CTRI/2017/12/010899已完成2 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 patientââ?¬•s assessment of arthritis pain was at least 40 mm VAS, patientââ?¬•s and the physicianââ?¬•s global assessment of arthritis was ââ?¬Å?poorââ?¬? or
- •Ã¢â?¬Å?very poorââ?¬?
- •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)
排除标准
- •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
研究者
相似试验
尚未招募
1 期
A prospective, randomized, double-blind, placebo parallel controlled study of Peiyuan Mingmu Pills in the treatment of retinitis pigmentosaretinitis pigmentosaITMCTR2100005438eye hospital, China Academy of Chinese Medical Sciences
招募中
1 期
Chinese medicine prevention and treatment program for novel coronavirus pneumonia (COVID-19): a perspective, double-blind, placebo, randomised controlled trialnovel coronavirus pneumonia (NCP)ITMCTR2000002964Zhejiang Chinese Medical University
进行中（未招募）
不适用
A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravisMedDRA version: 7.1Level: LLTClassification code 10028417Myasthenia gravisEUCTR2004-000596-34-CZF.Hoffmann-La Roche Ltd.136
进行中（未招募）
1 期
A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)EUCTR2005-001688-74-GBGuy's & St Thomas' NHS Foundation Trust70
尚未招募
3 期
In this study Garcinol 20% would be compared with an inert substance in reducing the risk of metabolic syndrome in obese individuals.CTRI/2020/02/023571Sami Labs Limited