An open single arm clinical trial to determine the therapeutic effect of Attai vidal (Leech therapy) in the management of Narithalai Vaatham (Gouty Arthritis)

OBJECTIVES:

To determine the therapeutic effect of leech therapy in the management of

Narithalai vatham (Gouty arthritis)

To evaluate the improvement of clinical signs and symptoms of Narithalai

vatham (Gouty arthritis) participants before and after treatment of leech

application.

To study the Siddha basic principles towards effect of Leech therapy.

METHODOLOGY:

STUDY DESIGN : An open single arm clinical trial

STUDY TYPE : Interventional study

STUDY PLACE : Ayothidoss Pandithar Hospital,National Institute of Siddha,

Tambaram Sanatorium, Chennai-47.

STUDY SIZE : 20 participants

STUDY PERIOD : 18 months

STUDY INTERVENTION : Attaividal

INCLUSION CRITERIA:

Age 20-65 years

All genders.

Having classical symptoms of gout- intense pain, tenderness, swelling, redness and

warmth and limitation of movements

EXCLUSION CRITERIA:

Participants with h/o uncontrolled Diabetes and Hypertension

Participants of bleeding disorders such as hemophilia, platelet disorder, capillary

bleeding and severe anemia

Immunocompromised patients such as AIDS, Cancer, SLE.

Pregnancy and lactation

Psychiatric illness

WITHDRAWAL CRITERIA:

Intolerance to leech therapy and development of any serious adverse reactions during

this trial Period clinical ASSESSMENT:

The classical presentation is with an acute mono arthritis, which affects the first

metatarsal phalangeal joint. other common sites are ankle, midfoot, knee, small joints

of hands, wrist and elbow.

Severe pain, swelling and warmth in thew affected joints.

Affected joints are warm, red and swollen.

Mild fever may be present

Tophi may be present in chronic, severe disease.OUTCOME:

The outcome of the study may reveal the therapeutic effect of Attaividal (Leech therapy) in

the management of Narithalai vatham (Gouty arthritis) assessing with the Visual Analogue