EFFICACY OF GUDABHAYA IN THE MANAGEMENT OF ARSHA W.S.R TO 1ST AND 2ND DEGREE HAEMORRHOIDS – A RANDOMIZED CONTROLLED CLINICAL TRIAL

NEED FOR THESTUDY:

Arsha orhaemorrhoids (piles) are the dilated veins within the anal canal in thesubepithelial region formedby radicals of superior, middleand inferior rectalveins1. Sedentarylife and prolonged sitting affectsAgni which results in Arsha.Arsha or haemorrhoids is one of the commonest problem which is seen inpresent era with incidence rate 50-60%2 and the prevalence rate ofpiles is 4.4% in the world, in about 10 million people 3.

Painless bleeding per anum during defecation is theprominent and Earliest symptom of haemorrhoids .4 It is of two typesviz, internal and external. Based on prolapsed pile mass internal haemorrhoidsare of 4 types viz, 1st, 2nd, 3rd and 4thdegree.1

People who are afraid of surgery, post-operative painand hospital stay prefers conservative management. Despiteof number of methods and careful techniques many subjectsexperience pain and discomfort which hampers their daily routine life.

Acharya sushrut mentionedBhaisaja chikitsa for newly formed arsha (w.s.r to 1st and 2 nd degreehaemorrhoid) with less symptoms and less complications5.BhaiÅŸaja Karma is a conservative,convenient, cost effective and non-invasive treatment and there is no fear ofcomplication, putrification and bleeding in comparison to others.

As per the reference of Bhaishajya Ratnawali, Gudabhayapacifies Pitta and Kapha and cures Kandu, Vedana and *Arsha.*6 To find a simple,non-invasive, easily available, safe and cost effective management of Arsha or haemorrhoids (1stand 2nd degree) Gudabhaya isselected for the study.

REVIEWOF LITERATURE:The word “Haemorrhoids†is derived from Greek wordHaima (bleed) + Rhoos (flowing), means bleeding. The pile is derived from theLatin word „Pilla‟ means Ball. It is downward slidingof anal cushionsabnormally due to straining or other causes.Present concept

is weakening of park’s ligament which isthe lower end of the external sphincter 7.

 The reference of Arshaor haemorrhoids is found in SushrutSamhita, Charak Samhita, Ashtangasangraha and Bhaishajya Ratnawali. 8,9,10.. Acharya Sushruta mentioned Arhsa as one among the Ashtamahagada11 Acharya Sushruta explained Arsha in more detail with its indication12 and also emphasized Bhaishaja Chikitsa12 in early stageof arsha and later kshara, shastra and agni karma are explained.

Gudarsha13is best correlated with Haemorrhoids. The reference of Gudabhayais taken from BhaishajyaRatnawali6.

 DRUG REVIEW:Gudabhaya contains 2 ingredients.

 

S.NO.

Dravya

Latin name

Parts used

Collection

Proportion

Pharmacological Properties

|1.

Abhaya (Haritaki)

Terminalia

Chebula Retz.

 Phala

GMP CERTIFIED PHARMACY

1 part

Antispasmodic Anti carcinogenic Antidiabetic, Anti mutagenic, Antioxidant, Antiulcer

|2.

Guda

Jaggery

 GMP CERTIFIED

PHARMACY

2 part

Digestive stimulant

GUDABHAYA:

Drugs

Rasa

Guna

Veerya

Vipaka

Karma

DoshaGh anata

|Abhaya

(Haritaki)

Madhura Amla Katu Tikta Kashaya

Guru

Ushna

Madhura

Vatanulom ana, Arshoghna

Tridoshag hna

|Guda

Madhura

Guru Snighda

Sheeta

Madhura

Dipaniya Pachaniya

Vatahara

PREVIOUSRESEARCH WOR KS

**1.**PATTANSHETTISNEHA and Y. M Santosh, (Dissertation submitted to KLE university) 2018 evaluated that Bhallatakadi Modaka (Study group) showsignificant result in Reduced appetite, Straning effects and Bleeding per anusin the Management of Arsha W.S.R to 1st and 2nd Degree Haemorrhoids at dose of2 TID (500mg each tablet) when given for 7 days but there is less difference inthe improvement of reduced appetite comparing other two assessment criteria 14 .

 **2.**SHANKARSANTOSH and Rao P.N, (Dissertation Submitted to the RajivGandhi University of Health Sciences, Karnataka, Bengaluru) 2018 evaluated that Bhallatakadi Modaka (study group) showsignificant result in Reduce pain and burning sensation in the Management of Pittaja Arsha ( Haemorrhoids) at dose of2gm twice a day when given for 15 days whereas constipation still persisted andin the Control group ( Arshakuthar rasa)no much reduction was noticed in the same features15 .

AIM:«To study the efficacy of Gudabhayain Arsha W.S.R 1st and2nd degree haemorrhoids.

  OBJECTIVE OF THE STUDY:1.       To evaluate the efficacy of Gudabhaya in the management of ArshaW.S.R 1st and 2nddegree haemorrhoids.

2.       To compare the efficacy of Gudabhayaover Arshakuthara Rasa in the management of

Arsha W.S.R 1st and 2nd degree haemorrhoids.

  HYPOTHESISH0:

Gudabhayaisnot effective inthe management of Arsha W.S.R 1stand 2nd degree

haemorrhoids.

H1:

Gudabhayais effective in the management ofArsha W.S.R 1st and 2nddegree haemorrhoids.

 RESEARCH QUESTION:Whether Gudabhaya issignificantly effective in the management of Arsha W.S.R 1st and 2nd degree haemorrhoidsor not when administered for 15 days?

MATERIALSSOURCE OF DATA: Thesource of the data for the presentstudy will be taken from classicaltexts, modern books, research articles, journals and internet.

DRUG PROCUREMENT:•         Abhaya and Guda powder will be procured from GMPcertified KLE Ayurveda Pharmacy, Khasbag, Belagavi.

•         Abhaya powder will be preparedat GMP certified KLE AyurvedaPharmacy, Khasbag, Belagavi.

•         Control drug will be procured from GMP certified KLE Ayurveda Pharmacy, Khasbag, Belagavi.

 SUBJECTS: Thepatients with age between 18 to 75 years of either sex will be taken for thestudy from OPD of KLE Ayurved Hospitaland Meddical ResearchCentre,Shahapur, Belagavi.

 METHODOLOGY RESEARCH DRUG:•         Gudabhaya6 (Trial drug)

•         ArshakutharaRasa 16(Control drug)

 ANALYTICAL STUDY:•         Authentication of raw drugs will be done by experts,in the AYUSH Approved drug testing laboratory CRF, KAHER’s Shri B.M.K AyurvedaMahavidyalaya, Shahapur, Belagavi.

•         Analytical study of finished product will be carriedout in the AYUSH Approved drugtesting laboratory, CRF, KAHER’s Shri B.M.K Ayurveda Mahavidyalaya, Shahapur,Belagavi.

PREPARATION:Method of Preparation of Gudabhaya

1.   Ingredients1. Abhaya Choorna– 1 part

2. Guda –2 parts

2. Preparation of Gudabhaya

•           One part of dry fruit of Abhaya (Haritaki) is taken and made into fine powder

•           The fine powder will be sieved.

•           All particles should pass through sieve with a nominal mesh aperture of180 micrometre.

•           Two parts of procured Guda powderis taken and pounded well.

•           One part ofsieved Abhaya (Haritaki) powder and two parts of guda powder is mixed thoroughly.

•           Then 15 gms of mixed powdered drug is stored in a sterilized air tight container.

•           Avoiding direct exposure to sunlight and air.

 PACKAGING AND STORAGEPackaging will be done in GMP Certified KLE Ayurveda Pharmacy, Khasbag, Belagavi,Karnataka and storage will be done in KLE Ayurveda Hospital and MedicalResearch centre, Belagavi.

 MAIN STUDY: CLINICAL STUDY

 STUDY TYPE – Interventional

 INTERVENTIONAL DRUG – Gudabhaya

STUDY DESIGN – Randomized Controlled Clinical Trial

 MASKING - Open label

 CONTROL - Standard

 SAMPLE SIZE – 30

 Patient will be selected bycomputerized block randomization method

 END POINT – Efficacyof Gudabhaya in Arsha W.S.R 1st and 2nd degree haemorrhoidswhen administered for 15 days.

Patient selected byRandomization chart –

SAMPLESIZE & CALCULATION

Group Name

Description

Sample size

|GROUP-A

Trial group

15

|GROUP-B

Control group

15

GROUPS ANDINTERVENTION INCLUDING FOLLOW UP:

NAME          OF

THE GROUP

SAMPLE SIZE

DRUGS

DOSE        AND

DURATION

FOLLOW UP

|GROUP A

Trial Group

15

Gudabhaya

15 gm twice a day

7th day and 15th day

|GROUP B

Control Group

15

Arshakuthar Rasa

250 mg twice a day

7th day and 15th day

DIAGNOSTICCRITERIA

1.  Constipation

2.  Bleeding per Anus

3.  Pile mass (by Proctoscopic examination)

*4.*Kandu and vedana

5.  Newly arisen Haemorrhoidswith less symptoms and complications5.

INCLUSION CRITERIAo  Patients with Arsha orhaemorrhoids (1st and 2nd degree)

 o Age between 18-75 yearsirrespective of gender.

 EXCLUSION CRITERIAo  Thrombosed Haemorrhoids, Prolapsed Haemorrhoids.

o  Haemorrhoids occurs with known secondary cause such asportal HTN, liver cirrhosis, etc.

o  History of known case of Systemic Illnesslike Carcinoma of Rectum, Inflammatory Bowel Diseases, DM, HIV I& II, HbsAg.

 WITHDRAWAL CRITERIA:The PrincipalInvestigator may stop your participation in the study at any time for one ormore of the following reasons.

 1.       Any serious adverse events requiring major interventions.

2.       Any time during the study, continuation of study drug could lead toharmful effect.

3.       Any untoward event where in investigator feelscontinuation of trial may jeopardise the health state of the subject.

4.       Subjects failure to follow the instructions of the Principal Investigator.

5.       If patient needs treatment that are not allowed in the study.

6.       Other administrative reasons

 STATISTICAL METHODS TO ANALYSE THE DATA:Suitable, descriptive and inferential statistical tests will beidentified and applied for testing the hypothesis on consulting a statistician.

EXPECTEDOUTCOMES:There may be significant effect of Gudabhayain the management Arsha w.s.r. 1stand 2nd degree haemorrhoids when administered for 15 days.

  RESCUE MEDICATION:Patients will be managed according to conventional line of treatmentdepending on type of complaints.

OBSERVATION:

Parameter

Baseline

7th Day

15th Day

|Constipation

    |Bleeding per Anus

    |No. of pile mass

    |Size of pile mass

STUDY DRUG DOSE : 15gm Twice a day 6.

 STUDY SITE :KLE Ayurveda Hospital and Medical Research centre,Belagavi

STUDY PEROID : 18 months

ROUTE OF ADMINISTRATION: ORAL

Anupana- Sheeta Jala

 Duration of treatment: 15 days

 Assessment: Baseline, 7th& 15th day

 SOP –Preparation of drug done as per SOP17, in KLEAyurveda Pharmacy, Belagavi.

ASSESSMENT CRITERIAAssessment will be done beforetreatment and after treatment

«  Subjective Parameters:1) Constipation

«  Objective Parameters:1)      Bleeding per anus

2)      Number of pile mass

3)      Degree of hemorrhoidalprolapse

A. Subjective Parameters:1) Constipation: ROME III diagnosticcriteria for functional gastro intestinal disorders18.

Q. Straining during at least 25%of defecations

Grades                   SymptomsGrade 0               Never

Grade 1             Lessthan once Week

Grade 2             1–6 Times/week

Grade 3             EveryDay

B. Objective Parameters 19**1)**Bleeding per Anus

G1-      Nil

G2-      Mild; occasional episodes (duringdefecation) G3-            Moderate;frequent episodes (during defecation)

G4-       Severe;persistent bleeding even without defecation with fall in Hb level (<10 gm/dL); requiring hematinics.

G5-       Very severe;bleeding in the form of jets and splashes with severe fall in Hb

level (<7 gm/dL); requiring bloodtransfusion**.**

2)Number of pilemassG1 -    None

G2-     One

G3-     Two

G4-     Three

G5-              Circumferential (presence ofsecondary hemorrhoids along with the involvement of all primary hemorrhoids)

3)   Degreeof hemorrhoidal prolapseG1- No hemorrhoidal prolapse

G2-    Prolapse upon straining that reducesspontaneously G3- Prolapse upon straining that needs manual reduction

G4- Prolapsed and irreduciblehemorrhoids but without ischemic changes.

G5- Prolapsed and irreduciblehemorrhoids with ischemic (gangrenous) changes.

EthicalClearance:BMK/20/PG/ST/4

 CTRI NO.Yet to be registered

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14.                   Pattanshetti S et al 2018 evaluated the ‘Effect of Bhallatakadi modaka in the Management of Arsha W.S.R to 1st and 2nd DegreeHaemorrhoids ’ KAHER Shri BMK

, belagavi,2018 -19.

15.             Shankar S -et al 2018 evaluate “A Clinical Study of Bhallatakadimodaka in the Management of Pittaja Arsha(Haemorrhoids) ‘SDM hassan’,2018-19.

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17.                   The Ayurvedic Pharmacopia of India Part -1 Volume8,First edition .27th Monograph page no.82.

18.                   DOUGLAS Drossman.GastroenterologyVol 130 No.5, RomeIII Diagnostic Criteria For Functional

19.                   PNR-Bleed†classification and Hemorrhoid SeverityScore, Journal of Coloproctology, jcoloproctol (rio j). 2 0 2 0;40(4):398–403 https://jcol.elsevier.es/en-pnrbleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423