Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis (Leech Therapy)

November 23, 2015 updated by: M. S. M. Shiffa, Hamdard University

Randomized Controlled Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis

This study has been designed to conduct as Randomized comparative clinical study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two groups, group B received Qurse Mafasil tablet orally two tablets two times daily for 8 weeks while group A received Leech therapy once weekly for 8 weeks along with Qurse mafasil.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • knee osteoarthritis

Exclusion Criteria:

  • pregnancy,
  • lactation,
  • anaemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Hirudinaria granulosa and Qurse mafasil are given
Biological: Hirudinaria granulosa, qurse mafasil
compare the efficacy of both groups
Other Names:
  • leech and drug
Active Comparator: Group B
Qurse mafasil only given
Biological: Hirudinaria granulosa, qurse mafasil
compare the efficacy of both groups
Other Names:
  • leech and drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
KOOS Score
Time Frame: end of 6 weeks
end of 6 weeks
VAS
Time Frame: end of 6 weeks
end of 6 weeks
Active Range of Motion
Time Frame: end of 6 weeks
end of 6 weeks
Knee circumference
Time Frame: end of 6 weeks
end of 6 weeks
15 m walking time test
Time Frame: end of 6 weeks
end of 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
KOOS subscores
Time Frame: end of 6 weeks
end of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamdard University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Estimate)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/AD/JH/058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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