Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka s36

[A] VI. BRIEF RESUME OF THE INTENDED WORK:

6.1 Need for the study: The various clinical manifestations of urinary system are categorized into obstructive and non-obstructive pathologies in Ayurveda. The obstructive urinary conditions are described under the heading Mootraghata. Mootraghata, a clinical entity predominated by the symptoms of “AGHATA” (either suppression or obstruction) to the out-flow of urine mainly due to vitiated “VAYU’. Sushruta describes twelve clinical manifestations causing obstruction or retention of urine. Asteela is one amongst twelve types of Mootraghata. This condition is also referred as Mootrasteela or vatasteela.

In Mootrasteela, a swelling is manifested in between the Gudamarga and Basti which resembles the shape of Asteela. The swelling is painless and firm in character, causes obstruction to the flow of urine. The disease presentation reveals that there will be extra growth due to the abnormal functioning of vitiated Vata dosha. This condition resembles the disease Benign Prostatic Hyperplasia (BPH), as described in Modern medical science. Benign prostatic hyperplasia (BPH) is a most condition seen in the surgical practice. It is evident in one-half of men by age 50 and 80% of men by age 80. It is not a life threatening disease. But it is more trouble some and affects the quality of life. The prostate is walnut- sized gland found between the Bladder and the urethra. This gland in the elderly men starts enlarging in its size and causes pressure over the urethra leading to gradual obstruction to urine flow. BPH even though is a part of a men’s normal aging process can be prevented.

Currently available conventional treatment options for the management of BPH include medications and surgery. The adverse effects of the medical treatment include headache, dizziness, hypotension, fatigueness, reduced libido etc. The surgical procedure aims at removal of prostate gland partially or completely by different approaches. Due to advanced age of the patient and associated other diseases surgical intervention will have limitations. Surgical procedures will overcome the prostatic obstructive pathology but posse’s greater threat to life during surgery, as well as, the early and delayed surgical complications often makes life of the sufferer more miserable. So there is a constant effort for a search of a non surgical approach in the management of BPH. Ayurvedic formulations in the management of BPH have been tried in past and shown encouraging results. Considering the limitations of previous studies and to avoid difficult procedures like Basti and Uttarabasti, a new easier approach is being tried in this study. In Mootrasteela as there is extra growth of Dhatu due to vata vitiation the formulations like Kalyana kshara and Dashamooladi kwatha have been selected for the clinical trial. Kshara has the potent property of Ksharana i.e. scrapping of unhealthy tissue when used internally too. Dashamooladi Kwatha also possesses vata shamana property. So because of these properties and with the hypothesis that Kalyana kshara and Dashamooladi Kwath reverses the pathology of BPH, these drugs have been selected. In the present study an attempt is also made to compare the efficacy of these formulations separately and in combination. 6.2 Review of literature:

1. Nidana,Prakaar,Lakshan of Mootraghata & Mootrasteela as described in.1 2. Chikitsa of Mootraghata & Mootrasteela as described in 1,5 3. Description of BPH is described in.2,4 4. Kalyana kshara as described in.6 5. Dashamooladi Kwatha as described in.3

Previous work done:

1. Joshi (MS) J.H. “Role of Punarnavadi compound in the management of Mootraghata w.s.r. to BPH”. Jamnagar 1995. 2. Saxena pankaj kumar “Urodynamic studies on basti karma in the management of BPH”. Varanasi 1995. 3. Kembhavi A S - “Clinical evaluation of Kshara and Uttara-basti in the management of mootraghata”. jamnagar 1998 4. Jagadish P. “Effect of Basti karma in the management of Atoni of Bladder w.s.r. to BPH”. Varanasi 1999. 5. Soni AB “Role of mustadi kalpa in the management of Mootraghata w.s.r. to BPH”. Gujarat Ayurvedic University, Jamnagar 1999. 6. Sharma Rajnish “Role of Gokshuradi misharana in the management of Mootraghata w.s.r. to BPH”. Jamnagar 2000. 7. Kulkarni N.H. “A Clinical Study on the role of devadarvyadi kashaya and dashamoola siddha taila Uttara basti in the management of Mootraghata w.s.r. to BPH”. Jamnagar 2002. 8. katti pramod M- “Clinical Evalution of Basti and Shamana Oushadhi in the management of Benign Prostatic Hyperplasia” Ayurveda Mahavidyalaya, Rajiv Gandhi University of Health Sciences, Hubli 2004 9. Krishna Navneet K. “A clinical study on the efficacy of the chandraprabha vati in benign prostatic hyperplasia”, Rajiv Gandhi University of Health Sciences, Bangalore, 2004. 10. Jadhav Sachin A. “To Study the effect of Erandataila paana (Caster oil ingestion) on vatashtheela w.s.r. to Benign Prostatic hypertrophy (BPH)”. Nasik 2005. 6.3 Objectives of the study:

1. To review and analyze available literature of Mootraghata & Mootrasteela in Ayurvedic texts. 2. To review and analyze BPH in Modern medical science. 3. To evaluate the comparative efficacy of Kalyana Kshara and Dashamooladi Kwath in Mootrasteela. 4. To study the probable mode of action of Kalyana kshara and Dashamooladi Kwatha in the management of BPH.

[B] VII. Materials and methods :

7.1 Source of Data :

 Patients attending the OPD and IPD of Ayurveda Mahavidyalaya Hospital, Hubli.  Kalyana kshara and Dashamooladi kwatha will be prepared in the department of Rasa shastra, Ayurveda Mahavidyalaya Hubli.

7.2 Method of Collection of data :

 A clinical survey of the patients attending the Shalya Tantra OPD and IPD of Ayurveda Mahavidyalaya Hubli, diagnosed as Mootrasteela (BPH) and fulfilling the inclusion criteria will be selected.  Patients will be registered and recorded as per the specially designed clinical proforma.  Literary review will be done from the literature available from the library of Ayurveda Mahavidyalaya Hubli, as well as, from the Journals and recent research publications concerned to the present study.

Inclusion Criteria:  Subject with signs and symptoms of Mootrasteela (BPH).  Subject with age group between 40 to 80 years.  Subject with mild BPH as per the American Urological Association symptom score index.  USG of bladder suggestive of residual urine less than 100ml.  USG of prostate suggestive of increased size and weight. Exclusion Criteria :

 Subject with other causes of prostate and Bladder leading to difficulty in passing urine and/or retention of urine will be excluded.  Subject with severe specific or non specific urinary tract infection will be excluded.  Subject with severe cardio vascular, renal or hepatic disorders are excluded.  Subject with infective diseases like HIV and HBsAg will be excluded.  Subject with Uncontrolled systemic diseases like Diabetes mellitus and Hypertension are excluded.  Subject with USG findings suggestive of Hydroureteronephrosis are excluded.

Parameters of Study: Following subjective and objective parameters will be considered for the study.

Subjective: Clinical features of BPH recommended by the American Urological Association, as mentioned below, are taken as subjective parameters.

1. Incomplete emptying 2. Frequency. 3. Intermittency. 4. Urgency. 5. Weak stream. 6. Straining 7. Sleeping.

Symptoms score before and after treatment will be done as per the American Urological association symptom score scale.

Objective: Objective parameters include, . Digital Rectal Examination of the prostate. . USG abdomen-Prostate weight, size and post voidal residual urine. ASSESSMENT CRITERIA:

A. Criteria of assessment will be based on improvement in subjective and objective parameters. Subjective: Changes observed in the symptoms after the treatment and the results will be categorized as,

Marked relief -- Above 75% improvement. Moderate relief -- 50 to 75% improvement. Mild relief -- 25 to 50% improvement. No relief -- Below 25% improvement.

Objective:

Based on the USG findings of prostate before and after treatment the results will be categorized as,

Marked relief –- Above 75% Reduction in residual urine, size and weight of Prostate. Moderate relief -- 50 to 75% Reduction in residual urine, size and weight of prostate. Mild relief -- 25 to 50% Reduction in residual urine, size and weight of prostate. No relief -- Below 25% Reduction in residual urine, size and weight of Prostate.

B. Over all assessment is done based on the improvement in subjective and objective symptom score index before and after treatment which will be subjected to statistical analysis. Study design : Present study is a comparative clinical study. Sample size : Minimum of 30 patients will be selected randomly and categorized in to three groups as Group A, Group B, and Group C

Group A: Sample size : Minimum of 10 patients Procedure : Internally Drug : Kalyana kshara Dosage : 500mg mixed in 20ml of water TID Duration : 3 months

Group B:

Sample size : Minimum of 10 patients Procedure : Internally Drug : Dashamooladi kwatha Dosage : 20ml TID Duration : 3 months Group C:

Sample size : Minimum of 10 patients

Procedure : Internally Kalyana kshara & Dashamooladi kwatha Drug : Kalyana kshara Dosage : 500mg mixed in 20ml of water TID Drug : Dashamooladi kwatha Dosage : 20ml TID Duration : 3 months

Follow up : 3 months.

7.3 Does the study require any investigations or intervention to be conducted on patients or other human or animals? if so please describe briefly.

YES INVESTIGATIONS :

 USG Abdomen – To assess the size and weight of the prostate. To assess the residual urine in bladder and to look for Hydrouretronephrosis.

 Blood - Hb % RBS Blood urea Serum Creatinin – The raised level indicates renal failure. Urine flow rate measurement if necessary.

7.4 Has ethical clearance been obtained from your institution incase of 7.3

[C] VIII . LIST OF REFERENCES:

1. Sushruta, Sushruta samhita,with the Nibandha Sangraha commentary of sri Dalhana Acharya, Edited by Vaidya Yadavaji Trikumji Acharya, Chaukhambha Orientalia Publisher, Varanasi, 8th Edition 2005, Uttara Tantra Chapter 58, page no.786-789,Pp 824. 2. Bailey and love’s, short practice of surgery, Edited by charles v, mann, 22nd Edition 1995, chapmann and Hall, ELBS London, page no.971-979, Pp1041. 3. Yogaratnakar, with the Vaidyaprabha Hindi commentary Edited by Dr.Indradev Tripathi and Dr.Daya shankar Tripathi, Krishanadas academy, Varanasi, 1st Edition 1998, page no.513-514, Pp 896. 4. Somen Das,A Concise Text Book of Surgery, Published by Dr.S.Das Calcutta, 4th Edition 2006, page no.1257-1269, Pp1344. 5. Yogaratnakar,with the Vaidyaprabha Hindi commentary Edited by Dr.Indradev Tripathi and Dr.Daya shankar Tripathi,Krishanadas academy,Varanasi,1st Edition 1998,page no.516,Pp 896. 6. Sahasra yog ,Dr.Ramnivas Sharma and Dr.Surendra Sharama , Chaukhambha Sanskruta Pratishtan, Dehli 3 rd Edition 2002, page no,153,Pp318, IX Signature of the Candidate. X Remarks of the Guide : Trial will be conducted under my direct supervision. The Synopsis of dissertation forwarded for needful action. XI Name and Designation of (In Block Letter)

11.1 Guide : Dr. S.K. BANNIGOL M.D. (Ayu)

PROFESSOR AND HEAD DEPARTMENT OF POST GRADUATE STUDIES IN SHALYA TANTRA, AYURVEDA MAHAVIDYALAYA HUBLI – 580024.

11.2 Signature

11.3 Co-Guide : Dr. THYAGARAJA M.S. (Ayu)

LECTURER, DEPARTMENT OF POST GRADUATE STUDIES IN SHALYA TANTRA, AYURVEDA MAHAVIDYALAYA HUBLI –580024.

11.4 Signature

11.5 Head of Department. : Dr. S.K. BANNIGOL M.D. (Ayu)

PROFESSOR AND HEAD DEPARTMENT OF POST GRADUATE STUDIES IN SHALYA TANTRA, AYURVEDA MAHAVIDYALAYA HUBLI – 580024.

11.6 Signature

12 Remarks of the chairman and Principal: The synopsis is recommended for registration.

12.1 Signature : Dr. M.A.KUNDAGOL PRINCIPAL AYURVEDA MAYAVIDYALAYA, HUBLI 580024.