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Clinical Trials/CTRI/2019/12/022217
CTRI/2019/12/022217CompletedPhase 2

An open labeled interventional clinical trial to evaluate the efficacy of Rhumed strong oil in the management of Osteoarthritis of knee joint.

Multani Pharmaceuticals Ltd New Delhi1 site in 1 country50 target enrollmentStarted: February 12, 2019Last updated:

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Assessment of pain

Study Overview

Brief Summary

It is an open labeled, single armed, single center, prospective, interventional clinical study to evaluate the efficacy of the Rhumed strong oil on 50 patients suffering from osteoarthritis of knee joint. The study will be conducted in Panchakarma department, NIA, Jaipur, Rajasthan. It will be advised to subjects to apply the oil 2 times a day on the affected knee joint/s for 15 days. The primary outcome measure will be to assess the efficacy of Rhumed strong oil in patients of Joints pain by assessing the degree of pain on day 0, day 15 and day 22. The secondary outcome will be assess the changes in swelling, tenderness, stiffness and restricted movement in joint.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
40.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age: from 40-70 years of either sex Subjects with symptoms of Osteoarthritis of knee joint Subjects who are willing to give informed consent any ready to comply the protocol Subjects who are ready to provide regular follow up till the completion of the study.

Exclusion Criteria

  • Patients of age below 40 years and above 70 years of either sex Patients having associated Pulmonary Tuberculosis, Burns, Open wounds and infective conditions, allergy, skin sensitivity , Knee joint replacement, Gouty arthritis, Rheumatoid arthritis etc.

Outcomes

Primary Outcomes

Assessment of pain

Time Frame: one year

Secondary Outcomes

  • Changes in the degree of swelling, stiffness, restricted movement of the joints, tenderness and development of any adverse effect(one year)

Investigators

Sponsor
Multani Pharmaceuticals Ltd New Delhi
Sponsor Class
Pharmaceutical industry-Indian

Study Sites (1)

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