An open labelled non randomized phase II clinical trial to evaluate the efficacy of leech therapy in siddha in the management of osteoarthritis

Phase 2

Recruiting

• Conditions: Osteoarthritis of knee, unspecified,

• Registration Number: CTRI/2023/06/054210
• Lead Sponsor: Dr R Shanmu

Brief Summary

This study is an open labelled non randomized phase II clinical trial to evaluate the efficacy of attaividal (leech therapy in siddha external therapy) in the management of azhal keel vayu(Osteoarthritis).The primary objective is to evaluate the improvement of clinical signs & symptoms in azhal keel vayu (osteoarthritis)patients before and after treatment of leech therapy . Hirudoventralis (leech) which have a size of 2 to 3 inches, in a number of 2 to 3

leeches for 3 to 5 sittings (based on severity of disease) for about 45 minutes to 1 hour will be introduced around the affected knee joint. Time

interval between the first and next consecutive leech therapy application session will be Seven days.In case of any adverse events (AE) is noticed, it will be referred to pharmacovigilence department and Further

management of patients will be given in OPD.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-21
• Study Start: 2023-06-28

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Patients having symptoms of pain in single or both knee joints, swelling, tenderness, stiffness, crepitation, restricted movements.
• 2.Patients who are willing to undergo Leech application 3.Willing to give specimen of blood for investigation whenever required.
• 4.Willing to attend OPD or admission in IPD for 48days.
• 5.Willing to take photograph before and after treatment.

Exclusion Criteria

• 1.History of Tuberculosis 2.History of Hepatitis B, AIDS, syphilis.
• 3.History of Heamophilia& Anticoagulant treatment 4.Pregnancy & lactation 5.Rheumatoid and other types of arthritis 6.Benign and malignant neoplasm 7.Trauma, Fracture, Ligament injury 8.Immuno compromised Patients 9.History of Psychiatric disorder 10.Surgery of the affected knee joint during the previous 3 month or joint replacement.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reduction in severity of joint pain, stiffness, tenderness & swelling	2weeks

Trial Locations

Locations (1)

Government siddha medical College and hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government siddha medical College and hospital

🇮🇳Tirunelveli, TAMIL NADU, India

DR R Shanmu

Principal investigator

9500966437

vishnu31190@gmail.com