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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Reduction in signs and symptoms of osteoarthritis
研究概览
简要总结
Inflammation is a cascade ofreactions by the body in response to harmful stimuli which can be in the formof pathogens or cuts and bruises. It is natural protective mechanism and helpsto start the healing process. However, inflammatory disorders occur when thereis abnormal inflammation and are associated with immune system. Inflammation can be both acute and chronic innature. Acute inflammation usuallyoccurs immediately within minutes and can last up to a few days. However chronic inflammation has a delayedonset and lasts longer.
KAL-13/KAL-13 Plus are Ayurvedicformulations designed to treat inflammatory disorders such as rheumatoidarthritis, 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 includingmicrogram quantities of mineral and amino acids added to KAL 13. These formulations contain Ayurvedic herbsprepared by a proprietary method for enhanced efficacy.
Based on the positive data from the pre-clinical studies for KAL-13 and KAL-13Plus, a clinical trial in human was conducted in osteoarthritic patients as perGCP guidelines at Banaras Hindu University, India. The primary objectives areto study - Reduction in signs and symptoms of osteoarthritis, Change frombaseline in the Western Ontario and McMaster Universities (WOMAC) 3.1osteoarthritis Index Composite, Pain, Morning Stiffness and Physical Functionsubscale scores. The secondary objective is assessment of osteoarthritis by Kellgrenand Lawrence scoring/grading.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •History of osteoarthritis of the knee characterized by pain of mild or moderate intensity.
- •Presence of persistent knee pain for at least 1 preceding month preceding the study.
- •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.
- •Diagnosis of osteoarthritis of the hip or knee
- •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
- •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.
- •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€
- •Have a mini mental state examination score of greater than or equal to 26 at screening
- •Medically stable condition
- •Ability to comply with the requirements of the study and to give informed consent
- •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).
排除标准
- •History of surgery , including arthroscopy, or major trauma to the study joint in the previous 12 months.
- •Radiographic evidence of severe osteoarthritis of the study joint based on the kellergen and Lawrence radiographic criteria of grade 4 osteoarthritis
- •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.
- •Morning stiffness of >30 minutes duration.
- •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
- •History of Joint replacement surgery in the affected joint or planned surgery involving the affected joint during the trial.
- •Significant renal impairment (> 1.5 times the upper limit of normal (ULN) of serum creatinine)
- •Active hepatic disease
- •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
- •Positive pregnancy test
- •Women of childbearing age who are willing to take adequate contraceptive precautions unless abstinence can be consider in the investigators opinion
- •Pregnant or lactating women or women intending to become pregnant
- •Patients awaiting a knee or hip joint replacement
- •Patients with other conditions that cause pain
- •Patients with congenital dislocation of the hip
- •Patients who have had operations on their hip due to previous trauma
- •Patients with other known rheumatic disease such as rheumatoid arthritis
- •Patients with the diagnosis gout
- •Patients who report a red or hot swollen joint and require further rheumatological assessment
- •Patients administered with intra-articular steroids for joints within 3 months prior to the study entry
- •History of allergy or contraindications to the ingredients present in the drug
- •History of uncontrolled or poorly controlled serum cholesterol
- •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
- •Gastrointestinal disorders
- •Thyroid dysfunction
- •Hepatic impairment/ acute liver disease or persistent elevations in liver function tests (3 times the upper limit of normal (ULN) of LFT.
结局指标
主要结局
Reduction in signs and symptoms of osteoarthritis
时间窗: 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)
Change from baseline in the western Ontario and McMaster Universities (WOMAC) 3.1 osteoarthritis Index composite, pain, Morning stiffness and physical function subscale scores
时间窗: 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)
次要结局
- Kellgren and Lawrence scoring/ assessment of osteoarthritis(Visit 1: Day -7 (Screening))