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临床试验/CTRI/2023/04/052114
CTRI/2023/04/052114招募中4 期

A clinical trial to assess the efficacy of the Ayurvedic Kneesol oil to claim substantiation in Rheumatoid arthritis on comparison with Dabur Rheumatil oil and Diclofenac gel (1% w/w) or spray (1 mg): An open labelled randomized single centric comparative three arm study.

Madhusudan Healthcare0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
招募中
发起方

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. Aged between 18 and 75 years old of either sex.
  • 2. If rheumatoid arthritis is moderately or severely active, the disease activity during the screening period and the baseline period must meet the following criteria:
  • Swollen joints count (SJC) >= 6 (based on 66 joint count) and tender joints count (Tender joints count: TJC) >= 6 (based on 68 joint count) (if the same joint has both swelling and Tenderness, this joint is included in the counts of swollen joints and tender joints).
  • 3. Morning stiffness in and around the joints for at least 6 weeks which is lasting at least 1 hr before the maximal improvement.
  • 4. Take medically approved non-drug contraceptive measures (such as drug-free intrauterine devices, condoms, female sterilization, and male sterilization) during the entire trial period and at least 3 months after the end of the medication, and no Pregnancy planner.
  • 5. Those who understand, voluntarily sign the informed consent form, and comply with the requirements of the research plan.

排除标准

  • 1. Those who have received any medical supportive treatments (such as whitening drugs, drugs for anaemia (except folic acid), liver-protecting and enzyme-lowering drugs, blood transfusions, etc.) within 2 weeks before screening.
  • 2. Patients with acute myocardial infarction, unstable angina pectoris, stroke, and cardiac insufficiency within 6 months before screening.
  • 3. The kidney, lung, digestive tract, nervous system and other serious diseased individuals (such as: poorly controlled severe diabetes, hypertension, interstitial pneumonia, obstructive Lung disease, bronchospasm, etc.), the investigator judged that it is not suitable to join the research.
  • 4. Those who have a history of smoking, alcoholism, or drug abuse within 12 months before screening.
  • 5. People with other primary or secondary immunodeficiencies in the past or at the time of screening, including patients with a history of HIV infection and positive HIV test results.
  • 6. Patients administering any herbal or topical herbal pain relief agents.
  • 7.The patients with current or recent corticosteroid treatment; or ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicines or concurrent pain relieving medication such as antipyretics, analgesics, tranquilizers, hypnotic, excessive alcohol, NSAIDs.
  • 8. Those who have participated in other clinical studies within 3 months before screening.
  • 9. Women who are preparing for pregnancy, pregnancy, lactation, or who become pregnant during the planned trial period

研究者

发起方
Madhusudan Healthcare

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