RAJIV GANDHI UNIVERSITY OF HEALH SCIENCES,

KARNATAKA, BANGALORE.

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION IN

M.S (AYURVEDA)

“EVALUATION OF EFFICACY OF KADALI KANDA PRATISARANIYA KSHARA IN THE MANAGEMENT OF RAKTHARSHAS”

DR.ARUN.S. R

1st year P.G Scholar,

Dept.of P.G Studies in ShalyaTantra,

Alva’s AyurvedaMedicalCollege,

Moodbidri,D.K(Dist),

Karnataka.

Guide Co-Guide

DR.RAVISHANKAR. A. G M S (AYU) DR.SUKESH.A, M. S (AYU)

PROFESSOR LECTURER

Dept.of P.G Studies in ShalyaTantra, Dept of P.G Studies in ShalyaTantra,

Alva’s Ayurveda Medical College, Alva’s Ayurveda Medical College,

Moodbidri, D.K Moodbidri, D.K

______

2012-2013

Alva’s Ayurveda MedicalCollege,

Moodbidri,D.K(Dist),

Karnataka

From,

Dr. ARUN.S.R,

1st year P.G Scholar,

Dept.of P.G Studies in ShalyaTantra,

Alva’s AyurvedaMedicalCollege,

Moodbidri, D.K (Dist)

Karnataka

To,

The Registrar,

RajivGandhiUniversity of Health Sciences,

Karnataka, Bangalore.

Through,

The Principal,

Alva’s AyurvedaMedicalCollege,

Moodbidri, D.K (Dist),

Karnataka

Sub: Submission of completed Proforma for registration of subject for Dissertation in M.S(Ay).

Respected sir,

I request you to kindly register the below mentioned subject against my name for the submission of dissertation to the Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore in partial fulfillment of M.S(Ay) in ShalyaTantra.

Title of Dissertation

“EVALUATION OF EFFICACY OF KADALI KANDA PRATISARANIYA KSHARA IN THE MANAGEMENT OF RAKTHARSHAS ”

I am here with enclosing completed proforma for the registration of subject for the dissertation in M.S (Ay)

Thanking you,

Place- Moodbidri yours faithfully

Date - Dr. ARUN.S.R

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT--DISSERTATION IN M.S (AYURVEDA) SHALYA TANTRA

1. NAME OF THE CANDIDATE Dr.ARUN S.R,

AND ADDRESS: 1ST YEAR P.G SCHOLAR,

DEPT OF P.G STUDIES IN SHALYA TANTRA,

ALVA’S AYURVEDAMEDICALCOLLEGE,

MOODBIDRI, D.K (DIST),

KARNATAKA-574227

PERMANENT ADDRESS: DR.ARUN S.R

S/O S. RAMANAN

VISWABHARATHY,

KUDAPPANAKUNNU,

THIRUVANANTHAPURAM-43(DIST),

KERALA

2. NAME OF THE INSTITUTE: ALVA’S AYURVEDAMEDICALCOLLEGE,

MOODBIDRI,D.K.( DIST),

KARNATAKA- 574227

3. COURSE OF STUDY AND SUBJECT: M.S (AYURVEDA), SHALYA TANTRA

4. DATE OF ADMISSIONTO COURSE: 06-09- 2012

5. TITLE OF THE TOPIC:

“EVALUATION OF EFFICACY OF KADALI KANDA PRATISARANIYA KSHARA IN THE MANAGEMENT OF RAKTHARSHAS”

6. BRIEF RESUME OF THE INTENDED WORK

6.1  Need for the study

In Ayurvedic literature the disease Arshas comes under the sub heading Mahagada1. Arshas is the term derived from’Ris’dathu means, that which changes the normal proceedings or activities of the body like an enemy8. Arshas is a Mamsavikara which occurs in gudavali and significantly disturbs the day to day activities of the person. In modern science Arshas is compared with Hemorrhoids (piles).

Among all the diseases of GIT, hemorrhoids is the most common and troublesome disease. This disease is not life threatening but makes the life of the sufferer more miserable. Clinical evidences shows that so many people suffer from discomfort and pain associated with hemorrhoids, in which many one are symptom less. The reason being the part is always subjected to natural stress and strain. Present days food habits also add to the increase in the ratio of incidence. By looking into the history great saint Adhishankara was suffered from hemorrhoids. King Nepolian lost the ‘Battle of Waterlo’ because of his acute hemorrhoids.

In our classics we got sufficient description regarding etiology, pathology, symptomatology, types, management and prognosis of Arshas2, 3,4,5,6,7,8,9. Since Vedic period till today efforts have been made to combat the condition through different modalities, but not all of them have been uniformly successful.

Sushrutacharya explained 4 therapeutic measures for the management of Arshas, ie Bheshaja, Ksharakarma, Agnikarma, and Shastrakarma. Ksharakarma is indicated in Pitta and Rakthapradhana Arshas or Abhyathara type, which is Mrudu, Prasrutha, Avaghada, and Uchritha3,6. The effect of Ksharakarma is praised so much that it can replace Shastrakarma since it does the functions of Chedana, Bhedhana and Lekhana karma without the help of Shastra, further Kshara has got properties of Shodhana, Ropana, and Stambhana1, 4, 7

Today advanced techniques and surgical procedures have been innovated for the management of Hemorrhoids. The present therapeutic modalities like Sclerotherapy, Lasertherapy, Cryosurgery, Stapling method IRCT etc need big cost, sophisticated instruments. Even though these looks simple, further it has its own disadvantages and limitations. Many of them are not affordable to common people.

In such cases the alternative better choice is Ksharakarma. Practically it has proven its efficacy in reducing the postoperative pain and discomfort compared to Hemorrhoidectomy. It can be done in aged patients and even those who are unfit for surgery.

Sushruta mentioned 23 drugs, in which most are UshnaVeeryapradhana drugs from which one can prepare Pratisaraniya Kshara. In this study among the 23 drugs, Kadalikanda has been selected which is a SheetaVeeryapradhana dravya10,11 by which PratisaraniyaKshara1, 4, 7 is to be prepared. Clinical Efficacy and Potency of Kadalikanda Pratisaraniya Kshara in the management of Raktarshas is evaluated. Further the Potency and Efficacy are compared with Apamarga Pratisaraniya Kshara.

6.2 Review of Literature

The review of literature includes screening of classical and contemporary literatures, journals, and internet sources to collect sufficient data for the study.

Ø  Description of Arshas and Arsha Chikitsa in Ayurveda Classics2,3,5,6,8,9

Ø  Preparation of Kadalikanda and Apamarga Pratisaraneeya Kshara1,4,7

Ø  Description about Kshara and its properties and procedure of Kshara karma1,4

Ø  Rachana and Kriya shareera of Guda (Anatomy and physiology of rectum and anal canal)2,5,8,12,13

Ø  Description of Hemorrhoids and its management in Modern Science14,15

Previous works done

Ø  Dr.MutteppaPatil – Clinico-Comparative study of Apamargakshara and Yavaksharalepa in the management of arsha with special reference to 2nd and 3rd degree Haemorrhoids, Dept of shalyatantra TMAE Society’s Ayurveda Medical College, Sanklapur 2009-2010

Ø  Dr.Muraledhar – A Comparative study on the effect of Apamarga and Vasadipratisarineeyakshara on Arshas, Dept of ShalyaTantra, Sullia.

Ø  Dr.Syan V.L – Management of Arshas with Arkadi Lepa, Trivandrum 2000-2001

Ø  Dr.Kedar M.Nita- Aclinical evaluation of Haridradi Lepa in Arsha(Hemorrhoids), Nagpur Government College 2004-2005

Ø  Dr.Sudhakumari.V – Aclinical study on management of Arshas with Vyoshyadi Choorna (internally) and Shirishabeejadi Lepa, Hyderabad 2004-2005

Ø  Dr.Mini p- A Clinical Study on the Effect of Apamarga Kshara in the MANAGEMENT OF ARSHAS, Trivandrum 2002

6.2  Objectives of the Study

Ø  Analytic evaluation to find the pH of both Ksharas.

Ø  To evaluate the efficacy of Kshara Karma in the management of Raktharshas.

Ø  To compare the efficacy between two ksharas in which the drug used to prepare Pratisaraniya Ksharas are with opposite qualities, i.e. Kadalikanda (Sheetaveerya ) and Apamarga (Ushnaveerya )

6.4 Hypothesis

H0- Kadalikanda Pratisaraniya Kshara is not having any effect over Raktarshas

H2- Both Kadalikanda and Apamarga Pratisaraniya Ksharas are significant

H3-There is significant effect of Kadalikanda Pratisaraniya Kshara over Apamarga Pratisaraniya Kshara

H4- There is significant effect of Apamarga Pratisaraniya Kshara over Kadalikanda Pratisaraniya Kshara

7. Materials and Methods.

7.1 Source

Literary Source

All the classical Ayurvedic, Modern literature, and Contemporary texts including the websites about the disease and treatment will be reviewed and documented for the intended study.

Sample source

Patients attending OPD and IPD, Department of Shalya Tantra, Alva’s Ayurveda Medical college Hospital, Moodbidri are randomly selected.

Drug source

Raw drugs will be identified and collected and preparation of Pratisaraneeya Kshara will be done according to classical method in laboratory attached to the PG studies Bhaishajya Kalpana Department, Alva’s Ayurveda Medical College, Moodbidri.

7.2 Method of collection of data

A clinical study with minimum of 40 patients fulfilling the inclusion criteria will be randomly selected and assigned into two equal group A & B of 20 patients each.

A) Diagnostic criteria:

1.  Bleeding per rectum

2.  Mass per rectum

3.  Mucous discharge per rectum

4.  Itching in and around the anus

5.  Proctoscopic evaluation

v  Number and

v  Position of pile mass

B) Inclusion criteria

1.  Patients between the age group of 16-60 years.

2.  Patients irrespective of sex, religion, occupation, and socio economic status.

3.  Patients with clinical features of 2nd and 3rd degree hemorrhoids

4.  Patients who are suffering from classical features of Raktharshas like, Mrdu, Prasrutha, Avagada and Uchrita.

C) Exclusion criteria

1.  Hemorrhoids associated with Fissure in Ano, Fistula in Ano, Rectal prolapse, Stricture, Perianal Abscess, Malignancy and Polyps.

2.  1st degree and 4th degree Hemorrhoids.

3.  Patients less than age of 16 and more than age of 60 years

4.  Patients with systemic diseases like Diabetes Mellitus, Hypertension, Tuberculosis, Ulcerative Colitis, Chron’s Disease, Renal disorders, Cardiac Disorders, HIV, Carcinoma of Rectum, and Autoimmune diseases.

c) Procedure

Procedure for Group A and Group B

Materials Required- Kadalikanda and Apamarga Pratisaraniya Kshara, Eka chidra Arshoyantra(Normal proctoscope),Dvichidra Arshoyantra(Slit proctoscope), Nimbuswarasa, Madhuyashtyadi taila, Xylocane 2% local anesthetic injection, Anesthetic gel/lubricants, Syringe with needle, Sterile water, Cotton, Gauze, Spoon,Thermal cautery machine etc

Poorvakarma

Ø  Advice the patient to remain nil orally for at least 4 hours prior to the procedure

Ø  The perianal and perineal part is shaved and cleaned well.

Ø  Soap water enema should be given 2 hours prior to the procedure.

Ø  Pre-medications and suitable anesthesia (local/spinal) will be administered according to the need.

Pradhanakarma

The patient should be made to lie down in lithotomy position. The anus and surrounding parts should be cleaned with aseptic solutions. Lubricated Eka chidra Arshoyantra (Normal proctoscope) should be introduced into the analcanal number, position and condition of the pile mass should be noted and the proctoscope is removed. Then Dvichidra Arshoyantra (Slit prctoscope) is introduced in such a way that the hemorrhoidal mass should prolapse through the slit of the proctoscope. The skin adjacent to the pile mass should be pulled laterally with the Alley's forceps to get a better view of hemorrhoids. The surrounding area is to be covered with gauze to prevent spilling of Kshara on healthy mucosa of rectum and anal canal.

Now the hemorrhoidal mass should be gently scraped with the rough surface of the spoon. Then Pratisaraniya Kshara( For Group A Kadalikanda Pratisaraniya Kshara and for Group B Apamarga Pratisaraniya Kshara ) is applied on the pile mass, and the opening of the proctoscope is closed with the hand for about 100 matrakaala (approximately 1minutes) or till the colour of the pile mass turned to Purple black (Pakwa Jamboophala Varna). Now with the help of guaze, the kshara should be wiped from the pile mass. After that the mass should be washed with nimbuswarasa and sterile water respectively. If Pakwa Jamboophala varna not appears in first sitting the procedure should be repeated once again. Likewise the procedure should be performed to all existing pile masses

If any associated external hemorrhoids or skin tags are present they are removed by Agni karma simultaneously.

Thereafter the anal canal should be packed with Vartis soaked in Madhuyastyadi taila. Externally dry dressing should be applied.

Paschatkarma

Ø  The patient should maintain nil orally after the procedure according to the requirement.

Ø  Packing is to be removed after3 to 4 hours.

Ø  Hot water sitz bath will be given for 10-15 minutes twice daily.

Ø  10 ml of Madhuyastyaadi taila should administer per rectally twice daily/after and before defecation.

Ø  Tab Nimbadi Guggulu - one tablet thrice daily with water.

Ø  Tab Gandhaka Rasayana one tablet thrice daily with water

Ø  Tab Kamadugda with Mouktika one tablet thrice daily with water

Ø  Analgesics and antibiotics administered according to the requirement.

Ø  Hareetaki Choorna ½ tsf at night.

Ø  Pathya ahara and viharas should be followed

Interventions:

Ø  Study period: Total study period including observation period and follow up will be of 42 days

Ø  Observation period will be of 21 days and the patient will be advised to come once in 7 days.

Ø  Follow up period will be of 21days after observation period and the patient will be advised to come once in 7 days.

f) Assessment criteria

Effect of treatment will be assessed on the basis of gradation of both subjective and objective parameters before and after treatment.

Subjective parameters:

Ø  Bleeding per rectum

Ø  Mass per rectum

Ø  Blackish brown discharge per rectum

Ø  Pain

Ø  Itching

Objective parameters:

Ø  Proctoscopic Evaluation

A detailed per-forma will be prepared and assessment is done based on gradations given for the subjective and objective parameters and analyzed statistically.

7.3 Does the study require any investigations or interventions to be conducted on patients or humans or animals? If so, please describe briefly:

Yes, this study will be conducted clinically on human subjects and no animal experiments will be carried out.

Investigations

Ø  Hb%

Ø  CT

Ø  BT

Ø  RBS

Ø  TC,DC

Ø  Any other investigations done according to the need.

7.4  Has the ethical clearance been obtained from your institution in case of above statement?

Yes, ethical clearance been obtained from the ethical committee constituted in this institution.

7.5Assesment of response

Assessment of response will be done by applying possible statistical test to the observations obtained before and after treatment

8 List of references:

  1. AcharyaSushrutha, Sushruthasamhita with Nibandhasangraha Commentary of Dalhanacharya and NyayachandrikaPanchika of Gayadasa on Sutrasthana- chapter no-33rd pg no 144,11th chapter pg no edited by YadavjiTrikamji, 9th edition, Chaukamba Orientalia,Varanasi.
  1. AcharyaSushrutha, Sushruthasamhita with Nibandhasangraha Commentary of Dalhanacharya and NyayachandrikaPanchika of Gayadasa on Nidanasthana- chapter no 2, pg no 270 edited by YadavjiTrikamji, 9th edition, Chaukamba Orientalia,Varanasi.
  1. AcharyaSushrutha, Sushruthasamhita with Nibandhasangraha Commentary of Dalhanacharya and NyayachandrikaPanchika of Gayadasa on Chiktsasthana- 6th chapter pg no 430 edited by YadavjiTrikamji, 9th edition, Chaukamba Orientalia,Varanasi.
  1. AcharyaSusrutha, Susrutha Samhita with English translation of text and Dalhana’s commentary on Sutrasthana- volume 1 chapter no 11th pg no 113,, edited by Priya Vrat Sharma, reprint year 2010, Chaukhamba ViswabharathiOriental publishes and Distributors Varanasi.
  1. AcharyaSusrutha, Susrutha Samhita with English translation of text and Dalhana’s commentary on Nidanasthna volume- 2 chapter no 7th, pg no 19 edited by Priya Vrat Sharma, reprint year 2010, Chaukhamba ViswabharathiOriental publishes and Distributors Varanasi.
  1. AcharyaSusrutha, Susrutha Samhita with English translation of text and Dalhana’s commentary on Chiktsasthana volume-2 chapter no 6, pg no-328 edited by Priya Vrat Sharma, reprint year 2010, Chaukhamba ViswabharathiOriental publishes and Distributors Varanasi.
  1. Acharaya Vaghbada, Ashtanga Hrdayam English translation by professor K.R Srikantha Murthy Sutrsthana- 30th chapter pg no-343, reprint year 2010, Chowkhamba press, Varanasi.
  1. Acharaya Vaghbada, Ashtanga Hrdayam English translation by professor K.R Srikantha Murthy Nidanasthana- 7th chapter pg no 66, reprint 2010, Chowkhamba press, Varanasi.
  1. Acharaya Vaghbada, Ashtanga Hrdayam English translation by professor K.R Srikantha Murthy Chikitsa sthana-8th chapter pg no-306, reprint 2010, Chowkhamba press, Varanasi.
  1. Dr.J L N Sastry, Dravya Guna Vijnana, Volume-2, page no-443,985, 3rd edition 2008, Chaukhambha Orientalia, Varanasi.
  1. Dr.Gyanendra Pandey, Dravya Guna Vijnana-Materia Medica, volume-2, page no-3 to 11, reprint 2004, Chowkhambha Krishna Das Academy- Varanasi
  1. Late Dr B D Chaurasia’s Human Anatomy volume-2, Lower Limb, Abdomen and Pelvis, 4th edition CBS publishers and distributors.
  1. John E.Hall, Arthur C.Guyton, Guyton And Hall Text Book of Medical Physiology, 12th edition, Published by Elsevier- Philadelphia
  1. Dr Somen Das, A Concise Text Book of Surgery,6th edition published by Dr S Das- Kolkata
  1. Bailey and Love’s Short Practice of Surgery edited by RCG-Russell, Norman S Williams and Christopher J.K Bulstrode -24th edition International Students Edition,

9. Signature of the candidate: