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Clinical Trials/CTRI/2024/01/061535
CTRI/2024/01/061535Not yet recruitingPhase 2/3

Clinical study to evaluate the efficacy of oral administration of Praval bhasma, Lakshadi guggulu and local application of Dashang Lepa with pinda tail on knee joints having arthritic changes in Hemophilia patients

Central Council for Research in Ayurvedic Sciences1 site in 1 country60 target enrollmentStarted: January 20, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
Improvement in pain by V.A.S score of Hemophilia patients having arthritic changes in knee joint.

Study Overview

Brief Summary

Hemophilia is the most common severe hereditary hemorrhagic disorder. Both Hemophilia A and B result from factor VIII and factor IX protein deficiency or dysfunction, respectively, and is characterized by prolonged and excessive bleeding after minor trauma or sometimes even spontaneously. There is Hemophilia C as well, which occurs due to deficiency of clotting factor XI but is rare. Recurrent joint bleeding (hemarthrosis) is the most frequent clinical manifestation of severe Hemophilia. Unless appropriately managed, even subclinical hemarthrosis can lead to the development of hemophilic arthropathy, a disabling condition characterized by joint remodeling, chronic pain, and a reduced quality of life, and eventually requires joint replacement. Given the lack of specific treatments to reduce blood‐induced synovitis, the prevention of bleeding is pivotal to the maintenance of joint health. Ayurveda has a great potential in dealing with the hemophilic arthropathy of joint caused by repeated hemarthrosis, but due to lack of awareness, study and researches, hemophilic patients are unable to take the treatment with the trust. My study will allow the hemophilic patients to use the Ayurvedic treatment with a trust to improve their quality of life, having less pain and improved confidence in them in this rare disorder.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
12.00 Year(s) to 40.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • Stage 2 or 3 or 4 arthritic changes present in knee joint.
  • Pre diagnosed patient suffering from moderate to severe Hemophilia A or B from factor assay 8 or 9 or having valid registered id card from Hemophilia society or any government hospital showing factor percentage.

Exclusion Criteria

  • Patient having Mild Hemophilia
  • Hemophilic patients whose Knee joints are not affected
  • Having stage 1 arthritic changes 4.

Outcomes

Primary Outcomes

Improvement in pain by V.A.S score of Hemophilia patients having arthritic changes in knee joint.

Time Frame: Day 1 | Day 30 | Day 45

Secondary Outcomes

  • -Improvement in Range of Motion ≥15 degree in affected knee joint by goniometer.(-Reduction in thickness of synovitis ≥1mm in affected knee joint by USG.)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Arun Kumar

Central Council for Research in Ayurvedic Sciences (CCRAS)

Study Sites (1)

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