NEED FOR THE STUDY:

Arsha or haemorrhoids (piles) are the dilated veins within the anal canal in the subepithelial region formed by radicals of superior, middle and inferior rectal veins¹. Sedentary life and prolonged sitting affects Agni which results in Arsha. Arsha or haemorrhoids is one of the commonest problem which is seen in present era with incidence rate 50-60%² and the prevalence rate of piles is 4.4% in the world, in about 10 million people ^3.

Painless bleeding per anum during defecation is the prominent and Earliest symptom of haemorrhoids .⁴ It is of two types viz, internal and external. Based on prolapsed pile mass internal haemorrhoids are of 4 types viz, 1^st, 2^nd, 3^rd and 4^th degree.¹

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

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

As per the reference of Bhaishajya Ratnawali, Gudabhaya pacifies 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 (1^st and 2^nd degree) Gudabhaya is selected for the study.

REVIEW OF LITERATURE:

The word “Haemorrhoids” is derived from Greek word Haima (bleed) + Rhoos (flowing), means bleeding. The pile is derived from the Latin word „Pilla‟ means Ball. It is downward sliding of anal cushions abnormally due to straining or other causes. Present concept

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

 

The reference of Arsha or haemorrhoids is found in Sushrut Samhita, Charak Samhita, Ashtanga sangraha 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 stage of arsha and later kshara, shastra and agni karma are explained.

Gudarsha¹³is best correlated with Haemorrhoids. The reference of Gudabhaya is taken from Bhaishajya Ratnawali^6.

 

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

 

 

PREVIOUS RESEARCH WOR KS

 

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

 

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

AIM:

« To study the efficacy of Gudabhaya in Arsha W.S.R 1^st and 2^nd degree haemorrhoids.

 

 

OBJECTIVE OF THE STUDY:

1.        To evaluate the efficacy of Gudabhaya in the management of Arsha W.S.R 1^st and 2^nd degree haemorrhoids.

2.        To compare the efficacy of Gudabhaya over Arshakuthara Rasa in the management of

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

 

 

HYPOTHESIS

 

 

H0:

Gudabhaya is not effective in the management of Arsha W.S.R 1^st and 2^nd degree

haemorrhoids.

H1:

 

Gudabhaya is effective in the management of Arsha W.S.R 1^st and 2^nd degree haemorrhoids.

 

RESEARCH QUESTION:

Whether Gudabhaya is significantly effective in the management of Arsha W.S.R 1^st and 2^nd degree haemorrhoids or not when administered for 15 days?

MATERIALS

SOURCE OF DATA: The source of the data for the present study will be taken from classical texts, modern books, research articles, journals and internet.

DRUG PROCUREMENT:

•          Abhaya and Guda powder will be procured from GMP certified KLE Ayurveda Pharmacy, Khasbag, Belagavi.

•          Abhaya powder will be prepared at GMP certified KLE Ayurveda Pharmacy, Khasbag, Belagavi.

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

 

SUBJECTS: The patients with age between 18 to 75 years of either sex will be taken for the study from OPD of KLE Ayurved Hospital and Meddical Research Centre,Shahapur, Belagavi.

 

METHODOLOGY RESEARCH DRUG:

•          Gudabhaya⁶ (Trial drug)

•          Arshakuthara Rasa 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 Ayurveda Mahavidyalaya, Shahapur, Belagavi.

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

PREPARATION:

Method of Preparation of Gudabhaya

 

1.   Ingredients

1. 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 of 180 micrometre.

•            Two parts of procured Guda powder is taken and pounded well.

•            One part of sieved 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 STORAGE

 

Packaging will be done in GMP Certified KLE Ayurveda Pharmacy, Khasbag, Belagavi, Karnataka and storage will be done in KLE Ayurveda Hospital and Medical Research 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 by computerized block randomization method

 

END POINT – Efficacy of Gudabhaya in Arsha W.S.R 1^st and 2^nd degree haemorrhoids when administered for 15 days.

Patient selected by Randomization chart –

SAMPLE SIZE & CALCULATION

 

Group Name	Description	Sample size
GROUP-A	Trial group	15
GROUP-B	Control group	15

GROUPS AND INTERVENTION 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

 

 

 

DIAGNOSTIC CRITERIA

 

1.  Constipation

2.  Bleeding per Anus

3.  Pile mass (by Proctoscopic examination)

4.  Kandu and vedana

5.  Newly arisen Haemorrhoids with less symptoms and complications⁵.

INCLUSION CRITERIA

o   Patients with Arsha or haemorrhoids (1^st and 2^nd degree)

 

o Age between 18-75 years irrespective of gender.

 

EXCLUSION CRITERIA

o   Thrombosed Haemorrhoids, Prolapsed Haemorrhoids.

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

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

 

WITHDRAWAL CRITERIA:

The Principal Investigator may stop your participation in the study at any time for one or more of the following reasons.

 

1.        Any serious adverse events requiring major interventions.

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

3.        Any untoward event where in investigator feels continuation 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 be identified and applied for testing the hypothesis on consulting a statistician.

EXPECTED OUTCOMES:

 

There may be significant effect of Gudabhaya in the management Arsha w.s.r. 1^st and 2^nd degree haemorrhoids when administered for 15 days.

 

 

RESCUE MEDICATION:

 

Patients will be managed according to conventional line of treatment depending 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 KLE Ayurveda Pharmacy, Belagavi.

ASSESSMENT CRITERIA

Assessment will be done before treatment and after treatment

«  Subjective Parameters:

1) Constipation

«  Objective Parameters:

1)      Bleeding per anus

2)      Number of pile mass

3)      Degree of hemorrhoidal prolapse

A. Subjective Parameters:

1) Constipation: ROME III diagnostic criteria for functional gastro intestinal disorders¹⁸.

Q. Straining during at least 25% of defecations

Grades                   Symptoms

Grade 0               Never

Grade 1             Less than once Week

Grade 2             1– 6 Times/week

Grade 3             Every Day

B. Objective Parameters ¹⁹

1)   Bleeding per Anus

G1-      Nil

G2-      Mild; occasional episodes (during defecation) 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 blood transfusion.

2) Number of pile mass

G1 -    None

G2-     One

G3-     Two

G4-     Three

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

3)   Degree of hemorrhoidal prolapse

G1- No hemorrhoidal prolapse

G2-    Prolapse upon straining that reduces spontaneously G3- Prolapse upon straining that needs manual reduction

G4- Prolapsed and irreducible hemorrhoids but without ischemic changes.

G5- Prolapsed and irreducible hemorrhoids with ischemic (gangrenous) changes.

Ethical Clearance:

 

BMK/20/PG/ST/4

 

CTRI NO.

 

Yet to be registered

 

Bibliographic References:

 

1.                   Das.S, A CONCISE TEXTBOOK OF SURGERY, 6^th ed. Kolkata: Old Mayors’ Court; 2010, Chapter 46. P -969

2.                         Gandagi N. ,Patil S.,The Medical Management of Arsha with Chirabilwadi Quatha and

Kaseesadi Thaila Sthanika Abhyanga, 2015 Vol 6 No 2 ISSN:0976- 5921 https://doi.org/10.47552/ijam.v6i2.574

3.                         Bhat S. SRB’s.Manual of surgery ,5th ed.: jaypee publication 2017.Chapter 25, p .971.

4.                         Nan AK. Undergraduate Surgery. 3rd ed. CBS publisher.2016, Chapter 50, p.566.

5.                   Trikamji J,editor, ( ed. reprint). Sushruta Samhita of Sushruta, Chikitsha sthana; Arshasam  chikitsitam:                       Chapter    6,    Verse    3.    Varansi:    Chaukhamba    Sanskrit Sansthan,2019;430

6.                         Mishra S, Bhaishaja Ratnavali,Sidhi prada Hindivyakhyan Chapter 9,Verse 23, Chaukamba Surabharti prakashan ,Varanasi.2014; 311

7.                         Bhat S. SRB’s.Manual of surgery ,5th ed.: jaypee publication 2017, Chapter 25.p .969