An open single arm single centric clinical trial to determine the effectiveness of kaalani ennai for the management of kaalani(corn foot)

BACKGROUND: Siddha system of medicine provides preventive, curative and rejuvenative health care management based on the principles of pancha boodham.The siddha system of medicines are broadly classified into 32 Internal medicines & 32 External medicines of which the external medicines play a significant role in the treatment & management of various skin diseases. Intermittent pressure and friction over a long period is likely to produce a corn.It represents hyperkeratosis formed by nature to protect the sensitive part of the skin and the underlying structures from such pressure and friction.It is a conical in shape, painful hyperkeratosis appears on the soles and over the toes.The hyperkeratosis of corn gets pushed into the skin causing pressure on nerve endings which produces pain.Clinically, a corn is seen as a polished, flesh coloured and circumscribed papule. According to siddha literature corn is caused by increased friction of foot without the usage of foot wear, piercing foot by thorns and walking through the coarse stones. Now days there is an increasing number of cases of Kaalani(corn foot). I had chosen this Kaalani Ennai preparation for treatment of kaalani(corn foot).ThisKaalani Ennai contains Gowri padanam (Arsenic penta sulfide), Castor oil, Cow’s butter.This formulation is indicated for the treatment of kaalani (Corn foot)  .This Ennai may be heal the corn by removing the hyperkeratosis of the skin.

OBJECTIVE: To determine the therapeutic effectiveness of Kaalani Ennai for the assessment of pain by Visual analogue scale and quality of life by EQ-5D Scale.

STUDY DESIGN: An open non randomised clinical trial with a total of 10 diagnosed patients of kaalani(corn foot) reporting at ayothidoss pandithar hospital national institute of siddha will be enrolled in the study.patients having History of uncontrolled Diabetes, Rheumatoid arthritis, Peripheral neuropathy, foot ulceration, taking oral steroid, Hansen’s disease will be excluded. The trial medicine Kaalani ennai as external medicine will be given for 48 days.

OUTCOME: The therapeutic effectiveness of Kaalani ennai for the management of pain will be determined by Visual analogue scale and quality of life will be monitored by EQ-5D Scale.