
No. 1134, 1st floor, 100 feet road, HAL 2nd Stage, Indiranagar, Bengaluru
Bangalore
KARNATAKA
560008
India |
| Phone |
|
| Fax |
08041808043 |
| Email |
jayashree@katraphyto.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kerala Ayurveda Limited |
| Address |
1134, 1st floor, 100 ft road, HAL 2nd Stage, Indiranagar, Bangalore |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Amit Rastogi |
Banaras Hindu University |
Department of Orthopedics Faculty of Medicine Institute of Medical Sciences Banaras Hindu University Varanasi 221005
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
9369192077
amitrastogibhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Osteoarthritis of Knee and/or Hip, (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
KAL-13 |
Investigational product, KAL-13, 400 mg capsule twice daily for 12 weeks, oral route |
| Intervention |
KAL-13 Plus |
Investigational product, KAL-13 Plus, 460 mg capsule twice daily for 12 weeks, oral route |
| Comparator Agent |
Placebo |
Placebo, 400 mg capsule twice daily for 12 weeks, oral route |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. History of osteoarthritis of the knee characterized by pain of mild or moderate intensity.
2. Presence of persistent knee pain for at least 1 preceding month preceding the study.
3. Require treatment with either analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months.
4. Diagnosis of osteoarthritis of the hip or knee
5. Diagnosis of hip OA: having hip pain and meeting criteria for at least 2 of the following:
5a) Westergren erythrocyte sedimentation rate of less than 20 mm/hr
5b)Radiographic femoral or acetabular osteophytes or
5c)Radiographic joint space narrowing
6. Diagnosis of knee OA: Diagnosing (by modified American College of Rheumatology criteria) OA of the knee with pain plus with at least one of the following:
6a)Age greater than 50 years
6b)Stiffness less than 30 minutes
6c)Crepitus on active motion and radiographic evidence of OA of the knee, defined as presence of osteophytes or joint space narrowing.
7. Symptomatic OA of the knee or hip was determined at the Baseline visit, if the patient’s assessment of arthritis pain was at least 40 mm VAS, patient’s and the physician’s global assessment of arthritis was “poor†or
“very poorâ€
8. Have a mini mental state examination score of greater than or equal to 26 at screening
9. Medically stable condition
10. Ability to comply with the requirements of the study and to give informed consent
11. Subjects must be willing and able to stop all current pain therapy for the duration of study. (SOS pain therapy will be available throughout the study) |
|
| ExclusionCriteria |
| Details |
1. History of surgery , including arthroscopy, or major trauma to the study joint in the previous 12 months.
2. Radiographic evidence of severe osteoarthritis of the study joint based on the kellergen and Lawrence radiographic criteria of grade 4 osteoarthritis
3. Signs of active study joint inflammation including redness, warmth, and/or if qualifying with osteoarthritis of knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination after the washout period.
4. Morning stiffness of >30 minutes duration.
5. Significantly incapacitated or disabled and would be categorized as ACR functional class III (able to perform only few or none of the duties of usual occupation or self-care) or IV (largely or wholly incapacitated) or unable to walk without assistive devices
6. History of Joint replacement surgery in the affected joint or planned surgery involving the affected joint during the trial.
7. Significant renal impairment (> 1.5 times the upper limit of normal (ULN) of serum creatinine)
8. Active hepatic disease
9. Acute meniscal injury to the study joint within 2 years of study entry, arthroscopy in the study joint within 6 months of the study entry
10. Weight in excess of 280 pounds (120 kg)
11. Positive pregnancy test
12. Women of childbearing age who are willing to take adequate contraceptive precautions unless abstinence can be consider in the investigators opinion
13. Pregnant or lactating women or women intending to become pregnant
14. Patients awaiting a knee or hip joint replacement
15. Patients with other conditions that cause pain
16. Patients with congenital dislocation of the hip
17. Patients who have had operations on their hip due to previous trauma
18. Patients with other known rheumatic disease such as rheumatoid arthritis
19. Patients with the diagnosis gout
20. Patients who report a red or hot swollen joint and require further rheumatological assessment
21. Patients administered with intra-articular steroids for joints within 3 months prior to the study entry
22. History of allergy or contraindications to the ingredients present in the drug
23. History of uncontrolled or poorly controlled serum cholesterol
24. Renal impairment/insufficiency (i.e., nephritis, polycystic kidney disease, acute or chronic renal failure, end-stage renal disease, >1.5 times the upper limit of normal (ULN) of serum creatinine, etc.,)AST, ALT >3 times the ULN
25. Gastrointestinal disorders
26. Thyroid dysfunction
27. Hepatic impairment/ acute liver disease or persistent elevations in liver function tests (3 times the upper limit of normal (ULN) of LFT |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Reduction in signs and symptoms of osteoarthritis
Change from baseline in the western Ontario and McMaster Universities (WOMAC) 3.1 osteoarthritis Index composite, pain, Morning stiffness and physical function subscale scores |
Visit 1: Day -7 (Screening)
Visit 2: Day 1 (Baseline)
Visit 3: Day 30 (Data Collection)
Visit 4: Day 60 (Data Collection)
Visit 5 Day 90 (Data Collection)
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Kellgren and Lawrence scoring/ assessment of osteoarthritis |
Visit 1: Day -7 (Screening)
Visit 2: Day 1 (Baseline)
Visit 5 Day 90 (Data Collection)
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2013 |
| Date of Study Completion (India) |
30/04/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Kindly note that we have not yet published this clinical study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Inflammation is a cascade of
reactions by the body in response to harmful stimuli which can be in the form
of pathogens or cuts and bruises. It is natural protective mechanism and helps
to start the healing process. However, inflammatory disorders occur when there
is abnormal inflammation and are associated with immune system. Inflammation can be both acute and chronic in
nature. Acute inflammation usually
occurs immediately within minutes and can last up to a few days. However chronic inflammation has a delayed
onset and lasts longer.
KAL-13/KAL-13 Plus are Ayurvedic
formulations designed to treat inflammatory disorders such as rheumatoid
arthritis, osteoarthritis, pain management, inflammatory bowel disease,
colitis, COPD (pulmonary inflammation), multiple sclerosis and psoriasis.
KAL-13 is an herbal preparation based on Ayurveda. KAL-13 Plus is composition including
microgram quantities of mineral and amino acids added to KAL 13. These formulations contain Ayurvedic herbs
prepared by a proprietary method for enhanced efficacy.
Based on the positive data from the pre-clinical studies for KAL-13 and KAL-13
Plus, a clinical trial in human was conducted in osteoarthritic patients as per
GCP guidelines at Banaras Hindu University, India. The primary objectives are
to study - Reduction in signs and symptoms of osteoarthritis, Change from
baseline in the Western Ontario and McMaster Universities (WOMAC) 3.1
osteoarthritis Index Composite, Pain, Morning Stiffness and Physical Function
subscale scores. The secondary objective is assessment of osteoarthritis by Kellgren
and Lawrence scoring/grading.
|