A CLINICAL STUDY TO EVALUATE THE ANALGESIC EFFECT OF Madhuca longifolia FLOWER EXTRACT SPRAY IN POST HAEMERRHOIDECTOMY PAIN MANAGEMENT

INTRODUCTION

·       Since years the concept of pain management is an important and primary concern in surgical practice. Pain is regarded as the fifth vital sign which should be addressed as important as other vital parameters in the post-operative period.

·       Pain is defined by the International Association for the Study of Pain (IASP) as-

‘An unpleasant sensory and emotional experience associated with actual or potential tissue damage mainly due to tissue trauma.

·       Post-operative pain management is very difficult especially in ano-rectal surgeries. Various types of formulations are available for external application. The main approach is-

à How to give relief from pain

à How to heal the wound speedily.

 •      Madhuca longifolia, commonly known as mahua, is indeed believed to have analgesic properties.

 So, further research is needed to fully understand its mechanism of action and effectiveness in pain management.

 NEED OF STUDYA lot of locally applicable medicines to be used after Ano-rectal surgeries are available in market. Most of them are difficult for application due to-

·       Painful application and irritation

·       Assistant is must in few cases

·       Aseptic precautions are not followed properly

 Benefits of Madhuca longifolia Spray

·       Easy to carry and handle

·       Less chances of contamination so safer to use on wound

·       Self-applicable, no assistant needed

·       Spreads evenly over a wide area, within fraction of seconds.

·       With less dose, more utilization of drug

    Previous work done by Dinesh Chandra which is published in Indian Journal of Pharmacology in 2001, he had concluded on statistical and observational grounds that 98% ethanolic extract and aqueuos extract of Madhuca longifolia shown non-significant results.

REVIEW OF LITERATURE-Bhavprakasha, Purvakhanda,chapter 7 (Amradi phala varga)/79-81·       Madhuca longifolia is an indigenous medicinal plant. Madhooka or Mahua is mentioned in several Ayurvedicliteratures which are Bhavaprakash of Bhavmishra[3], Adarsh nighantu

·       Madhuca longifolia is reported to contain chemical constituents like sapogenins, triterpenoids, steroids, saponins, flavonoids and glycosides. After a lot of therapeutic research on mahua, it is shown that it has ethnomedicinal properties such as antibacterial, anticancer, hepatoprotective, antiulcer, antihyperglycemic and analgesic activities. [7]

·         Latin name: Madhuca longifolia

·         Common name: Madhooka, Mahua

    

SR.

NO

SANSKRIT

NAME

RASA

GUNA

VIRYA

VIPAK

KARMA

Useful part

|1.

Madhooka (Madhuca longifolia)

Madhura

, Kashay

Guru, Snigdha

Sheeta

Madhur

Vatapitta shamak

Flowers

 PREVIOUS WORK DONE·        ANALGESIC EFFECT OF AQUEOUS AND ALCOHOLIC EXTRACTS OF MADHUKA LONGIFOLIA (KOEING) DINESH CHANDRA DEPARTMENT OF PHARMACOLOGY, MAULANA AZAD MEDICAL COLLEGE, NEW DELHI-110 002,2000

 ·        CHEMICAL COMPOSITION OF ESSENTIAL OIL OF MADHUCA LONGIFOLIA VAR. LATIFOLIA(ROXB.) A. CHEV. FLOWERS YOGESH CHANDRAKANT SURYAWANSHHI AND DIGAMBAR NABHU MOKAT ,2019

·        DEVELOPMENT AND EVALUATION OF CLINICAL EFFICACY OF DASHANG AEROSOL SPRAY IN POST HAEMORRHOIDECTOMY PAIN MANAGEMENT,DR DEEP, DR SHIRODE,2024

AIMS & OBJECTIVES AIM-·       To develop and study the clinical efficacy of Madhuca longifolia flowers extract sprayOBJECTIVES-•        To prepare Flowers extract spray from Madhuca longifolia•        To study phytochemical analysis of Madhuca longifolia flowers extract•        To assess the analgesic effect of Madhuca longifolia flowers extract spray HYPOTHESISNULL HYPOTHESIS [H0]

·       Madhuca longifolia flowers extract spray is not effective in post haemorrhoidectomy pain.

 ALTERNATIVE HYPOTHESIS [H1]·       Madhuca longifolia flowers extract spray is effective in post haemorrhoidectomy pain.

  RESEARCH QUESTION:Ø  Is Madhuca longifolia flowers extract spray beneficial in post haemorrhoidectomy pain management?

MATERIALS AND METHODS:1.       Sources of data

 1)     Literary source

 2)     Pharmaceutical source

 3)     Clinical source

 2.     Method of collection of data

   1.  SOURCES OF DATA1) Literary source :

·       Review of Pain: All classical, modern literature and contemporary texts including the journals and websites about pain, its pathology and management procedure will be reviewed and documented for the study.

·       Drug Review: The Literature of Madhuca longifolia will be collected from the texts of Ayurveda & Modern Science and also will be updated with relevant journals and internet Information will be collected from modern texts and relevant research literature also.

2) Pharmaceutical source:

A.       Raw material(Madhuca longifolia ) will be collected and authenticated by expert

B.       Identification at Department of Dravyaguna, Parul Institute of Ayurved.

C.       Authentication of the drug will be done by botanist, Parul university.

 D.       Drug preparation**:**

Raw material(Madhuca longifolia ) will be

collected and authenticated by expert

Analytical studies of Raw drugs at GMP certified pharmacy-as per API guidelines

Madhuca longifolia Flowers extract preparation (by soxhlet apparatus)

We will add suitable preservative in the spray formulation

Preparation and packaging of Madhuca longifolia flower extract spray

 ·       Madhuca longifolia Flowers extract spray will be applied as per requirement (size, site and shape of wound) until wound gets wet.

·       With minimum 6 hours interval between 2 application as per severity of pain.

 3)     CLINICAL SOURCE:No. of 30 post haemorrhoidectomy patients suffering from pain will be selected irrespective of their Gender, Occupation, Religion, socio-economic status etc., from the IPD of Shalya Tantra Department, Parul Ayurved Hospital, Limda

2.    METHOD OF COLLECTION OF DATAa)   Sample size : 30

b)  Study design: Single arm open clinical study.

c)   Duration of treatment: Madhuca longifoliaflowers extract spray will be applied after the removal of anal pack

Ø  Applied for 7 days during the post-operative period.

d)  Selection criteria:

·       Patients undergone haemorrhoidectomy by Local or spinal anaesthesia, complaining of pain, who has given consent to do the study.

e)   Diagnostic criteria:

·       Patients undergone haemorrhoidectomy by Local or spinal anaesthesia,

 ·       Patients having complaint of pain after haemorrhoidectomy.

f)   Inclusion criteria:

1.     Patients undergone haemorrhoidectomy by Local or spinal anaesthesia, complaining of pain, irrespective of their gender & Occupation.

2.       Patients who are above 18 years and below 60 years of age.

 g)  Exclusion criteria:

1.     Patient with uncontrolled diabetes mellitus and hypertension.

2.     Patients who are taking NSAIDs regularly for other conditions.

3.     Patients who are regularly taking alcohol

4.     Patient non-allergic to Madhuca longifolia or Madhuca longifolia products

h)  Assessment criteria:

·       Assessment will be done on the basis of specially prepared proforma for assessing the relief in signs & symptoms by scoring pattern.

 (i)               Subjective criteria–

a.      Pain

b.     Recurrence of pain

a) Assessment of severity of pain:

·       The assessment of the pain will be done with the standard VAS [8]:

 

 VAS ranges from 0-10, 0 means no pain and 10 means unbearable pain

b)  Assessment of effect of MadhookaFlowers extract spray as per recurrence of pain

  

RECURRENCE OF PAIN

GRADE

|No Pain up to 6 hours

0

|Recurrence of pain after 3 hours

1

|Recurrence of pain between 1.5 – 3 hours

2

|Recurrence of pain within 1.5 hours

3

  (ii)             Objective criteria :–

a.      Tenderness

b.     Swelling

  **A)**Assessment of Tenderness

TENDERNESS ASSESMENT

GRADE

|Tolerance to pressure

Grade 0

|Little response to sudden pressure

Grade 1

|Wincing of face on super slight touch

Grade 2

|Resists to touch and rigidity

Grade 3

**B)**Assessment Of Swelling

SWELLING ASSESMENT

GRADE

|Absent

Grade 0

|Slight red, tender and hot with painful movement and without indurations

Grade 1

|More red, having painful movement, with more local temperature and with indurations

Grade 2

|Hot, resist to touch and with more indurations

Grade 3

STUDY DURATION: ·       Madhuca longifolia Flowers extract spray will be applied for 7 days during the post-operative period after the removal of anal pack.

ASSESSMENT OF PATIENT:·       The patients will be observed and assessed on 1st, 3rd, 5th and 7th post-operative day.

  LABORATORY INVESTIGATIONS:·       No investigation will be required as already patient will be having all the basic investigations done before surgery.

 INTERVENTION·       Madhuca longifolia Flowers extract spray will be applied 6 hourly, starting from the first complaint of pain in the post-operative period after the removal of anal pack for a period of 7 days.

 PROCEDURE·       PURVAKARMA:- Subject undergone hemorrhoidectomy when complains of pain, the anal pack will be removed and the site will be cleaned with distilled water.

·       PRADHANA KARMA:- The Madhuca longifolia flowers extract spray will be applied at the operated site.

·       PASCHAT KARMA:- Covering will be done with sterile gauze.

·       Quantity of extract per spray= Approx. 0.5ml

No. of sprays/ sitting= 2 (0.5 X 2=1.0ml)

Total no. of sittings per day= 4 sittings

Total quantity of extract required per patient= Approx. 30ml

  CONCOMITANT MEDICINES

·       Antibiotics (Reconstituent Inj. Ceftriaxone in the dose of  500 mg  will be diluated in 100 ml NS given by IV route in the pre-operative period)  for 2-3 days followed by oral antibiotics Tab cefixime 200 mg or as per order of consultants.

·        Tab. Triphala Guggulu 2 BD for 7 days

·       Tab. Eranda Brista Haritaki 2 HS for 7 days

·       Avagaha Swedanawith Panchavalakal Kashaya twice daily.

·       Daily dressing with 5% povidine iodine solution.

  RESCUE MEDICINE·       Inj. Diclofenac sodium 75mg IM – 1 ampule. (SOS with minimum 6 hours interval between 2 doses) if pain doesn’t subside with Madhuca longifolia flowers extract spray and patient not able to tolerate the pain (patients with pain severity between 7-10).