Dr. Bheemgopal. S

From,

DR.BHEEMGOPAL.S.

Department post graduate studies in Panchakarma,

Shree Shivayogeeshwar Rural Ayurvedic Medical College and Hospital,

Inchal-591121

Tq-Saundatti Dist- Belgaum
To,

The Registrar,

Rajiv Gandhi University of Health Sciences,

Bangalore.
Through,

The Principal and H.O.D of Panchakarma

Shree Shivayogeeshwar Rural Ayurvedic Medical College and Hospital

Inchal-591121

Tq-Saundatti Dist- Belgaum

Respected Sir,
Sub:- Submission of completed proforma for registration of subject for dissertation.
I request you to kindly register the below mentioned subject against my name for submission of dissertation to Rajiv Gandhi University of Health Sciences, Bangalore for the partial fulfillment of M.D.(Ayu) in Panchakarma.
Title of Dissertation
“THE ROLE OF PICCHA BASTI WITH SHRIPHALADI KALKA IN THE MANAGEMENT OF GRAHANI W.S.R TO IRRITABLE BOWEL SYNDROME (IBS)”.
Here I am enclosing completed proforma for registration of subject for dissertation.

Thanking you

Yours Faithfully
Place: INCHAL (DR.BHEEMGOPAL.S)

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

ANEXURE- II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION.

1. NAME OF THE CANDIDATE : DR.BHEEMGOPAL. I. S.

AND ADDRESS C/O. H. N. SHANABHOGAR

POST: KUNIKERA

KUNIKERA

KOPPAL-583232

KARNATAKA.

2. NAME OF THE INSTITUTION : SHRI SHIVAYOGESHWARA RURAL

AYURVEDIC MEDICAL COLLEGE

AND HOSPITAL, INCHAL-591102

DIST - BELGAUM.

3. COURSE OF THE STUDY : AYURVEDA VACHASPATI.

SUBJECT : M.D. (AYU) PANCHAKARMA.
4. DATE OF ADMISSION : DECEMBER 2012
5. TITLE OF THE TOPIC :
“THE ROLE OF PICCHA BASTI WITH SHRIPHALADI KALKA IN THE MANAGEMENT OF GRAHANI W.S.R TO IRRITABLE BOWEL SYNDROME (IBS)”.
6. BRIEF RESUME OF THE INTENDED WORK :

6.1 NEED FOR THE STUDY

Ayurveda is science of life, which is more concerned with the maintainance and promotion of positive health as well as curing the diseases. Ayurveda defines health as status where all Dosha , Dhatu, Mala & Agni are in equilibrium state , Malakriya is in Sama Avasta, Atma, Indriya and Manah are in Prasanna Avasta. In the current mechanized life, health of an individual is directly related to life style. The changes in the food, habitat, stress and strain are the main culprits in the causation of various diseases.

All diseases are due to Mandagni. Qualities of Agni and Pitta are similar. Sushruta considers Pittadhara Kala as Grahani, which is located between Amashaya and Pakwasaya. Sushruta mentioned Grahani as seat of Pachaka Pitta, which receives and retains food substances. The relation between Grahani and Agni is reciprocal and interdependent, thus Adharadheya Bhava is present. Grahani, Arsha , Atisara and Pravahika manifests mainly due to the improper Agni and related Dosha-Dusya dusti.

Grahani is tridoshatmaka disorder of digestive system occurs due to vitiation of Pachakapitta, Samanvayu, Apanavayu, Kledaka Kapha. In Grahani , Agni and Vata Dosha decide the course. The functional dependency between normal Vata and Agni is altered to a significant level. Samanya laxana of Grahani includes abdominal pain, passage of foul smelling semisolid or liquid stools, evacuation of mucous stools after taking meals, painful defecation, acidic eructation and others include Arochaka , Hasta- Pada Shotha, Karsya & Dourbalya etc.

Irritable bowel syndrome (IBS) or spastic colon is a functional bowel disorder charecterised by abdominal pain and altered bowel habit which may be in the form of altered stool frequency (diarrhea or constipation) or altered stool form (thin, hard, firm or soft). Symptoms that are commonly associated with IBS include passage of mucus, sense of incomplete evacuation of bowel, relief of pain after defecation and abdominal bloating. Psychological stress exacerbates gastro-intestinal distress in patients with IBS to a great degree than in the normal population.

IBS is affected to 3-20 percent of the population. Statistics reports says Incidence of IBS is 100 to 200 new cases per year 1 lack persons. Population based studies suggest that the prevalence of IBS is 10% to 15% , but only a portion of those affected seek medical care. IBS is the most common reason for referral to a Gastroenterologist, accounting for 20% to 50% of referred patients. IBS presentation is most common between 30 to 50 year of age, common in adolescent group. Presentation in old age is rare. Women are most commonly affected, ratio is 2:1.Demography report says IBS is more common in families.

Symptomatic treatment for Diarrhea or Constipation combined with antidepressant therapy forms the mainstay or treatment for most patients with mild to moderate disease. Patients with severe or refractory disease may benefit from the addition of newer agents designed to modify neurotransmitter pathways, such as the serotonin pathway. It needs multi component treatment for better result. Treatment is symptomatic; there is no cure.

The treatment line of Grahani is similar to Ajirna and Atisara Chikitsa. Treatment principles include Deepana- Pachana Choorna, Snehana, Svedana, Niruha,Virechana and Anuvasana, Sura-Asava-Takraprayoga etc.

As Grahani is a chronic condition, disease of Annavaha and Pureeshvaha srotas, its adhistana is Pittadhara Kala and Grahani, Dharuna Svabhava and Kastasadhya Vyadhi, Basti is choosen for treatment. Basti is designated as Ardha or Sampoorna chikitsa of all disorders. Piccha Basti is indicated in Jeerna Atisara avasta and Jeerna Grahani by Charaka and Vagbhat. Piccha Basti is a kind of Niruha Basti. Characteristics of Nirooha include those which eradicates vitiated Dosha from body, increases strength of body and has Achintya sakti. It stabilizes the normal function of Dosha, Dhatu, Mala. So it is planned to undertake Piccha Basti to evaluate its role in the management of Grahani (IBS).

The present study is intended to evaluate the role of Piccha Basti individually and combinely with Shriphaladi Kalka in the management of Grahani w.s.r to Irritable Bowel Syndrome

6.2. REVIEW OF LITERATURE :

1. 
   Explanation of Grahani^1,2,3.
   
2. 
   Explanation of Irritable Bowel Syndrome^4,5,6
   
3. 
   Piccha Basti⁷.
   
4. 
   Ksheera shatphala Ghrita⁸.
   
5. 
   Shriphaladi Kalka⁹.
   

PREVIOUS WORKS DONE ON GRAHANI ROGA :

1. 
   Venkateshwaralu. E. - Clinical study on the effect of Changeri Ghrita in Grahani -Dr.B.R.K.R.G.A.College Vijayawada (2004).
   
2. 
   Raksha.N.Mer – Clinical study on Manasikabhava in IBS and its management with Kutajadi Avalehya and Medhya Rasayana, GAU, Jamnagar(2006).
   
3. 
   Satish. G.I – A controlled clinical study to evaluate the effect of Bilvadi Ghrita Matra Basti in the management of Grahani, RGUHS, Banglore (2005).
   
4. 
   Ranjani . K.Rajan – A clinical study to evaluate the combined effect of Mustakarista and Mahakalyanaka Kashaya in Grahani w.s.r to IBS associate with stress, RGUHS, Banglore(2008).
   
5. 
   Dr.Belvadi Santosh Neelappa – A controlled clinical study on the role of Takra Basti in Vataja Grahani, Dept of Kayachikitsa, GAMC, Mysore 2001
   

6.3 OBJECTIVES OF STUDY :

1. 
   To study Grahani according to Ayurvedic text and Irritable Bowel Syndrome in modern medicine indetail.
   
2. 
   To assess the role of Piccha basti alone in the management of Grahani (IBS).
   
3. 
   To assess the role of Piccha basti along with Shriphaladi Kalka in the management of Grahani (IBS).
   
4. 
   To compare the study of both in the management of Grahani (IBS).
   

HYPOTHESIS.

1. 
   Null hypothesis – The treatment design is not effective in management of IBS.
   
2. 
   Research hypothesis - The treatment design is effective in the management of IBS.
   

7. MATERIALS AND METHODS :

1. 
   SOURCE OF DATA.
   

In the present study the research scholar proposes to take the patients attending the OPD & IPD of Shri Shivayogeeshwar Rural Ayurvedic Medical College & Hospital,INCHAL and other associated hospitals

7.2 METHODS OF COLLECTION OF DATA :

1. 
   Clinical data - A clinical survey of the patients attending the OPD & IPD of Shri Shivayogeeshwar Rural Ayurvedic Medical College & Hospital,INCHAL and other associated hospitals, will be made and patients fulfilling the criteria of diagnosis as per the proforma will be selected for the study.
   
2. 
   Literary data - Review of literature will be collected from the library of Post Graduation Department of Shri Shivayogeeshwar Rural Ayurvedic Medical College & Hospital, INCHAL and from authentic research journals, websites and digital publications etc.
   
3. 
   Drug resource – The drug required for the clinical study will be procured and prepared in the Department of Rasa shastra and Baisajya kalpana Shri Shivayogeeshwar Rural Ayurvedic Medical College & Hospital, INCHAL.
   
4. 
   The data which are obtained by clinical trail will be statistically analysed by applying student ‘t’ test and other relevant statistical tests of significance.
   

5. 
   Ingradients of Trial medicine:
   

Piccha basti dravya : Kshirapakarth Dravya-Yavasa mula,Kusha mula,Kashamula,Shalmali Pushpa , Nyagrodha Srunga, Udumbara Srunga, Asvatta Srunga , Jala, Kalka of- Salmali niryasa,Samanga, Utpala, Vatsaka Bija,priyangu, padmakesara, Ghrita, Madhu, Sarkara.

Kshira shatphala ghrita : Pippali, Pippali mula, Chavya, Chitraka, Nagara, Yava kshara, Ghrita.

Shriphaladi Kalka : Shriphala shalatu kalka, Nagar churna, Guda

INCLUSION CRITERIA:

1. 
   subjects with clinical features of IBS and classical laxana of Grahani
   
2. 
   Subjects of either sex between age group 30-60 year.
   
3. 
   Subjects fit for Basti karma.
   

EXCLUSION CRITERIA:

1. 
   Subjects age group below 30 and above 60 year of either sex
   
2. 
   Subjects unfit for Basti karma.
   
3. 
   Subjects presenting with IBS which includes crohn’s disease and ulcerative colitis, acute conditions like cholera, gastro-enterites.
   
4. 
   Subjects with uncontrolled metabolic disorders and other systemic disorders.
   
5. 
   Pregnency and lactating mothers.
   

DIAGNOSTIC CRITERIA:

• 
  Diagnosis is by clinical criteria (Manning criteria or Rome III criteria) along with cost effective exclusion of organic disease. Symptoms must have been present for atleast for 3 days per month in the last 3 month, with symptoms onset at least 6 month before diagnosis.
  
• 
  Muhur badda muhur drava mala pravritti.
  
• 
  Ama mala pravritti.
  

PARAMETERS OF STUDY :

SUBJECTIVE PARAMETERS :

• 
  Abdominal pain (udara shool)
  
• 
  Abdominal distension (adhmana)
  
• 
  Increased frequency of stool (muhur muhur mala pravritti)
  
• 
  Feeling of incomplete evacuation (krite api akrite asamgyah)
  
• 
  Postprandial urgency in defecation
  
• 
  Passing stool after meal.
  

OBJECTIVE PARAMETERS :

• 
  Consistency of stool
  
• 
  Mucous in stool.
  

STUDY DESIGN : open clinical trial.

SAMPLE SIZE: A minimum of 30 patients will be selected incidentally and randomly categorized into 2 group, each group of 15 patients.

GROUP - A :

• 
  Amapachana will be done until Nirama lakshanas are seen.
  
• 
  Piccha Basti in Yoga Basti schedule
  
• 
  8 days of procedure follows 16 day of Parihara Kala. Shriphaladi Kalka is given orally 32 days including Parihara Kala.
  

GROUP - B :

• 
  Amapachana will be done until Nirama lakshanas are seen.
  
• 
  Pichha basti in Yoga Basti schedule
  
• 
  8 days of procedure follows 16 days of Parihara Kala.
  

Total duration of treatment: 24 day follow up : 32 days.

CRITERIA FOR ASSESSMENT:

The criteria for assessment were done based on the improvement shown in the modified “GASTRO- INTESTINAL SYMPTOM RATING SCALE(GSRS)”.

ASSESSMENT CRITERIA:

The score thus obtained before and after the treatment was statistically analyzed. The overall improvement was recorded after the completion of the treatment as;

• 
  Marked relief: 75% & above improvement
  
• 
  Moderate relief : 50% - 74% improvement
  
• 
  Mild relief : 25%-49%iprovement
  
• 
  No relief : below 25% improvement.
  

7.3 Does the study require any investigations or interventions to be conducted on

patients or other humans or animals ? if so please describe briefly.

YES

INVESTIGATIONS :

Screening studies to rule out disorders other than irritable bowel syndrome include the following because IBS is in part a diagnosis of exclusion. Others may be required depending on the specific presenting symptoms.

Recommended for all patients ;

• 
  Complete blood count - to screen for anaemia, inflammation , infection
  
• 
  Stool microscopy and culture - to screen for entric pathogens, amoebiasis and other infectious conditions.
  
• 
  Abdominal ultrasound scanning and Proctoscopic examination – if necessary.
  
• 
  Other tests – if necessary.
  

INTERVENTION CHART:

GROUP - A : Amapachana with Suntyadi Choorna

Dosage : 500 mg twice daily before food with Ushna Jala.

Duration : Till Niraamalakshana are seen.

Sthanika Abhyanga with Murchita Tila Taila & Sthanika Swedana

Basti : Piccha basti in Yoga Basti schedule

Dosage : 12 pala i.e approximately 720 ml.

Duration : 8 days

Parihara kala : 16 days

Total duration : 24 days.

Follow up : 32 days ( each visit at an interval of 8 days) with administration of ShriphaladiKalka orally along with Takra Anupana twice daily after food.

GROUP- B : Amapachana with Suntyadi Choorna

Dosage : 500 mg twice daily before food with Usna Jala.

Duration : Till Niraama lakshana are seen

Sthanika Abhyanga with Murchita Tila Taila & Sthanika Swedana

Basti : Piccha basti in Yoga Basti schedule

Dosage : 12 pala i.e approximately 720 ml.

Duration : 8 days

Parihara : 16 days

Total duration : 24 days

Follow up : 32 days ( each visit at an interval of 8 day) without shamanaushadi administration

7.4 Has the ethical clearance been obtained from your institution in case of 7.3

YES

Ethical clearance has been obtained by the ethical committee constituted by Shri Shivayogeeshwar Rural Ayurvedic Medical College & Hospital, INCHAL and written consent will be taken by each individual patient or by an attendant if the patient is illiterate, on a printed consent form.

8. LIST OF REFERANCES:

1. 
   Agnivesha, Charaka Samhita , Sanskrit Commentary by Chakrapani,edited by Yadavaji Trikamji Acharya, Chaukhamba Surbharti Prakashan, Varanasi, 2011, 511-525pp.
   
2. 
   Sushruta,Sushruta Samhita ,sanskrit Commentary by sri Dalhanacharya edited by Yadavaji Trikamji Acharya , Chaukhamba Prakashana,Varanasi 2011, 709-710pp.
   
3. 
   Vagbhata, Ashtanga Hridaya, Sanskrit Commentary by Arundatta, edited by Pt Hari Sadasiva Sastri Paradakara, Chaukamba Surbharati Prakashan, Varanasi,2010,665-672pp.
   
4. 
   Harrison’s Principles of medicine, edited by Eugene Braunwald, Anthony S.Faudi, Dennis L.Kasper, Stephen L.Hauser, Dan L.Longo, J.Larry Jameson,Mc Graw-Hill publications, 16^th edition,volume II, page-1789.
   
5. 
   ASPI F.Golwalla & Sharukh A Golwalla, Medicine for students, Publication The National book Depot, Mumbai, 22^nd edition,2008, 36-37pp.
   
6. 
   Website - www.wikipedia.org/wiki/irritable_bowel_syndrome. Date-25.08.2013
   

- www.digestive.niddk.nih.gov/IBS. Date-25.08.2013

- www.clinicalkey.com/Gastroentrology/IBS.html. Date-25.08.2013.

7. 
   Agnivesh, Charaka samhita, with Ayurveda Deepika Teeka of Chakrapanidatta, edited by Vaidya Yadavji Trikamji Acharya, Hindi vyakya, chaukambha Sanskrit samsthan, 4^th edition , Chikitsa Sthana adhyaya 14^th /224-229, page –510.
   
8. 
   Agnivesh, Charaka Samhita, with Ayurveda Deepika Teeka of Chakrapanidatta, edited by Vaidya Yadavji Trikamji Acharya, Hindi vyakya, chaukambha Sanskrit samsthan, 4^th edition , Chikitsa Sthana adhyaya 5^th /147-148, page –443.
   
9. 
   Chakradatta of Chakrapanidatta, hindi comentary by Dr Indradev Tripati, edited by Acharya Ramanath Dvivedi, Chaukamba publications ,Varanasi,2011, 4^thchapter/11^th sloka, Page- 46.
   

09. Signature of Candidate :

(Dr. Bheemgopal.S.)

10. Remarks or the guide :

11. Name and Designation :

11.1 Guide : DR. G.S.HADIMANI._{M.D (AYU)}

Reader, Dept. of Panchakarma

SSRAMC and Hospital, Inchal-591121

11.2 Signature :

11.3 Co-Guide : DR. KIRAN M. KHOT, _{M.D (AYU)}

Reader, Dept. of Panchakarma

SSRAMC and Hospital, Inchal-591121

11.4 Signature :

11.5 Head of the Department : Dr. D. JAYAPRAKASH, _{M.D. (AYU)}

Professor and HOD Dept. of Panchakarama

SSRAMC and Hospital, Inchal-591121

11.6 Signature :

12. Remarks of Chairman

and Principal :

12.1 Signature and Seal :

Principal/CMO

(Dr. G. VINAY MOHAN)