ISRCTN15418623已完成不适用
The effects of Morus alba and Acacia catechu on quality of life and overall function in adults with osteoarthritis of the knee
nigen0 个研究点目标入组 135 人开始时间: 2017年5月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
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
- 性别
- All
入选标准
- •1. Males and females, aged 35 to 75 years
- •2. BMI < 35 kg/m2
- •3. Knee pain for at least 15 of the 30 days prior to the start of the study
- •4. Symptoms of knee pain for at least 6 months
- •5. Grade I, II or III using Kellgren-Lawrence classification according to the screening X-ray
- •6. Able to walk
- •7. VAS-D score of = 6 at the randomization visit. Subjects will have stopped taking his/her usual medication at the screening visit (which will be 7 to 28 days prior to the randomization visit) and will not have taken rescue medication for the 2 days prior to the randomization visit
- •8. For subjects with Type 2 Diabetes, has HgbA1c of = 7.5%
- •9. Surgically sterile, post-menopausal or agrees to use an acceptable method of birth control
- •10. Agrees to not use any new vitamin and/or mineral supplement until after study completion
- •11. Agrees to not take any dietary or herbal supplements until after study completion. Seven-day washout period prior to visit 2 allowed
- •12. Agrees to not take any dietary or herbal supplements purported to decrease inflammation, body pain and/or improve joint health including glucosamine and MSM. Thirty-day washout period prior to visit 2 allowed
- •13. Willing and able to comply with the protocol including: attending 6 visits and discontinuing his/her usual OA medication and only taking acetaminophen in addition to the study product throughout the study period
- •14. Able to understand and sign the informed consent to participate in the study
排除标准
- •1. Active heart disease or presence of a pacemaker
- •2. Cerebrovascular disease
- •3. Uncontrolled high blood pressure (if deemed clinically significant by the investigator)
- •4. Renal or hepatic impairment/disease
- •5. Type I diabetes
- •6. Bipolar disorder
- •7. Parkinson’s disease
- •8. Neuromuscular disease
- •9. Unstable thyroid disease
- •10. Immune disorder (such as HIV/AIDS)
- •11. Multiple sclerosis or any other autoimmune disorder
- •12. Any inflammatory arthritic condition
- •13. Acute septic arthritis
- •14. Fibromyalgia or other chronic pain syndromes (OA in locations other than knee allowed)
- •15. Gout, pseudogout and hyperuricemia
- •16. Paget’s disease
- •17. Active peptic ulcer disease and/or history of upper gastrointestinal bleeding
- •18. Any medical condition deemed exclusionary by the Principal Investigator (PI)
- •19. A history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening
- •20. A history of psychiatric illness requiring hospitalization in the past 6 months
- •21. Ssignificant injury to the target joint within the past 12 months
- •22. History of joint replacement surgery at the index knee
- •23. History of arthroscopic surgery on the affected knee in the past 12 months or plans to have surgery in the next 6 months
- •24. Sulfa allergy or an allergy to sulphonamide
- •25. Allergy to shellfish and/or shrimp
- •26. Known allergy or sensitivity to any of the ingredients in the test product
- •27. Subjects with low blood pressure can only be included with PI approval due to potential worsening with Acacia catechu (Senegalia catechu).
- •28. Treated with oral corticosteroids within 4 weeks prior to screening
- •29. Intra-articular corticosteroids in the target joint within 3 months prior to screening
- •30. Hyaluronic acid injected in the target joint within 6 months prior to screening
- •31. Currently taking anticoagulants or antiplatelets
- •32. Unstable dose of medication (defined as fewer than 90 days at the same dose)
- •33. Currently taking any medication deemed exclusionary by PI
- •34. Evidence of hepatic or renal dysfunction as evidenced by ALT, AST, AP being > 2 times the upper limit of normal or serum creatinine value > 1.5 times the upper limit of normal or other clinically significant abnormal clinical laboratory value per PI discretion
- •35. History of drug or alcohol abuse in the past 12 months
- •36. Plans to have surgery over the next 12 weeks
- •37. Pregnant, lactating, or planning to become pregnant during the study period
- •38. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data
- •39. Participating or has participated in another research study within 30 days prior to visit 2
研究者
相似试验
已完成
不适用
The effect of Quercus persica L and Lawsonia inermis L ointment on episiotomy wound healing in primiparous women in 2014-2015Haematoma of obstetric woundCondition 1: Infection of obstetric surgical wound. Condition 2: Haematoma of obstetric wound. Condition 3: Dehiscence of episiotomy wound.Infection of obstetric surgical woundDisruption of perineal obstetric woundIRCT2015060122521N1Shahrekord University of Medical Sciences160
招募中
2 期
Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules on the treatment ofvaginal infectioCondition 1: Inflammatory disease of cervix uteri. Condition 2: Candidiasis of vulva and vagina. Condition 3: Vaginitis.Inflammatory disease of cervix uteriCandidiasis of vulva and vaginaB37.3N76.0Acute vaginitisIRCT20131110015349N4Islamic Azad University100
尚未招募
2 期
Obesity Management in Ayurveda with Khadira saara churna tabletsCTRI/2024/03/064827Dr Santhosh
已完成
不适用
The effect of Achillea millefolium and Hypericum perforatum ointments on episiotomy wound healingepisiotomy wound.Disruption of perineal obstetric woundIRCT2016072629084N1Shahrekord University of Medical Sceinces140
尚未招募
3 期
The effect of quercetin and berberine on pulmonary arterial hypertensioIRCT20230220057462N1Bam University of Medical Sciences140