An open single arm clinical trial to evaluate the therapeutic effect of thokkanam with thazhuthalai thailam and valinoi otradam for the management of kumbavatham( Adhesive capsulitis)

INTRODUCTION

The Siddha system of medicine is one of the traditional systems of medicine prevalent in South India. Thokkanam is one of the oldest and simplest forms of Siddha treatment. It improves muscle tone, stimulates blood circulation, and helps eliminate waste products throughout the body. At its best, Thokkanam can potentially restore the individual’s physical and mental 4 health. Otradam is an effective and potential therapy to alleviate musculoskeletal disorders. Adhesive Capsulitis describes a pathological process in which the body forms excessive scar tissue or adhesions across the glenohumeral joint, leading to stiffness, pain, and dysfunction. In Yugi Vaidhya Chinthamani, vatha diseases are classified into 80 types. Kumbavatham is characterized by pain, restricted movements in the shoulder joint and arm, burning sensation in eyes and cheeks, giddiness and twitching over the scalp, pain below the umbilicus, and burning sensation in the tongue.

OBJECTIVE: To evaluate the therapeutic effect of Thokkanam with Thazhuthalai thailam and Valinoi otradam in reducing the clinical signs and symptoms of Kumbavatham (Adhesive capsulitis) assessed by using the SPADI scale and Goniometric measurements.

METHODOLOGY:

STUDY DESIGN : An open single-arm clinical trial. STUDY TYPE : Interventional study STUDY PLACE : Pura maruthuvam OPD, Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai-47. SAMPLE SIZE : 30 SAMPLING METHOD : Consecutive sampling STUDY PERIOD : 18 months STUDY INTERVENTION : Thokkanam and Otradam.

FREQUENCY OF TREATMENT PROCEDURE: (Total-35 days)

• Session 1: Consecutively for 7 days • Rest for another 7 days • Session 2: Consecutively for another 7 days • Rest for another 7 days • Session 3: Consecutively for another 7 days

TESTS AND ASSESSMENTS:

1. Clinical assessment. 2. Siddha system of examination. 3. Routine laboratory investigations. 4. Special test

EXPECTED OUTCOME OF THE STUDY:

The expected outcome of the study will reveal the therapeutic effect of Thokkanam with Thazhuthalai thailam (External) and Valinoi Otradam in reducing the clinical signs and symptoms of Kumbavatham (Adhesive capsulitis) assessed by using the SPADI scale (Shoulder pain and disability index) and goniometric measurements from the baseline assessment with Minimally clinically Important Difference (MCID) of 8 and 13 points.