Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis (Leech Therapy)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hirudinaria granulosa, qurse mafasil
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Qurse mafasil, leech therapy, Hirudinaria granulosa
Eligibility Criteria
Inclusion Criteria:
- knee osteoarthritis
Exclusion Criteria:
- pregnancy,
- lactation,
- anaemia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Hirudinaria granulosa and Qurse mafasil are given
Qurse mafasil only given
Outcomes
Primary Outcome Measures
KOOS Score
VAS
Active Range of Motion
Knee circumference
15 m walking time test
Secondary Outcome Measures
KOOS subscores
Full Information
NCT ID
NCT02612974
First Posted
November 20, 2015
Last Updated
November 23, 2015
Sponsor
Hamdard University
1. Study Identification
Unique Protocol Identification Number
NCT02612974
Brief Title
Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
Acronym
Leech Therapy
Official Title
Randomized Controlled Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamdard University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study has been designed to conduct as Randomized comparative clinical study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Qurse mafasil, leech therapy, Hirudinaria granulosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Hirudinaria granulosa and Qurse mafasil are given
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Qurse mafasil only given
Intervention Type
Biological
Intervention Name(s)
Hirudinaria granulosa, qurse mafasil
Other Intervention Name(s)
leech and drug
Intervention Description
compare the efficacy of both groups
Primary Outcome Measure Information:
Title
KOOS Score
Time Frame
end of 6 weeks
Title
VAS
Time Frame
end of 6 weeks
Title
Active Range of Motion
Time Frame
end of 6 weeks
Title
Knee circumference
Time Frame
end of 6 weeks
Title
15 m walking time test
Time Frame
end of 6 weeks
Secondary Outcome Measure Information:
Title
KOOS subscores
Time Frame
end of 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
knee osteoarthritis
Exclusion Criteria:
pregnancy,
lactation,
anaemia
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
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