AIMS AND OBJECTIVES: To clinically evaluate the efficacy of the Manjistadi Lepa in the management of superficial phlebitis. METHODLOGY: A. DIAGNOSTIC CRITERIA: Diagnosis will be made on the basis of following features: a. Localised swelling b. Tenderness c. Redness d. Increased local temperature e. Fever (with or without) f. Cord like induration of veins localized at cannula site (with or without) B. SELECTION CRITERIA INCLUSION CRITERIA 1) Clinical signs and symptoms of Superficial phlebitis as a result of injury. 2) Established cases of Superficial phlebitis in varicose veins . 3)Established cases of Superficial phlebitis at the site of canula insertion EXCLUSION CRITERIA: 1)Patients with immunocompromised status like HIV,HBsAG and Tuberculosis. 2)Patients with Deep Vein Thrombosis 3)Patients with uncontrolled hyperglycemia (HbA1c>8 %) ASSESSMENT CRITERIA The effect of therapy will be assessed by subjective and objective parameters based on the clinical observation before and after treatment by grading. SUBJECTIVE PARAMETERS: A)Pain
OBJECTIVE PARAMETERS : A)Swelling B)Palpable venous cord C)Erythema D)Local raise in temperature E)Tenderness VIP SCORE – VISUAL INFUSION PHLEBITIS GRADES | DETAILS | SIGNS | GRADE 0 | NO SIGNS OF PHLEBITIS | | GRADE 1 | POSSIBLY FIRST SIGN OF PHLEBITIS | o SLIGHT PAIN AT IV SITE OR SLIGHT REDNESS | GRADE 2 | EARLY STAGE OF PHLEBITIS | o PAIN AT IV SITE , o REDNESS, o SWELLING | GRADE 3 | MEDIUM STAGE OF PHLEBITIS | o PAIN ALONG CANULA PATH, o REDNESS AROUND, o SWELLING | GRADE 4 | ADVANCED STAGE OF PHLEBTITIS | o PAIN ALONG CANULA PATH, REDNESS AROUND, o SWELLING, o PALPABLE VENOUS CORD | GRADE 5 | ADVANCED STAGE OF PHLEBTITIS | o PAIN ALONG CANULA PATH, o REDNESS AROUND, o SWELLING, o PALPABLE VENOUS CORD, o PYREXIA | TENDERNESS GRADES | DETAILS | GRADE 0 | NO PAIN | GRADE 1 | TENDERNESS TO PALPATION WITHOUT GRIMACE OR FLINCH | GRADE 2 | TENDERNESS WITH GRIMACE OR FLINCH | GRADE 3 | JUMP SIGN IS POSITIVE , WITHDRAWAL | GRADE 4 | WITHDRAWAL TO NON-NOXIOUS STIMULI ( SUPERFICIAL PALPATION, PIN PRICK , GENTLE PERCUSSION) | PAIN GRADING ACCORDING TO NRS SCALE RATING | PAIN LEVEL | 0 | NO PAIN | 1-3 | MILD PAIN ( NAGGING , ANNOYING , INTERFERING LITTLE WITH ACTIVITIES OF LIFE ) -ADLs | 4-6 | MODERATE PAIN ( INTERFERES SIGNIFICANTLY WITH ADLs | 7-10 | SEVERE PAIN ( DISABLING , UNABLE TO PERFORM ADLs) | LOCAL TEMPRATURE ( IN COMPARISON TO NORMAL SURROUNDING SKIN ) GRADES | DETAILS | Grade 0 | Normal | Grade 1 | Raised | SWELLING GRADES | DETAILS | Grade 0 | Absent | Grade 1 | Present | STUDY DESIGN The study will be open label single arm clinical study. INTERVENTION (TREATMENT PLAN) Pre- operative / Poorva Karma Informed consent will be taken from patient and patient party The patient is obtained into suitable position for the application of Manjistadi Lepa They will be then explained about the procedure Site of application will be cleaned properly Operative procedures / Pradhana karma · Freshly prepared Sheeta Manjisthadi lepa(sheeta pradeha) is applied over the affected site in the Pratiloma Gati with a thickness of 0.4-0.8 cm (Ardra Maheesha Charma) · The Lepa is kept in situ till cracks were noted or till the patient complaines of stretching sensation, i.e. before it dried completely. Post-operative / Paschat karma After when Lepa gets dry, it will be cleaned with lukewarm water gently with cotton. METHOD OF PREPARATION: Sukshma Churna of all the above mentioned ingredients were taken in equal quantity in a bowl and Lepa was prepared by mixing it with cold water and this was applied to patients Duration of the treatment: Local application of Manjistadi lepa twice daily for 7 days or till the signs and symptoms resolves . Follow up study: After completion of treatment the patient will be asked to followed at an interval of 7 days twice to know if the signs and symptoms has resolved or not. REFERENCES: 1. Sushruta Samhita; with Nibandha Sangraha commentary of Sri Dalhanacharya, & Nyachandrika Panjikacommentry of Gayadas; edited by Yadavji Trikumji Acharya; Chaukhamba Orientalia Varanasi; 7th Edition2002; Chikitsa sthana 3/47; pg 418 and 3/8; pg 415. 2. Sharangdhar: Virachitha Sharangadhara Samhita, Commentry by Dr.Smt.Shailaja Srivastava, Chaukhamba Orientalia Varanasi Uttarkhand, 11th Chapter, 1-2nd Sloka; 3. S. Das: Concise text book of surgery. Published by Dr. S. Das, 13 old Mayor’s court, Calcutta, India 700005. 3rd edition 2001. Pg No 68, 173, 212, 213. 4. SRB’s Manual of Surgery by Sriram Bhat, 2nd edition 2007, Jaypee publications, EMCA House 23/23B, Ansariroad, Daryagani. New Delhi. 5.Article-Utility of Manjistadi lepa in soft tissue inflammation by Dr Pallavi A.Hegde and Dr P.H Hemantha Kumar 6. Study on incidence of phlebitis following the use of pherpheral intravenous catheter Abhijit Mandal and K Raghu 7. A comprehensive review of Rubia cordifolia L.: Traditional uses, phytochemistry, pharmacological activities, and clinical applications 8. Glycyrrhizin showed anti-arthritic and anti-inflammatory effect on formaldehyde induced rat paw edema. (Gujral et al, 1961a) 9. The anti-inflammatory activity of Glycyrretic acid and its diacetate was similar to that of hydrocortisone. (Tangri et al, 1964) 10. The anti-inflammatory response of Glycyrrhiza glabra was found to be equivalent to that of oxyphenbutazone. It appeared to possess a more potent anti-pyretic and anti- exudative activity in comparison to oxyphenbutazone. (Saxema et al, 1970) |