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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02612974
Other study ID # 2009/AD/JH/058
Secondary ID
Status Completed
Phase Phase 2
First received November 20, 2015
Last updated November 23, 2015
Start date January 2010
Est. completion date June 2012

Study information

Verified date November 2015
Source Hamdard University
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- knee osteoarthritis

Exclusion Criteria:

- pregnancy,

- lactation,

- anaemia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Hirudinaria granulosa, qurse mafasil
compare the efficacy of both groups

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hamdard University

Outcome

Type Measure Description Time frame Safety issue
Primary KOOS Score end of 6 weeks No
Primary VAS end of 6 weeks No
Primary Active Range of Motion end of 6 weeks No
Primary Knee circumference end of 6 weeks No
Primary 15 m walking time test end of 6 weeks No
Secondary KOOS subscores end of 6 weeks No
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