MANAGEMENT OF PILES WITH ORAL AYURVEDIC MEDICINE

Phase 2/3

Completed

Conditions: Second degree hemorrhoids. Ayurveda Condition: ARSAH,

Registration Number: CTRI/2021/09/036575

Lead Sponsor: KAHER Shri B M K Ayurveda Mahavidyalaya

Brief Summary: **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 affects*Agni* 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* mentioned*Bhaisaja 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*, *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 (1stand 2nd degree) *Gudabhaya* isselected for the study.

REVIEWOF LITERATURE:The word â€œHaemorrhoidsâ€ is derived from Greek wordHaima (bleed) + Rhoos (flowing), means bleeding. The pile is derived from theLatin word â€žPillaâ€Ÿ 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 *Arsha*or 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 Chikitsa*12 in early stageof *arsha* and later *kshara, shastra and agni karma* are explained.

Gudarsha13is best correlated with Haemorrhoids. The reference of *Gudabhaya*is taken from *Bhaishajya*Ratnawali6.

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:Â«To study the efficacy of *Gudabhaya*in *Arsha* W.S.R 1st and2nd degree haemorrhoids.

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

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

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

  HYPOTHESIS**H****0****:**

*Gudabhaya*isnot effective inthe management of *Arsha* W.S.R 1stand 2nd degree

haemorrhoids.

**H****1****:**

*Gudabhaya*is effective in the management of*Arsha* 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?

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

DRUG PROCUREMENT:â€¢         *Abhaya* and *Guda* powder will be procured from GMPcertified KLE Ayurveda Pharmacy, Khasbag, Belagavi.

â€¢         *Abhaya* powder will be preparedat GMP certified KLE AyurvedaPharmacy, Khasbag, Belagavi.

â€¢         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:â€¢         *Gudabhaya*6 (Trial drug)

â€¢         *ArshakutharaRasa* 16(Control drug)

ANALYTICAL STUDY:â€¢         Authentication of raw drugs will be done by experts,in the AYUSH Approved drug testing laboratory CRF, KAHERâ€™s Shri B.M.K AyurvedaMahavidyalaya, Shahapur, Belagavi.

â€¢         Analytical study of finished product will be carriedout in the AYUSH Approved drugtesting laboratory, CRF, KAHERâ€™s Shri B.M.K Ayurveda Mahavidyalaya, Shahapur,Belagavi.

PREPARATION:Method of Preparation of *Gudabhaya*

1.   Ingredients1. *Abhaya Choorna*â€“ 1 part

2. *Guda* â€“2 parts

***2.*** **Preparation of *Gudabhaya***

â€¢           One part of dry fruit of *Abhaya* (*Haritaki*) is taken and made into fine powder

â€¢           The fine powder will be sieved.

â€¢           All particles should pass through sieve with a nominal mesh aperture of180 micrometre.

â€¢           Two parts of procured *Guda* powderis taken and pounded well.

â€¢           One part ofsieved *Abhaya* (*Haritaki*) powder and two parts of *guda* powder is mixed thoroughly.

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

â€¢           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 **â€“** Interventional

INTERVENTIONAL DRUG **â€“** *Gudabhaya*

STUDY DESIGN â€“ Randomized Controlled Clinical Trial

MASKING - Open label

CONTROL **-** Standard

SAMPLE SIZE **â€“** 30

Patient will be selected bycomputerized block randomization method

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

Patient selected byRandomization chart â€“

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 *Gudabhaya*in 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** â€“Preparation of drug done as per SOP17, in KLEAyurveda Pharmacy, Belagavi.

ASSESSMENT CRITERIAAssessment will be done beforetreatment and after treatment

Â« Subjective Parameters:1) Constipation

Â« 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             1â€“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 (<10â€¯gm/dL); requiring hematinics.

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

level (<7â€¯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

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

2.                        Gandagi N. ,PatilS.,The Medical Management of *Arsha* with *Chirabilwadi Quatha* and

*Kaseesadi Thaila Sthanika Abhyanga*, 2015 Vol6 No 2 ISSN:0976- 5921 <https://doi.org/10.47552/ijam.v6i2.574>

3.                        Bhat S. SRB’s.Manual of surgery ,5th ed.: jaypee publication2017.Chapter 25, p .971.

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

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

6.                        Mishra S, *BhaishajaRatnavali*,Sidhi prada Hindivyakhyan Chapter 9,Verse 23, ChaukambaSurabharti prakashan ,Varanasi.2014; 311

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

8.                        Dvivedi BKand goswami p editor; *Charak Samhita* editedwith *Ayurveda tattvasandipika*,*Chikitsa Sthana*, *ChikitsitamAdhyaya*, Chapter 14, Verse 147, Chaukambha krishandasacademy Sanskrit , Varanasi Reprint 2016.

9.                  TrikamjiJ,editor, ( ed. reprint ). *SushrutaSamhita* of *SushrutaNidanasthana*;;*Arshasamnidanam*: Chapter 2,.Varansi:Chaukhamba Sanskrit Sansthan,, 2019;

10.             UpadhyayaV, (ed. reprint) *Astanga Hruday* of *Vagbhata, Nidanasthana*; *Arsha Nidana Adhyaya*: Chapter 7.Varanasi: ChaukhambhaSurbhartiPrakashan, 2019

11.                   Trikamji J,editor, (ed. reprint). *Sushruta Samhita* of *Sushruta*,*Sutra sthana*; *AvaraniyamAdhyaya*: Chapter 33, Verse 4. Varansi: ChaukhambaSanskrit Sansthan,, 2019;144.

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

13.                   .Dvivedi BK and goswami p (ed. Reprint); *Charak Samhita* edited with Ayurvedatattvasandipika,*Chikitsa Sthana*, *ChikitsitamAdhyaya,* Chapter 14, Verse 6,Chaukambha krishandas academy Sanskrit , Varanasi 2016. P.470.

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

, belagavi,2018 -19.

15.             Shankar S -et al 2018 evaluate â€œA Clinical Study of *Bhallatakadimodaka* in the Management of *Pittaja Arsha*(Haemorrhoids) â€˜SDM hassanâ€™,2018-19.

16.                   Mishra S edi. ,Bhaishaja Ratnavali,Sidhi prada HindivyakhyanChapter 9,Verse 238, Chaukamba Surabharti prakashan ,Varanasi.2014; 330

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-Bleedâ€ classification and Hemorrhoid SeverityScore, Journal of Coloproctology, jcoloproctol (rio j). 2 0 2 0;40(4):398â€“4[03](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423) [https://jcol.elsevier.es/en](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[-](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[pnr](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[bleed](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[-](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[classification](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[-](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[hemorrhoid](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[-](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[severity](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[-](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[scorea](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[-](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[articulo](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[-](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)[S2237936320300423](https://jcol.elsevier.es/en-pnr-bleed-classification-hemorrhoid-severity-scorea-articulo-S2237936320300423)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1 Patients with Arsha or haemorrhoids 1st and 2nd degree.

Exclusion Criteria

1 Thrombosed Haemorrhoids Prolapsed Haemorrhoids 2 Haemorrhoids occurs with known secondary cause such as portal HTN liver cirrhosis etc 3 History of known case of Systemic Illness like Carcinoma of Rectum Inflammatory Bowel Diseases DM HIV I & II HbsAg.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Constipation	Baseline \| 7th day \| 15th day
2 Bleeding per anus	Baseline \| 7th day \| 15th day
3 Number of pile mass	Baseline \| 7th day \| 15th day
4 Degree of hemorrhoidal prolapse	Baseline \| 7th day \| 15th day

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): KAHERs Shri B M K Ayurveda Mahavidyalaya and Hospital
🇮🇳
Belgaum, KARNATAKA, India
KAHERs Shri B M K Ayurveda Mahavidyalaya and Hospital
🇮🇳Belgaum, KARNATAKA, India
Dr Hitesh dagar
Principal investigator
8447119161
hiteshdagar2019@gmail.com