An Open Labelled Randomised Double Arm Clinical Study To Evaluate The Efficacy Of Ashwagandhadi Granules With and Without Cupping Therapy In The Management Of Manyastambh W.S.R. to Cervical Spondylosis

This is an open-labelled, randomized, comparative double-arm interventional clinical study designed to evaluate the efficacy of Ashwagandhadi granules in the management of Manyastambha (Cervical Spondylosis), both with and without wet cupping therapy. A total of 40 patients aged 18–60 years fulfilling diagnostic criteria will be randomly divided into two groups: Group A will receive Ashwagandhadi granules (5 g BD with warm water after food) along with wet cupping therapy, and Group B will receive Ashwagandhadi granules alone for a duration of 60 days. Wet cupping will be performed in Group A at the suprascapular region and C7–T1 junction, with 1 sitting every 15 days (maximum 4 sittings). Patients will be followed up on the 15th, 30th, 45th, and 60th day. Assessment will be done using subjective parameters such as pain (Shoola), stiffness (Sandhigraha), headache, vertigo (Bhrama), tingling sensation, numbness, and tenderness (Sparshasahishnuta) with grading scales. Objective assessment parameters will include Visual Analogue Scale (VAS) for pain, Neck Disability Index (NDI) for functional disability, Range of Motion (ROM) of cervical spine measured by goniometer (flexion, extension, lateral flexion, and rotation), and Quality of Life (QOL) evaluation using the SF-36 questionnaire. Radiological screening will be performed using X-ray cervical spine lateral view. Laboratory investigations planned for patient safety include CBC, RBS, HBsAg, HIV, Bleeding Time (BT), and Clotting Time (CT) (BT and CT applicable specifically for cupping therapy patients). Safety monitoring will be ensured through adverse event recording, and rescue medication (Diclofenac sodium 75 mg SOS) will be provided if required.