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Clinical Trials/CTRI/2023/04/052114
CTRI/2023/04/052114
Recruiting
Phase 4

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 sites0 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Madhusudan Healthcare
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Madhusudan Healthcare

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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