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临床试验/CTRI/2019/10/021691
CTRI/2019/10/021691已完成未知

A Randomized Double Blind Placebo Controlled Clinical Study to Evaluate Comparative Clinical Efficacy and Tolerability of an Herbal Blend and its Advanced Formulation in Subjects with Mild to Moderate Knee Osteoarthritis

aila Nutraceuticals0 个研究点目标入组 90 人开始时间: 待定最近更新:
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试验速览

阶段
未知
状态
已完成
发起方
入组人数
90
研究概览入排标准研究者记录与标识符相似试验

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. Ambulatory, male and female subjects of 40ââ?¬â??70 years of age with a Body Mass Index (BMI) of 20 to 29 kg/m2.
  • •2. Subjects with VAS score between 40 and 70 mm.
  • •3. Subjects with Knee osteoarthritis grade II to III of Kellgren and Lawrence assessed based on X-ray.
  • •4. Willing to refrain from use of glucosamine, chondroitin, MSM, DMSO, doxycycline, ibuprofen, aspirin or other NSAIDS (other than paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial.
  • •5. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
  • •6. Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
  • •7. Subjects ready to discontinue the use of supplementations including vitamins, glucosamine + chondroitin, herbals or other topical applications.
  • •8. Agree to participate in the study through a written informed consent.
  • •9. Willing to comply with all the study related activities

排除标准

  • •1. Previous injury and or surgery to the knee.
  • •2. Expectation of surgery during the study period.
  • •3. Subjects with uncontrolled Diabetes (FPG >125 mg/dL) and Hypertension (Systolic > 120 mmHg and Diastolic >80 mmHg).
  • •4. Subjects suffering from COPD or having history of any respiratory or breathing disorders.
  • •5. Subjects used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders.
  • •6. Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study period.
  • •7. Subjects having known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to herbal products.
  • •8. Have taken any corticosteroid, indomethacin within 1 month prior to the enrollment or intra-articular treatment/injections with corticosteroid or hyaluronic acid within 6 months prior to enrollment.
  • •9. History of congestive heart failure or any vascular conditions.
  • •10. Subjects with HIV Positive status.
  • •11. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
  • •12. History of Systemic Lupus Erythematous (SLE).
  • •13. Alcohol intake >2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
  • •14. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
  • •15. Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
  • •16. Have taken acetaminophen or paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any herbal products within 7 days prior to the screening visit (visit 1)
  • •17. History of heart, liver, lung cancer or chronic diseases
  • •18. Allergies to any ingredient in the investigational products
  • •19. Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures

研究者

发起方
aila Nutraceuticals

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